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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-005724-17 | |||
| U1111-1125-8949 | Other Identifier | UTN |
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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
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Primary Objective:
To provide metastatic colorectal cancer participants with access to aflibercept and to document the overall safety in these participants
Secondary Objective:
To document the Health-Related Quality of Life of aflibercept in this participants population
Each participants will be treated until disease progression, unacceptable toxicity, death, Investigator's decision or participant's refusal for further treatment (whichever comes first). Participants were followed-up during study treatment and for at least 30 days after last administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | Experimental | 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-Fluorouracil (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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AFLIBERCEPT AVE0005 | Drug | Pharmaceutical form:Concentrate for solution for infusion Route of administration: Intravenous |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 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. | Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) |
| Number of Participants With Abnormal Hematological Parameters | 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. | Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) |
| Number of Participants With International Normalized Ratio (INR) | 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. | Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) |
| Number of Participants With Abnormal Electrolytes Parameters |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. |
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Inclusion criteria :
Exclusion criteria:
The above information wass not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number 840-002 | Muscle Shoals | Alabama | 35661 | United States | ||
| Investigational Site Number 840-008 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31221542 | Derived | Riechelmann RP, Srimuninnimit V, Bordonaro R, Kavan P, Di Bartolomeo M, Maiello E, Cicin I, Garcia-Alfonso P, Chau I, Fedyanin MY, Martos CF, Ter-Ovanesov M, Peeters M, Ko YJ, Yalcin S, Karthaus M, Aparicio J, Heinemann V, Picard P, Bury D, Drea E, Sobrero A. Aflibercept Plus FOLFIRI for Second-line Treatment of Metastatic Colorectal Cancer: Observations from the Global Aflibercept Safety and Health-Related Quality-of-Life Program (ASQoP). Clin Colorectal Cancer. 2019 Sep;18(3):183-191.e3. doi: 10.1016/j.clcc.2019.05.003. Epub 2019 May 15. |
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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]).
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 10, 2012 | Jan 29, 2018 |
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| FOLFIRI | Drug | irinotecan, 5-FU and leucovorin |
|
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. |
| Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) |
| Number of Participants With Abnormal Renal and Liver Function Parameters | 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. | Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) |
| Creatinine Clearance of Aflibercept Plus FOLFIRI | 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). | Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) |
| Number of Participants With Other Abnormal Biochemistry Parameters | 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. | Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) |
| Number of Participants With Abnormal Non-Gradable Biochemistry Parameters | 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. | Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) |
| Number of Participants With Proteinuria Events | 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. | Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) |
| Number of Participants With Proteinuria Grade >=2 | 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. | Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) |
| Number of Participants With Urinary Protein-Creatinine Ratio (UPCR) | 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. | Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) |
| Number of Participants With Proteinuria (Grade>=2) Concomitant With Hematuria and /or Hypertension | 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. | Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) |
| Number of Participants With Cycle Delay and/or Dose Modification | 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. | Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) |
| 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) |
| Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales | 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. | 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) |
| Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales | 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. | 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) |
| Change From Baseline in HRQL EQ-5D-3L Quality of Life: Single Index Utility Score | 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. | 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) |
| Change From Baseline in HRQL EQ-5D-3L VAS Score | 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. | 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) |
| Corona |
| California |
| 92879 |
| United States |
| Investigational Site Number 840-007 | Fountain Valley | California | 92708 | United States |
| Investigational Site Number 840-004 | Riverside | California | 92501 | United States |
| Investigational Site Number 840-006 | Indianapolis | Indiana | 46254 | United States |
