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: 2026-03-09
Results Overview
EFS was based on RECIST 1.1 as assessed by the investigator and was 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 were disease free after surgery); clinical progression as evidenced by peritoneal carcinomatosis confirmed by preoperative laparoscopy or laparotomy (for participants who were 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), were 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
2026-03-09
Participant Flow
Of the 1007 participants that were randomized to trial, 1001 received treatment.
Participant milestones
| Measure |
Placebo + FLOT Cohort
Neoadjuvant: Prior to surgery, participants received 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 received 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
XP=cisplatin+capecitabine and FP=cisplatin+5-fluorouracil. Neoadjuvant: Prior to surgery, participants received 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 received 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 received 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 received 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 received 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 received 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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
103
|
402
|
402
|
100
|
|
Overall Study
Treated
|
103
|
399
|
400
|
99
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
103
|
402
|
402
|
100
|
Reasons for withdrawal
| Measure |
Placebo + FLOT Cohort
Neoadjuvant: Prior to surgery, participants received 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 received 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
XP=cisplatin+capecitabine and FP=cisplatin+5-fluorouracil. Neoadjuvant: Prior to surgery, participants received 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 received 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 received 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 received 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 received 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 received 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.
|
|---|---|---|---|---|
|
Overall Study
Sponsor Decision
|
47
|
188
|
173
|
58
|
|
Overall Study
Withdrawal by Subject
|
3
|
12
|
6
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
9
|
1
|
1
|
|
Overall Study
Death
|
53
|
193
|
221
|
39
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants With Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-585/KEYNOTE-585)
Baseline characteristics by cohort
| Measure |
Pembrolizumab + XP/FP
n=402 Participants
XP=cisplatin+capecitabine and FP=cisplatin+5-fluorouracil. Neoadjuvant: Prior to surgery, participants received 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 received 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 received 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 received 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 received 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 received 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 received 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 received 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=68 Participants
|
221 Participants
n=69 Participants
|
58 Participants
n=137 Participants
|
64 Participants
n=565 Participants
|
550 Participants
n=127 Participants
|
|
Age, Customized
From 65 to 84 years
|
194 Participants
n=68 Participants
|
181 Participants
n=69 Participants
|
42 Participants
n=137 Participants
|
39 Participants
n=565 Participants
|
456 Participants
n=127 Participants
|
|
Age, Customized
85 years and older
|
1 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=137 Participants
|
0 Participants
n=565 Participants
|
1 Participants
n=127 Participants
|
|
Sex: Female, Male
Female
|
114 Participants
n=68 Participants
|
115 Participants
n=69 Participants
|
22 Participants
n=137 Participants
|
32 Participants
n=565 Participants
|
283 Participants
n=127 Participants
|
|
Sex: Female, Male
Male
|
288 Participants
n=68 Participants
|
287 Participants
n=69 Participants
|
78 Participants
n=137 Participants
|
71 Participants
n=565 Participants
|
724 Participants
n=127 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
44 Participants
n=68 Participants
|
54 Participants
n=69 Participants
|
11 Participants
n=137 Participants
|
9 Participants
n=565 Participants
|
118 Participants
n=127 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
333 Participants
n=68 Participants
|
323 Participants
n=69 Participants
|
89 Participants
n=137 Participants
|
94 Participants
n=565 Participants
|
839 Participants
n=127 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
25 Participants
n=68 Participants
|
25 Participants
n=69 Participants
|
0 Participants
n=137 Participants
|
0 Participants
n=565 Participants
|
50 Participants
n=127 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
1 Participants
n=137 Participants
|
0 Participants
