Trial Outcomes & Findings for Assessing a Regorafenib-irinotecan Combination Versus Regorafenib Alone in Metastatic Colorectal Cancer Patients (NCT NCT03829462)
NCT ID: NCT03829462
Last Updated: 2025-11-21
Results Overview
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
377 participants
Primary outcome timeframe
Up to 36 months
Results posted on
2025-11-21
Participant Flow
Patients were recruited at 11 academic medical centers between March 2019 (first patient screened but non randomized) and august 2024.The first patient was randomized on September 18, 2019 and the last patient was randomized in march 2024.
After enrollment, a screening was carried out according to the polymorphism (A870A rs603965) of cyclin D1, a protein involved in cell cycle regulation.Of 377 enrolled patients, 66 patients met selection criteria and were randomized to the study.In the protocol, we had planned to randomize 78 patients, but we had also specified that endpoints could be analyzed as soon as 55 events (deaths) were reached (i.e when one of the two is reached first).
Participant milestones
| Measure |
Irinotecan + Regorafenib (REGIRI)
irinotecan (180 mg/m2) at day1 of each cycle + regorafenib (160 mg/day) from day 2 to day 8
Regorafenib: regorafenib tab 40 mg i.e 160 mg/day
Irinotecan: irinotecan 120 mg/m2 cycle 1, 150 mg/m2 cycle 2, 180 mg/m2 cycle 3 and more
|
Regorafenib
Regorafenib (160 mg/day) for 3 weeks followed by 1 week off
Regorafenib: regorafenib tab 40 mg i.e 160 mg/day
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
33
|
|
Overall Study
Per Protocol Population at 8 Weeks With a Evaluation by CT Scan
|
27
|
29
|
|
Overall Study
COMPLETED
|
27
|
29
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
Reasons for withdrawal
| Measure |
Irinotecan + Regorafenib (REGIRI)
irinotecan (180 mg/m2) at day1 of each cycle + regorafenib (160 mg/day) from day 2 to day 8
Regorafenib: regorafenib tab 40 mg i.e 160 mg/day
Irinotecan: irinotecan 120 mg/m2 cycle 1, 150 mg/m2 cycle 2, 180 mg/m2 cycle 3 and more
|
Regorafenib
Regorafenib (160 mg/day) for 3 weeks followed by 1 week off
Regorafenib: regorafenib tab 40 mg i.e 160 mg/day
|
|---|---|---|
|
Overall Study
No tumoral evaluation due to progression disease
|
6
|
3
|
|
Overall Study
No treatment due to progression disease
|
0
|
1
|
Baseline Characteristics
Of 33 patients randomized to arm A, 21 are men. Of 33 patients randomized to arm B, 15 are men.
Baseline characteristics by cohort
| Measure |
Irinotecan + Regorafenib (REGIRI)
n=33 Participants
irinotecan (180 mg/m2) at day1 of each cycle + regorafenib (160 mg/day) from day 2 to day 8
Regorafenib: regorafenib tab 40 mg i.e 160 mg/day
Irinotecan: irinotecan 120 mg/m2 cycle 1, 150 mg/m2 cycle 2, 180 mg/m2 cycle 3 and more
|
Regorafenib
n=33 Participants
Regorafenib (160 mg/day) for 3 weeks followed by 1 week off
Regorafenib: regorafenib tab 40 mg i.e 160 mg/day
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=33 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=66 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=33 Participants
|
21 Participants
n=33 Participants
|
38 Participants
n=66 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=33 Participants
|
12 Participants
n=33 Participants
|
28 Participants
n=66 Participants
|
|
Age, Continuous
|
65 years
n=33 Participants
|
64 years
n=33 Participants
|
64 years
n=66 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=33 Participants
|
18 Participants
n=33 Participants
|
30 Participants
n=66 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=33 Participants
|
15 Participants
n=33 Participants
|
36 Participants
n=66 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=33 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=66 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=33 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=66 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=33 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=66 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=33 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=66 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=33 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=66 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=33 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=66 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
33 Participants
n=33 Participants
|
33 Participants
n=33 Participants
|
66 Participants
n=66 Participants
|
|
Region of Enrollment
France
|
33 participants
n=33 Participants
|
33 participants
n=33 Participants
|
66 participants
n=66 Participants
|
|
RAt Sarcoma virus (RAS) Status
wild RAS
|
15 participants
n=33 Participants
|
14 participants
n=33 Participants
|
29 participants
n=66 Participants
|
|
RAt Sarcoma virus (RAS) Status
Mutant RAS
|
18 participants
n=33 Participants
|
19 participants
n=33 Participants
|
37 participants
n=66 Participants
|
|
Genotype of cycline D1 (polymorphism A/A)
|
33 participants
n=33 Participants
|
33 participants
n=33 Participants
|
66 participants
n=66 Participants
|
|
Microsatellite Stability (MSS) Status
Missing
|
4 participants
n=33 Participants
|
4 participants
n=33 Participants
|
8 participants
n=66 Participants
|
|
Microsatellite Stability (MSS) Status
Mutant MSS (microsatellite stability biomarker)
|
29 participants
n=33 Participants
|
29 participants
n=33 Participants
|
58 participants
n=66 Participants
|
|
v-RAF murine sarcoma viral oncogene homolog B (BRAF) Status
Wild BRAF
|
29 participants
n=33 Participants
|
23 participants
n=33 Participants
|
52 participants
n=66 Participants
|
|
v-RAF murine sarcoma viral oncogene homolog B (BRAF) Status
Mutant BRAF
|
1 participants
n=33 Participants
|
1 participants
n=33 Participants
|
2 participants
n=66 Participants
|
|
v-RAF murine sarcoma viral oncogene homolog B (BRAF) Status
Missing
|
3 participants
n=33 Participants
|
9 participants
n=33 Participants
|
12 participants
n=66 Participants
|
|
World Health Organization (WHO) status performance index
WHO=0
|
10 participants
n=33 Participants
|
18 participants
n=33 Participants
|
25 participants
n=66 Participants
|
|
World Health Organization (WHO) status performance index
WHO=1
|
23 participants
n=33 Participants
|
18 participants
n=33 Participants
|
41 participants
n=66 Participants
|
|
MALE WEIGHT
|
75.2 KG
n=21 Participants • Of 33 patients randomized to arm A, 21 are men. Of 33 patients randomized to arm B, 15 are men.
