Trial Outcomes & Findings for Safety and Quality of Life Study of Aflibercept in Patients With Metastatic Colorectal Cancer Previously Treated With an Oxaliplatin-Based Regimen (NCT NCT01571284)
NCT ID: NCT01571284
Last Updated: 2018-04-17
Results Overview
Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an adverse event (AE) without regard to possibility of causal relationship with this treatment. A serious AE (SAE): 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. National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Version 4.03 was used to assess severity (Grade 1=mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening/disabling) of AEs.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
781 participants
Primary outcome timeframe
Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks)
Results posted on
2018-04-17
Participant Flow
The study was conducted at 151 sites in 23 countries. A total of 798 participants were screened between 30 May 2012 and 03 January 2015, out of which 781 participants were enrolled and 779 participants were 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.
|
|---|---|
|
Overall Study
STARTED
|
781
|
|
Overall Study
Safety Population
|
779
|
|
Overall Study
COMPLETED
|
612
|
|
Overall Study
NOT COMPLETED
|
169
|
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.
|
|---|---|
|
Overall Study
Participant's decision
|
84
|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Enrolled but not treated
|
2
|
|
Overall Study
Other than specified above
|
80
|
Baseline Characteristics
Number of participants analyzed = participants with available data for specified measure.
Baseline characteristics by cohort
| Measure |
Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)
n=779 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.
|
|---|---|
|
Age, Continuous
|
60.3 years
STANDARD_DEVIATION 11.0 • n=779 Participants
|
|
Sex: Female, Male
Female
|
314 Participants
n=779 Participants
|
|
Sex: Female, Male
Male
|
465 Participants
n=779 Participants
|
|
Race/Ethnicity, Customized
White
|
631 Participants
n=779 Participants
|
|
Race/Ethnicity, Customized
Black or African
|
8 Participants
n=779 Participants
|
|
Race/Ethnicity, Customized
American Asian
|
121 Participants
n=779 Participants
|
|
Race/Ethnicity, Customized
Other
|
19 Participants
n=779 Participants
|
|
Body Surface Area (BSA)
|
1.80 m^2
STANDARD_DEVIATION 0.23 • n=779 Participants
|
|
Systolic Blood Pressure
|
126.4 mmHg
STANDARD_DEVIATION 13.4 • n=776 Participants • Number of participants analyzed = participants with available data for specified measure.
|
|
Diastolic Blood Pressure
|
76.4 mmHg
STANDARD_DEVIATION 9.0 • n=776 Participants • Number of participants analyzed = participants with available data for specified measure.
|
|
Any Relevant Medical/Surgical History
|
640 Participants
n=779 Participants
|
|
History of Thrombovascular Event and/or Presence of Cardiovascular Risk Factor
|
424 Participants
n=779 Participants
|
|
Time From Initial Histological Diagnosis till Baseline Visit
|
19.1 Months
STANDARD_DEVIATION 17.2 • n=779 Participants
|
|
Location of Primary Tumor
Colon
|
406 Participants
n=779 Participants
|
|
Location of Primary Tumor
Recto sigmoid
|
171 Participants
n=779 Participants
|
|
Location of Primary Tumor
Rectum
|
200 Participants
n=779 Participants
|
|
Location of Primary Tumor
Other
|
2 Participants
n=779 Participants
|
|
Histology
Adenocarcinoma
|
778 Participants
n=779 Participants
|
|
Histology
Other
|
1 Participants
n=779 Participants
|
|
Organs with Metastases at Baseline
1
|
358 Participants
n=779 Participants
|
|
Organs with Metastases at Baseline
>1
|
421 Participants
n=779 Participants
|
|
Eastern Cooperative Oncology Group Performance Status (ECOG PS)
0
|
484 Participants
n=779 Participants
|
|
Eastern Cooperative Oncology Group Performance Status (ECOG PS)
1
|
292 Participants
n=779 Participants
|
|
Eastern Cooperative Oncology Group Performance Status (ECOG PS)
Missing
|
3 Participants
n=779 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks)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 adverse event (AE) without regard to possibility of causal relationship with this treatment. A serious AE (SAE): 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. National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Version 4.03 was used to assess severity (Grade 1=mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening/disabling) of AEs.
Outcome measures
| Measure |
Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)
n=779 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.
|
|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Any TEAE (All Grades)
|
769 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Any TEAEs (Grades 3-4)
|
609 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Any serious TEAE
|
272 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Any serious related TEAE
|
159 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Any TEAE leading to death
|
47 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Any TEAE (permanent treatment discontinuation)
|
208 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Any TEAE (premature treatment discontinuation)
|
104 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks)Population: Safety population. Here, 'Number Analyzed = participants with available data for specified categories.
Abnormal hematological parameters included: anaemia, thrombocytopenia, leukopenia and neutropenia. Number of participants with each of these parameters were analyzed by grades (All Grades and Grades 3-4 as per NCI CTCAE (Version 4.03), where Grade 1=mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening/disabling. All Grades included Grades 1-4.
Outcome measures
| Measure |
Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)
n=779 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.
|
|---|---|
|
Number of Participants With Abnormal Hematological Parameters
Anaemia: All Grades
|
535 Participants
|
|
Number of Participants With Abnormal Hematological Parameters
Anaemia: Grades 3-4
|
14 Participants
|
|
Number of Participants With Abnormal Hematological Parameters
Thrombocytopenia: All Grades
|
293 Participants
|
|
Number of Participants With Abnormal Hematological Parameters
Thrombocytopenia: Grades 3-4
|
13 Participants
|
|
Number of Participants With Abnormal Hematological Parameters
Leukopenia: All Grades
|
532 Participants
|
|
Number of Participants With Abnormal Hematological Parameters
Leukopenia: Grades 3-4
|
72 Participants
|
|
Number of Participants With Abnormal Hematological Parameters
Neutropenia: All Grades
|
450 Participants
|
|
Number of Participants With Abnormal Hematological Parameters
Neutropenia: Grades 3-4
|
227 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks)Population: Safety population. Here, 'Number Analyzed' = participants with available data for specified categories.
The INR is a derived measure of the prothrombin time. The INR is the ratio of a participant's prothrombin time to a normal control sample. Normal range (without anti coagulation therapy): 0.8-1.2; Targeted range (with anti coagulation therapy) 2.0-3.0.
Outcome measures
| Measure |
Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)
n=779 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.
|
|---|---|
|
Number of Participants With International Normalized Ratio (INR)
INR<1.5
|
106 Participants
|
|
Number of Participants With International Normalized Ratio (INR)
INR>=1.5 to <3
|
0 Participants
|
|
Number of Participants With International Normalized Ratio (INR)
INR>=3 to <5
|
2 Participants
|
|
Number of Participants With International Normalized Ratio (INR)
INR>=5
|
2 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks)Population: Safety population. Here, 'Number Analyzed' = participants with available data for specified categories.
Abnormal electrolytes parameters included: hyponatremia, hypernatremia, hypocalcemia, hypercalcemia, hypokalemia, and hyperkalemia. Number of participants with each of these parameters were analyzed by grades ( All Grades and Grades 3-4 as per NCI CTCAE Version 4.03, where Grade 1=mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening/disabling. All Grades included Grades 1-4.
Outcome measures
| Measure |
Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)
n=779 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.
|
|---|---|
|
Number of Participants With Abnormal Electrolytes Parameters
Hyponatremia: All Grades
|
181 Participants
|
|
Number of Participants With Abnormal Electrolytes Parameters
Hyponatremia: Grades 3-4
|
32 Participants
|
|
Number of Participants With Abnormal Electrolytes Parameters
Hypernatremia: All Grades
|
75 Participants
|
|
Number of Participants With Abnormal Electrolytes Parameters
Hypernatremia: Grades 3-4
|
1 Participants
|
|
Number of Participants With Abnormal Electrolytes Parameters
Hypocalcemia: All Grades
|
213 Participants
|
|
Number of Participants With Abnormal Electrolytes Parameters
Hypocalcemia: Grades 3-4
|
5 Participants
|
|
Number of Participants With Abnormal Electrolytes Parameters
Hypercalcemia: All Grades
|
52 Participants
|
|
Number of Participants With Abnormal Electrolytes Parameters
Hypercalcemia: Grades 3-4
|
2 Participants
|
|
Number of Participants With Abnormal Electrolytes Parameters
Hypokalemia: All Grades
|
121 Participants
|
|
Number of Participants With Abnormal Electrolytes Parameters
Hypokalemia: Grades 3-4
|
16 Participants
|
|
Number of Participants With Abnormal Electrolytes Parameters
Hyperkalemia: All Grades
|
166 Participants
|
|
Number of Participants With Abnormal Electrolytes Parameters
Hyperkalemia: Grades 3-4
|
10 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks)Population: Safety population. Here, 'Number Analyzed' = participants with available data for specified categories.
