Trial Outcomes & Findings for Colorectal Cancer Metastatic (NCT NCT01670721)
NCT ID: NCT01670721
Last Updated: 2016-11-28
Results Overview
Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on-treatment period. On-treatment period was defined as the time from the first dose of treatment to 30 days after the last dose of treatment (either Aflibercept or FOLFIRI). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
175 participants
Primary outcome timeframe
Baseline upto 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure:723 days)
Results posted on
2016-11-28
Participant Flow
The study was conducted at 38 sites in France. A total of 182 participants were screened between 08 August 2012 and 30 June 2014, out of which 175 participants were enrolled and treated.
Participants enrolled in the study to assess the safety of Aflibercept in participants treated with a combination of Aflibercept with FOLFIRI regimen (Irinotecan, Leucovorin and 5-Fluorouracil \[5-FU\]).
Participant milestones
| Measure |
Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)
Aflibercept 4 mg/kg intravenous (IV) infusion over 60 minutes followed by Irinotecan 180 mg/m\^2 IV infusion over 90 minutes and Leucovorin 400 mg/m\^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m\^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m\^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until disease progression (DP), unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment.
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|---|---|
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Overall Study
STARTED
|
175
|
|
Overall Study
COMPLETED
|
122
|
|
Overall Study
NOT COMPLETED
|
53
|
Reasons for withdrawal
| Measure |
Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)
Aflibercept 4 mg/kg intravenous (IV) infusion over 60 minutes followed by Irinotecan 180 mg/m\^2 IV infusion over 90 minutes and Leucovorin 400 mg/m\^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m\^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m\^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until disease progression (DP), unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment.
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|---|---|
|
Overall Study
Participant's decision
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15
|
|
Overall Study
Other than specified above
|
38
|
Baseline Characteristics
Colorectal Cancer Metastatic
Baseline characteristics by cohort
| Measure |
Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)
n=175 Participants
Aflibercept 4 mg/kg IV infusion over 60 minutes followed by Irinotecan 180 mg/m\^2 IV infusion over 90 minutes and Leucovorin 400 mg/m\^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m\^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m\^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until DP, unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment.
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|---|---|
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Age, Continuous
|
64.5 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
77 Participants
n=5 Participants
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|
Sex: Female, Male
Male
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98 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline upto 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure:723 days)Population: Safety population defined as the participants who signed the informed consent form and received at least part of one dose of study treatment.
Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on-treatment period. On-treatment period was defined as the time from the first dose of treatment to 30 days after the last dose of treatment (either Aflibercept or FOLFIRI). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.
Outcome measures
| Measure |
Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)
n=175 Participants
Aflibercept 4 mg/kg IV infusion over 60 minutes followed by Irinotecan 180 mg/m\^2 IV infusion over 90 minutes and Leucovorin 400 mg/m\^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m\^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m\^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until DP, unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment.
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|---|---|
|
Percentage of Participants With Adverse Events (AEs)
Any TEAE
|
100.00 Percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs)
Any serious TEAE
|
40.6 Percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs)
Any serious related TEAE
|
21.1 Percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs)
Any TEAE leading to death
|
9.1 Percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs)
Any TEAE (permanent treatment discontinuation)
|
23.4 Percentage of participants
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|
Percentage of Participants With Adverse Events (AEs)
Any TEAE (premature treatment discontinuation)
|
16.0 Percentage of participants
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SECONDARY outcome
Timeframe: Pre-dose at Baseline, Day 1 of every odd cycle; and at end of treatment (30 days after last study treatment) (maximum exposure: 99 weeks)Population: EORTC QLQ-C30 analysis population: participants who signed informed consent form; had an evaluable QLQ-C30 questionnaire at baseline and at least one evaluable assessment post baseline and received at least part of one dose of study treatment(either Aflibercept or FOLFIRI).Here, n=number of participants with available data at specified time-points.