| Investigational Site Number 840-011 | Metairie | Louisiana | 70006 | United States |
| Investigational Site Number 840-001 | Rockville | Maryland | 20850 | United States |
| Investigational Site Number 840-010 | Howell Township | New Jersey | 07731 | United States |
| Investigational Site Number 840-012 | Albuquerque | New Mexico | 87106 | United States |
| Investigational Site Number 840-009 | Farmington | New Mexico | 87401 | United States |
| Investigational Site Number 840-003 | Lake Success | New York | 11042 | United States |
| Investigational Site Number 840-005 | Middletown | Ohio | 45042 | United States |
| Investigational Site Number 056010 | Aalst | 9300 | Belgium |
| Investigational Site Number 056015 | Arlon | 6700 | Belgium |
| Investigational Site Number 056004 | Bonheiden | 2820 | Belgium |
| Investigational Site Number 056001 | Edegem | 2650 | Belgium |
| Investigational Site Number 056012 | Ghent | 9000 | Belgium |
| Investigational Site Number 056009 | Haine-Saint-Paul | 7100 | Belgium |
| Investigational Site Number 056003 | Liège | 4000 | Belgium |
| Investigational Site Number 056007 | Liège | 4000 | Belgium |
| Investigational Site Number 056014 | Loverval | 6280 | Belgium |
| Investigational Site Number 056013 | Turnhout | 2300 | Belgium |
| Investigational Site Number 056002 | Verviers | 4800 | Belgium |
| Investigational Site Number 056011 | Yvoir | 5530 | Belgium |
| Investigational Site Number 008 | Brasília | 70390-150 | Brazil |
| Investigational Site Number 009 | Curitiba | 80530-010 | Brazil |
| Investigational Site Number 012 | Fortaleza | Brazil |
| Investigational Site Number 006 | Passo Fundo | 99010-260 | Brazil |
| Investigational Site Number 003 | Porto Alegre | 90470-340 | Brazil |
| Investigational Site Number 002 | Rio de Janeiro | 22793-080 | Brazil |
| Investigational Site Number 011 | Salvador | 40170-070 | Brazil |
| Investigational Site Number 013 | São José do Rio Preto | 15090-000 | Brazil |
| Investigational Site Number 001 | São Paulo | 01246-000 | Brazil |
| Investigational Site Number 004 | São Paulo | 01308-050 | Brazil |
| Investigational Site Number 005 | São Paulo | 01321-000 | Brazil |
| Investigational Site Number 124002 | Calgary | T2N 4N2 | Canada |
| Investigational Site Number 124003 | Montreal | H1T 2M4 | Canada |
| Investigational Site Number 124005 | Montreal | H2W1S6 | Canada |
| Investigational Site Number 124004 | Ottawa | K1H8L6 | Canada |
| Investigational Site Number 124006 | Québec | G1S4L8 | Canada |
| Investigational Site Number 124001 | Toronto | M4N3M5 | Canada |
| Investigational Site Number 152001 | Santiago | Chile |
| Investigational Site Number 152003 | Santiago | Chile |
| Investigational Site Number 203005 | Brno | 65653 | Czechia |
| Investigational Site Number 203003 | Olomouc | 77900 | Czechia |
| Investigational Site Number 203001 | Ostrava | 70852 | Czechia |
| Investigational Site Number 203002 | Prague | 12808 | Czechia |
| Investigational Site Number 203004 | Prague | 15006 | Czechia |
| Investigational Site Number 203006 | Zlín | Czechia |
| Investigational Site Number 208001 | Cph Ø | 2100 | Denmark |
| Investigational Site Number 208003 | Hillerød | 3400 | Denmark |
| Investigational Site Number 208002 | Odense C | 5000 | Denmark |
| Investigational Site Number 246001 | Oulu | 90220 | Finland |
| Investigational Site Number 246002 | Turku | 20520 | Finland |
| Investigational Site Number 276-016 | Aschaffenburg | 63739 | Germany |
| Investigational Site Number 276-010 | Augsburg | 86150 | Germany |
| Investigational Site Number 276-011 | Berlin | 10707 | Germany |
| Investigational Site Number 276-012 | Erlangen | 91054 | Germany |
| Investigational Site Number 276-009 | Frankfurt am Main | 60389 | Germany |
| Investigational Site Number 276-013 | Frankfurt am Main | 60590 | Germany |
| Investigational Site Number 276-004 | Halle | 06120 | Germany |
| Investigational Site Number 276-007 | Krefeld | 47805 | Germany |
| Investigational Site Number 276-003 | Lebach | 66822 | Germany |
| Investigational Site Number 276-019 | Leipzig | 04103 | Germany |
| Investigational Site Number 276-008 | Ludwigsburg | 71640 | Germany |
| Investigational Site Number 276-018 | Magdeburg | 39104 | Germany |
| Investigational Site Number 276-014 | Magdeburg | 39130 | Germany |
| Investigational Site Number 276-006 | Moers | 47441 | Germany |
| Investigational Site Number 276-001 | München | 81377 | Germany |
| Investigational Site Number 276-002 | München | 81737 | Germany |
| Investigational Site Number 276-015 | Northeim | 37154 | Germany |
| Investigational Site Number 276-017 | Velbert | 42551 | Germany |
| Investigational Site Number 276-005 | Weiden/Oberpfalz | 92637 | Germany |
| Investigational Site Number 276-020 | Wolfsburg | 38440 | Germany |
| Investigational Site Number 372002 | Dublin | Ireland |
| Investigational Site Number 372004 | Galway | Ireland |
| Investigational Site Number 372001 | Wilton | Ireland |
| Investigational Site Number 376002 | Haifa | 31096 | Israel |
| Investigational Site Number 376001 | Jerusalem | 91120 | Israel |
| Investigational Site Number 376005 | Petah Tikva | 49100 | Israel |
| Investigational Site Number 376003 | Tel Aviv | 64239 | Israel |
| Investigational Site Number 376004 | Tel Litwinsky | 52621 | Israel |
| Investigational Site Number 380-005 | Ancona | 60100 | Italy |
| Investigational Site Number 380-029 | Bergamo | 24128 | Italy |
| Investigational Site Number 380-021 | Bologna | 40133 | Italy |
| Investigational Site Number 380-004 | Brescia | Italy |
| Investigational Site Number 380-007 | Candiolo | Italy |
| Investigational Site Number 380-012 | Catania | Italy |
| Investigational Site Number 380-019 | Catanzaro | Italy |
| Investigational Site Number 380-023 | Florence | Italy |
| Investigational Site Number 380-001 | Genova | 16132 | Italy |
| Investigational Site Number 380-014 | Meldola | Italy |
| Investigational Site Number 380-016 | Messina | Italy |