|
82.6 KG
n=15 Participants • Of 33 patients randomized to arm A, 21 are men. Of 33 patients randomized to arm B, 15 are men.
|
77.5 KG
n=36 Participants • Of 33 patients randomized to arm A, 21 are men. Of 33 patients randomized to arm B, 15 are men.
|
|
FEMALE WEIGHT
|
56.1 KG
n=12 Participants • Of 33 patients randomized to arm A, 12 are women. Of 33 patients randomized to arm B, 18 are women.
|
65.2 KG
n=18 Participants • Of 33 patients randomized to arm A, 12 are women. Of 33 patients randomized to arm B, 18 are women.
|
61.3 KG
n=30 Participants • Of 33 patients randomized to arm A, 12 are women. Of 33 patients randomized to arm B, 18 are women.
|
|
Body Mass Index (BMI)
|
24.4 kg/m²
n=33 Participants
|
25.3 kg/m²
n=33 Participants
|
24.6 kg/m²
n=66 Participants
|
|
Significant medical and surgical history
no
|
3 participants
n=33 Participants
|
6 participants
n=33 Participants
|
9 participants
n=66 Participants
|
|
Significant medical and surgical history
yes
|
30 participants
n=33 Participants
|
27 participants
n=33 Participants
|
57 participants
n=66 Participants
|
|
Ongoing signs and symptoms
no
|
11 participants
n=33 Participants
|
10 participants
n=33 Participants
|
21 participants
n=66 Participants
|
|
Ongoing signs and symptoms
yes
|
22 participants
n=33 Participants
|
23 participants
n=33 Participants
|
45 participants
n=66 Participants
|
|
Location of primary tumor
Right colon
|
8 participants
n=33 Participants
|
7 participants
n=33 Participants
|
15 participants
n=66 Participants
|
|
Location of primary tumor
Left colon
|
9 participants
n=33 Participants
|
7 participants
n=33 Participants
|
16 participants
n=66 Participants
|
|
Location of primary tumor
transverse colon
|
1 participants
n=33 Participants
|
3 participants
n=33 Participants
|
4 participants
n=66 Participants
|
|
Location of primary tumor
Recto-sigmoid junction
|
6 participants
n=33 Participants
|
7 participants
n=33 Participants
|
13 participants
n=66 Participants
|
|
Location of primary tumor
Rectum
|
9 participants
n=33 Participants
|
9 participants
n=33 Participants
|
18 participants
n=66 Participants
|
|
Tumor (T) from TNM classification given by pathologist
T1 (tumor invading the submucosa)
|
1 participants
n=33 Participants
|
0 participants
n=33 Participants
|
1 participants
n=66 Participants
|
|
Tumor (T) from TNM classification given by pathologist
T2 (tumor invading the muscularis)
|
0 participants
n=33 Participants
|
3 participants
n=33 Participants
|
3 participants
n=66 Participants
|
|
Tumor (T) from TNM classification given by pathologist
T3 (tumor invading the subserosa)
|
17 participants
n=33 Participants
|
7 participants
n=33 Participants
|
24 participants
n=66 Participants
|
|
Tumor (T) from TNM classification given by pathologist
T4 (tumor perforating the peritoneum or invading other organs)
|
7 participants
n=33 Participants
|
13 participants
n=33 Participants
|
20 participants
n=66 Participants
|
|
Tumor (T) from TNM classification given by pathologist
Tis (in situ carcinoma)
|
0 participants
n=33 Participants
|
1 participants
n=33 Participants
|
1 participants
n=66 Participants
|
|
Location of metastases
Lung
|
12 participants
n=33 Participants
|
14 participants
n=33 Participants
|
26 participants
n=66 Participants
|
|
Tumor (T) from TNM classification given by pathologist
Tx (unknown)
|
8 participants
n=33 Participants
|
9 participants
n=33 Participants
|
17 participants
n=66 Participants
|
|
pN (node) from TNM classification given by pathologist
pN0 (no lymph node invaded)
|
3 participants
n=33 Participants
|
7 participants
n=33 Participants
|
10 participants
n=66 Participants
|
|
pN (node) from TNM classification given by pathologist
pN1 (1 to 3 lymph nodes invaded)
|
12 participants
n=33 Participants
|
7 participants
n=33 Participants
|
19 participants
n=66 Participants
|
|
pN (node) from TNM classification given by pathologist
pN2 (> 4 lymph nodes invaded)
|
8 participants
n=33 Participants
|
9 participants
n=33 Participants
|
17 participants
n=66 Participants
|
|
Location of metastases
Liver
|
25 participants
n=33 Participants
|
27 participants
n=33 Participants
|
52 participants
n=66 Participants
|
|
pN (node) from TNM classification given by pathologist
pNx (unknown)
|
10 participants