EORTC-QLQ-C30 is a cancer-specific instrument with 30 questions for evaluation of new chemotherapy and provides an assessment of participant reported outcome dimensions. First 28 questions used 4-point scale (1=not at all,2=a little,3=quite a bit,4=very much) for evaluating 5 functional scales (physical,role,emotional,cognitive,social), 3 symptom scales (fatigue,nausea/vomiting,pain) \& other single items. For each item,high score represented high level of symptomatology/problem. Last 2 questions represented participant's assessment of overall health \& quality of life, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 observed values and change from baseline for global health status (scoring of questions 29 \& 30) and 5 functional scales, 3 symptom scales and other single items (scoring of questions 1 to 28). Answers were converted into grading scale, with values between 0 and 100. A high score represented a favorable outcome with a best quality of life for participant.
Outcome measures
| Measure |
Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)
n=152 Participants
Aflibercept 4 mg/kg IV infusion over 60 minutes followed by Irinotecan 180 mg/m\^2 IV infusion over 90 minutes and Leucovorin 400 mg/m\^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m\^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m\^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until DP, unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment.
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|---|---|
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Change From Baseline in Health Related Quality of Life (HRQL) European Organization for Research and Treatment for Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Baseline (n=148)
|
69.54 units on a scale
Standard Deviation 18.97
|
|
Change From Baseline in Health Related Quality of Life (HRQL) European Organization for Research and Treatment for Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
At Cycle 37 (n=2)
|
-8.33 units on a scale
Standard Deviation 11.79
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|
Change From Baseline in Health Related Quality of Life (HRQL) European Organization for Research and Treatment for Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
At Cycle 43 (n=2)
|
-12.50 units on a scale
Standard Deviation 5.89
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|
Change From Baseline in Health Related Quality of Life (HRQL) European Organization for Research and Treatment for Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
At Cycle 47 (n=1)
|
0.00 units on a scale
Standard Deviation NA
As only one participant was analyzed at cycle 47, standard deviation could not be calculated.
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|
Change From Baseline in Health Related Quality of Life (HRQL) European Organization for Research and Treatment for Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
At end of study treatment (n=73)
|
-11.19 units on a scale
Standard Deviation 24.38
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|
Change From Baseline in Health Related Quality of Life (HRQL) European Organization for Research and Treatment for Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
At Cycle 3 (n=130)
|
-7.56 units on a scale
Standard Deviation 19.78
|
|
Change From Baseline in Health Related Quality of Life (HRQL) European Organization for Research and Treatment for Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
At Cycle 5 (n=99)
|
-10.86 units on a scale
Standard Deviation 19.76
|
|
Change From Baseline in Health Related Quality of Life (HRQL) European Organization for Research and Treatment for Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
At Cycle 7 (n=72)
|
-8.22 units on a scale
Standard Deviation 20.00
|
|
Change From Baseline in Health Related Quality of Life (HRQL) European Organization for Research and Treatment for Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
At Cycle 9 (n=51)
|
-9.31 units on a scale
Standard Deviation 19.34
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Change From Baseline in Health Related Quality of Life (HRQL) European Organization for Research and Treatment for Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
At Cycle 11 (n=45)
|
-14.81 units on a scale
Standard Deviation 21.24
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Change From Baseline in Health Related Quality of Life (HRQL) European Organization for Research and Treatment for Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
At Cycle 13 (n=25)
|
-12.67 units on a scale
Standard Deviation 24.31
|
|
Change From Baseline in Health Related Quality of Life (HRQL) European Organization for Research and Treatment for Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
At Cycle 15 (n=24)
|
-12.50 units on a scale
Standard Deviation 18.22
|
|