Renal and liver function parameters included: creatinine, hyperbilirubinemia, aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase. Number of participants with each of these parameters were analyzed by grades (All Grades and Grades 3-4) as per NCI CTCAE version 4.03, where Grade 1=mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening/disabling. All Grades included Grades 1-4.
Outcome measures
| Measure |
Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)
n=779 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.
|
|---|---|
|
Number of Participants With Abnormal Renal and Liver Function Parameters
Creatinine: All Grades
|
161 Participants
|
|
Number of Participants With Abnormal Renal and Liver Function Parameters
Creatinine: Grades 3-4
|
2 Participants
|
|
Number of Participants With Abnormal Renal and Liver Function Parameters
Hyperbilirubinemia: All Grades
|
130 Participants
|
|
Number of Participants With Abnormal Renal and Liver Function Parameters
Hyperbilirubinemia: Grades 3-4
|
9 Participants
|
|
Number of Participants With Abnormal Renal and Liver Function Parameters
AST: All Grades
|
342 Participants
|
|
Number of Participants With Abnormal Renal and Liver Function Parameters
AST: Grades 3-4
|
12 Participants
|
|
Number of Participants With Abnormal Renal and Liver Function Parameters
ALT: All Grades
|
270 Participants
|
|
Number of Participants With Abnormal Renal and Liver Function Parameters
ALT: Grades 3-4
|
10 Participants
|
|
Number of Participants With Abnormal Renal and Liver Function Parameters
Alkaline phosphatase: All Grades
|
465 Participants
|
|
Number of Participants With Abnormal Renal and Liver Function Parameters
Alkaline phosphatase: Grades 3-4
|
23 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks)Population: Safety population. Overall number of participants analyzed = participants evaluable for this outcome measure.
Creatinine clearance is a measure of kidney function. Creatinine clearance rate is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Creatinine clearance can be measured directly or estimated using established formulas. For this study, the creatinine clearance was calculated using the Cockroft-Gault or Modification of Diet in Renal Disease (MDRD).
Outcome measures
| Measure |
Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)
n=312 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.
|
|---|---|
|
Creatinine Clearance of Aflibercept Plus FOLFIRI
|
71.4 mL/min
Standard Deviation 29.3
|
PRIMARY outcome
Timeframe: Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks)Population: Safety population. Here, 'Number Analyzed' = participants with available data for specified categories.
Other abnormal biochemistry parameters included: hypoglycemia, hyperglycemia and hypoalbuminemia. Number of participants with each of these parameters were analyzed by grades (All Grades and Grades 3-4) as per NCI CTCAE Version 4.03, where Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening/disabling. All Grades included Grades 1-4.
Outcome measures
| Measure |
Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)
n=779 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.
|
|---|---|
|
Number of Participants With Other Abnormal Biochemistry Parameters
Hypoglycemia: All Grades
|
90 Participants
|
|
Number of Participants With Other Abnormal Biochemistry Parameters
Hypoglycemia: Grades 3-4
|
6 Participants
|
|
Number of Participants With Other Abnormal Biochemistry Parameters
Hyperglycemia: All Grades
|
403 Participants
|
|
Number of Participants With Other Abnormal Biochemistry Parameters
Hyperglycemia: Grades 3-4
|
30 Participants
|
|
Number of Participants With Other Abnormal Biochemistry Parameters
Hypoalbuminemia: All Grades
|
241 Participants
|
|
Number of Participants With Other Abnormal Biochemistry Parameters
Hypoalbuminemia: Grades 3-4
|
6 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks)Population: Safety population. Here, 'Number Analyzed = participants with available data for specified categories.
Non-gradeable biochemistry parameters included; chloride, urea, total protein, blood urea nitrogen (BUN) and lactate dehydrogenase (LDH). Number of participants with \<lower limit of normal ranges (LLN) and \>upper limit of normal ranges (ULN) for each of these parameters were reported.
Outcome measures
| Measure |
Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)
n=779 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.
|
|---|---|
|
Number of Participants With Abnormal Non-Gradable Biochemistry Parameters
Chloride<LLN
|
135 Participants
|
|
Number of Participants With Abnormal Non-Gradable Biochemistry Parameters
Chloride>ULN
|
217 Participants
|
|
Number of Participants With Abnormal Non-Gradable Biochemistry Parameters
BUN<LLN
|
41 Participants
|
|
Number of Participants With Abnormal Non-Gradable Biochemistry Parameters
BUN>ULN
|
83 Participants
|
|
Number of Participants With Abnormal Non-Gradable Biochemistry Parameters
UREA<LLN
|
60 Participants
|
|
Number of Participants With Abnormal Non-Gradable Biochemistry Parameters
UREA>ULN
|
250 Participants
|
|
Number of Participants With Abnormal Non-Gradable Biochemistry Parameters
LDH<LLN
|
79 Participants
|
|
Number of Participants With Abnormal Non-Gradable Biochemistry Parameters
LDH>ULN
|
423 Participants
|
|
Number of Participants With Abnormal Non-Gradable Biochemistry Parameters
Total proteins<LLN
|
162 Participants
|
|
Number of Participants With Abnormal Non-Gradable Biochemistry Parameters
Total proteins>ULN
|
77 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks)Population: Safety population.
Proteinuria is defined as the ratio of protein to creatinine. Number of participants with proteinuria were analyzed by grades (Grades 1, 2, 3 ,4) as per NCI CTCAE Version 4.03 where Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening/disabling.
Outcome measures
| Measure |
Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)
n=779 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.
|
|---|---|
|
Number of Participants With Proteinuria Events
Grade 1
|
286 Participants
|
|
Number of Participants With Proteinuria Events
Grade 2
|
123 Participants
|
|
Number of Participants With Proteinuria Events
Grade 3
|
54 Participants
|
|
Number of Participants With Proteinuria Events
Grade 4
|
5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks)Population: Safety population
Proteinuria is defined as the ratio of protein to creatinine. Number of participants with proteinuria grade \>=2 (graded as per NCI CTCAE Version 4.03), where Grade\>=2 represents moderate to life-threatening/disabling event.
Outcome measures
| Measure |
Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)
n=779 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.
|
|---|---|
|
Number of Participants With Proteinuria Grade >=2
|
182 participants
|
PRIMARY outcome
Timeframe: Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks)Population: Safety population. Here, 'Number Analyzed = participants with available data for specified categories.
Urinary protein creatinine ratio (UPCR) corresponds to the ratio of the urinary protein and urinary creatinine concentration (expressed in mg/dL). This ratio provides an accurate quantification of 24-hours urinary protein excretion. There is a high correlation between morning UPCR and 24-hour proteinuria in participants with normal or reduced renal functions. Normal ratio is \< or = 1.
Outcome measures
| Measure |
Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)
n=779 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.
|
|---|---|
|
Number of Participants With Urinary Protein-Creatinine Ratio (UPCR)
UPCR<=1
|
265 Participants
|
|
Number of Participants With Urinary Protein-Creatinine Ratio (UPCR)
UPCR>=1 to <=2
|
51 Participants
|
|
Number of Participants With Urinary Protein-Creatinine Ratio (UPCR)
UPCR>=2 to <=3
|
24 Participants
|
|
Number of Participants With Urinary Protein-Creatinine Ratio (UPCR)
UPCR>3
|
27 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks)Population: Safety population.