n=33 Participants
|
10 participants
n=33 Participants
|
20 participants
n=66 Participants
|
|
pM from TNM classification given by pathologist
M0 (absence of metastasis)
|
6 participants
n=33 Participants
|
4 participants
n=33 Participants
|
10 participants
n=66 Participants
|
|
pM from TNM classification given by pathologist
M1 (presence of metastasis)
|
22 participants
n=33 Participants
|
20 participants
n=33 Participants
|
42 participants
n=66 Participants
|
|
pM from TNM classification given by pathologist
MX (unknown)
|
5 participants
n=33 Participants
|
9 participants
n=33 Participants
|
14 participants
n=66 Participants
|
|
lymph-node removal
no
|
14 participants
n=33 Participants
|
17 participants
n=33 Participants
|
31 participants
n=66 Participants
|
|
lymph-node removal
yes
|
19 participants
n=33 Participants
|
16 participants
n=33 Participants
|
35 participants
n=66 Participants
|
|
Number of patients with nodes removed
|
19 Participants
n=33 Participants
|
16 Participants
n=33 Participants
|
35 Participants
n=66 Participants
|
|
Number of patients with invaded nodes
|
19 Participants
n=33 Participants
|
16 Participants
n=33 Participants
|
35 Participants
n=66 Participants
|
|
Type of adenocarcinoma
Colloide adenocarcinoma
|
2 participants
n=33 Participants
|
3 participants
n=33 Participants
|
2 participants
n=66 Participants
|
|
Type of adenocarcinoma
LIEBERKUHNIEN adenocarcinoma
|
27 participants
n=33 Participants
|
33 participants
n=33 Participants
|
60 participants
n=66 Participants
|
|
Type of adenocarcinoma
Other adenocarcinoma
|
4 participants
n=33 Participants
|
0 participants
n=33 Participants
|
4 participants
n=66 Participants
|
|
Number of metastatic sites
1 metastatic site
|
18 participants
n=33 Participants
|
18 participants
n=33 Participants
|
36 participants
n=66 Participants
|
|
Number of metastatic sites
2 metastatic sites
|
11 participants
n=33 Participants
|
13 participants
n=33 Participants
|
24 participants
n=66 Participants
|
|
Number of metastatic sites
3 metastatic sites
|
3 participants
n=33 Participants
|
2 participants
n=33 Participants
|
5 participants
n=66 Participants
|
|
Number of metastatic sites
4 metastatic sites
|
1 participants
n=33 Participants
|
0 participants
n=33 Participants
|
1 participants
n=66 Participants
|
|
Location of metastases
Peritoneum
|
10 participants
n=33 Participants
|
3 participants
n=33 Participants
|
13 participants
n=66 Participants
|
|
Location of metastases
Distant lymph nodes
|
4 participants
n=33 Participants
|
4 participants
n=33 Participants
|
8 participants
n=66 Participants
|
|
Location of metastases
Other (ovaries, adrenal glands, peritoneum)
|
2 participants
n=33 Participants
|
2 participants
n=33 Participants
|
4 participants
n=66 Participants
|
|
Previous surgery number
0
|
8 participants
n=33 Participants
|
8 participants
n=33 Participants
|
16 participants
n=66 Participants
|
|
Previous surgery number
1
|
13 participants
n=33 Participants
|
9 participants
n=33 Participants
|
22 participants
n=66 Participants
|
|
Previous surgery number
2
|
12 participants
n=33 Participants
|
12 participants
n=33 Participants
|
24 participants
n=66 Participants
|
|
Previous surgery number
3
|
0 participants
n=33 Participants
|
3 participants
n=33 Participants
|
3 participants
n=66 Participants
|
|
Previous surgery number
4
|
0 participants
n=33 Participants
|
1 participants
n=33 Participants
|
1 participants
n=66 Participants
|
|
Carcinoembryonic antigen (CEA) Biomarker
|
57.1 ng/ml
n=33 Participants
|
46.1 ng/ml
n=33 Participants
|
52.75 ng/ml
n=66 Participants
|
|
Carbohydrate Antigen 19-9 (CA 19-9) Biomarker
|
98 U/ml
n=33 Participants
|
68 U/ml
n=33 Participants
|
89 U/ml
n=66 Participants
|
PRIMARY outcome
Timeframe: Up to 36 monthsPopulation: Population per-protocol
Outcome measures
| Measure |
Irinotecan + Regorafenib (REGIRI)
n=27 Participants
irinotecan (180 mg/m2) at day1 of each cycle + regorafenib (160 mg/day) from day 2 to day 8
Regorafenib: regorafenib tab 40 mg i.e 160 mg/day
Irinotecan: irinotecan 120 mg/m2 cycle 1, 150 mg/m2 cycle 2, 180 mg/m2 cycle 3 and more
|
Regorafenib
n=29 Participants
Regorafenib (160 mg/day) for 3 weeks followed by 1 week off
Regorafenib: regorafenib tab 40 mg i.e 160 mg/day
|
|---|---|---|