| Investigational Site Number 380-013 | Milan | Italy |
| Investigational Site Number 380-015 | Milan | Italy |
| Investigational Site Number 380-025 | Milan | Italy |
| Investigational Site Number 380-022 | Naples | Italy |
| Investigational Site Number 380-028 | Novara | Italy |
| Investigational Site Number 380-017 | Padova | Italy |
| Investigational Site Number 380-002 | Pisa | Italy |
| Investigational Site Number 380-008 | Reggio Emilia | 42125 | Italy |
| Investigational Site Number 380-024 | Roma | 00189 | Italy |
| Investigational Site Number 380-010 | Roma | Italy |
| Investigational Site Number 380-011 | Roma | Italy |
| Investigational Site Number 380-006 | San Giovanni Rotondo | Italy |
| Investigational Site Number 380-026 | Sassari | Italy |
| Investigational Site Number 380-020 | Terni | Italy |
| Investigational Site Number 380-009 | Torino | Italy |
| Investigational Site Number 380-003 | Udine | Italy |
| Investigational Site Number 380-018 | Verona | Italy |
| Investigational Site Number 1 | Beirut | Lebanon |
| Investigational Site Number 484002 | Mexico City | 06760 | Mexico |
| Investigational Site Number 484009 | Mexico City | 57205 | Mexico |
| Investigational Site Number 484010 | México, D.F. | 06726 | Mexico |
| Investigational Site Number 484001 | Monterrey | 64060 | Mexico |
| Investigational Site Number 528001 | Hoofddorp | 2134TM | Netherlands |
| Investigational Site Number 528002 | Zwolle | 8025AB | Netherlands |
| Investigational Site Number 578002 | Bergen | 5021 | Norway |
| Investigational Site Number 578001 | Oslo | 0407 | Norway |
| Investigational Site Number 630-001 | Rio Peidras | 927 | Puerto Rico |
| Investigational Site Number 643003 | Kazan' | 420029 | Russia |
| Investigational Site Number 643001 | Moscow | 115478 | Russia |
| Investigational Site Number 643004 | Moscow | 115478 | Russia |
| Investigational Site Number 643005 | Moscow | 115478 | Russia |
| Investigational Site Number 643002 | Moscow | 123448 | Russia |
| Investigational Site Number 643006 | Moscow | 129301 | Russia |
| Investigational Site Number 643009 | Saint Petersburg | 186646 | Russia |
| Investigational Site Number 724016 | Alicante | 03010 | Spain |
| Investigational Site Number 724008 | Barakaldo | 48903 | Spain |
| Investigational Site Number 724012 | Cáceres | 10003 | Spain |
| Investigational Site Number 724002 | Córdoba | 14004 | Spain |
| Investigational Site Number 724013 | Donostia / San Sebastian | 20014 | Spain |
| Investigational Site Number 724014 | L'Hospitalet de Llobregat | 08907 | Spain |
| Investigational Site Number 724003 | Madrid | 28007 | Spain |
| Investigational Site Number 724015 | Madrid | 28034 | Spain |
| Investigational Site Number 724005 | Madrid | 28041 | Spain |
| Investigational Site Number 724004 | Málaga | 29010 | Spain |
| Investigational Site Number 724010 | Sabadell | 08208 | Spain |
| Investigational Site Number 724011 | Santander | 39008 | Spain |
| Investigational Site Number 724006 | Santiago de Compostela | 15706 | Spain |
| Investigational Site Number 724001 | Valencia | 46009 | Spain |
| Investigational Site Number 724009 | Valencia | 46009 | Spain |
| Investigational Site Number 724007 | Zaragoza | 50009 | Spain |
| Investigational Site Number 752_002 | Jönköping | 55185 | Sweden |
| Investigational Site Number 752_001 | Vaxjo | 35185 | Sweden |
| Investigational Site Number 764002 | Bangkok | 10330 | Thailand |
| Investigational Site Number 764003 | Bangkok | 10400 | Thailand |
| Investigational Site Number 764008 | Bangkok | 10400 | Thailand |
| Investigational Site Number 764001 | Bangkok | Thailand |
| Investigational Site Number 764006 | Bangkok | Thailand |
| Investigational Site Number 764005 | Bangkok,TH | Thailand |
| Investigational Site Number 764009 | Chiang Mai | 50200 | Thailand |
| Investigational Site Number 764004 | Khon Kaen | 40002 | Thailand |
| Investigational Site Number 764010 | Laksi | 10210 | Thailand |
| Investigational Site Number 764007 | Lopburi | 15000 | Thailand |
| Investigational Site Number 792-06 | Adana | 01250 | Turkey (Türkiye) |
| Investigational Site Number 792-01 | Ankara | 06100 | Turkey (Türkiye) |
| Investigational Site Number 792-09 | Ankara | 06200 | Turkey (Türkiye) |
| Investigational Site Number 792-08 | Ankara | Turkey (Türkiye) |
| Investigational Site Number 792-02 | Çapa | 34390 | Turkey (Türkiye) |
| Investigational Site Number 792010 | Edirne | Turkey (Türkiye) |
| Investigational Site Number 792-05 | Gaziantep | Turkey (Türkiye) |
| Investigational Site Number 792012 | Istanbul | 34093 | Turkey (Türkiye) |
| Investigational Site Number 792-03 | Istanbul | 34865 | Turkey (Türkiye) |
| Investigational Site Number 792-04 | Istanbul | Turkey (Türkiye) |
| Investigational Site Number 792-007 | Izmir | 35100 | Turkey (Türkiye) |
| Investigational Site Number 792011 | Izmir | Turkey (Türkiye) |
| Investigational Site Number 826005 | Dudley | DY1 2HQ | United Kingdom |
| Investigational Site Number 826011 | Hull | HU165JQ | United Kingdom |
| Investigational Site Number 826008 | Leicester | LE15WW | United Kingdom |
| Investigational Site Number 826007 | London | NW1 2PJ | United Kingdom |
| Investigational Site Number 826012 | London | SE17EH | United Kingdom |
| Investigational Site Number 826003 | Maidstone | ME169QQ | United Kingdom |
| Investigational Site Number 826009 | Manchester | M204BX | United Kingdom |
| Investigational Site Number 826004 | Newcastle upon Tyne | NE77DN | United Kingdom |
| Investigational Site Number 826006 | Northwood | HA62RN | United Kingdom |
| Investigational Site Number 826002 | Southampton | SO60YD | United Kingdom |
| Investigational Site Number 826001 | Sutton | SM25PT | United Kingdom |
| Investigational Site Number 826010 | Taunton | TA15DA | United Kingdom |
| Safety Population | Participants who signed informed consent form and received at least part of one dose of treatment. |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