Proteinuria is defined as the presence of excess proteins in the urine (assessed either by spot sample, dipstick/ urine protein or 24 hour urine collection). Hematuria is defined as the presence of blood in urine (positive dipstick for RBC or reported AE). Number of participants with proteinuria grade \>=2 (graded as per NCI CTCAE Version 4.03), where Grade\>=2 represents moderate to life-threatening/disabling event. Hypertension (high blood pressure) is defined as having a blood pressure reading of more than 140/90 mmHg over a number of weeks.
Outcome measures
| Measure |
Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)
n=779 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.
|
|---|---|
|
Number of Participants With Proteinuria (Grade>=2) Concomitant With Hematuria and /or Hypertension
Proteinuria with hematuria
|
72 Participants
|
|
Number of Participants With Proteinuria (Grade>=2) Concomitant With Hematuria and /or Hypertension
Proteinuria with hypertension
|
4 Participants
|
|
Number of Participants With Proteinuria (Grade>=2) Concomitant With Hematuria and /or Hypertension
Proteinuria with hematuria and hypertension
|
3 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks)Population: Safety population defined as the participants who signed the informed consent form and received at least one dose of study treatment.
A theoretical cycle is a 2 week period i.e. 14 days. A cycle is delayed if duration of previous cycle is greater than 14+2 days ; dose modification includes dose reduction and dose omission.
Outcome measures
| Measure |
Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)
n=779 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.
|
|---|---|
|
Number of Participants With Cycle Delay and/or Dose Modification
No delay and no dose modification
|
119 Participants
|
|
Number of Participants With Cycle Delay and/or Dose Modification
Any delay and/or dose modification
|
660 Participants
|
|
Number of Participants With Cycle Delay and/or Dose Modification
Delay only
|
163 Participants
|
|
Number of Participants With Cycle Delay and/or Dose Modification
Delay and Aflibercept modified
|
39 Participants
|
|
Number of Participants With Cycle Delay and/or Dose Modification
Delay and FOLFIRI modified
|
308 Participants
|
|
Number of Participants With Cycle Delay and/or Dose Modification
Delay and Aflibercept and Folfiri modified
|
97 Participants
|
|
Number of Participants With Cycle Delay and/or Dose Modification
Only Aflibercept modified
|
5 Participants
|
|
Number of Participants With Cycle Delay and/or Dose Modification
Only FOLFIRI modified
|
43 Participants
|
|
Number of Participants With Cycle Delay and/or Dose Modification
Both Aflibercept and FOLFIRI modified
|
5 Participants
|
SECONDARY outcome
Timeframe: Pre-dose at Baseline, Day 1 of every odd cycle (from Cycle 3 to 35); at the end of treatment (EOT) (within 30 days of last treatment) (maximum exposure: 214 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, 'Number Analyzed' = participants analyzed at specified timepoints.
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 favourable outcome with a best quality of life for participant.
Outcome measures
| Measure |
Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)
n=636 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.
|
|---|---|
|
Mean 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 Score): Global Health Status
Baseline
|
68.61 units on a scale
Standard Deviation 20.48
|
|
Mean 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 Score): Global Health Status
Change at Cycle 3
|
-3.34 units on a scale
Standard Deviation 18.83
|
|
Mean 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 Score): Global Health Status
Change at Cycle 5
|
-4.70 units on a scale
Standard Deviation 18.89
|
|
Mean 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 Score): Global Health Status
Change at Cycle 7
|
-3.63 units on a scale
Standard Deviation 22.02
|
|
Mean 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 Score): Global Health Status
Change at Cycle 9
|
-3.97 units on a scale
Standard Deviation 21.31
|
|
Mean 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 Score): Global Health Status
Change at Cycle 11
|
-5.85 units on a scale
Standard Deviation 22.26
|
|
Mean 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 Score): Global Health Status
Change at Cycle 13
|
-2.26 units on a scale
Standard Deviation 21.69
|
|
Mean 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 Score): Global Health Status
Change at Cycle 15
|
-3.05 units on a scale
Standard Deviation 22.46
|
|
Mean 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 Score): Global Health Status
Change at Cycle 17
|
-1.18 units on a scale
Standard Deviation 22.50
|
|
Mean 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 Score): Global Health Status
Change at Cycle 19
|
-2.36 units on a scale
Standard Deviation 22.92
|
|
Mean 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 Score): Global Health Status
Change at Cycle 21
|
-5.56 units on a scale
Standard Deviation 23.77
|
|
Mean 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 Score): Global Health Status
Change at Cycle 23
|
-6.86 units on a scale
Standard Deviation 19.94
|
|
Mean 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 Score): Global Health Status
Change at Cycle 25
|
-8.05 units on a scale
Standard Deviation 16.89
|
|
Mean 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 Score): Global Health Status
Change at Cycle 27
|
-10.14 units on a scale
Standard Deviation 17.58
|
|
Mean 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 Score): Global Health Status
Change at Cycle 29
|
-8.33 units on a scale
Standard Deviation 14.05
|
|
Mean 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 Score): Global Health Status
Change at Cycle 31
|
-9.44 units on a scale
Standard Deviation 16.92
|
|
Mean 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 Score): Global Health Status
Change at Cycle 33
|
-11.36 units on a scale
Standard Deviation 21.82
|
|
Mean 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 Score): Global Health Status
Change at Cycle 35
|
-5.83 units on a scale
Standard Deviation 20.81
|
|
Mean 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 Score): Global Health Status
Change at EOT
|
-8.82 units on a scale
Standard Deviation 23.95
|
SECONDARY outcome
Timeframe: Pre-dose at Baseline, Day 1 of every odd cycle (from Cycle 3 to 35); at EOT (within 30 days of last treatment) (maximum exposure: 214 weeks)Population: EORTC QLQ-C30 analysis population. Here, 'Number Analyzed' = participants analyzed at specified timepoints.
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 favourable outcome with a best quality of life for participant.
Outcome measures
| Measure |
Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)
n=636 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.