|
Overall Survival
|
9 Month
Interval 6.1 to 14.5
|
5.5 Month
Interval 3.8 to 13.4
|
SECONDARY outcome
Timeframe: Up to 36 monthsPopulation: Intention to treat
Outcome measures
| Measure |
Irinotecan + Regorafenib (REGIRI)
n=33 Participants
irinotecan (180 mg/m2) at day1 of each cycle + regorafenib (160 mg/day) from day 2 to day 8
Regorafenib: regorafenib tab 40 mg i.e 160 mg/day
Irinotecan: irinotecan 120 mg/m2 cycle 1, 150 mg/m2 cycle 2, 180 mg/m2 cycle 3 and more
|
Regorafenib
n=33 Participants
Regorafenib (160 mg/day) for 3 weeks followed by 1 week off
Regorafenib: regorafenib tab 40 mg i.e 160 mg/day
|
|---|---|---|
|
Progression-free Survival (PFS)
|
3.6 month
Interval 2.0 to 4.2
|
1.9 month
Interval 1.8 to 2.1
|
SECONDARY outcome
Timeframe: Up to 36 monthsPopulation: Intention to treat
Outcome measures
| Measure |
Irinotecan + Regorafenib (REGIRI)
n=33 Participants
irinotecan (180 mg/m2) at day1 of each cycle + regorafenib (160 mg/day) from day 2 to day 8
Regorafenib: regorafenib tab 40 mg i.e 160 mg/day
Irinotecan: irinotecan 120 mg/m2 cycle 1, 150 mg/m2 cycle 2, 180 mg/m2 cycle 3 and more
|
Regorafenib
n=33 Participants
Regorafenib (160 mg/day) for 3 weeks followed by 1 week off
Regorafenib: regorafenib tab 40 mg i.e 160 mg/day
|
|---|---|---|
|
Time to Deterioration
|
4.6 month
Interval 3.6 to 5.0
|
2.1 month
Interval 1.4 to 3.0
|
SECONDARY outcome
Timeframe: Through study completion, up to 14 monthsOutcome measures
| Measure |
Irinotecan + Regorafenib (REGIRI)
n=27 Participants
irinotecan (180 mg/m2) at day1 of each cycle + regorafenib (160 mg/day) from day 2 to day 8
Regorafenib: regorafenib tab 40 mg i.e 160 mg/day
Irinotecan: irinotecan 120 mg/m2 cycle 1, 150 mg/m2 cycle 2, 180 mg/m2 cycle 3 and more
|
Regorafenib
n=29 Participants
Regorafenib (160 mg/day) for 3 weeks followed by 1 week off
Regorafenib: regorafenib tab 40 mg i.e 160 mg/day
|
|---|---|---|
|
Number of Participants With Disease Control Rate
|
20 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Through treatment completion, up to 14 monthsPopulation: Population Per protocol
Outcome measures
| Measure |
Irinotecan + Regorafenib (REGIRI)
n=27 Participants
irinotecan (180 mg/m2) at day1 of each cycle + regorafenib (160 mg/day) from day 2 to day 8
Regorafenib: regorafenib tab 40 mg i.e 160 mg/day
Irinotecan: irinotecan 120 mg/m2 cycle 1, 150 mg/m2 cycle 2, 180 mg/m2 cycle 3 and more
|
Regorafenib
n=29 Participants
Regorafenib (160 mg/day) for 3 weeks followed by 1 week off
Regorafenib: regorafenib tab 40 mg i.e 160 mg/day
|
|---|---|---|
|
Number of Patients With an Objective Response Rate
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 36 monthsPopulation: Intention to treat
Outcome measures
| Measure |
Irinotecan + Regorafenib (REGIRI)
n=33 Participants
irinotecan (180 mg/m2) at day1 of each cycle + regorafenib (160 mg/day) from day 2 to day 8
Regorafenib: regorafenib tab 40 mg i.e 160 mg/day
Irinotecan: irinotecan 120 mg/m2 cycle 1, 150 mg/m2 cycle 2, 180 mg/m2 cycle 3 and more
|
Regorafenib
n=32 Participants
Regorafenib (160 mg/day) for 3 weeks followed by 1 week off
Regorafenib: regorafenib tab 40 mg i.e 160 mg/day
|
|---|---|---|
|
Assessment of Adverse Events by Using the NCI-CTCAE Version 5.0 Scale (Grade Max Per Patient)
Grade 1
|
4 Participants
|
2 Participants
|
|
Assessment of Adverse Events by Using the NCI-CTCAE Version 5.0 Scale (Grade Max Per Patient)
Grade 2
|
13 Participants
|
8 Participants
|
|
Assessment of Adverse Events by Using the NCI-CTCAE Version 5.0 Scale (Grade Max Per Patient)
Grade 3
|
9 Participants
|
21 Participants
|
|
Assessment of Adverse Events by Using the NCI-CTCAE Version 5.0 Scale (Grade Max Per Patient)
Grade 4
|
4 Participants
|
1 Participants
|
|
Assessment of Adverse Events by Using the NCI-CTCAE Version 5.0 Scale (Grade Max Per Patient)
Grade 5
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Questionnaire is assessed until 16 weeks (baseline, 8 weeks and 16 weeks)Population: The number of patients differs from the ITT population because some patients have not completed the questionnaires. Therefore the analysis is carried out on a smaller population, those who responded to the questionnaires. The table below shows the median scores of scales ranging from 0 to 100.