Safety population defined as the participants who signed the informed consent form and received at least part of one dose of study treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Body Surface Area (BSA) | Mean | Standard Deviation | m^2 |
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| Systolic Blood Pressure | Number of participants analyzed = participants with available data for specified measure. | Mean | Standard Deviation | mmHg |
| ||||||||||||||||
| Diastolic Blood Pressure | Number of participants analyzed = participants with available data for specified measure. | Mean | Standard Deviation | mmHg |
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| Any Relevant Medical/Surgical History | Any relevant medical/surgical history including detailed cardiovascular risk factors and prior vascular events if any. | Count of Participants | Participants |
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| History of Thrombovascular Event and/or Presence of Cardiovascular Risk Factor | Count of Participants | Participants |
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| Time From Initial Histological Diagnosis till Baseline Visit | Mean | Standard Deviation | Months |
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| Location of Primary Tumor | Count of Participants | Participants |
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| Histology | Count of Participants | Participants |
| ||||||||||||||||||
| Organs with Metastases at Baseline | Count of Participants | Participants |
| ||||||||||||||||||
| Eastern Cooperative Oncology Group Performance Status (ECOG PS) | ECOG PS is used to assess how the disease affects the daily living abilities of the participant. It ranges on the scale from 0-5 (0= normal activity; 1= symptoms but ambulatory; 2= in bed for less than (<) 50 percent (%) of the time; 3= in bed for greater than (>) 50% of the time; 4= 100% bedridden; 5= dead. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 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. | Safety population defined as the participants who signed the informed consent form and received at least part of one dose of study treatment. | Posted | Count of Participants | Participants | Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) |
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| Primary | Number of Participants With Abnormal Hematological Parameters | 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. | Safety population. Here, 'Number Analyzed = participants with available data for specified categories. | Posted | Count of Participants | Participants | Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) |
|
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| Primary | Number of Participants With International Normalized Ratio (INR) | 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. | Safety population. Here, 'Number Analyzed' = participants with available data for specified categories. | Posted | Count of Participants | Participants | Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) |
|
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| Primary | Number of Participants With Abnormal Electrolytes Parameters | 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. | Safety population. Here, 'Number Analyzed' = participants with available data for specified categories. | Posted | Count of Participants | Participants | Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) |
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| Primary | Number of Participants With Abnormal Renal and Liver Function Parameters | 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. | Safety population. Here, 'Number Analyzed' = participants with available data for specified categories. | Posted | Count of Participants | Participants | Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) |
|
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| Primary | Creatinine Clearance of Aflibercept Plus FOLFIRI | 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). | Safety population. Overall number of participants analyzed = participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mL/min | Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) |
|
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| Primary | Number of Participants With Other Abnormal Biochemistry Parameters | 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. | Safety population. Here, 'Number Analyzed' = participants with available data for specified categories. | Posted | Count of Participants | Participants | Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) |
|
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| Primary | Number of Participants With Abnormal Non-Gradable Biochemistry Parameters | 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. | Safety population. Here, 'Number Analyzed = participants with available data for specified categories. | Posted | Count of Participants | Participants | Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) |
|
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| Primary | Number of Participants With Proteinuria Events | 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. | Safety population. | Posted | Count of Participants | Participants | Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) |
|
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| Primary | Number of Participants With Proteinuria Grade >=2 | 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. | Safety population | Posted | Number | participants | Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) |
|
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| Primary | Number of Participants With Urinary Protein-Creatinine Ratio (UPCR) | 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. | Safety population. Here, 'Number Analyzed = participants with available data for specified categories. | Posted | Count of Participants | Participants | Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Proteinuria (Grade>=2) Concomitant With Hematuria and /or Hypertension | 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. | Safety population. | Posted | Count of Participants | Participants | Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) |