|
|---|---|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Emotional - Change at Cycle 5
|
0.74 units on a scale
Standard Deviation 19.32
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Cognitive - Change at Cycle 17
|
-3.45 units on a scale
Standard Deviation 19.38
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Social - Change at Cycle 13
|
-5.56 units on a scale
Standard Deviation 24.03
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Social - Change at Cycle 33
|
-1.52 units on a scale
Standard Deviation 17.41
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Physical - Change at Cycle 7
|
-4.62 units on a scale
Standard Deviation 16.23
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Physical - Change at Cycle 9
|
-4.36 units on a scale
Standard Deviation 15.79
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Physical - Change at Cycle 11
|
-6.99 units on a scale
Standard Deviation 17.89
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Physical - Change at Cycle 13
|
-4.99 units on a scale
Standard Deviation 16.17
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Physical - Change at Cycle 15
|
-3.54 units on a scale
Standard Deviation 15.99
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Physical - Change at Cycle 17
|
-5.10 units on a scale
Standard Deviation 16.20
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Physical - Change at Cycle 19
|
-5.68 units on a scale
Standard Deviation 16.23
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Physical - Change at Cycle 21
|
-5.70 units on a scale
Standard Deviation 13.01
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Physical - Change at Cycle 23
|
-7.87 units on a scale
Standard Deviation 14.38
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Physical - Change at Cycle 25
|
-5.75 units on a scale
Standard Deviation 12.18
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Physical - Change at Cycle 27
|
-6.59 units on a scale
Standard Deviation 11.64
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Physical - Change at Cycle 29
|
-7.67 units on a scale
Standard Deviation 11.09
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Physical - Change at Cycle 31
|
-9.33 units on a scale
Standard Deviation 14.65
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Physical - Change at Cycle 33
|
-5.45 units on a scale
Standard Deviation 9.81
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Physical - Change at Cycle 35
|
-10.00 units on a scale
Standard Deviation 13.05
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Physical - Change at EOT
|
-11.16 units on a scale
Standard Deviation 21.65
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Role - Baseline
|
79.91 units on a scale
Standard Deviation 26.25
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Role - Change at Cycle 3
|
-6.26 units on a scale
Standard Deviation 25.22
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Role - Change at Cycle 5
|
-5.66 units on a scale
Standard Deviation 23.26
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Role - Change at Cycle 7
|
-6.68 units on a scale
Standard Deviation 24.29
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Role - Change at Cycle 9
|
-6.55 units on a scale
Standard Deviation 23.95
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Role - Change at Cycle 11
|
-8.76 units on a scale
Standard Deviation 26.35
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Role - Change at Cycle 13
|
-7.36 units on a scale
Standard Deviation 23.41
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Role - Change at Cycle 15
|
-7.18 units on a scale
Standard Deviation 21.98
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Role - Change at Cycle 17
|
-9.58 units on a scale
Standard Deviation 22.54
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Role - Change at Cycle 19
|
-9.84 units on a scale
Standard Deviation 22.44
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Role - Change at Cycle 21
|
-9.78 units on a scale
Standard Deviation 18.11
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Role - Change at Cycle 23
|
-10.65 units on a scale
Standard Deviation 18.32
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Role - Change at Cycle 25
|
-10.92 units on a scale
Standard Deviation 17.97
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Role - Change at Cycle 27
|
-10.14 units on a scale
Standard Deviation 17.22
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Role - Change at Cycle 29
|
-10.83 units on a scale
Standard Deviation 17.33
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Role - Change at Cycle 31
|
-14.44 units on a scale
Standard Deviation 18.76
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Role - Change at Cycle 33
|
-15.15 units on a scale
Standard Deviation 15.73
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Role - Change at Cycle 35
|
-15.00 units on a scale
Standard Deviation 16.57
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Role - Change at EOT
|
-12.11 units on a scale
Standard Deviation 28.22
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Emotional - Baseline
|
78.96 units on a scale
Standard Deviation 20.60
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Emotional - Change at Cycle 3
|
1.14 units on a scale
Standard Deviation 19.95
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Physical - Baseline
|
81.79 units on a scale
Standard Deviation 19.41
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Physical - Change at Cycle 3
|
-3.73 units on a scale
Standard Deviation 15.15
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Physical - Change at Cycle 5
|
-3.95 units on a scale
Standard Deviation 15.22
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Emotional - Change at Cycle 7
|
1.58 units on a scale
Standard Deviation 20.91
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Emotional - Change at Cycle 9
|
1.69 units on a scale
Standard Deviation 21.38
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Emotional - Change at Cycle 11
|
0.08 units on a scale
Standard Deviation 20.40
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Emotional - Change at Cycle 13
|
0.93 units on a scale
Standard Deviation 20.08
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Emotional - Change at Cycle 15
|
2.51 units on a scale
Standard Deviation 20.23
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Emotional - Change at Cycle 17
|
2.91 units on a scale
Standard Deviation 18.23
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Emotional - Change at Cycle 19
|
1.39 units on a scale
Standard Deviation 17.60
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Emotional - Change at Cycle 21
|
0.06 units on a scale
Standard Deviation 17.86
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Emotional - Change at Cycle 23
|
1.75 units on a scale
Standard Deviation 19.29
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Emotional - Change at Cycle 25
|
4.98 units on a scale
Standard Deviation 15.86
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Emotional - Change at Cycle 27
|
1.57 units on a scale
Standard Deviation 17.64
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Emotional - Change at Cycle 29
|
2.64 units on a scale
Standard Deviation 17.88
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Emotional - Change at Cycle 31
|
1.30 units on a scale
Standard Deviation 17.78
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Emotional - Change at Cycle 33
|
0.25 units on a scale
Standard Deviation 3.82
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Emotional - Change at Cycle 35
|
-0.00 units on a scale
Standard Deviation 5.56
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Emotional - Change at EOT
|
-2.87 units on a scale
Standard Deviation 22.52
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Cognitive - Baseline
|
86.90 units on a scale
Standard Deviation 19.26
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Cognitive - Change at Cycle 3
|
-1.77 units on a scale
Standard Deviation 16.92
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Cognitive - Change at Cycle 5
|
-1.87 units on a scale
Standard Deviation 16.58
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Cognitive - Change at Cycle 7
|
-1.99 units on a scale
Standard Deviation 19.71
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Cognitive - Change at Cycle 9
|
-2.18 units on a scale
Standard Deviation 20.17
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Cognitive - Change at Cycle 11
|
-4.27 units on a scale
Standard Deviation 20.29
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Cognitive - Change at Cycle 13
|
-2.83 units on a scale
Standard Deviation 17.40
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Cognitive - Change at Cycle 15
|
-2.28 units on a scale
Standard Deviation 19.40
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Cognitive - Change at Cycle 19
|
-5.00 units on a scale
Standard Deviation 22.19
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Cognitive - Change at Cycle 21
|
-5.56 units on a scale
Standard Deviation 16.28
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Cognitive - Change at Cycle 23
|
-5.71 units on a scale
Standard Deviation 14.54
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Cognitive - Change at Cycle 25
|
-6.90 units on a scale
Standard Deviation 21.14
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Cognitive - Change at Cycle 27
|
-5.80 units on a scale
Standard Deviation 16.37
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Cognitive - Change at Cycle 29
|
-6.67 units on a scale
Standard Deviation 18.26
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Cognitive - Change at Cycle 31
|
-5.56 units on a scale
Standard Deviation 15.00
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Cognitive - Change at Cycle 33
|
-10.61 units on a scale
Standard Deviation 17.12
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Cognitive - Change at Cycle 35
|
-11.67 units on a scale
Standard Deviation 13.72
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Cognitive- Change at EOT
|
-4.98 units on a scale
Standard Deviation 22.67
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Social - Baseline
|
80.57 units on a scale
Standard Deviation 24.68
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Social - Change at Cycle 3
|
-2.05 units on a scale
Standard Deviation 22.83
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Social - Change at Cycle 5
|
-2.86 units on a scale
Standard Deviation 21.60
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Social - Change at Cycle 7
|
-4.78 units on a scale
Standard Deviation 23.65
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Social - Change at Cycle 9
|
-4.56 units on a scale
Standard Deviation 23.84
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Social - Change at Cycle 11
|
-7.09 units on a scale
Standard Deviation 24.83
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Social - Change at Cycle 15
|
-6.18 units on a scale
Standard Deviation 23.23
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Social - Change at Cycle 17
|
-5.56 units on a scale
Standard Deviation 22.69
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Social - Change at Cycle 19
|
-5.28 units on a scale
Standard Deviation 22.02
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Social - Change at Cycle 21
|
-5.56 units on a scale
Standard Deviation 21.61
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Social - Change at Cycle 23
|
-7.62 units on a scale
Standard Deviation 17.78
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Social - Change at Cycle 25
|
-4.60 units on a scale
Standard Deviation 18.31
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Social - Change at Cycle 27
|
-2.17 units on a scale
Standard Deviation 17.63
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Social - Change at Cycle 29
|
-5.00 units on a scale
Standard Deviation 18.81
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Social - Change at Cycle 31
|
-7.78 units on a scale
Standard Deviation 25.09
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Social - Change at Cycle 35
|
-1.67 units on a scale
Standard Deviation 14.59
|
|
Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales
Social - Change at EOT
|
-9.01 units on a scale
Standard Deviation 26.23
|
SECONDARY outcome
Timeframe: Pre-dose at Baseline, Day 1 of every odd cycle (from Cycle 3 to 35); at EOT (within 30 days of last treatment) (maximum exposure: 214 weeks)Population: EORTC QLQ-C30 analysis population. Here, "Number Analyzed = participants analyzed at specified timepoints.