Change From Baseline in Health Related Quality of Life (HRQL) European Organization for Research and Treatment for Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
At Cycle 17 (n=14)
|
-14.29 units on a scale
Standard Deviation 15.82
|
|
Change From Baseline in Health Related Quality of Life (HRQL) European Organization for Research and Treatment for Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
At Cycle 19 (n=12)
|
-15.28 units on a scale
Standard Deviation 11.70
|
|
Change From Baseline in Health Related Quality of Life (HRQL) European Organization for Research and Treatment for Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
At Cycle 21 (n=10)
|
-15.83 units on a scale
Standard Deviation 19.82
|
|
Change From Baseline in Health Related Quality of Life (HRQL) European Organization for Research and Treatment for Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
At Cycle 23 (n=6)
|
-9.72 units on a scale
Standard Deviation 20.01
|
|
Change From Baseline in Health Related Quality of Life (HRQL) European Organization for Research and Treatment for Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
At Cycle 25 (n=4)
|
-8.33 units on a scale
Standard Deviation 6.80
|
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Change From Baseline in Health Related Quality of Life (HRQL) European Organization for Research and Treatment for Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
At Cycle 27 (n=4)
|
-12.50 units on a scale
Standard Deviation 15.96
|
|
Change From Baseline in Health Related Quality of Life (HRQL) European Organization for Research and Treatment for Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
At Cycle 29 (n=2)
|
-8.33 units on a scale
Standard Deviation 11.79
|
|
Change From Baseline in Health Related Quality of Life (HRQL) European Organization for Research and Treatment for Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
At Cycle 31 (n=2)
|
-16.67 units on a scale
Standard Deviation 0.00
|
|
Change From Baseline in Health Related Quality of Life (HRQL) European Organization for Research and Treatment for Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
At Cycle 33 (n=1)
|
0.00 units on a scale
Standard Deviation NA
As only one participant was analyzed at cycle 33, standard deviation could not be calculated.
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|
Change From Baseline in Health Related Quality of Life (HRQL) European Organization for Research and Treatment for Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
At Cycle 35 (n=1)
|
0.00 units on a scale
Standard Deviation NA
As only one participant was analyzed at cycle 35, standard deviation could not be calculated.
|
|
Change From Baseline in Health Related Quality of Life (HRQL) European Organization for Research and Treatment for Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
At Cycle 39 (n=2)
|
-8.33 units on a scale
Standard Deviation 11.79
|
|
Change From Baseline in Health Related Quality of Life (HRQL) European Organization for Research and Treatment for Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
At Cycle 41 (n=2)
|
-8.33 units on a scale
Standard Deviation 11.79
|
|
Change From Baseline in Health Related Quality of Life (HRQL) European Organization for Research and Treatment for Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
At Cycle 45 (n=2)
|
-4.17 units on a scale
Standard Deviation 17.68
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SECONDARY outcome
Timeframe: Pre-dose at Baseline, Day 1 of every odd cycle; and at end of treatment (30 days after last study treatment) (maximum exposure: 99 weeks)Population: EQ-5D analysis population: participants who signed informed consent form, had an evaluable EQ-5D questionnaire at baseline and at least one evaluable assessment post baseline and received at least part of one dose of study treatment (either Aflibercept or FOLFIRI).Here, n = number of participants with available data at specified time-points.
EQ-5D was a standardized HRQL questionnaire consisting of EQ-5D descriptive system and Visual Analogue Scale (VAS). EQ-5D descriptive system comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression measured on 3 levels (no problem, some problems \& severe problems) within a particular EQ-5D dimension. 5 dimensional 3-level system was converted into single index utility score. Possible values for single index utility score ranged from -0.594 (severe problems in all dimensions) to 1.0 (no problem in all dimensions) on scale where 1 represented best possible health state.
Outcome measures
| Measure |
Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)
n=148 Participants
Aflibercept 4 mg/kg IV infusion over 60 minutes followed by Irinotecan 180 mg/m\^2 IV infusion over 90 minutes and Leucovorin 400 mg/m\^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m\^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m\^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until DP, unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment.