n=565 Participants
|
1 Participants
n=127 Participants
|
|
Race (NIH/OMB)
Asian
|
194 Participants
n=68 Participants
|
193 Participants
n=69 Participants
|
4 Participants
n=137 Participants
|
4 Participants
n=565 Participants
|
395 Participants
n=127 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=137 Participants
|
0 Participants
n=565 Participants
|
0 Participants
n=127 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=68 Participants
|
5 Participants
n=69 Participants
|
1 Participants
n=137 Participants
|
2 Participants
n=565 Participants
|
11 Participants
n=127 Participants
|
|
Race (NIH/OMB)
White
|
178 Participants
n=68 Participants
|
174 Participants
n=69 Participants
|
92 Participants
n=137 Participants
|
97 Participants
n=565 Participants
|
541 Participants
n=127 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=68 Participants
|
7 Participants
n=69 Participants
|
2 Participants
n=137 Participants
|
0 Participants
n=565 Participants
|
14 Participants
n=127 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
22 Participants
n=68 Participants
|
23 Participants
n=69 Participants
|
0 Participants
n=137 Participants
|
0 Participants
n=565 Participants
|
45 Participants
n=127 Participants
|
|
Geographic Region
Asia
|
190 Participants
n=68 Participants
|
191 Participants
n=69 Participants
|
3 Participants
n=137 Participants
|
3 Participants
n=565 Participants
|
387 Participants
n=127 Participants
|
|
Geographic Region
US
|
3 Participants
n=68 Participants
|
6 Participants
n=69 Participants
|
9 Participants
n=137 Participants
|
7 Participants
n=565 Participants
|
25 Participants
n=127 Participants
|
|
Geographic Region
Western Europe
|
104 Participants
n=68 Participants
|
95 Participants
n=69 Participants
|
56 Participants
n=137 Participants
|
70 Participants
n=565 Participants
|
325 Participants
n=127 Participants
|
|
Geographic Region
ROW
|
105 Participants
n=68 Participants
|
110 Participants
n=69 Participants
|
32 Participants
n=137 Participants
|
23 Participants
n=565 Participants
|
270 Participants
n=127 Participants
|
|
Tumor Staging
Stage II
|
82 Participants
n=68 Participants
|
80 Participants
n=69 Participants
|
22 Participants
n=137 Participants
|
31 Participants
n=565 Participants
|
215 Participants
n=127 Participants
|
|
Tumor Staging
Stage III
|
302 Participants
n=68 Participants
|
306 Participants
n=69 Participants
|
74 Participants
n=137 Participants
|
66 Participants
n=565 Participants
|
748 Participants
n=127 Participants
|
|
Tumor Staging
Stage IVa
|
18 Participants
n=68 Participants
|
15 Participants
n=69 Participants
|
4 Participants
n=137 Participants
|
6 Participants
n=565 Participants
|
43 Participants
n=127 Participants
|
|
Tumor Staging
Missing
|
0 Participants
n=68 Participants
|
1 Participants
n=69 Participants
|
0 Participants
n=137 Participants
|
0 Participants
n=565 Participants
|
1 Participants
n=127 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 was based on RECIST 1.1 as assessed by the investigator and was 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 were disease free after surgery); clinical progression as evidenced by peritoneal carcinomatosis confirmed by preoperative laparoscopy or laparotomy (for participants who were 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), were 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 received 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 received 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 received 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 received 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 + XP/FP and Pembrolizumab + FLOT Cohort Combined
FLOT=docetaxel+oxaliplatin+5FU+leucovorin (calcium folinate). Neoadjuvant and adjuvant pembrolizumab+XP/FP and neoadjuvant and adjuvant pembrolizumab+FLOT Cohort treatment arms combined
|
Placebo + XP/FP and Placebo + FLOT Cohort Combined
Neoadjuvant and adjuvant placebo+XP/FP and neoadjuvant and adjuvant placebo+FLOT Cohort treatment arms combined
|
|---|---|---|---|---|
|
Event-free Survival (EFS) Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms
|
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 was defined as the percentage of participants having a pathCR based on central review. pathCR was defined as no invasive disease within an entirely submitted and evaluated gross lesion, and histologically negative nodes. The percentage of participants having pathCR was 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 received 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 received 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 received 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 received 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 + XP/FP and Pembrolizumab + FLOT Cohort Combined
FLOT=docetaxel+oxaliplatin+5FU+leucovorin (calcium folinate). Neoadjuvant and adjuvant pembrolizumab+XP/FP and neoadjuvant and adjuvant pembrolizumab+FLOT Cohort treatment arms combined
|
Placebo + XP/FP and Placebo + FLOT Cohort Combined
