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| ID | Type | Description | Link |
|---|---|---|---|
| AVE0005B/2001 |
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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
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This study evaluated the efficacy and safety of aflibercept in the treatment of participants with advanced chemoresistant non-small cell lung adenocarcinoma (NSCLA).
Primary objective:
Secondary objective:
This study employed an Independent Review Committee (IRC) for radiological tumor assessments. For all tumor assessment-related efficacy variables, two analyses were performed: the primary analysis was based on Independent Review Committee (IRC) reviewed data and the secondary analysis was based on Investigator evaluation.
In addition, both Response Evaluation Criteria In Solid Tumors (RECIST) and Modified Response Evaluation Criteria In Solid Tumors (mRECIST) were used to assess tumors. Where as RECIST criteria only consider the longest diameter of the tumors for calculations pertaining to changes in tumor size, mRECIST assessments also account for the differences in the cavities of lesions observed in non-small-cell lung cancer (NSCLC). Responses based on RECIST and mRECIST are reported.
The study included :
Withdrawal criteria that led to treatment discontinuation were:
After discontinuing treatment, participants remained on the study until the last post-treatment visit or until recovery of drug related toxicities, whichever was later.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| aflibercept 4.0 mg/kg | Experimental | Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept every 2 weeks until a study withdrawal criterion was met. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) | Drug | Aflibercept 4.0 mg/kg administered intravenously (IV) over a period of at least 1 hour once every 2 weeks. Aflibercept could be reduced by 1 dose level (to 3.0 mg/kg) or 2 dose levels (to 2.0 mg/kg) in case of uncontrolled hypertension or urinary protein >3.5 g/24 hours. Intrapatient dose escalation was not to be permitted. Participants requiring more than 2 dose level reductions would be withdrawn from study treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Confirmed Objective Response (OR) Based Upon Modified Response Evaluation Criteria in Solid Tumors (RECIST) Assessed by the Independent Review Committee (IRC). | OR was either complete response (CR) or partial response (PR) based on RECIST or modified RECIST. CR was the disappearance of all target/nor-target lesions; and PR was at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, with reference to the baseline sum LD (According to modified RECIST, to calculate LD for cavitated lesions, the longest cavitation diameters were subtracted from the LD of cavitated target lesions). Assessments were made by the IRC, and confirmed by repeat tumor imaging 4-6 weeks after documentation of the initial response. | up to 2.5 years from initial treatment |
| Confirmed Objective Response Based Upon Modified Response Evaluation Criteria in Solid Tumors (RECIST) Assessed by the Investigator. | OR was either complete response (CR) or partial response (PR) based on RECIST or modified RECIST. CR was the disappearance of all target/nor-target lesions; and PR was at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, with reference to the baseline sum LD (According to modified RECIST, to calculate LD for cavitated lesions, the longest cavitation diameters were subtracted from the LD of cavitated target lesions). Assessments were made by the Investigator, and confirmed by repeat tumor imaging 4-6 weeks after documentation of the initial response. | up to 2.5 years from initial treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DR) | DR was the time interval from the first complete response (CR) or partial response (PR) to the date of tumor progression or death from any cause, whichever was earlier. The duration of response was calculated only for those participants who achieved CR or PR. | up to 2.5 years from initial treatment |
Not provided
Participants who met the following criteria were eligible for the study.
Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| ICD CSD | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | Bridgewater | New Jersey | 08807 | United States | ||
| Sanofi-Aventis Administrative Office |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20593550 | Result | Leighl NB, Raez LE, Besse B, Rosen PJ, Barlesi F, Massarelli E, Gabrail N, Hart LL, Albain KS, Berkowitz L, Melnyk O, Shepherd FA, Sternas L, Ackerman J, Shun Z, Miller VA, Herbst RS. A multicenter, phase 2 study of vascular endothelial growth factor trap (Aflibercept) in platinum- and erlotinib-resistant adenocarcinoma of the lung. J Thorac Oncol. 2010 Jul;5(7):1054-9. doi: 10.1097/jto.0b013e3181e2f7fb. |
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98 participants were registered into the study, of whom, 96 were exposed to study treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Aflibercept 4.0 mg/kg | Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks until a study withdrawal criterion was met. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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Not provided
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|
| Progression-free Survival (PFS) Time Assessed by the Independent Review Committee (IRC) |
PFS time was interval from the date of registration to the date of tumor progression (by RECIST or modified RECIST), or death from any cause, whichever was earlier. Median PFS time was estimated from Kaplan-Meier Plots. Progression was at least a 20% increase in the sum of the longest diameter (LD) of tumors, compared to smallest sum LD recorded since treatment started, or the appearance of one or more new tumors. If a participant did not progress or die, the date was censored to the date of last valid tumor assessment or the date of data cut-off, whichever was earlier. |
| up to 2.5 years from initial treatment |
| Progression-free Survival (PFS) Time Assessed by the Investigator | PFS time was interval from the date of registration to the date of tumor progression (by RECIST or modified RECIST), or death from any cause, whichever was earlier. If a participant did not progress or die, the date was censored to the date of last valid tumor assessment or the date of data cut-off, whichever was earlier. Median PFS time was estimated from Kaplan-Meier Plots. Progression was at least a 20% increase in the sum of the longest diameter (LD) of tumors, compared to smallest sum LD recorded since treatment started, or the appearance of one or more new tumors. | up to 2.5 years from initial treatment |
| Overall Survival (OS) | OS was the time interval between registration to the date of death from any cause. The median time for OS was estimated from Kaplan-Meier Plots. A participant was to be censored for the OS analysis if the participant was alive by the study cut-off date. The censoring date was either the date that the participant was last known to be alive or the date of study cut-off, whichever came earlier. | up to 2.5 years from initial treatment |
| Heath-related Quality of Life (QOL) Measured Via the Lung Cancer Subscale | HRQL was assessed with the Functional Assessment of Cancer Therapy-Lung Cancer Subscale (FACT-LCS) questionnaire, which was completed by the participants on Day 1 of Cycle 1 only (for baseline value), then on Day 14 of each even-numbered cycle to evaluate the participants symptoms. The questionnaire scored 7 symptoms: shortness of breath, weight loss, clarity in thinking, coughing, appetite, chest tightness, ease of breathing, on a 0-4 scale. The total FACT-LCS score ranged from 0-28 (where 28 was related to the worst outcome). To calculate a change, the baseline score was subtracted from the score obtained after treatment. A negative value implied an improvement in HRQL. | Baseline to 2.5 years |
| Overall Safety - Number of Participants With Adverse Events | All AEs regardless of seriousness or relationship to study treatment, spanning from the first administration of study treatment until 60 days after the last administration of study treatment, were recorded, and followed until resolution or stabilization. The number of participants with all treatment emergent adverse events (TEAE), serious adverse events (SAE), TEAE leading to death, and TEAE leading to permanent treatment discontinuation are reported. | up to 60+/-5 days after treatment discontinuation, or or until TEAE was resolved or stabilized (Collected till 18 July 2008) |
| Number of Participants With Laboratory Abnormalities | Participants with abnormal laboratory results for
| Up to 2.5 years |
| Peak of Free Aflibercept (VEGF Trap) | Plasma free aflibercept levels after the first aflibercept infusion were estimated by a validated direct measured by enzyme-linked immunosorbent assay (ELISA), with a limit of quantification (LOQ) of 15.6 ng/mL. | Day 1 of the first infusion of Aflibercept (cycle 1) |
| Free and VEGF-bound Trough Aflibercept Concentrations (VEGF Trap) | Median free and VEGF-bound trough concentrations were determined at the end of each cycle beyond Cycle 2 (Steady-state) for each participant. Plasma free aflibercept levels were estimated by a validated direct ELISA, with an LOQ of 15.6 ng/mL. Plasma VEGF-bound aflibercept levels were also estimated by a separate validated direct ELISA with an LOQ of 43.9 ng/mL. Mean ± SD (coefficient of variation [CV%]) values were estimated from the median values calculated for each participant. | At the end of each treatment cycle (up to 2.5 years) |
| Number of Participants With Anti-drug Antibodies | Anti-drug antibodies in a participant's serum sample were assayed with an anti-drug ELISA assay, with a lower limit of quantitation of 238.4 ng/mL for an undiluted human serum sample. Serum for anti-drug antibody analysis was collected pre-dose on every fourth cycle after Cycle 1 Day 1 (at 8 week intervals), at end of treatment (EOT), and during post-treatment follow-up 60 days after the last dose. | up to 2.5 years after initial treatment |