|
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| Primary | Number of Participants With Cycle Delay and/or Dose Modification | 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. | Safety population defined as the participants who signed the informed consent form and received at least one dose of study treatment. | Posted | Count of Participants | Participants | Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) |
|
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| Secondary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 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) |
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| Secondary | Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales | 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. | EORTC QLQ-C30 analysis population. Here, 'Number Analyzed' = participants analyzed at specified timepoints. | Posted | Mean | Standard Deviation | units on a scale | 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) |
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| Secondary | Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales | 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. | EORTC QLQ-C30 analysis population. Here, "Number Analyzed = participants analyzed at specified timepoints. | Posted | Mean | Standard Deviation | units on a scale | 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) |
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| Secondary | Change From Baseline in HRQL EQ-5D-3L Quality of Life: Single Index Utility Score | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 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) |
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| Secondary | Change From Baseline in HRQL EQ-5D-3L VAS Score | 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. | EQ-5D analysis population. Here, 'Number Analyzed' = participants analyzed at specified timepoints. | Posted | Mean | Standard Deviation | units on a scale | 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) |
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 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. | 48 | 779 | 272 | 779 | 744 | 779 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDra 19.0 | Systematic Assessment |
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| Febrile Neutropenia | Blood and lymphatic system disorders | MedDra 19.0 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDra 19.0 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDra 19.0 | Systematic Assessment |
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| Thrombotic Microangiopathy | Blood and lymphatic system disorders | MedDra 19.0 | Systematic Assessment |
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| Acute Myocardial Infarction | Cardiac disorders | MedDra 19.0 | Systematic Assessment |
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| Angina Pectoris | Cardiac disorders | MedDra 19.0 | Systematic Assessment |
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| Atrial Fibrillation | Cardiac disorders | MedDra 19.0 | Systematic Assessment |
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| Atrial Flutter | Cardiac disorders | MedDra 19.0 | Systematic Assessment |
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| Atrial Thrombosis | Cardiac disorders | MedDra 19.0 | Systematic Assessment |
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| Cardiac Failure | Cardiac disorders | MedDra 19.0 | Systematic Assessment |
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| Cardiac Failure Congestive | Cardiac disorders | MedDra 19.0 | Systematic Assessment |
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| Cardio-Respiratory Arrest | Cardiac disorders | MedDra 19.0 | Systematic Assessment |
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| Coronary Artery Thrombosis | Cardiac disorders | MedDra 19.0 | Systematic Assessment |
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| Supraventricular Tachycardia | Cardiac disorders | MedDra 19.0 | Systematic Assessment |
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| Ventricular Tachycardia | Cardiac disorders | MedDra 19.0 | Systematic Assessment |
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| Retinal Detachment | Eye disorders | MedDra 19.0 | Systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | MedDra 19.0 | Systematic Assessment |
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| Abdominal Pain Upper | Gastrointestinal disorders | MedDra 19.0 | Systematic Assessment |
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| Anal Fissure | Gastrointestinal disorders | MedDra 19.0 | Systematic Assessment |
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| Anal Fistula | Gastrointestinal disorders | MedDra 19.0 | Systematic Assessment |
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| Anorectal Ulcer | Gastrointestinal disorders | MedDra 19.0 | Systematic Assessment |
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| Ascites | Gastrointestinal disorders | MedDra 19.0 | Systematic Assessment |
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| Colitis | Gastrointestinal disorders | MedDra 19.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDra 19.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDra 19.0 | Systematic Assessment |
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| Duodenal Ulcer Haemorrhage | Gastrointestinal disorders | MedDra 19.0 | Systematic Assessment |
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| Enteritis | Gastrointestinal disorders | MedDra 19.0 | Systematic Assessment |