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|---|---|
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Change From Baseline in HRQL European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L) Index Score
At Cycle 5 (n=96)
|
-0.08 units on a scale
Standard Deviation 0.25
|
|
Change From Baseline in HRQL European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L) Index Score
At Cycle 43 (n=1)
|
0.00 units on a scale
Standard Deviation NA
As only one participant was analyzed at cycle 43, standard deviation could not be calculated.
|
|
Change From Baseline in HRQL European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L) Index Score
Baseline (n=148)
|
0.78 units on a scale
Standard Deviation 0.21
|
|
Change From Baseline in HRQL European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L) Index Score
At Cycle 3 (n=127)
|
-0.04 units on a scale
Standard Deviation 0.23
|
|
Change From Baseline in HRQL European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L) Index Score
At Cycle 7 (n=72)
|
-0.05 units on a scale
Standard Deviation 0.20
|
|
Change From Baseline in HRQL European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L) Index Score
At Cycle 9 (n=49)
|
-0.09 units on a scale
Standard Deviation 0.23
|
|
Change From Baseline in HRQL European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L) Index Score
At Cycle 11 (n=43)
|
-0.06 units on a scale
Standard Deviation 0.20
|
|
Change From Baseline in HRQL European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L) Index Score
At Cycle 13 (n=24)
|
-0.09 units on a scale
Standard Deviation 0.14
|
|
Change From Baseline in HRQL European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L) Index Score
At Cycle 15 (n=25)
|
-0.10 units on a scale
Standard Deviation 0.16
|
|
Change From Baseline in HRQL European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L) Index Score
At Cycle 17 (n=14)
|
-0.03 units on a scale
Standard Deviation 0.10
|
|
Change From Baseline in HRQL European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L) Index Score
At Cycle 19 (n=12)
|
-0.10 units on a scale
Standard Deviation 0.12
|
|
Change From Baseline in HRQL European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L) Index Score
At Cycle 21 (n=10)
|
-0.03 units on a scale
Standard Deviation 0.18
|
|
Change From Baseline in HRQL European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L) Index Score
At Cycle 23 (n=6)
|
-0.08 units on a scale
Standard Deviation 0.15
|
|
Change From Baseline in HRQL European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L) Index Score
At Cycle 25 (n=3)
|
0.04 units on a scale
Standard Deviation 0.22
|
|
Change From Baseline in HRQL European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L) Index Score
At Cycle 27 (n=3)
|
-0.09 units on a scale
Standard Deviation 0.20
|
|
Change From Baseline in HRQL European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L) Index Score
At Cycle 29 (n=2)
|
-0.18 units on a scale
Standard Deviation 0.04
|
|
Change From Baseline in HRQL European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L) Index Score
At Cycle 31 (n=1)
|
0.00 units on a scale
Standard Deviation NA
As only one participant was analyzed at cycle 31, standard deviation could not be calculated.
|
|
Change From Baseline in HRQL European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L) Index Score
At Cycle 37 (n=1)
|
-0.15 units on a scale
Standard Deviation NA
As only one participant was analyzed at cycle 37, standard deviation could not be calculated.
|
|
Change From Baseline in HRQL European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L) Index Score
At Cycle 39 (n=1)
|
0.00 units on a scale
Standard Deviation NA
As only one participant was analyzed at cycle 39, standard deviation could not be calculated.
|
|
Change From Baseline in HRQL European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L) Index Score
At Cycle 41 (n=1)
|
0.00 units on a scale
Standard Deviation NA
As only one participant was analyzed at cycle 41, standard deviation could not be calculated.
|
|
Change From Baseline in HRQL European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L) Index Score
At Cycle 45 (n=1)
|
0.00 units on a scale
Standard Deviation NA
As only one participant was analyzed at cycle 45, standard deviation could not be calculated.
|
|
Change From Baseline in HRQL European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L) Index Score
At end of study treatment (n=71)
|
-0.20 units on a scale
Standard Deviation 0.31
|
SECONDARY outcome
Timeframe: Pre-dose at Baseline, Day 1 of every odd cycle; and at end of treatment (30 days after last study treatment) (maximum exposure: 99 weeks)Population: EQ-5D analysis population: participants who signed informed consent form, had an evaluable EQ-5D questionnaire at baseline and at least one evaluable assessment post baseline and received at least part of one dose of study treatment (either Aflibercept or FOLFIRI).Here, n = number of participants with available data at specified time-points.