Neoadjuvant and adjuvant placebo+XP/FP and neoadjuvant and adjuvant placebo+FLOT Cohort treatment arms combined
|
|---|---|---|---|---|
|
Pathological Complete Response (pathCR) Rate - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms
|
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 was defined as the time from randomization to death due to any cause. OS was 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 received 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 received 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 received 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 received 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 + XP/FP and Pembrolizumab + FLOT Cohort Combined
FLOT=docetaxel+oxaliplatin+5FU+leucovorin (calcium folinate). Neoadjuvant and adjuvant pembrolizumab+XP/FP and neoadjuvant and adjuvant pembrolizumab+FLOT Cohort treatment arms combined
|
Placebo + XP/FP and Placebo + FLOT Cohort Combined
Neoadjuvant and adjuvant placebo+XP/FP and neoadjuvant and adjuvant placebo+FLOT Cohort treatment arms combined
|
|---|---|---|---|---|
|
Overall Survival (OS) - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms
|
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 was 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 was 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 received 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 received 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 received 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 received 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 + XP/FP and Pembrolizumab + FLOT Cohort Combined
FLOT=docetaxel+oxaliplatin+5FU+leucovorin (calcium folinate). Neoadjuvant and adjuvant pembrolizumab+XP/FP and neoadjuvant and adjuvant pembrolizumab+FLOT Cohort treatment arms combined
|
Placebo + XP/FP and Placebo + FLOT Cohort Combined
Neoadjuvant and adjuvant placebo+XP/FP and neoadjuvant and adjuvant placebo+FLOT Cohort treatment arms combined
|
|---|---|---|---|---|
|
Number of Participants Who Experienced 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 was 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 was 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 received 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 received 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 received 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 received 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 + XP/FP and Pembrolizumab + FLOT Cohort Combined
FLOT=docetaxel+oxaliplatin+5FU+leucovorin (calcium folinate). Neoadjuvant and adjuvant pembrolizumab+XP/FP and neoadjuvant and adjuvant pembrolizumab+FLOT Cohort treatment arms combined
|
Placebo + XP/FP and Placebo + FLOT Cohort Combined
Neoadjuvant and adjuvant placebo+XP/FP and neoadjuvant and adjuvant placebo+FLOT Cohort treatment arms combined
|
|---|---|---|---|---|
|
Number of Participants Who Discontinued Study Treatment Due to an AE - Pembrolizumab+FLOT and Placebo+FLOT Cohorts
|
37 Participants
|
26 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 89 monthsPopulation: The analysis population consisted of all participants who received ≥1 dose of study treatment for the Pembrolizumab+XP/FP and Placebo+XP/FP treatment arms separately and in combination with the Pembrolizumab+FLOT and Placebo+FLOT Cohorts, as pre-specified per protocol.
An AE was 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 experienced at least one AE was 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
| Measure |
Pembrolizumab + XP/FP
n=399 Participants
XP=cisplatin+capecitabine and FP=cisplatin+5-fluorouracil. Neoadjuvant: Prior to surgery, participants received 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 received 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
Neoadjuvant: Prior to surgery, participants received 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 received 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 + XP/FP and Pembrolizumab + FLOT Cohort Combined
n=498 Participants
FLOT=docetaxel+oxaliplatin+5FU+leucovorin (calcium folinate). Neoadjuvant and adjuvant pembrolizumab+XP/FP and neoadjuvant and adjuvant pembrolizumab+FLOT Cohort treatment arms combined
|
Placebo + XP/FP and Placebo + FLOT Cohort Combined
n=503 Participants
Neoadjuvant and adjuvant placebo+XP/FP and neoadjuvant and adjuvant placebo+FLOT Cohort treatment arms combined
|
|---|---|---|---|---|
|
Number of Participants Who Experienced One or More Adverse Events (AEs) - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms Separately and in Combination With the Pembrolizumab+FLOT and Placebo+FLOT Cohorts
|
396 Participants
|
398 Participants
|
495 Participants
|
501 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 17 monthsPopulation: The analysis population consisted of all participants who received ≥1 dose of study treatment for the Pembrolizumab+XP/FP and Placebo+XP/FP treatment arms separately and in combination with the Pembrolizumab+FLOT and Placebo+FLOT Cohorts, as pre-specified in the protocol.