| Laval |
| Canada |
| Sanofi-Aventis Administrative Office | Paris | France |
| TREATED |
|
| ONGOING TREATMENT |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Aflibercept 4.0 mg/kg | Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks until a study withdrawal criterion was met. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Number | 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 | Confirmed Objective Response (OR) Based Upon Modified Response Evaluation Criteria in Solid Tumors (RECIST) Assessed by the Independent Review Committee (IRC). | OR was either complete response (CR) or partial response (PR) based on RECIST or modified RECIST. CR was the disappearance of all target/nor-target lesions; and PR was at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, with reference to the baseline sum LD (According to modified RECIST, to calculate LD for cavitated lesions, the longest cavitation diameters were subtracted from the LD of cavitated target lesions). Assessments were made by the IRC, and confirmed by repeat tumor imaging 4-6 weeks after documentation of the initial response. | Simon's cohort: The first 84 evaluable participants, based on Simon's two-stage study design that required 84 evaluable participants to maintain a targeted 90% power. | Posted | Number | Participants | up to 2.5 years from initial treatment |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Duration of Response (DR) | DR was the time interval from the first complete response (CR) or partial response (PR) to the date of tumor progression or death from any cause, whichever was earlier. The duration of response was calculated only for those participants who achieved CR or PR. | No modified RECIST responses, as confirmed by the IRC review, were observed. Only 2 responders were reported by the Investigators. Therefore, the analyses for duration of response was not performed. | Posted | up to 2.5 years from initial treatment |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) Time Assessed by the Independent Review Committee (IRC) | PFS time was interval from the date of registration to the date of tumor progression (by RECIST or modified RECIST), or death from any cause, whichever was earlier. Median PFS time was estimated from Kaplan-Meier Plots. Progression was at least a 20% increase in the sum of the longest diameter (LD) of tumors, compared to smallest sum LD recorded since treatment started, or the appearance of one or more new tumors. If a participant did not progress or die, the date was censored to the date of last valid tumor assessment or the date of data cut-off, whichever was earlier. | All registered participants. 18 participants were censored. | Posted | Median | 95% Confidence Interval | weeks | up to 2.5 years from initial treatment | Participants with PFS Events | Participants |
| ||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) Time Assessed by the Investigator | PFS time was interval from the date of registration to the date of tumor progression (by RECIST or modified RECIST), or death from any cause, whichever was earlier. If a participant did not progress or die, the date was censored to the date of last valid tumor assessment or the date of data cut-off, whichever was earlier. Median PFS time was estimated from Kaplan-Meier Plots. Progression was at least a 20% increase in the sum of the longest diameter (LD) of tumors, compared to smallest sum LD recorded since treatment started, or the appearance of one or more new tumors. | All registered participants. 17 participants were censored. | Posted | Median | 95% Confidence Interval | weeks | up to 2.5 years from initial treatment | Participants with PFS Events | Participants |
| ||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS was the time interval between registration to the date of death from any cause. The median time for OS was estimated from Kaplan-Meier Plots. A participant was to be censored for the OS analysis if the participant was alive by the study cut-off date. The censoring date was either the date that the participant was last known to be alive or the date of study cut-off, whichever came earlier. | All registered participants. 38 participants were censored for OS. | Posted | Median | 95% Confidence Interval | months | up to 2.5 years from initial treatment | Participant with OS Event (death) | Participants |
|
| |||||||||||||||||||||||||||
| Secondary | Heath-related Quality of Life (QOL) Measured Via the Lung Cancer Subscale | HRQL was assessed with the Functional Assessment of Cancer Therapy-Lung Cancer Subscale (FACT-LCS) questionnaire, which was completed by the participants on Day 1 of Cycle 1 only (for baseline value), then on Day 14 of each even-numbered cycle to evaluate the participants symptoms. The questionnaire scored 7 symptoms: shortness of breath, weight loss, clarity in thinking, coughing, appetite, chest tightness, ease of breathing, on a 0-4 scale. The total FACT-LCS score ranged from 0-28 (where 28 was related to the worst outcome). To calculate a change, the baseline score was subtracted from the score obtained after treatment. A negative value implied an improvement in HRQL. | All registered participants with available questionnaires at the timepoint assessed. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 2.5 years |
|
| |||||||||||||||||||||||||||||
| Secondary | Overall Safety - Number of Participants With Adverse Events | All AEs regardless of seriousness or relationship to study treatment, spanning from the first administration of study treatment until 60 days after the last administration of study treatment, were recorded, and followed until resolution or stabilization. The number of participants with all treatment emergent adverse events (TEAE), serious adverse events (SAE), TEAE leading to death, and TEAE leading to permanent treatment discontinuation are reported. | All participants who received at least part of 1 dose of study treatment. | Posted | Number | participants | up to 60+/-5 days after treatment discontinuation, or or until TEAE was resolved or stabilized (Collected till 18 July 2008) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Laboratory Abnormalities | Participants with abnormal laboratory results for