EQ-5D VAS was used to record a participant's rating for his/her current health-related quality of life state and captured on a vertical VAS (0-100), where 0 = worst imaginable health state and 100 = best imaginable health state. Baseline corresponded to last evaluable assessment before treatment administration.
Outcome measures
| Measure |
Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)
n=148 Participants
Aflibercept 4 mg/kg IV infusion over 60 minutes followed by Irinotecan 180 mg/m\^2 IV infusion over 90 minutes and Leucovorin 400 mg/m\^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m\^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m\^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until DP, unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment.
|
|---|---|
|
Change From Baseline in HRQL EQ-5D-3L VAS Score
At cycle 17 (n=13)
|
-10.31 units on a scale
Standard Deviation 17.44
|
|
Change From Baseline in HRQL EQ-5D-3L VAS Score
Baseline (n=125)
|
69.48 units on a scale
Standard Deviation 19.10
|
|
Change From Baseline in HRQL EQ-5D-3L VAS Score
At cycle 3 (n=94)
|
-6.23 units on a scale
Standard Deviation 17.82
|
|
Change From Baseline in HRQL EQ-5D-3L VAS Score
At cycle 5 (n=76)
|
-7.62 units on a scale
Standard Deviation 17.23
|
|
Change From Baseline in HRQL EQ-5D-3L VAS Score
At cycle 7 (n=57)
|
-7.79 units on a scale
Standard Deviation 14.14
|
|
Change From Baseline in HRQL EQ-5D-3L VAS Score
At cycle 9 (n=38)
|
-7.55 units on a scale
Standard Deviation 16.12
|
|
Change From Baseline in HRQL EQ-5D-3L VAS Score
At cycle 11 (n=36)
|
-8.67 units on a scale
Standard Deviation 16.09
|
|
Change From Baseline in HRQL EQ-5D-3L VAS Score
At cycle 13 (n=22)
|
-8.95 units on a scale
Standard Deviation 17.56
|
|
Change From Baseline in HRQL EQ-5D-3L VAS Score
At cycle 15 (n=22)
|
-12.41 units on a scale
Standard Deviation 19.57
|
|
Change From Baseline in HRQL EQ-5D-3L VAS Score
At cycle 19 (n=10)
|
-15.70 units on a scale
Standard Deviation 18.19
|
|
Change From Baseline in HRQL EQ-5D-3L VAS Score
At cycle 21 (n=8)
|
-15.13 units on a scale
Standard Deviation 19.87
|
|
Change From Baseline in HRQL EQ-5D-3L VAS Score
At cycle 23 (n=5)
|
-8.80 units on a scale
Standard Deviation 10.71
|
|
Change From Baseline in HRQL EQ-5D-3L VAS Score
At cycle 25 (n=2)
|
-13.00 units on a scale
Standard Deviation 4.24
|
|
Change From Baseline in HRQL EQ-5D-3L VAS Score
At cycle 27 (n=3)
|
-15.67 units on a scale
Standard Deviation 9.81
|
|
Change From Baseline in HRQL EQ-5D-3L VAS Score
At cycle 29 (n=2)
|
-17.50 units on a scale
Standard Deviation 3.54
|
|
Change From Baseline in HRQL EQ-5D-3L VAS Score
At cycle 31 (n=1)
|
-15.00 units on a scale
Standard Deviation NA
As only one participant was analyzed at cycle 31, standard deviation could not be calculated.
|
|
Change From Baseline in HRQL EQ-5D-3L VAS Score
At cycle 37 (n=1)
|
-15.00 units on a scale
Standard Deviation NA
As only one participant was analyzed at cycle 37, standard deviation could not be calculated.
