NCT04083235 · ADVERSE EVENTS

Adverse events

A Study to Assess the Effectiveness and Safety of Irinotecan Liposome Injection, 5-fluorouracil/Leucovorin Plus Oxaliplatin in Patients Not Previously Treated for Metastatic Pancreatic Cancer, Compared to Nab-paclitaxel+Gemcitabine Treatment · Source last updated 2026-04-20

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
Other-event reporting threshold: 5%

The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
NALIRIFOX Participants were treated with irinotecan liposome injection 50 mg/m\^2 followed by oxaliplatin 60 mg/m\^2, followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.	207 / 370	364 / 370	345 / 370
Nab-paclitaxel+Gemcitabine Participants were treated with nab-paclitaxel 125 mg/m\^2 followed by gemcitabine 1000 mg/m\^2 IV on Days 1, 8 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.	198 / 379	371 / 379	359 / 379

Group identifiers: EG000: NALIRIFOX · EG001: Nab-paclitaxel+Gemcitabine

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (27.0)
stats
group Id
EG000
num Affected
23
num At Risk
370
num Events
28
group Id
EG001
num Affected
9
num At Risk
379
num Events
9
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (27.0)
stats
group Id
EG000
num Affected
22
num At Risk
370
num Events
27
group Id
EG001
num Affected
6
num At Risk
379
num Events
6
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (27.0)
stats
group Id
EG000
num Affected
18
num At Risk
370
num Events
25
group Id
EG001
num Affected
3
num At Risk
379
num Events
4
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (27.0)
stats
group Id
EG000
num Affected
9
num At Risk
370
num Events
11
group Id
EG001
num Affected
8
num At Risk
379
num Events
8
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (27.0)
stats
group Id
EG000
num Affected
18
num At Risk
370
num Events
18
group Id
EG001
num Affected
17
num At Risk
379
num Events
17
term
COVID-19
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (27.0)
stats
group Id
EG000
num Affected
7
num At Risk
370
num Events
7
group Id
EG001
num Affected
13
num At Risk
379
num Events
13
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (27.0)
stats
group Id
EG000
num Affected
9
num At Risk
370
num Events
10
group Id
EG001
num Affected
12
num At Risk
379
num Events
14
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (27.0)
stats
group Id
EG000
num Affected
10
num At Risk
370
num Events
10
group Id
EG001
num Affected
7
num At Risk
379
num Events
7
term
Pulmonary embolism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (27.0)
stats
group Id
EG000
num Affected
6
num At Risk
370
num Events
7
group Id
EG001
num Affected
8
num At Risk
379
num Events
8
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA (27.0)
stats
group Id
EG000
num Affected
4
num At Risk
370
num Events
4
group Id
EG001
num Affected
8
num At Risk
379
num Events
8
term
Deep vein thrombosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (27.0)
stats
group Id
EG000
num Affected
6
num At Risk
370
num Events
7
group Id
EG001
num Affected
5
num At Risk
379
num Events
6
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (27.0)
stats
group Id
EG000
num Affected
7
num At Risk
370
num Events
7
group Id
EG001
num Affected
4
num At Risk
379
num Events
4
term
Colitis

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (27.0)
stats
group Id
EG000
num Affected
257
num At Risk
370
num Events
580
group Id
EG001
num Affected
136
num At Risk
379
num Events
221
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (27.0)
stats
group Id
EG000
num Affected
216
num At Risk
370
num Events
417
group Id
EG001
num Affected
161
num At Risk
379
num Events
219
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (27.0)
stats
group Id
EG000
num Affected
140
num At Risk
370
num Events
227
group Id
EG001
num Affected
95
num At Risk
379
num Events
169
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (27.0)
stats
group Id
EG000
num Affected
54
num At Risk
370
num Events
94
group Id
EG001
num Affected
45
num At Risk
379
num Events
54
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (27.0)
stats
group Id
EG000
num Affected
96
num At Risk
370
num Events
119
group Id
EG001
num Affected
111
num At Risk
379
num Events
140
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (27.0)
stats
group Id
EG000
num Affected
92
num At Risk
370
num Events
112
group Id
EG001
num Affected
72
num At Risk
379
num Events
80
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (27.0)
stats
group Id
EG000
num Affected
29
num At Risk
370
num Events
30
group Id
EG001
num Affected
14
num At Risk
379
num Events
16
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (27.0)
stats
group Id
EG000
num Affected
121
num At Risk
370
num Events
181
group Id
EG001
num Affected
143
num At Risk
379
num Events
183
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (27.0)
stats
group Id
EG000
num Affected
111
num At Risk
370
num Events
173
group Id
EG001
num Affected
103
num At Risk
379
num Events
170
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (27.0)
stats
group Id
EG000
num Affected
53
num At Risk
370
num Events
61
group Id
EG001
num Affected
108
num At Risk
379
num Events
135
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (27.0)
stats
group Id
EG000
num Affected
53
num At Risk
370
num Events
69
group Id
EG001
num Affected
16
num At Risk
379
num Events
20
term
Mucosal inflammation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (27.0)
stats
group Id
EG000
num Affected
37
num At Risk
370
num Events
48
group Id
EG001
num Affected
82
num At Risk
379
num Events
131
term
Pyrexia