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=636 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 EORTC QLQ-C30 Score: Symptom Scales
Insomnia - Change at Cycle 3
|
0.37 units on a scale
Standard Deviation 27.36
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Appetite loss - Change at Cycle 7
|
9.84 units on a scale
Standard Deviation 27.80
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Appetite loss - Change at Cycle 29
|
15.00 units on a scale
Standard Deviation 20.16
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Constipation - Baseline
|
12.71 units on a scale
Standard Deviation 21.61
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Diarrhoea - Baseline
|
10.37 units on a scale
Standard Deviation 19.47
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Diarrhoea - Change at Cycle 19
|
15.25 units on a scale
Standard Deviation 25.76
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Financial difficulties - Change at Cycle 21
|
4.44 units on a scale
Standard Deviation 25.23
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Fatigue - Baseline
|
29.16 units on a scale
Standard Deviation 23.48
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Fatigue - Change at Cycle 3
|
7.35 units on a scale
Standard Deviation 21.62
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Fatigue - Change at Cycle 5
|
8.40 units on a scale
Standard Deviation 21.88
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Fatigue - Change at Cycle 7
|
9.54 units on a scale
Standard Deviation 22.60
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Fatigue - Change at Cycle 9
|
7.89 units on a scale
Standard Deviation 21.80
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Fatigue - Change at Cycle 11
|
11.30 units on a scale
Standard Deviation 23.73
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Fatigue - Change at Cycle 13
|
8.33 units on a scale
Standard Deviation 21.72
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Fatigue - Change at Cycle 15
|
7.41 units on a scale
Standard Deviation 22.38
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Fatigue - Change at Cycle 17
|
6.70 units on a scale
Standard Deviation 21.25
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Fatigue - Change at Cycle 19
|
8.93 units on a scale
Standard Deviation 19.83
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Fatigue - Change at Cycle 21
|
10.39 units on a scale
Standard Deviation 17.90
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Fatigue - Change at Cycle 23
|
10.80 units on a scale
Standard Deviation 18.49
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Fatigue - Change at Cycle 25
|
7.66 units on a scale
Standard Deviation 19.94
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Fatigue - Change at Cycle 27
|
9.66 units on a scale
Standard Deviation 18.74
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Fatigue - Change at Cycle 29
|
11.67 units on a scale
Standard Deviation 18.55
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Fatigue - Change at Cycle 31
|
14.07 units on a scale
Standard Deviation 21.61
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Fatigue - Change at Cycle 33
|
15.15 units on a scale
Standard Deviation 21.81
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Fatigue - Change at Cycle 35
|
14.44 units on a scale
Standard Deviation 18.92
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Fatigue - Change at EOT
|
12.31 units on a scale
Standard Deviation 25.56
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Nausea and Vomiting - Baseline
|
5.88 units on a scale
Standard Deviation 13.99
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Nausea and Vomiting - Change at Cycle 3
|
6.68 units on a scale
Standard Deviation 19.81
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Nausea and Vomiting - Change at Cycle 5
|
6.98 units on a scale
Standard Deviation 19.79
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Nausea and Vomiting - Change at Cycle 7
|
6.61 units on a scale
Standard Deviation 18.07
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Nausea and Vomiting - Change at Cycle 9
|
6.20 units on a scale
Standard Deviation 19.68
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Nausea and Vomiting - Change at Cycle 11
|
8.97 units on a scale
Standard Deviation 19.83
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Nausea and Vomiting - Change at Cycle 13
|
6.82 units on a scale
Standard Deviation 14.71
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Nausea and Vomiting - Change at Cycle 15
|
6.85 units on a scale
Standard Deviation 16.33
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Nausea and Vomiting - Change at Cycle 17
|
3.45 units on a scale
Standard Deviation 15.49
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Nausea and Vomiting - Change at Cycle 19
|
6.56 units on a scale
Standard Deviation 14.04
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Nausea and Vomiting - Change at Cycle 21
|
3.99 units on a scale
Standard Deviation 14.14
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Nausea and Vomiting - Change at Cycle 23
|
7.87 units on a scale
Standard Deviation 10.90
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Nausea and Vomiting - Change at Cycle 25
|
4.02 units on a scale
Standard Deviation 8.52
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Nausea and Vomiting - Change at Cycle 27
|
7.25 units on a scale
Standard Deviation 11.04
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Nausea and Vomiting - Change at Cycle 29
|
1.67 units on a scale
Standard Deviation 5.13
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Nausea and Vomiting - Change at Cycle 31
|
13.33 units on a scale
Standard Deviation 28.31
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Nausea and Vomiting - Change at Cycle 33
|
3.03 units on a scale
Standard Deviation 6.74
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Nausea and Vomiting - Change at Cycle 35
|
3.33 units on a scale
Standard Deviation 7.03
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Nausea and Vomiting - Change at EOT
|
6.64 units on a scale
Standard Deviation 21.11
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Pain - Baseline
|
20.47 units on a scale
Standard Deviation 25.08
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Pain - Change at Cycle 3
|
2.68 units on a scale
Standard Deviation 25.02
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Pain - Change at Cycle 5
|
2.52 units on a scale
Standard Deviation 23.48
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Pain - Change at Cycle 7
|
3.00 units on a scale
Standard Deviation 24.98
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Pain - Change at Cycle 9
|
2.72 units on a scale
Standard Deviation 24.45
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Pain - Change at Cycle 11
|
6.64 units on a scale
Standard Deviation 23.68
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Pain - Change at Cycle 13
|
5.16 units on a scale
Standard Deviation 19.79
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Pain - Change at Cycle 15
|
7.26 units on a scale
Standard Deviation 21.91
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Pain - Change at Cycle 17
|
9.39 units on a scale
Standard Deviation 22.97
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Pain - Change at Cycle 19
|
8.74 units on a scale
Standard Deviation 22.28
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Pain - Change at Cycle 21
|
7.25 units on a scale
Standard Deviation 18.14
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Pain - Change at Cycle 23
|
8.33 units on a scale
Standard Deviation 19.31
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Pain - Change at Cycle 25
|
5.75 units on a scale
Standard Deviation 21.02
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Pain - Change at Cycle 27
|
5.07 units on a scale
Standard Deviation 17.72
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Pain - Change at Cycle 29
|
4.17 units on a scale
Standard Deviation 16.11
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Pain - Change at Cycle 31
|
10.00 units on a scale
Standard Deviation 23.40
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Pain - Change at Cycle 33
|
7.58 units on a scale
Standard Deviation 22.81
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Pain - Change at Cycle 35
|
6.67 units on a scale
Standard Deviation 21.08
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Pain - Change at EOT
|
10.85 units on a scale
Standard Deviation 28.99
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Dyspnoea - Baseline
|
13.45 units on a scale
Standard Deviation 22.01
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Dyspnoea - Change at Cycle 3
|
3.63 units on a scale
Standard Deviation 22.96
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Dyspnoea - Change at Cycle 5
|
5.75 units on a scale
Standard Deviation 24.06
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Dyspnoea - Change at Cycle 7
|
6.98 units on a scale
Standard Deviation 24.47
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Dyspnoea - Change at Cycle 9
|
6.89 units on a scale
Standard Deviation 24.38
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Dyspnoea - Change at Cycle 11
|
8.19 units on a scale
Standard Deviation 26.59
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Dyspnoea - Change at Cycle 13
|
6.36 units on a scale
Standard Deviation 25.37
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Dyspnoea - Change at Cycle 15
|
3.58 units on a scale
Standard Deviation 24.65
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Dyspnoea - Change at Cycle 17
|
5.16 units on a scale
Standard Deviation 24.54
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Dyspnoea - Change at Cycle 19
|
6.78 units on a scale
Standard Deviation 26.82
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Dyspnoea - Change at Cycle 21
|
3.79 units on a scale
Standard Deviation 22.98
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Dyspnoea - Change at Cycle 23
|
4.04 units on a scale
Standard Deviation 20.00
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Dyspnoea - Change at Cycle 25
|
1.23 units on a scale
Standard Deviation 21.64
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Dyspnoea - Change at Cycle 27
|
3.03 units on a scale
Standard Deviation 22.79
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Dyspnoea - Change at Cycle 29
|
-1.75 units on a scale
Standard Deviation 23.50
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Dyspnoea - Change at Cycle 31
|
16.67 units on a scale
Standard Deviation 28.50
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Dyspnoea - Change at Cycle 33
|
16.67 units on a scale
Standard Deviation 17.57
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Dyspnoea - Change at Cycle 35
|
16.67 units on a scale
Standard Deviation 23.57
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Dyspnoea - Change at EOT
|
6.53 units on a scale
Standard Deviation 25.79
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Insomnia - Baseline
|
24.15 units on a scale
Standard Deviation 28.09
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Insomnia - Change at Cycle 5
|
-0.08 units on a scale
Standard Deviation 28.48
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Insomnia - Change at Cycle 7
|
-2.37 units on a scale
Standard Deviation 29.63
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Insomnia - Change at Cycle 9
|
-0.24 units on a scale
Standard Deviation 29.37
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Insomnia - Change at Cycle 11