|
|
Change From Baseline in HRQL EQ-5D-3L VAS Score
At cycle 39 (n=1)
|
-15.00 units on a scale
Standard Deviation NA
As only one participant was analyzed at cycle 39, standard deviation could not be calculated.
|
|
Change From Baseline in HRQL EQ-5D-3L VAS Score
At cycle 41 (n=1)
|
-15.00 units on a scale
Standard Deviation NA
As only one participant was analyzed at cycle 41, standard deviation could not be calculated.
|
|
Change From Baseline in HRQL EQ-5D-3L VAS Score
At cycle 43 (n=1)
|
-15.00 units on a scale
Standard Deviation NA
As only one participant was analyzed at cycle 43, standard deviation could not be calculated.
|
|
Change From Baseline in HRQL EQ-5D-3L VAS Score
At cycle 45 (n=1)
|
-15.00 units on a scale
Standard Deviation NA
As only one participant was analyzed at cycle 45, standard deviation could not be calculated.
|
|
Change From Baseline in HRQL EQ-5D-3L VAS Score
At end of study treatment (n=55)
|
-13.05 units on a scale
Standard Deviation 20.82
|
Adverse Events
Aflibercept + FOLFIRI(Irinotecan, 5-Fluorouracil & Leucovorin)
Serious events: 71 serious events
Other events: 172 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aflibercept + FOLFIRI(Irinotecan, 5-Fluorouracil & Leucovorin)
n=175 participants at risk
Aflibercept 4 mg/kg IV infusion over 60 minutes followed by Irinotecan 180 mg/m\^2 IV infusion over 90 minutes and Leucovorin 400 mg/m\^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m\^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m\^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until DP, unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment (maximum exposure: Week 99).
|
|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.57%
1/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
1.1%
2/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Blood and lymphatic system disorders
PANCYTOPENIA
|
0.57%
1/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Eye disorders
VITREOUS HAEMORRHAGE
|
0.57%
1/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
1.7%
3/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Gastrointestinal disorders
ANAL FISTULA
|
0.57%
1/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Gastrointestinal disorders
DIARRHOEA
|
4.6%
8/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Gastrointestinal disorders
GASTROINTESTINAL FISTULA
|
0.57%
1/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.57%
1/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
1.7%
3/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Gastrointestinal disorders
NAUSEA
|
1.1%
2/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Gastrointestinal disorders
PANCREATITIS
|
0.57%
1/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
0.57%
1/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Gastrointestinal disorders
RECTOURETHRAL FISTULA
|
0.57%
1/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Gastrointestinal disorders
SMALL INTESTINAL PERFORATION
|
0.57%
1/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Gastrointestinal disorders
STOMATITIS
|
0.57%
1/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Gastrointestinal disorders
SUBILEUS
|
1.1%
2/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Gastrointestinal disorders
TOOTH LOSS
|
0.57%
1/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Gastrointestinal disorders
VOMITING
|
0.57%
1/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
General disorders
ASTHENIA
|
0.57%
1/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
General disorders
DISEASE PROGRESSION
|
5.1%
9/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
General disorders
FATIGUE
|
0.57%
1/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
|
4.6%
8/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
0.57%
1/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
General disorders
PYREXIA
|
1.7%
3/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Hepatobiliary disorders
HEPATIC FAILURE
|
1.1%
2/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Infections and infestations
ABDOMINAL WALL ABSCESS
|
0.57%
1/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Infections and infestations
DEVICE RELATED INFECTION
|
0.57%
1/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Infections and infestations
DEVICE RELATED SEPSIS
|
0.57%
1/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Infections and infestations
ESCHERICHIA INFECTION
|
0.57%
1/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Infections and infestations
INFECTION
|
1.1%
2/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Infections and infestations
LUNG INFECTION
|
1.1%
2/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Infections and infestations
PELVIC ABSCESS
|
0.57%
1/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Infections and infestations
SEPSIS
|
0.57%
1/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Infections and infestations
SEPTIC SHOCK
|
0.57%
1/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Infections and infestations
TOOTH INFECTION
|
0.57%
1/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Injury, poisoning and procedural complications
HEAD INJURY
|
0.57%
1/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
0.57%
1/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Investigations
LAPAROSCOPY
|
0.57%
1/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
1.1%
2/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.57%
1/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
0.57%