The Quality of Life questionnaire (QLQ-C30) is a 30-item instrument designed to measure quality of life in all cancer patients. The QLQ-C30 incorporates five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), a global health status, and a number of single items assessing additional symptoms commonly reported by cancer patients (dyspnea, loss of appetite, insomnia and diarrhea) and perceived financial impact of the disease. Score 0 to 100 for all subscales. * Functional scale : 0 the worst outcome, 100 is the best outcome, * Symptomatic scale : 0 the best outcome, 100 is the worst outcome Global functioning measures how much a person's symptoms affect their day-to-day life and role functioning assesses a patient's ability to perform daily activities, leisure time activities, and work on a scale of 0 to 100 (0 the worst outcome and 100 the best outcome).
Outcome measures
| Measure |
Irinotecan + Regorafenib (REGIRI)
n=21 Participants
irinotecan (180 mg/m2) at day1 of each cycle + regorafenib (160 mg/day) from day 2 to day 8
Regorafenib: regorafenib tab 40 mg i.e 160 mg/day
Irinotecan: irinotecan 120 mg/m2 cycle 1, 150 mg/m2 cycle 2, 180 mg/m2 cycle 3 and more
|
Regorafenib
n=16 Participants
Regorafenib (160 mg/day) for 3 weeks followed by 1 week off
Regorafenib: regorafenib tab 40 mg i.e 160 mg/day
|
|---|---|---|
|
Quality of Life Questionnaire
GLOBAL HEALTH STATUS AT BASELINE
|
63 Units on a scale
Interval 25.0 to 83.33
|
67 Units on a scale
Interval 16.67 to 100.0
|
|
Quality of Life Questionnaire
PHYSICAL FUNCTIONING AT BASELINE
|
93 Units on a scale
Interval 46.67 to 100.0
|
75 Units on a scale
Interval 16.67 to 100.0
|
|
Quality of Life Questionnaire
ROLE FUNCTIONING AT BASELINE
|
100 Units on a scale
Interval 0.0 to 100.0
|
75 Units on a scale
Interval 16.67 to 100.0
|
|
Quality of Life Questionnaire
EMOTIONAL FUNCTIONING AT BASELINE
|
83 Units on a scale
Interval 25.0 to 100.0
|
92 Units on a scale
Interval 25.0 to 100.0
|
|
Quality of Life Questionnaire
COGNITIVE FUNCTIONING AT BASELINE
|
83 Units on a scale
Interval 33.33 to 100.0
|
100 Units on a scale
Interval 50.0 to 100.0
|
|
Quality of Life Questionnaire
SOCIAL FUNCTIONING AT BASELINE
|
100 Units on a scale
Interval 33.33 to 100.0
|
75 Units on a scale
Interval 33.33 to 100.0
|
|
Quality of Life Questionnaire
ASTHENIA AT BASELINE
|
33 Units on a scale
Interval 0.0 to 77.78
|
33 Units on a scale
Interval 0.0 to 88.89
|
|
Quality of Life Questionnaire
NAUSEA AND VOMITING AT BASELINE
|
0 Units on a scale
Interval 0.0 to 66.67
|
0 Units on a scale
Interval 0.0 to 100.0
|
|
Quality of Life Questionnaire
PAIN AT BASELINE
|
33 Units on a scale
Interval 0.0 to 100.0
|
17 Units on a scale
Interval 0.0 to 100.0
|
|
Quality of Life Questionnaire
DYSPNEA AT BASELINE
|
0 Units on a scale
Interval 0.0 to 66.67
|
17 Units on a scale
Interval 0.0 to 66.67
|
|
Quality of Life Questionnaire
INSOMNIA AT BASELINE
|
33 Units on a scale
Interval 0.0 to 100.0
|
33 Units on a scale
Interval 0.0 to 100.0
|
|
Quality of Life Questionnaire
APPETITE LOSS AT BASELINE
|
0 Units on a scale
Interval 0.0 to 100.0
|
17 Units on a scale
Interval 0.0 to 100.0
|
|
Quality of Life Questionnaire
DIARRHEA AT BASELINE
|
0 Units on a scale
Interval 0.0 to 100.0
|
17 Units on a scale
Interval 0.0 to 66.67
|
|
Quality of Life Questionnaire
FINANCIAL DIFFICULTIES AT BASELINE
|
0 Units on a scale
Interval 0.0 to 66.67
|
0 Units on a scale
Interval 0.0 to 33.33
|
|
Quality of Life Questionnaire
GLOBAL HEALTH STATUS AT 8 WEEKS
|
67 Units on a scale
Interval 33.33 to 83.33
|
50 Units on a scale
Interval 33.33 to 83.33
|
|
Quality of Life Questionnaire
PHYSICAL FUNCTIONING AT 8 WEEKS
|
87 Units on a scale
Interval 33.33 to 100.0
|
40 Units on a scale
Interval 33.33 to 80.0
|
|
Quality of Life Questionnaire
ROLE FUNCTIONING AT 8 WEEKS
|
83 Units on a scale
Interval 33.33 to 100.0
|
33 Units on a scale
Interval 0.0 to 66.67
|
|
Quality of Life Questionnaire
EMOTIONAL FUNCTIONING AT 8 WEEKS
|
83 Units on a scale
Interval 41.67 to 100.0
|
83 Units on a scale
Interval 33.33 to 100.0
|
|
Quality of Life Questionnaire
COGNITIVE FUNCTIONING AT 8 WEEKS
|
83 Units on a scale
Interval 50.0 to 100.0
|
100 Units on a scale
Interval 16.67 to 100.0
|
|
Quality of Life Questionnaire
SOCIAL FUNCTIONING AT 8 WEEKS
|
83 Units on a scale
Interval 0.0 to 100.0
|
83 Units on a scale
Interval 16.67 to 100.0
|
|
Quality of Life Questionnaire
ASTHENIA AT 8 WEEKS
|
33 Units on a scale
Interval 0.0 to 100.0
|
78 Units on a scale
Interval 22.22 to 100.0
|
|
Quality of Life Questionnaire
NAUSEA AND VOMITING AT 8 WEEKS
|
0 Units on a scale
Interval 0.0 to 33.33
|
0 Units on a scale
Interval 0.0 to 83.33
|
|
Quality of Life Questionnaire
PAIN AT 8 WEEKS
|
33 Units on a scale
Interval 0.0 to 100.0
|
67 Units on a scale
Interval 0.0 to 100.0
|
|
Quality of Life Questionnaire
DYSPNEA AT 8 WEEKS
|
33 Units on a scale
Interval 0.0 to 100.0
|
33 Units on a scale
Interval 0.0 to 100.0
|
|
Quality of Life Questionnaire
INSOMNIA AT 8 WEEKS
|
0 Units on a scale
Interval 0.0 to 100.0
|
33 Units on a scale
Interval 0.0 to 100.0
|
|
Quality of Life Questionnaire
APPETITE LOSS AT 8 WEEKS
|
0 Units on a scale
Interval 0.0 to 100.0
|
33 Units on a scale
Interval 0.0 to 100.0
|
|
Quality of Life Questionnaire
DIARRHEA AT 8 WEEKS
|
33 Units on a scale
Interval 0.0 to 100.0
|
33 Units on a scale
Interval 0.0 to 100.0
|
|
Quality of Life Questionnaire
FINANCIAL DIFFICULTIES AT 8 WEEKS
|
0 Units on a scale
Interval 0.0 to 66.67
|
0 Units on a scale
Interval 0.0 to 33.33
|
|
Quality of Life Questionnaire
GLOBAL HEALTH STATUS AT 16 WEEKS
|
58 Units on a scale
Interval 16.67 to 100.0
|
58 Units on a scale
Interval 41.67 to 66.67
|
|
Quality of Life Questionnaire
PHYSICAL FUNCTIONING AT 16 WEEKS
|
80 Units on a scale
Interval 53.33 to 100.0
|
63 Units on a scale
Interval 53.33 to 80.0
|
|
Quality of Life Questionnaire
ROLE FUNCTIONING AT 16 WEEKS
|
67 Units on a scale
Interval 33.33 to 100.0
|
67 Units on a scale
Interval 50.0 to 83.33
|
|
Quality of Life Questionnaire
EMOTIONAL FUNCTIONING AT 16 WEEKS
|
75 Units on a scale
Interval 41.67 to 100.0
|
79 Units on a scale
Interval 75.0 to 83.33
|
|
Quality of Life Questionnaire
COGNITIVE FUNCTIONING AT 16 WEEKS
|
100 Units on a scale
Interval 66.67 to 100.0
|
92 Units on a scale
Interval 83.33 to 100.0