|
2.56 units on a scale
Standard Deviation 28.86
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Insomnia - Change at Cycle 13
|
0.65 units on a scale
Standard Deviation 26.89
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Insomnia - Change at Cycle 15
|
-2.19 units on a scale
Standard Deviation 27.01
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Insomnia - Change at Cycle 17
|
-1.92 units on a scale
Standard Deviation 25.60
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Insomnia - Change at Cycle 19
|
1.64 units on a scale
Standard Deviation 23.12
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Insomnia - Change at Cycle 21
|
0.74 units on a scale
Standard Deviation 25.11
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Insomnia - Change at Cycle 23
|
-0.93 units on a scale
Standard Deviation 33.32
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Insomnia - Change at Cycle 25
|
-0.00 units on a scale
Standard Deviation 28.17
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Insomnia - Change at Cycle 27
|
-1.52 units on a scale
Standard Deviation 24.07
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Insomnia - Change at Cycle 29
|
-3.33 units on a scale
Standard Deviation 30.40
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Insomnia - Change at Cycle 31
|
-4.44 units on a scale
Standard Deviation 41.53
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Insomnia - Change at Cycle 33
|
-6.06 units on a scale
Standard Deviation 32.72
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Insomnia - Change at Cycle 35
|
-3.33 units on a scale
Standard Deviation 33.15
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Insomnia - Change at EOT
|
5.31 units on a scale
Standard Deviation 32.50
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Appetite loss - Baseline
|
17.38 units on a scale
Standard Deviation 26.01
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Appetite loss - Change at Cycle 3
|
9.10 units on a scale
Standard Deviation 28.64
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Appetite loss - Change at Cycle 5
|
9.02 units on a scale
Standard Deviation 28.14
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Appetite loss - Change at Cycle 9
|
9.98 units on a scale
Standard Deviation 27.18
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Appetite loss - Change at Cycle 11
|
14.53 units on a scale
Standard Deviation 28.27
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Appetite loss - Change at Cycle 13
|
10.67 units on a scale
Standard Deviation 27.12
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Appetite loss - Change at Cycle 15
|
10.74 units on a scale
Standard Deviation 25.90
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Appetite loss - Change at Cycle 17
|
8.91 units on a scale
Standard Deviation 24.75
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Appetite loss - Change at Cycle 19
|
9.84 units on a scale
Standard Deviation 24.60
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Appetite loss - Change at Cycle 21
|
13.04 units on a scale
Standard Deviation 25.80
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Appetite loss - Change at Cycle 23
|
12.38 units on a scale
Standard Deviation 25.67
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Appetite loss - Change at Cycle 25
|
11.49 units on a scale
Standard Deviation 20.46
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Appetite loss - Change at Cycle 27
|
15.94 units on a scale
Standard Deviation 22.18
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Appetite loss - Change at Cycle 31
|
15.56 units on a scale
Standard Deviation 24.77
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Appetite loss - Change at Cycle 33
|
15.15 units on a scale
Standard Deviation 22.92
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Appetite loss - Change at Cycle 35
|
16.67 units on a scale
Standard Deviation 17.57
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Appetite loss - Change at EOT
|
12.03 units on a scale
Standard Deviation 33.48
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Constipation - Change at Cycle 3
|
2.42 units on a scale
Standard Deviation 25.25
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Constipation - Change at Cycle 5
|
3.77 units on a scale
Standard Deviation 26.52
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Constipation - Change at Cycle 7
|
2.63 units on a scale
Standard Deviation 26.09
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Constipation - Change at Cycle 9
|
5.35 units on a scale
Standard Deviation 26.68
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Constipation - Change at Cycle 11
|
4.42 units on a scale
Standard Deviation 26.47
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Constipation - Change at Cycle 13
|
4.58 units on a scale
Standard Deviation 25.95
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Constipation - Change at Cycle 15
|
4.92 units on a scale
Standard Deviation 26.30
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Constipation - Change at Cycle 17
|
5.43 units on a scale
Standard Deviation 23.35
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Constipation - Change at Cycle 19
|
8.33 units on a scale
Standard Deviation 21.81
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Constipation - Change at Cycle 21
|
6.06 units on a scale
Standard Deviation 18.00
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Constipation - Change at Cycle 23
|
9.26 units on a scale
Standard Deviation 21.98
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Constipation - Change at Cycle 25
|
5.75 units on a scale
Standard Deviation 17.97
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Constipation - Change at Cycle 27
|
1.45 units on a scale
Standard Deviation 12.22
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Constipation - Change at Cycle 29
|
6.67 units on a scale
Standard Deviation 20.52
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Constipation - Change at Cycle 31
|
22.22 units on a scale
Standard Deviation 32.53
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Constipation - Change at Cycle 33
|
12.12 units on a scale
Standard Deviation 16.82
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Constipation - Change at Cycle 35
|
10.00 units on a scale
Standard Deviation 16.10
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Constipation - Change at EOT
|
3.78 units on a scale
Standard Deviation 27.33
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Diarrhoea - Change at Cycle 3
|
11.72 units on a scale
Standard Deviation 28.16
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Diarrhoea - Change at Cycle 5
|
10.85 units on a scale
Standard Deviation 28.29
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Diarrhoea - Change at Cycle 7
|
14.63 units on a scale
Standard Deviation 29.94
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Diarrhoea - Change at Cycle 9
|
11.44 units on a scale
Standard Deviation 26.44
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Diarrhoea - Change at Cycle 11
|
15.46 units on a scale
Standard Deviation 27.26
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Diarrhoea - Change at Cycle 13
|
11.26 units on a scale
Standard Deviation 24.00
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Diarrhoea - Change at Cycle 15
|
11.02 units on a scale
Standard Deviation 28.02
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Diarrhoea - Change at Cycle 17
|
10.34 units on a scale
Standard Deviation 21.75
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Diarrhoea - Change at Cycle 21
|
14.07 units on a scale
Standard Deviation 24.09
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Diarrhoea - Change at Cycle 23
|
18.52 units on a scale
Standard Deviation 21.74
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Diarrhoea - Change at Cycle 25
|
10.34 units on a scale
Standard Deviation 22.01
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Diarrhoea - Change at Cycle 27
|
13.64 units on a scale
Standard Deviation 19.68
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Diarrhoea - Change at Cycle 29
|
16.67 units on a scale
Standard Deviation 25.36
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Diarrhoea - Change at Cycle 31
|
20.00 units on a scale
Standard Deviation 24.56
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Diarrhoea - Change at Cycle 33
|
18.18 units on a scale
Standard Deviation 22.92
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Diarrhoea - Change at Cycle 35
|
30.00 units on a scale
Standard Deviation 18.92
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Diarrhoea - Change at EOT
|
7.31 units on a scale
Standard Deviation 24.26
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Financial difficulties - Baseline
|
20.12 units on a scale
Standard Deviation 30.25
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Financial difficulties - Change at Cycle 3
|
-1.83 units on a scale
Standard Deviation 23.80
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Financial difficulties - Change at Cycle 5
|
-1.32 units on a scale
Standard Deviation 24.00
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Financial difficulties - Change at Cycle 7
|
-0.99 units on a scale
Standard Deviation 27.68
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Financial difficulties - Change at Cycle 9
|
-0.49 units on a scale
Standard Deviation 26.80
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Financial difficulties - Change at Cycle 11
|
3.30 units on a scale
Standard Deviation 25.64
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Financial difficulties - Change at Cycle 13
|
1.11 units on a scale
Standard Deviation 27.96
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Financial difficulties - Change at Cycle 15
|
-0.27 units on a scale
Standard Deviation 27.94
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Financial difficulties - Change at Cycle 17
|
0.77 units on a scale
Standard Deviation 27.36
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Financial difficulties - Change at Cycle 19
|
1.67 units on a scale
Standard Deviation 29.70
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Financial difficulties - Change at Cycle 23
|
2.94 units on a scale
Standard Deviation 23.74
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Financial difficulties - Change at Cycle 25
|
-4.60 units on a scale
Standard Deviation 19.36
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Financial difficulties - Change at Cycle 27
|
-2.90 units on a scale
Standard Deviation 24.44
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Financial difficulties - Change at Cycle 29
|
0.00 units on a scale
Standard Deviation 21.63
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Financial difficulties - Change at Cycle 31
|
-2.22 units on a scale
Standard Deviation 19.79
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Financial difficulties - Change at Cycle 33
|
-3.03 units on a scale
Standard Deviation 17.98
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Financial difficulties - Change at Cycle 35
|
0.00 units on a scale
Standard Deviation 15.71
|
|
Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales
Financial difficulties - Change at EOT
|
2.97 units on a scale
Standard Deviation 27.90
|
SECONDARY outcome
Timeframe: Pre-dose at Baseline, Day 1 of every odd cycle (from Cycle 3 to 35); at EOT (within 30 days of last treatment) (maximum exposure: 214 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, 'Number Analyzed' = participants analyzed at specified timepoints.