An AE was 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 was 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
| Measure |
Pembrolizumab + XP/FP
n=399 Participants
XP=cisplatin+capecitabine and FP=cisplatin+5-fluorouracil. Neoadjuvant: Prior to surgery, participants received 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 received 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
Neoadjuvant: Prior to surgery, participants received 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 received 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 + XP/FP and Pembrolizumab + FLOT Cohort Combined
n=498 Participants
FLOT=docetaxel+oxaliplatin+5FU+leucovorin (calcium folinate). Neoadjuvant and adjuvant pembrolizumab+XP/FP and neoadjuvant and adjuvant pembrolizumab+FLOT Cohort treatment arms combined
|
Placebo + XP/FP and Placebo + FLOT Cohort Combined
n=503 Participants
Neoadjuvant and adjuvant placebo+XP/FP and neoadjuvant and adjuvant placebo+FLOT Cohort treatment arms combined
|
|---|---|---|---|---|
|
Number of Participants Who Discontinued Study Treatment Due to an AE - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms Separately and in Combination With the Pembrolizumab+FLOT and Placebo+FLOT Cohorts
|
123 Participants
|
103 Participants
|
160 Participants
|
129 Participants
|
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 was defined as the time from post-surgery baseline scan until the first occurrence of local or distant recurrence or death from any cause and was 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 received 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 received 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 received 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 received 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 + XP/FP and Pembrolizumab + FLOT Cohort Combined
FLOT=docetaxel+oxaliplatin+5FU+leucovorin (calcium folinate). Neoadjuvant and adjuvant pembrolizumab+XP/FP and neoadjuvant and adjuvant pembrolizumab+FLOT Cohort treatment arms combined
|
Placebo + XP/FP and Placebo + FLOT Cohort Combined
Neoadjuvant and adjuvant placebo+XP/FP and neoadjuvant and adjuvant placebo+FLOT Cohort treatment arms combined
|
|---|---|---|---|---|
|
Disease-free Survival (DFS) Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms
|
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 was defined as the time from randomization to death due to any cause. OS was 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 received 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 received 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 received 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 received 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 + XP/FP and Pembrolizumab + FLOT Cohort Combined
FLOT=docetaxel+oxaliplatin+5FU+leucovorin (calcium folinate). Neoadjuvant and adjuvant pembrolizumab+XP/FP and neoadjuvant and adjuvant pembrolizumab+FLOT Cohort treatment arms combined
|
Placebo + XP/FP and Placebo + FLOT Cohort Combined
Neoadjuvant and adjuvant placebo+XP/FP and neoadjuvant and adjuvant placebo+FLOT Cohort treatment arms combined
|
|---|---|---|---|---|
|
Overall Survival (OS) - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms 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 was based on RECIST 1.1 as assessed by the investigator and was 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 were disease free after surgery); clinical progression as evidenced by peritoneal carcinomatosis confirmed by preoperative laparoscopy or laparotomy (for participants who were 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), were 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 received 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 received 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 received 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 received 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 + XP/FP and Pembrolizumab + FLOT Cohort Combined
FLOT=docetaxel+oxaliplatin+5FU+leucovorin (calcium folinate). Neoadjuvant and adjuvant pembrolizumab+XP/FP and neoadjuvant and adjuvant pembrolizumab+FLOT Cohort treatment arms combined
|
Placebo + XP/FP and Placebo + FLOT Cohort Combined
Neoadjuvant and adjuvant placebo+XP/FP and neoadjuvant and adjuvant placebo+FLOT Cohort treatment arms combined
|
|---|---|---|---|---|
|
Event-free Survival (EFS) Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms 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: 174 serious events
Other events: 392 other events
Deaths: 200 deaths
Placebo + XP/FP
Serious events: 160 serious events
Other events: 392 other events
Deaths: 225 deaths
Pembrolizumab + FLOT Cohort
Serious events: 66 serious events
Other events: 99 other events
Deaths: 40 deaths
Placebo + FLOT Cohort
Serious events: 51 serious events
Other events: 103 other events
Deaths: 56 deaths
Pembrolizumab + XP/FP and Pembrolizumab + FLOT Combined
Serious events: 240 serious events
Other events: 491 other events
Deaths: 240 deaths
Placebo + XP/FP and Placebo + FLOT Combined
Serious events: 211 serious events
Other events: 495 other events
Deaths: 281 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 received 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 received 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 received 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 received 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 received 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 received 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 received 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 received 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 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 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 11 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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
Acute cholecystitis necrotic
|
0.00%
0/399 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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
|
1.8%
7/399 • Number of events 7 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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
Compression fracture
|
0.00%
0/399 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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
|
0.00%
0/399 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 received 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 received 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 received 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 received 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 received 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 received 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 received 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 received 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 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 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
|
41.4%
165/399 • Number of events 228 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
39.5%
158/400 • Number of events 210 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 46 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
38.2%
190/498 • Number of events 274 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
36.6%
184/503 • Number of events 259 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 9 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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
|
8.3%
33/399 • Number of events 35 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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%
39/498 • Number of events 42 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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
|
14.3%
57/399 • Number of events 96 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
16.0%
64/400 • Number of events 87 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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%
81/498 • Number of events 133 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 141 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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
|
5.3%
21/399 • Number of events 21 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 34 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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
|
27.1%
108/399 • Number of events 151 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 149 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 28 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 43 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
25.9%
129/498 • Number of events 179 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 192 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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
|
37.1%
148/399 • Number of events 218 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
32.2%
129/400 • Number of events 203 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
68.7%
68/99 • Number of events 141 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 174 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
43.4%
216/498 • Number of events 359 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
40.6%
204/503 • Number of events 377 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 59 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 50 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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
|
5.0%
20/399 • Number of events 22 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 10 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 32 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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
|
1.5%
6/399 • Number of events 6 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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
|
4.3%
17/399 • Number of events 19 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 27 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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
|
59.9%
239/399 • Number of events 463 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
61.3%
245/400 • Number of events 499 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 108 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
59.6%