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| Enterocutaneous Fistula | Gastrointestinal disorders | MedDra 19.0 | Systematic Assessment |
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| Enterovesical Fistula | Gastrointestinal disorders | MedDra 19.0 | Systematic Assessment |
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| Faecaloma | Gastrointestinal disorders | MedDra 19.0 | Systematic Assessment |
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| Fistula Of Small Intestine | Gastrointestinal disorders | MedDra 19.0 | Systematic Assessment |
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| Gastrointestinal Fistula | Gastrointestinal disorders | MedDra 19.0 | Systematic Assessment |
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| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDra 19.0 | Systematic Assessment |
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| Gastrointestinal Hypomotility | Gastrointestinal disorders | MedDra 19.0 | Systematic Assessment |
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| Gastrointestinal Perforation | Gastrointestinal disorders | MedDra 19.0 | Systematic Assessment |
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| Gingival Bleeding | Gastrointestinal disorders | MedDra 19.0 | Systematic Assessment |
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| Haematemesis | Gastrointestinal disorders | MedDra 19.0 | Systematic Assessment |
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| Haemorrhoids | Gastrointestinal disorders | MedDra 19.0 | Systematic Assessment |
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| Haemorrhoids Thrombosed | Gastrointestinal disorders | MedDra 19.0 | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | MedDra 19.0 | Systematic Assessment |
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| Ileus Paralytic | Gastrointestinal disorders | MedDra 19.0 | Systematic Assessment |
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| Inguinal Hernia | Gastrointestinal disorders | MedDra 19.0 | Systematic Assessment |
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| Intestinal Obstruction | Gastrointestinal disorders | MedDra 19.0 | Systematic Assessment |
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| Intestinal Perforation | Gastrointestinal disorders | MedDra 19.0 | Systematic Assessment |
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| Large Intestine Perforation | Gastrointestinal disorders | MedDra 19.0 | Systematic Assessment |
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| Lower Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDra 19.0 | Systematic Assessment |
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| Melaena | Gastrointestinal disorders | MedDra 19.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDra 19.0 | Systematic Assessment |
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| Odynophagia | Gastrointestinal disorders | MedDra 19.0 | Systematic Assessment |
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| Oesophagitis | Gastrointestinal disorders | MedDra 19.0 | Systematic Assessment |
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| Proctalgia | Gastrointestinal disorders | MedDra 19.0 | Systematic Assessment |
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| Proctitis | Gastrointestinal disorders | MedDra 19.0 | Systematic Assessment |
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| Rectal Haemorrhage | Gastrointestinal disorders | MedDra 19.0 | Systematic Assessment |
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| Rectal Perforation | Gastrointestinal disorders | MedDra 19.0 | Systematic Assessment |
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| Rectal Tenesmus | Gastrointestinal disorders | MedDra 19.0 | Systematic Assessment |
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| Small Intestinal Obstruction | Gastrointestinal disorders | MedDra 19.0 | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDra 19.0 | Systematic Assessment |
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| Subileus | Gastrointestinal disorders | MedDra 19.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDra 19.0 | Systematic Assessment |
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| Asthenia | General disorders | MedDra 19.0 | Systematic Assessment |
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| Chest Pain | General disorders | MedDra 19.0 | Systematic Assessment |
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| Disease Progression | General disorders | MedDra 19.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDra 19.0 | Systematic Assessment |
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| General Physical Health Deterioration | General disorders | MedDra 19.0 | Systematic Assessment |
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| Malaise | General disorders | MedDra 19.0 | Systematic Assessment |
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| Multiple Organ Dysfunction Syndrome | General disorders | MedDra 19.0 | Systematic Assessment |
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| Pain | General disorders | MedDra 19.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDra 19.0 | Systematic Assessment |
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| Sudden Death | General disorders | MedDra 19.0 | Systematic Assessment |
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| Cholangitis | Hepatobiliary disorders | MedDra 19.0 | Systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | MedDra 19.0 | Systematic Assessment |
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| Cholecystitis Acute | Hepatobiliary disorders | MedDra 19.0 | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDra 19.0 | Systematic Assessment |
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| Cholestasis | Hepatobiliary disorders | MedDra 19.0 | Systematic Assessment |