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=623 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 Quality of Life: Single Index Utility Score
Change at Cycle 7
|
-0.04 units on a scale
Standard Deviation 0.23
|
|
Change From Baseline in HRQL EQ-5D-3L Quality of Life: Single Index Utility Score
Change at Cycle 9
|
-0.05 units on a scale
Standard Deviation 0.24
|
|
Change From Baseline in HRQL EQ-5D-3L Quality of Life: Single Index Utility Score
Change at Cycle 13
|
-0.05 units on a scale
Standard Deviation 0.20
|
|
Change From Baseline in HRQL EQ-5D-3L Quality of Life: Single Index Utility Score
Baseline
|
0.77 units on a scale
Standard Deviation 0.24
|
|
Change From Baseline in HRQL EQ-5D-3L Quality of Life: Single Index Utility Score
Change at Cycle 3
|
-0.02 units on a scale
Standard Deviation 0.23
|
|
Change From Baseline in HRQL EQ-5D-3L Quality of Life: Single Index Utility Score
Change at Cycle 5
|
-0.03 units on a scale
Standard Deviation 0.22
|
|
Change From Baseline in HRQL EQ-5D-3L Quality of Life: Single Index Utility Score
Change at Cycle 11
|
-0.07 units on a scale
Standard Deviation 0.25
|
|
Change From Baseline in HRQL EQ-5D-3L Quality of Life: Single Index Utility Score
Change at Cycle 15
|
-0.06 units on a scale
Standard Deviation 0.23
|
|
Change From Baseline in HRQL EQ-5D-3L Quality of Life: Single Index Utility Score
Change at Cycle 17
|
-0.05 units on a scale
Standard Deviation 0.24
|
|
Change From Baseline in HRQL EQ-5D-3L Quality of Life: Single Index Utility Score
Change at Cycle 19
|
-0.05 units on a scale
Standard Deviation 0.18
|
|
Change From Baseline in HRQL EQ-5D-3L Quality of Life: Single Index Utility Score
Change at Cycle 21
|
-0.09 units on a scale
Standard Deviation 0.20
|
|
Change From Baseline in HRQL EQ-5D-3L Quality of Life: Single Index Utility Score
Change at Cycle 23
|
-0.14 units on a scale
Standard Deviation 0.26
|
|
Change From Baseline in HRQL EQ-5D-3L Quality of Life: Single Index Utility Score
Change at Cycle 25
|
-0.08 units on a scale
Standard Deviation 0.21
|
|
Change From Baseline in HRQL EQ-5D-3L Quality of Life: Single Index Utility Score
Change at Cycle 27
|
-0.08 units on a scale
Standard Deviation 0.21
|
|
Change From Baseline in HRQL EQ-5D-3L Quality of Life: Single Index Utility Score
Change at Cycle 29
|
-0.08 units on a scale
Standard Deviation 0.20
|
|
Change From Baseline in HRQL EQ-5D-3L Quality of Life: Single Index Utility Score
Change at Cycle 31
|
-0.12 units on a scale
Standard Deviation 0.30
|
|
Change From Baseline in HRQL EQ-5D-3L Quality of Life: Single Index Utility Score
Change at Cycle 33
|
0.02 units on a scale
Standard Deviation 0.14
|
|
Change From Baseline in HRQL EQ-5D-3L Quality of Life: Single Index Utility Score
Change at Cycle 35
|
-0.05 units on a scale
Standard Deviation 0.14
|
|
Change From Baseline in HRQL EQ-5D-3L Quality of Life: Single Index Utility Score
Change at EOT
|
-0.11 units on a scale
Standard Deviation 0.30
|
SECONDARY outcome
Timeframe: Pre-dose at Baseline, Day 1 of every odd cycle (from Cycle 3 to 35); at EOT (within 30 days of last treatment) (maximum exposure: 214 weeks)Population: EQ-5D analysis population. Here, 'Number Analyzed' = participants analyzed at specified timepoints.
EQ-5D was a standardized HRQL questionnaire consisting of EQ-5D descriptive system and 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. The VAS recorded the respondent's self-rated health on a vertical visual analogue scale. The VAS 'thermometer' has endpoints of 100 (Best imaginable health state) at the top and 0 (Worst imaginable health state) at the bottom. This information can be used as a quantitative measure of health outcome as judged by the individual respondents.
Outcome measures
| Measure |
Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)
n=623 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
Change at Cycle 35
|
-8.88 units on a scale
Standard Deviation 11.53
|
|
Change From Baseline in HRQL EQ-5D-3L VAS Score
Change at EOT
|
-6.67 units on a scale
Standard Deviation 17.38
|
|
Change From Baseline in HRQL EQ-5D-3L VAS Score
Baseline
|
72.81 units on a scale
Standard Deviation 18.28
|
|
Change From Baseline in HRQL EQ-5D-3L VAS Score
Change at Cycle 3
|
-1.85 units on a scale
Standard Deviation 15.35
|
|
Change From Baseline in HRQL EQ-5D-3L VAS Score
Change at Cycle 5
|
-2.15 units on a scale
Standard Deviation 14.31
|
|
Change From Baseline in HRQL EQ-5D-3L VAS Score
Change at Cycle 7
|
-2.20 units on a scale
Standard Deviation 16.33
|
|
Change From Baseline in HRQL EQ-5D-3L VAS Score
Change at Cycle 9
|
-2.74 units on a scale
Standard Deviation 14.28
|
|
Change From Baseline in HRQL EQ-5D-3L VAS Score
Change at Cycle 11
|
-3.10 units on a scale
Standard Deviation 14.40
|
|
Change From Baseline in HRQL EQ-5D-3L VAS Score
Change at Cycle 13
|
-2.36 units on a scale
Standard Deviation 15.29
|
|
Change From Baseline in HRQL EQ-5D-3L VAS Score
Change at Cycle 15
|
-1.05 units on a scale
Standard Deviation 15.51
|
|
Change From Baseline in HRQL EQ-5D-3L VAS Score
Change at Cycle 17
|
-1.91 units on a scale
Standard Deviation 13.54
|
|
Change From Baseline in HRQL EQ-5D-3L VAS Score
Change at Cycle 19
|
-3.06 units on a scale
Standard Deviation 13.85
|
|
Change From Baseline in HRQL EQ-5D-3L VAS Score
Change at Cycle 21
|
-2.13 units on a scale
Standard Deviation 14.98
|
|
Change From Baseline in HRQL EQ-5D-3L VAS Score
Change at Cycle 23
|
-5.77 units on a scale
Standard Deviation 13.50
|
|
Change From Baseline in HRQL EQ-5D-3L VAS Score
Change at Cycle 25
|
-7.28 units on a scale
Standard Deviation 10.53
|
|
Change From Baseline in HRQL EQ-5D-3L VAS Score
Change at Cycle 27
|
-4.94 units on a scale
Standard Deviation 8.68
|
|
Change From Baseline in HRQL EQ-5D-3L VAS Score
Change at Cycle 29
|
-8.80 units on a scale
Standard Deviation 10.12
|
|
Change From Baseline in HRQL EQ-5D-3L VAS Score
Change at Cycle 31
|
-6.69 units on a scale
Standard Deviation 12.61
|
|
Change From Baseline in HRQL EQ-5D-3L VAS Score
Change at Cycle 33
|
-7.90 units on a scale
Standard Deviation 13.08
|
Adverse Events
Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)
Serious events: 272 serious events
Other events: 744 other events
Deaths: 48 deaths
Serious adverse events
| Measure |
Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)
n=779 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.