|
|
Quality of Life Questionnaire
SOCIAL FUNCTIONING AT 16 WEEKS
|
67 Units on a scale
Interval 33.33 to 100.0
|
75 Units on a scale
Interval 66.67 to 100.0
|
|
Quality of Life Questionnaire
ASTHENIA AT 16 WEEKS
|
44 Units on a scale
Interval 0.0 to 88.89
|
44 Units on a scale
Interval 22.22 to 66.67
|
|
Quality of Life Questionnaire
NAUSEA AND VOMITING AT 16 WEEKS
|
0 Units on a scale
Interval 0.0 to 100.0
|
0 Units on a scale
Interval 0.0 to 100.0
|
|
Quality of Life Questionnaire
PAIN AT 16 WEEKS
|
33 Units on a scale
Interval 0.0 to 66.67
|
8 Units on a scale
Interval 0.0 to 66.67
|
|
Quality of Life Questionnaire
DYSPNEA AT 16 WEEKS
|
0 Units on a scale
Interval 0.0 to 66.67
|
33 Units on a scale
Interval 0.0 to 33.33
|
|
Quality of Life Questionnaire
INSOMNIA AT 16 WEEKS
|
33 Units on a scale
Interval 0.0 to 66.67
|
50 Units on a scale
Interval 0.0 to 100.0
|
|
Quality of Life Questionnaire
APPETITE LOSS AT 16 WEEKS
|
0 Units on a scale
Interval 0.0 to 100.0
|
33 Units on a scale
Interval 0.0 to 66.67
|
|
Quality of Life Questionnaire
DIARRHEA AT 16 WEEKS
|
33 Units on a scale
Interval 0.0 to 100.0
|
33 Units on a scale
Interval 0.0 to 66.67
|
|
Quality of Life Questionnaire
FINANCIAL DIFFICULTIES AT 16 WEEKS
|
0 Units on a scale
Interval 0.0 to 66.67
|
0 Units on a scale
Interval 0.0 to 0.0
|
Adverse Events
Irinotecan + Regorafenib (REGIRI)
Serious events: 21 serious events
Other events: 33 other events
Deaths: 32 deaths
Regorafenib
Serious events: 20 serious events
Other events: 32 other events
Deaths: 27 deaths
Serious adverse events
| Measure |
Irinotecan + Regorafenib (REGIRI)
n=33 participants at risk
irinotecan (180 mg/m2) at day1 of each cycle + regorafenib (160 mg/day) from day 2 to day 8
Regorafenib: regorafenib tab 40 mg i.e 160 mg/day
Irinotecan: irinotecan 120 mg/m2 cycle 1, 150 mg/m2 cycle 2, 180 mg/m2 cycle 3 and more
|
Regorafenib
n=33 participants at risk
Regorafenib (160 mg/day) for 3 weeks followed by 1 week off
Regorafenib: regorafenib tab 40 mg i.e 160 mg/day
|
|---|---|---|
|
Metabolism and nutrition disorders
Anorexia
|
6.1%
2/33 • Number of events 2 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
6.1%
2/33 • Number of events 2 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
General disorders
Deterioration in general condition
|
9.1%
3/33 • Number of events 3 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
12.1%
4/33 • Number of events 4 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
General disorders
Fever
|
6.1%
2/33 • Number of events 2 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Cardiac disorders
Stroke
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
General disorders
Infusion related reaction
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
9.1%
3/33 • Number of events 3 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Infections and infestations
Catheter infection
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Vascular disorders
Pulmonary embolism
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Vascular disorders
Arterial hypertension
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
9.1%
3/33 • Number of events 3 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Gastrointestinal disorders
Stenosis of coloretal anastomosis
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Gastrointestinal disorders
Coloanal fistula
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Gastrointestinal disorders
Oesophageal hemorrhage
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Gastrointestinal disorders
Occlusive syndrome
|
6.1%
2/33 • Number of events 2 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Infections and infestations
Urinary tract infection
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Infections and infestations
Sepsis due to digestive perforation
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
General disorders
Left superior member hemiparesis
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Surgical and medical procedures
Malposition of Hubert needle
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Skin and subcutaneous tissue disorders
Maculopapular exanthema
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
General disorders
Disease progression
|
6.1%
2/33 • Number of events 2 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Gastrointestinal disorders
Rectal fistula
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
Other adverse events
| Measure |
Irinotecan + Regorafenib (REGIRI)
n=33 participants at risk
irinotecan (180 mg/m2) at day1 of each cycle + regorafenib (160 mg/day) from day 2 to day 8
Regorafenib: regorafenib tab 40 mg i.e 160 mg/day
Irinotecan: irinotecan 120 mg/m2 cycle 1, 150 mg/m2 cycle 2, 180 mg/m2 cycle 3 and more
|
Regorafenib
n=33 participants at risk
Regorafenib (160 mg/day) for 3 weeks followed by 1 week off
Regorafenib: regorafenib tab 40 mg i.e 160 mg/day
|
|---|---|---|
|
Investigations
GGT increased
|
36.4%
12/33 • Number of events 17 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
15.2%
5/33 • Number of events 7 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Investigations
Lipase increased
|
3.0%
1/33 • Number of events 2 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
12.1%
4/33 • Number of events 6 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Investigations
Weight loss
|
18.2%
6/33 • Number of events 7 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
18.2%
6/33 • Number of events 8 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
42.4%
14/33 • Number of events 21 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
3.0%
1/33 • Number of events 2 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Infections and infestations
Candida infection
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Skin and subcutaneous tissue disorders
Skin rash
|
6.1%
2/33 • Number of events 2 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Skin and subcutaneous tissue disorders
Erythroderma
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Skin and subcutaneous tissue disorders
Hypertrichosis
|
3.0%
1/33 • Number of events 2 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Skin and subcutaneous tissue disorders
Itching
|
6.1%
2/33 • Number of events 3 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