1/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.57%
1/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
0.57%
1/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
INFECTED NEOPLASM
|
0.57%
1/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO CENTRAL NERVOUS SYSTEM
|
1.1%
2/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTATIC PAIN
|
0.57%
1/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Nervous system disorders
CEREBELLAR ISCHAEMIA
|
0.57%
1/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.57%
1/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Nervous system disorders
DIZZINESS
|
0.57%
1/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Nervous system disorders
HEADACHE
|
0.57%
1/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
0.57%
1/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
0.57%
1/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Psychiatric disorders
DEPRESSION
|
0.57%
1/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Renal and urinary disorders
RENAL COLIC
|
0.57%
1/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Renal and urinary disorders
RENAL FAILURE
|
1.1%
2/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Renal and urinary disorders
URINARY RETENTION
|
0.57%
1/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Reproductive system and breast disorders
PRIAPISM
|
0.57%
1/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.57%
1/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.57%
1/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.57%
1/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
1.1%
2/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
2.3%
4/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY OEDEMA
|
0.57%
1/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Surgical and medical procedures
HEPATECTOMY
|
0.57%
1/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Surgical and medical procedures
INTRAPERITONEAL HYPERTHERMIC CHEMOTHERAPY
|
0.57%
1/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Vascular disorders
PHLEBITIS
|
0.57%
1/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Vascular disorders
THROMBOSIS
|
0.57%
1/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Vascular disorders
VARICOSE ULCERATION
|
0.57%
1/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
Other adverse events
| Measure |
Aflibercept + FOLFIRI(Irinotecan, 5-Fluorouracil & Leucovorin)
n=175 participants at risk
Aflibercept 4 mg/kg IV infusion over 60 minutes followed by Irinotecan 180 mg/m\^2 IV infusion over 90 minutes and Leucovorin 400 mg/m\^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m\^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m\^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until DP, unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment (maximum exposure: Week 99).
|
|---|---|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
20.6%
36/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
8.0%
14/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Gastrointestinal disorders
CONSTIPATION
|
22.3%
39/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Gastrointestinal disorders
DIARRHOEA
|
69.1%
121/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
5.7%
10/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Gastrointestinal disorders
NAUSEA
|
49.1%
86/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Gastrointestinal disorders
PROCTALGIA
|
5.7%
10/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
6.3%
11/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Gastrointestinal disorders
STOMATITIS
|
47.4%
83/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Gastrointestinal disorders
VOMITING
|
26.9%
47/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
General disorders
ASTHENIA
|
56.0%
98/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
General disorders
FATIGUE
|
18.9%
33/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
22.3%
39/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
General disorders
PYREXIA
|
8.0%
14/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Investigations
WEIGHT DECREASED
|
38.9%
68/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
33.7%
59/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
5.7%
10/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
10.3%
18/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
6.3%
11/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Nervous system disorders
DYSGEUSIA
|
7.4%
13/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Nervous system disorders
HEADACHE
|
18.3%
32/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
10.9%
19/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Nervous system disorders
PARAESTHESIA
|
5.1%
9/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Renal and urinary disorders
PROTEINURIA
|
14.3%
25/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
12.6%
22/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
9.7%
17/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
24.6%
43/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
20.6%
36/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Skin and subcutaneous tissue disorders
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
|
13.1%
23/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
|
Vascular disorders
HYPERTENSION
|
42.3%
74/175 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 723) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
- Publication restrictions are in place
Restriction type: OTHER