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| Hepatic Failure | Hepatobiliary disorders | MedDra 19.0 | Systematic Assessment |
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| Jaundice Cholestatic | Hepatobiliary disorders | MedDra 19.0 | Systematic Assessment |
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| Portal Hypertension | Hepatobiliary disorders | MedDra 19.0 | Systematic Assessment |
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| Anaphylactic Shock | Immune system disorders | MedDra 19.0 | Systematic Assessment |
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| Abdominal Abscess | Infections and infestations | MedDra 19.0 | Systematic Assessment |
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| Abdominal Infection | Infections and infestations | MedDra 19.0 | Systematic Assessment |
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| Abdominal Wall Abscess | Infections and infestations | MedDra 19.0 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDra 19.0 | Systematic Assessment |
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| Catheter Site Abscess | Infections and infestations | MedDra 19.0 | Systematic Assessment |
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| Device Related Infection | Infections and infestations | MedDra 19.0 | Systematic Assessment |
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| Diabetic Foot Infection | Infections and infestations | MedDra 19.0 | Systematic Assessment |
| |
| Escherichia Urinary Tract Infection | Infections and infestations | MedDra 19.0 | Systematic Assessment |
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| Febrile Infection | Infections and infestations | MedDra 19.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDra 19.0 | Systematic Assessment |
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| Gastroenteritis Escherichia Coli | Infections and infestations | MedDra 19.0 | Systematic Assessment |
| |
| Herpes Zoster | Infections and infestations | MedDra 19.0 | Systematic Assessment |
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| Herpes Zoster Meningoencephalitis | Infections and infestations | MedDra 19.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDra 19.0 | Systematic Assessment |
| |
| Infective Myositis | Infections and infestations | MedDra 19.0 | Systematic Assessment |
| |
| Klebsiella Infection | Infections and infestations | MedDra 19.0 | Systematic Assessment |
| |
| Localised Infection | Infections and infestations | MedDra 19.0 | Systematic Assessment |
| |
| Lower Respiratory Tract Infection | Infections and infestations | MedDra 19.0 | Systematic Assessment |
| |
| Lung Infection | Infections and infestations | MedDra 19.0 | Systematic Assessment |
| |
| Neutropenic Infection | Infections and infestations | MedDra 19.0 | Systematic Assessment |
| |
| Neutropenic Sepsis | Infections and infestations | MedDra 19.0 | Systematic Assessment |
| |
| Parainfluenzae Virus Infection | Infections and infestations | MedDra 19.0 | Systematic Assessment |
| |
| Pelvic Abscess | Infections and infestations | MedDra 19.0 | Systematic Assessment |
| |
| Periodontitis | Infections and infestations | MedDra 19.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDra 19.0 | Systematic Assessment |
| |
| Phlebitis Infective | Infections and infestations | MedDra 19.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDra 19.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDra 19.0 | Systematic Assessment |
| |
| Rectal Abscess | Infections and infestations | MedDra 19.0 | Systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDra 19.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDra 19.0 | Systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDra 19.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDra 19.0 | Systematic Assessment |
| |
| Streptococcal Bacteraemia | Infections and infestations | MedDra 19.0 | Systematic Assessment |
| |
| Tracheobronchitis | Infections and infestations | MedDra 19.0 | Systematic Assessment |
| |
| Tuberculosis | Infections and infestations | MedDra 19.0 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDra 19.0 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDra 19.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDra 19.0 | Systematic Assessment |
| |
| Accidental Exposure To Product | Injury, poisoning and procedural complications | MedDra 19.0 | Systematic Assessment |
| |
| Accidental Overdose | Injury, poisoning and procedural complications | MedDra 19.0 | Systematic Assessment |
| |
| Anastomotic Leak | Injury, poisoning and procedural complications | MedDra 19.0 | Systematic Assessment |
| |
| Contrast Media Reaction | Injury, poisoning and procedural complications | MedDra 19.0 | Systematic Assessment |
| |
| Gastrointestinal Stoma Complication | Injury, poisoning and procedural complications | MedDra 19.0 | Systematic Assessment |
| |
| Hip Fracture | Injury, poisoning and procedural complications | MedDra 19.0 | Systematic Assessment |
| |
| Meniscus Injury | Injury, poisoning and procedural complications | MedDra 19.0 | Systematic Assessment |
| |
| Stoma Site Haemorrhage | Injury, poisoning and procedural complications | MedDra 19.0 | Systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDra 19.0 | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDra 19.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDra 19.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDra 19.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDra 19.0 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDra 19.0 | Systematic Assessment |
| |
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDra 19.0 | Systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDra 19.0 | Systematic Assessment |
| |
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDra 19.0 | Systematic Assessment |
| |
| Cancer Pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 19.0 | Systematic Assessment |
| |