6.1%
2/33 • Number of events 2 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Skin and subcutaneous tissue disorders
Acneiform rash
|
3.0%
1/33 • Number of events 2 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
12.1%
4/33 • Number of events 4 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Skin and subcutaneous tissue disorders
Skin dryness
|
6.1%
2/33 • Number of events 3 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Skin and subcutaneous tissue disorders
Sweating
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Skin and subcutaneous tissue disorders
Hand-foot syndrome
|
30.3%
10/33 • Number of events 15 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
39.4%
13/33 • Number of events 19 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Renal and urinary disorders
Cystitis
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
3.0%
1/33 • Number of events 2 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Renal and urinary disorders
Acute renal failure
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
6.1%
2/33 • Number of events 2 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Nervous system disorders
Headache
|
12.1%
4/33 • Number of events 4 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
12.1%
4/33 • Number of events 5 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Nervous system disorders
Dysgueusia
|
6.1%
2/33 • Number of events 3 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Nervous system disorders
Insomnia
|
3.0%
1/33 • Number of events 2 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
3.0%
1/33 • Number of events 2 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Nervous system disorders
Peripheral neuropathy
|
18.2%
6/33 • Number of events 10 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
18.2%
6/33 • Number of events 9 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Nervous system disorders
Peripheral neuropathyneuralgia
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Nervous system disorders
Paresthesia
|
9.1%
3/33 • Number of events 4 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Gastrointestinal disorders
Canker sore
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
9.1%
3/33 • Number of events 4 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Gastrointestinal disorders
Ascites
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Gastrointestinal disorders
Bloating
|
3.0%
1/33 • Number of events 2 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Gastrointestinal disorders
Colic
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
57.6%
19/33 • Number of events 30 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
60.6%
20/33 • Number of events 50 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
9.1%
3/33 • Number of events 5 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Gastrointestinal disorders
haemorrhoids
|
3.0%
1/33 • Number of events 2 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Gastrointestinal disorders
Mucositis
|
9.1%
3/33 • Number of events 6 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
15.2%
5/33 • Number of events 6 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Gastrointestinal disorders
Nausea
|
45.5%
15/33 • Number of events 23 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Gastrointestinal disorders
odynophagia
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Gastrointestinal disorders
rectorrhagia
|
6.1%
2/33 • Number of events 3 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
9.1%
3/33 • Number of events 4 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Gastrointestinal disorders
Gastroesophageal reflux
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
6.1%
2/33 • Number of events 2 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Gastrointestinal disorders
Rectal syndrome
|
6.1%
2/33 • Number of events 2 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Gastrointestinal disorders
Vomiting
|
15.2%
5/33 • Number of events 5 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
9.1%
3/33 • Number of events 4 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Blood and lymphatic system disorders
Anemia
|
12.1%
4/33 • Number of events 5 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
18.2%
6/33 • Number of events 7 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Gastrointestinal disorders
Leucopenia
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
6.1%
2/33 • Number of events 2 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Gastrointestinal disorders
Neutropenia
|
18.2%
6/33 • Number of events 8 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Blood and lymphatic system disorders
Thrombopenia
|
6.1%
2/33 • Number of events 3 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
21.2%
7/33 • Number of events 10 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Gastrointestinal disorders
Cholestasis
|
21.2%
7/33 • Number of events 8 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
6.1%
2/33 • Number of events 2 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Gastrointestinal disorders
Hepatic pain
|
6.1%
2/33 • Number of events 2 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.0%
1/33 • Number of events 2 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Musculoskeletal and connective tissue disorders
Right hip pain
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
9.1%
3/33 • Number of events 5 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
9.1%
3/33 • Number of events 4 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
3.0%
1/33 • Number of events 2 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Musculoskeletal and connective tissue disorders
Bones pain
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
6.1%
2/33 • Number of events 3 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Musculoskeletal and connective tissue disorders
Right knee pain
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
12.1%
4/33 • Number of events 5 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Musculoskeletal and connective tissue disorders
Sciatica pain
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
6.1%
2/33 • Number of events 2 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Musculoskeletal and connective tissue disorders