297/498 • Number of events 571 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
60.8%
306/503 • Number of events 610 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 165 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
27.0%
108/400 • Number of events 175 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
37.4%
37/99 • Number of events 60 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
27.9%
139/498 • Number of events 225 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
30.2%
152/503 • Number of events 248 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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
|
21.6%
86/399 • Number of events 154 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
19.0%
76/400 • Number of events 119 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 28 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
18.4%
19/103 • Number of events 26 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
21.1%
105/498 • Number of events 182 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 145 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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
|
0.50%
2/399 • Number of events 2 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 18 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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
|
22.1%
88/399 • Number of events 133 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
22.8%
91/400 • Number of events 125 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
52.4%
54/103 • Number of events 87 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
29.1%
145/498 • Number of events 209 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
28.8%
145/503 • Number of events 212 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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
|
15.5%
62/399 • Number of events 73 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
13.8%
55/400 • Number of events 66 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
24.3%
25/103 • Number of events 32 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 116 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
15.9%
80/503 • Number of events 98 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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
|
1.5%
6/399 • Number of events 6 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 13 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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%
8/103 • Number of events 8 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 21 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 27 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 26 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 27 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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%
26/503 • Number of events 27 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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
|
6.3%
25/399 • Number of events 37 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 35 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 20 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 57 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 55 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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
|
7.3%
29/399 • Number of events 39 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 34 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 18 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 57 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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%
36/503 • Number of events 55 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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
|
1.5%
6/399 • Number of events 8 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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
|
12.5%
50/399 • Number of events 69 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 87 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
11.0%
55/498 • Number of events 74 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 88 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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
|
11.3%
45/399 • Number of events 81 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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%
56/498 • Number of events 105 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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
|
26.1%
104/399 • Number of events 107 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
34.3%
34/99 • Number of events 37 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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%
27/103 • Number of events 29 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
27.7%
138/498 • Number of events 144 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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%
131/503 • Number of events 140 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 144 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 176 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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
|
39.6%
158/399 • Number of events 256 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
41.8%
167/400 • Number of events 249 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
32.0%
33/103 • Number of events 42 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
39.6%
197/498 • Number of events 312 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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%
200/503 • Number of events 291 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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%
19/498 • Number of events 21 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 13 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 22 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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
|
4.8%
19/399 • Number of events 24 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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
|
8.3%
33/399 • Number of events 47 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
11.8%
47/400 • Number of events 58 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 17 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 64 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
12.9%
65/503 • Number of events 89 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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
|
3.3%
13/399 • Number of events 14 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 13 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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%
24/498 • Number of events 27 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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%
19/498 • Number of events 20 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 24 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 18 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 44 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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%
30/503 • Number of events 31 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 18 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 13 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
9.3%
47/503 • Number of events 59 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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%
31/400 • Number of events 39 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 51 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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%
27/103 • Number of events 30 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
10.3%
52/503 • Number of events 55 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 16 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 45 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 57 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
5.5%
22/400 • Number of events 22 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 12 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 34 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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
|
3.5%
14/399 • Number of events 15 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 29 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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
|
2.8%
11/399 • Number of events 11 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 22 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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
|
1.3%
5/399 • Number of events 5 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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
|
5.3%
21/399 • Number of events 23 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
10.2%
51/498 • Number of events 56 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 73 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 78 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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
|
13.8%
55/399 • Number of events 64 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
5.5%
22/400 • Number of events 27 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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%
71/498 • Number of events 86 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 34 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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%
28/400 • Number of events 34 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 47 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 37 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 14 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 51 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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
|
4.5%
18/399 • Number of events 18 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 27 • Up to approximately 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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 89 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related 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