Complete source fields

description

The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.

event Groups

deaths Num Affected
345
deaths Num At Risk
370
description
Participants were treated with irinotecan liposome injection 50 mg/m\^2 followed by oxaliplatin 60 mg/m\^2, followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
id
EG000
other Num Affected
364
other Num At Risk
370
serious Num Affected
207
serious Num At Risk
370
title
NALIRIFOX
deaths Num Affected
359
deaths Num At Risk
379
description
Participants were treated with nab-paclitaxel 125 mg/m\^2 followed by gemcitabine 1000 mg/m\^2 IV on Days 1, 8 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
id
EG001
other Num Affected
371
other Num At Risk
379
serious Num Affected
198
serious Num At Risk
379
title
Nab-paclitaxel+Gemcitabine

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (27.0)
stats
group Id
EG000
num Affected
257
num At Risk
370
num Events
580
group Id
EG001
num Affected
136
num At Risk
379
num Events
221
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (27.0)
stats
group Id
EG000
num Affected
216
num At Risk
370
num Events
417
group Id
EG001
num Affected
161
num At Risk
379
num Events
219
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (27.0)
stats
group Id
EG000
num Affected
140
num At Risk
370
num Events
227
group Id
EG001
num Affected
95
num At Risk
379
num Events
169
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (27.0)
stats
group Id
EG000
num Affected
54
num At Risk
370
num Events
94
group Id
EG001
num Affected
45
num At Risk
379
num Events
54
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (27.0)
stats
group Id
EG000
num Affected
96
num At Risk
370
num Events
119
group Id
EG001
num Affected
111
num At Risk
379
num Events
140
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (27.0)
stats
group Id
EG000
num Affected
92
num At Risk
370
num Events
112
group Id
EG001
num Affected
72
num At Risk
379
num Events
80
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (27.0)
stats
group Id
EG000
num Affected
29
num At Risk
370
num Events
30
group Id
EG001
num Affected
14
num At Risk
379
num Events
16
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (27.0)
stats
group Id
EG000
num Affected
121
num At Risk
370
num Events
181
group Id
EG001
num Affected
143
num At Risk
379
num Events
183
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (27.0)
stats
group Id
EG000
num Affected
111
num At Risk
370
num Events
173
group Id
EG001
num Affected
103
num At Risk
379
num Events
170
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (27.0)
stats
group Id
EG000
num Affected
53
num At Risk
370
num Events
61
group Id
EG001
num Affected
108
num At Risk
379
num Events
135
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (27.0)
stats
group Id
EG000
num Affected
53
num At Risk
370
num Events
69
group Id
EG001
num Affected
16
num At Risk
379
num Events
20
term
Mucosal inflammation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (27.0)
stats
group Id
EG000
num Affected
37
num At Risk
370
num Events
48
group Id
EG001
num Affected
82
num At Risk
379
num Events
131
term
Pyrexia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (27.0)
stats
group Id
EG000
num Affected
23
num At Risk
370
num Events
28
group Id
EG001
num Affected
9
num At Risk
379
num Events
9
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (27.0)
stats
group Id
EG000
num Affected
22
num At Risk
370
num Events
27
group Id
EG001
num Affected
6
num At Risk
379
num Events
6
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (27.0)
stats
group Id
EG000
num Affected
18
num At Risk
370
num Events
25
group Id
EG001
num Affected
3
num At Risk
379
num Events
4
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (27.0)
stats
group Id
EG000
num Affected
9
num At Risk
370
num Events
11
group Id
EG001
num Affected
8
num At Risk
379
num Events
8
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (27.0)
stats
group Id
EG000
num Affected
18
num At Risk
370
num Events
18
group Id
EG001
num Affected
17
num At Risk
379
num Events
17
term
COVID-19
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (27.0)
stats
group Id
EG000
num Affected
7
num At Risk
370
num Events
7
group Id
EG001
num Affected
13
num At Risk
379
num Events
13
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (27.0)
stats
group Id
EG000
num Affected
9
num At Risk
370
num Events
10
group Id
EG001
num Affected
12
num At Risk
379
num Events
14
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (27.0)
stats
group Id
EG000
num Affected
10
num At Risk
370
num Events
10
group Id
EG001
num Affected
7
num At Risk
379
num Events
7
term
Pulmonary embolism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (27.0)
stats
group Id
EG000
num Affected
6
num At Risk
370
num Events
7
group Id
EG001
num Affected
8
num At Risk
379
num Events
8
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA (27.0)
stats
group Id
EG000
num Affected
4
num At Risk
370
num Events
4
group Id
EG001
num Affected
8
num At Risk
379
num Events
8
term
Deep vein thrombosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (27.0)
stats
group Id
EG000
num Affected
6
num At Risk
370
num Events
7
group Id
EG001
num Affected
5
num At Risk
379
num Events
6
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (27.0)
stats
group Id
EG000
num Affected
7
num At Risk
370
num Events
7
group Id
EG001
num Affected
4
num At Risk
379
num Events
4
term
Colitis

time Frame

Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.

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