| Metastases To Central Nervous System | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 19.0 | Systematic Assessment |
| |
| Tumour Associated Fever | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 19.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDra 19.0 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDra 19.0 | Systematic Assessment |
| |
| Generalised Tonic-Clonic Seizure | Nervous system disorders | MedDra 19.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDra 19.0 | Systematic Assessment |
| |
| Paraparesis | Nervous system disorders | MedDra 19.0 | Systematic Assessment |
| |
| Posterior Reversible Encephalopathy Syndrome | Nervous system disorders | MedDra 19.0 | Systematic Assessment |
| |
| Subarachnoid Haemorrhage | Nervous system disorders | MedDra 19.0 | Systematic Assessment |
| |
| White Matter Lesion | Nervous system disorders | MedDra 19.0 | Systematic Assessment |
| |
| Thrombosis In Device | Product Issues | MedDra 19.0 | Systematic Assessment |
| |
| Confusional State | Psychiatric disorders | MedDra 19.0 | Systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | MedDra 19.0 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDra 19.0 | Systematic Assessment |
| |
| Nephrotic Syndrome | Renal and urinary disorders | MedDra 19.0 | Systematic Assessment |
| |
| Prerenal Failure | Renal and urinary disorders | MedDra 19.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDra 19.0 | Systematic Assessment |
| |
| Urinary Retention | Renal and urinary disorders | MedDra 19.0 | Systematic Assessment |
| |
| Acute Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDra 19.0 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDra 19.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDra 19.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDra 19.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDra 19.0 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDra 19.0 | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDra 19.0 | Systematic Assessment |
| |
| Pneumonia Aspiration | Respiratory, thoracic and mediastinal disorders | MedDra 19.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDra 19.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDra 19.0 | Systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDra 19.0 | Systematic Assessment |
| |
| Pulmonary Haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDra 19.0 | Systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDra 19.0 | Systematic Assessment |
| |
| Thoracic Haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDra 19.0 | Systematic Assessment |
| |
| Cancer Surgery | Surgical and medical procedures | MedDra 19.0 | Systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDra 19.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDra 19.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDra 19.0 | Systematic Assessment |
| |
| Orthostatic Hypotension | Vascular disorders | MedDra 19.0 | Systematic Assessment |
| |
| Peripheral Ischaemia | Vascular disorders | MedDra 19.0 | Systematic Assessment |
| |
| Vena Cava Thrombosis | Vascular disorders | MedDra 19.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDra 19.0 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDra 19.0 | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDra 19.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDra 19.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDra 19.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDra 19.0 | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDra 19.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDra 19.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDra 19.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDra 19.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDra 19.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDra 19.0 | Systematic Assessment |
| |
| Weight Decreased | Investigations | MedDra 19.0 | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDra 19.0 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDra 19.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDra 19.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDra 19.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDra 19.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDra 19.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDra 19.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDra 19.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDra 19.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDra 19.0 | Systematic Assessment |
| |
| Palmar-Plantar Erythrodysaesthesia Syndrome | Skin and subcutaneous tissue disorders | MedDra 19.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDra 19.0 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi | 800-633-1610 | 1# | Contact-US@sanofi.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 1, 2016 | Jan 29, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| C533178 | aflibercept |
| C480833 | IFL protocol |
Not provided
Not provided
Not provided
|
|
| American Asian |
|
|
| Other |
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| Rectum |
|
|
| Other |
|
|
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|
| 1 |
|
|
| Missing |
|
|
| Title | Measurements |
|---|---|
|
| Any serious related TEAE |
|
| Any TEAE leading to death |
|
| Any TEAE (permanent treatment discontinuation) |
|
| Any TEAE (premature treatment discontinuation) |
|
|
|
|
|
|
|
|
|
|
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|
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| Participants |
|
|
|
Aflibercept 4 mg/kg IV infusion over 60 minutes followed by Irinotecan 180 mg/m^2 IV infusion over 90 minutes and Leucovorin 400 mg/m^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until DP, unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment. |
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| Units | Counts |
|---|---|
| Participants |
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|