Caruncle inflammation
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
15.2%
5/33 • Number of events 6 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
21.2%
7/33 • Number of events 9 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.1%
3/33 • Number of events 5 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Musculoskeletal and connective tissue disorders
Running nose
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
12.1%
4/33 • Number of events 5 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
6.1%
2/33 • Number of events 3 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Respiratory, thoracic and mediastinal disorders
Breathlessness
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Respiratory, thoracic and mediastinal disorders
Nose bleeding
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial syndrome
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
3/33 • Number of events 3 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
9.1%
3/33 • Number of events 3 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Vascular disorders
Hypertension
|
9.1%
3/33 • Number of events 4 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
27.3%
9/33 • Number of events 13 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Vascular disorders
Hypotension
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Vascular disorders
Heat/cold sensation
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Infections and infestations
Abscess
|
9.1%
3/33 • Number of events 4 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Infections and infestations
Erysipelas
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Infections and infestations
Facial folliculatis
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Infections and infestations
Gingivitis
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Infections and infestations
Urinary infection
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Infections and infestations
Right eye stye
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Infections and infestations
Paronychia
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Infections and infestations
Scrotal skin superinfection
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Investigations
Aspartate aminotransferase increased
|
27.3%
9/33 • Number of events 12 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
12.1%
4/33 • Number of events 5 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Investigations
Alanine aminotransferase increased
|
21.2%
7/33 • Number of events 10 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
6.1%
2/33 • Number of events 2 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Investigations
Alkaline phosphatase increased
|
6.1%
2/33 • Number of events 2 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Investigations
Blood bilirubin increased
|
15.2%
5/33 • Number of events 7 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
6.1%
2/33 • Number of events 2 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Investigations
Creatinine increased
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Surgical and medical procedures
Anastomosis stenosis
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Metabolism and nutrition disorders
Albumenia
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Metabolism and nutrition disorders
Anorexia
|
27.3%
9/33 • Number of events 12 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
30.3%
10/33 • Number of events 16 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Metabolism and nutrition disorders
Hyperkaliema
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Metabolism and nutrition disorders
Cytolysis
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
3.0%
1/33 • Number of events 2 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Metabolism and nutrition disorders
Hypokaliema
|
6.1%
2/33 • Number of events 2 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
General disorders
Deterioration general condition
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
15.2%
5/33 • Number of events 5 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
General disorders
Pain
|
21.2%
7/33 • Number of events 9 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
48.5%
16/33 • Number of events 25 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
General disorders
Asthenia
|
75.8%
25/33 • Number of events 37 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
57.6%
19/33 • Number of events 31 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
General disorders
Fever
|
21.2%
7/33 • Number of events 10 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
21.2%
7/33 • Number of events 8 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
General disorders
Edema of the limbs
|
6.1%
2/33 • Number of events 2 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
General disorders
Inflammatory syndrome
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Ear and labyrinth disorders
Tinnitus
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Nervous system disorders
Voice alteration
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Vascular disorders
Flushing
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopneumopathy
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Vascular disorders
Pulmonary embolism
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Gastrointestinal disorders
Epigastralgia
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Cardiac disorders
Atrial fibrillation
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Gastrointestinal disorders
Rectal fistula
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Infections and infestations
Sepsis
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Ear and labyrinth disorders
Left ear deafness
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Gastrointestinal disorders
Occlusion
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
6.1%
2/33 • Number of events 2 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
0.00%
0/33 • Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
|
Additional Information
Dr Emmanuelle Samalin
Institut régional du Cancer de Montpellier
Phone: 467613136
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place