|
|---|---|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.90%
7/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
1.5%
12/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.8%
14/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Blood and lymphatic system disorders
Thrombotic Microangiopathy
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.26%
2/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Cardiac disorders
Angina Pectoris
|
0.26%
2/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Cardiac disorders
Atrial Flutter
|
0.26%
2/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Cardiac disorders
Atrial Thrombosis
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Cardiac disorders
Cardiac Failure
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Cardiac disorders
Coronary Artery Thrombosis
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.26%
2/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Eye disorders
Retinal Detachment
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.0%
8/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.51%
4/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Anal Fissure
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Anal Fistula
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Anorectal Ulcer
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Ascites
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Colitis
|
0.26%
2/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Constipation
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
39/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Duodenal Ulcer Haemorrhage
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Enteritis
|
0.26%
2/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Enterocutaneous Fistula
|
0.51%
4/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Enterovesical Fistula
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Faecaloma
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Fistula Of Small Intestine
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Gastrointestinal Fistula
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Gastrointestinal Hypomotility
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Gastrointestinal Perforation
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Gingival Bleeding
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Haematemesis
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.26%
2/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Haemorrhoids Thrombosed
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Ileus
|
0.26%
2/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Ileus Paralytic
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
1.5%
12/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Intestinal Perforation
|
0.51%
4/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Large Intestine Perforation
|
0.51%
4/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Lower Gastrointestinal Haemorrhage
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Melaena
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Nausea
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Odynophagia
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Proctalgia
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Proctitis
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.26%
2/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Rectal Perforation
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Rectal Tenesmus
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.51%
4/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Stomatitis
|
1.2%
9/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Subileus
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Vomiting
|
1.3%
10/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
General disorders
Asthenia
|
0.26%
2/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
General disorders
Chest Pain
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
General disorders
Disease Progression
|
3.0%
23/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
General disorders
Fatigue
|
0.51%
4/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
General disorders
General Physical Health Deterioration
|
0.64%
5/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
General disorders
Malaise
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
General disorders
Multiple Organ Dysfunction Syndrome
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
General disorders
Pain
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
General disorders
Pyrexia
|
1.5%
12/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
General disorders
Sudden Death
|
0.26%
2/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Hepatobiliary disorders
Cholangitis
|
0.26%
2/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.26%
2/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Hepatobiliary disorders
Cholestasis
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Hepatobiliary disorders
Hepatic Failure
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Hepatobiliary disorders
Jaundice Cholestatic
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Hepatobiliary disorders
Portal Hypertension
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Immune system disorders
Anaphylactic Shock
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Infections and infestations
Abdominal Abscess
|
0.26%
2/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Infections and infestations
Abdominal Infection
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Infections and infestations
Abdominal Wall Abscess
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Infections and infestations
Bronchitis
|
0.39%
3/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Infections and infestations
Catheter Site Abscess
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Infections and infestations
Device Related Infection
|
0.90%
7/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Infections and infestations
Diabetic Foot Infection
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Infections and infestations
Escherichia Urinary Tract Infection
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Infections and infestations
Febrile Infection
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Infections and infestations
Gastroenteritis
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Infections and infestations
Gastroenteritis Escherichia Coli
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Infections and infestations
Herpes Zoster
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Infections and infestations
Herpes Zoster Meningoencephalitis
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Infections and infestations
Infection
|
0.64%
5/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Infections and infestations
Infective Myositis
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Infections and infestations
Klebsiella Infection
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Infections and infestations
Localised Infection
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.39%
3/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Infections and infestations
Lung Infection
|
0.39%
3/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Infections and infestations
Neutropenic Infection
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Infections and infestations
Neutropenic Sepsis
|
0.39%
3/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Infections and infestations
Parainfluenzae Virus Infection
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Infections and infestations
Pelvic Abscess
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Infections and infestations
Periodontitis
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Infections and infestations
Pharyngitis
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Infections and infestations
Phlebitis Infective
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Infections and infestations
Pneumonia
|
1.0%
8/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Infections and infestations
Pyelonephritis
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Infections and infestations
Rectal Abscess
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Infections and infestations
Respiratory Tract Infection
|
0.39%
3/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Infections and infestations
Sepsis
|
0.90%
7/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Infections and infestations
Septic Shock
|
0.26%
2/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Infections and infestations
Sinusitis
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Infections and infestations
Streptococcal Bacteraemia
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Infections and infestations
Tracheobronchitis
|
0.26%
2/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Infections and infestations
Tuberculosis
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Infections and infestations
Urinary Tract Infection
|
0.64%
5/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Infections and infestations
Urosepsis
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Accidental Exposure To Product
|
0.26%
2/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Accidental Overdose
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Anastomotic Leak
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Contrast Media Reaction
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Gastrointestinal Stoma Complication
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Meniscus Injury
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Stoma Site Haemorrhage
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Investigations
Alanine Aminotransferase Increased
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.64%
5/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.26%
2/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer Pain
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases To Central Nervous System
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour Associated Fever
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Nervous system disorders
Dizziness
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Nervous system disorders
Encephalopathy
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Nervous system disorders
Generalised Tonic-Clonic Seizure
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Nervous system disorders
Headache
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Nervous system disorders
Paraparesis
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Nervous system disorders
Posterior Reversible Encephalopathy Syndrome
|
0.39%
3/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Nervous system disorders
Subarachnoid Haemorrhage
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Nervous system disorders
White Matter Lesion
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Product Issues
Thrombosis In Device
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Psychiatric disorders
Confusional State
|
0.51%
4/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.39%
3/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.39%
3/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Renal and urinary disorders
Nephrotic Syndrome
|
0.64%
5/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Renal and urinary disorders
Prerenal Failure
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Renal and urinary disorders
Proteinuria
|
0.26%
2/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Renal and urinary disorders
Urinary Retention
|
0.26%
2/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Pulmonary Oedema
|
0.26%
2/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.51%
4/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.26%
2/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.26%
2/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.26%
2/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Aspiration
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
1.2%
9/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Haemorrhage
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.26%
2/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Thoracic Haemorrhage
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Surgical and medical procedures
Cancer Surgery
|
0.26%
2/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.51%
4/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Vascular disorders
Hypertension
|
1.4%
11/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Vascular disorders
Hypotension
|
0.26%
2/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Vascular disorders
Orthostatic Hypotension
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Vascular disorders
Peripheral Ischaemia
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Vascular disorders
Vena Cava Thrombosis
|
0.13%
1/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
Other adverse events
| Measure |
Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)
n=779 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.
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
35.6%
277/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Abdominal Pain
|
19.3%
150/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
8.6%
67/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Constipation
|
19.0%
148/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Diarrhoea
|
59.6%
464/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Nausea
|
43.3%
337/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Proctalgia
|
5.0%
39/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Stomatitis
|
42.2%
329/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Vomiting
|
24.4%
190/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
General disorders
Asthenia
|
24.6%
192/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
General disorders
Fatigue
|
36.3%
283/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
General disorders
Pyrexia
|
11.2%
87/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Investigations
Weight Decreased
|
22.0%
171/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
26.4%
206/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
6.0%
47/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Nervous system disorders
Headache
|
13.5%
105/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Psychiatric disorders
Insomnia
|
6.9%
54/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Renal and urinary disorders
Proteinuria
|
13.1%
102/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.3%
57/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
16.8%
131/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.0%
62/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
19.6%
153/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
18.4%
143/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysaesthesia Syndrome
|
10.1%
79/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
|
Vascular disorders
Hypertension
|
47.4%
369/779 • All AEs were collected from signature of the informed consent form up to the final visit (214 weeks) 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 \[either aflibercept or FOLFIRI\]). Analysis was performed on safety population.
|
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