| All participants who received at least part of 1 dose of study treatment. | Posted | Number | Participants | Up to 2.5 years |
|
| ||||||||||||||||||||||||||||||
| Secondary | Peak of Free Aflibercept (VEGF Trap) | Plasma free aflibercept levels after the first aflibercept infusion were estimated by a validated direct measured by enzyme-linked immunosorbent assay (ELISA), with a limit of quantification (LOQ) of 15.6 ng/mL. | All participants who received at least part of 1 dose of study treatment and had evaluable blood samples. | Posted | Mean | Standard Deviation | micrograms/mL | Day 1 of the first infusion of Aflibercept (cycle 1) |
|
| |||||||||||||||||||||||||||||
| Secondary | Free and VEGF-bound Trough Aflibercept Concentrations (VEGF Trap) | Median free and VEGF-bound trough concentrations were determined at the end of each cycle beyond Cycle 2 (Steady-state) for each participant. Plasma free aflibercept levels were estimated by a validated direct ELISA, with an LOQ of 15.6 ng/mL. Plasma VEGF-bound aflibercept levels were also estimated by a separate validated direct ELISA with an LOQ of 43.9 ng/mL. Mean ± SD (coefficient of variation [CV%]) values were estimated from the median values calculated for each participant. | All participants who received at least part of 1 dose of study treatment and had evaluable blood samples on Day 1 of Cycle 3 for measurement of VEGF-bound aflibercept. | Posted | Mean | Standard Deviation | micrograms/mL | At the end of each treatment cycle (up to 2.5 years) |
|
| |||||||||||||||||||||||||||||
| Primary | Confirmed Objective Response Based Upon Modified Response Evaluation Criteria in Solid Tumors (RECIST) Assessed by the Investigator. | OR was either complete response (CR) or partial response (PR) based on RECIST or modified RECIST. CR was the disappearance of all target/nor-target lesions; and PR was at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, with reference to the baseline sum LD (According to modified RECIST, to calculate LD for cavitated lesions, the longest cavitation diameters were subtracted from the LD of cavitated target lesions). Assessments were made by the Investigator, and confirmed by repeat tumor imaging 4-6 weeks after documentation of the initial response. | Simon's cohort: The first 84 evaluable participants, based on Simon's two-stage study design that required 84 evaluable participants to maintain a targeted 90% power. | Posted | Number | participants | up to 2.5 years from initial treatment |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Anti-drug Antibodies | Anti-drug antibodies in a participant's serum sample were assayed with an anti-drug ELISA assay, with a lower limit of quantitation of 238.4 ng/mL for an undiluted human serum sample. Serum for anti-drug antibody analysis was collected pre-dose on every fourth cycle after Cycle 1 Day 1 (at 8 week intervals), at end of treatment (EOT), and during post-treatment follow-up 60 days after the last dose. | All participants who received at least part of 1 dose of study treatment and had evaluable blood samples. | Posted | Number | participants | up to 2.5 years after initial treatment |
|
|
From treatment initiation to February 24, 2009.
Not provided
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 | 4 mg/kg | Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks until a study withdrawal criterion was met. | 48 | 96 | 93 | 96 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Obstruction gastric | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
| |
| Radiation injury | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Non-systematic Assessment |
| |
| Metastatic pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Non-systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Reversible posterior leukoencephalopathy syndrome | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Bladder stenosis | Renal and urinary disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Axillary vein thrombosis | Vascular disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Superior vena caval occlusion | Vascular disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 11.1 | Non-systematic Assessment |
|
The investigator shall have the right to independently publish study results from his site after a multicenter publication, or 12 months after the completion of the study by all sites. He must provide the sponsor a copy of any such publication derived from the study for review and comment at least 45 days (20 days for abstracts) in advance of any submission, and delay publication till the approval of the publication is given in writing by the Sponsor (not to exceed ninety days).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi | Contact-Us@Sanofi.com |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D008175 | Lung Neoplasms |
| D009369 | Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D009362 | Neoplasm Metastasis |
| D002277 | Carcinoma |
| D004194 | Disease |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| C533178 | aflibercept |
Not provided
Not provided
Not provided
| Asian, Oriental |
|
| Unknown or Not Reported |
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| Units | Counts |
|---|---|
| Participants |
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| Participants with PFS Events |
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| Units | Counts |
|---|---|
| Participants |
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| Participants with PFS Events |
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| Participant with OS Event (death) |
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