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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-001422-27 | EudraCT Number |
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The purpose of this study is to test the safety and effectiveness of PF-03446962 when given as a single agent. Tumors require new blood vessels to support their ability to grow and to spread (metastasize). New treatments aimed at preventing these blood vessels have the ability to improve the clinical management of cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-03446962 | Drug | To determine the maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of PF-03446962 administered in patients with advanced solid tumors. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD): Part 1 | MTD was defined as highest dose level for which no more than 1 participant in a dose cohort experienced DLT and at least 2 out of 3/6 participants in the next higher dose. DLT was defined as any of the following events occurring during the first 42 days of study drug: any grade greater than or equal to 3 hematologic and non-hematologic toxicity, all non-disease-related adverse events (AEs). | Baseline up to 42 days after the start of each increased treatment dose |
| Recommended Phase 2 Dose (RP2D): Part 1 | RP2D was defined as the lower dose level to MTD based on the safety profile. | Baseline up to 42 days after the start of each increased treatment dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (AEs): Part 1 and Part 2 | An all causality AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Treatment-related AEs was any untoward medical occurrence in participant that was attributed to study drug. Treatment-emergent events were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Serum Concentration (Cmax): Part 1 and Part 2 | 0 hr (pre-dose),0.5,1,1.5,2,5,10,24 hr post-dose on Day (D) 1,3,5,8,11,15,22 of Cycle (C) 1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to cycle 12, 28 days after last dose for dose (up to 3 months after last dose for >=2 mg/kg arms) | |
| Minimum Observed Serum Trough Concentration (Cmin): Part 1 and Part 2 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States | ||
| Medical University of South Carolina, Hollings Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27329247 | Derived | Simonelli M, Zucali P, Santoro A, Thomas MB, de Braud FG, Borghaei H, Berlin J, Denlinger CS, Noberasco C, Rimassa L, Kim TY, English PA, Abbattista A, Gallo Stampino C, Carpentieri M, Williams JA. Phase I study of PF-03446962, a fully human monoclonal antibody against activin receptor-like kinase-1, in patients with hepatocellular carcinoma. Ann Oncol. 2016 Sep;27(9):1782-7. doi: 10.1093/annonc/mdw240. Epub 2016 Jun 20. | |
| 26655846 |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | PF-03446962 0.5 mg/kg: Part 1 | PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity. |
| FG001 | PF-03446962 1 mg/kg: Part 1 | PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity. |
| FG002 | PF-03446962 2 mg/kg : Part 1 | PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity. |
| FG003 | PF-03446962 3 mg/kg: Part 1 | PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity. |
| FG004 | PF-03446962 4.5 mg/kg: Part 1 | PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity. |
| FG005 | PF-03446962 6.75 mg/kg: Part 1 | PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity. |
| FG006 | PF-03446962 10 mg/kg: Part 1 | PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity. |
| FG007 | PF-03446962 15 mg/kg: Part 1 | PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity. |
| FG008 | PF-03446962 7 mg/kg: Part 2 | PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part 1: Dose Escalation Phase |
|
| |||||||||||||||||||||
| Part 2: Exploratory Phase |
|
Safety population included all enrolled participants who received at least one dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | PF-03446962 | All participants who received PF-03446962 intravenous infusion (0.5 milligram/kilogram [mg/kg], 1 mg/kg, 2 mg, 3 mg/kg, 4.5 mg/kg, 6.75 mg/kg, 10 mg/kg, 15 mg/kg, 7 mg/kg), on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression or unacceptable toxicity. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Maximum Tolerated Dose (MTD): Part 1 | MTD was defined as highest dose level for which no more than 1 participant in a dose cohort experienced DLT and at least 2 out of 3/6 participants in the next higher dose. DLT was defined as any of the following events occurring during the first 42 days of study drug: any grade greater than or equal to 3 hematologic and non-hematologic toxicity, all non-disease-related adverse events (AEs). | The MTD analysis set included all participants who were enrolled in the dose escalation part of the study and received at least 1 dose of study drug. | Posted | Number | milligram/kilogram (mg/kg) | Baseline up to 42 days after the start of each increased treatment dose |
|
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The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PF-03446962 | All participants who received PF-03446962 intravenous infusion (0.5 milligram/kilogram [mg/kg], 1 mg/kg, 2 mg, 3 mg/kg, 4.5 mg/kg, 6.75 mg/kg, 10 mg/kg, 15 mg/kg, 7 mg/kg), on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression or unacceptable toxicity. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v16.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v16.0 | Non-systematic Assessment |
Results for tumor vascular function adopting dynamic contrast enhanced-magnetic resonance imaging (DCE-MRI) was not reported as per change in planned analysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| ID | Term |
|---|---|
| C575087 | ascrinvacumab |
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| Cycle 1 of Day 1 up to 28 days after the last dose of treatment |
| Number of Participants With Treatment Emergent Adverse Events (AEs) Based on Severity: Part 1 and Part 2 | AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to severity; Grade 0 (no change from normal); grade 1 (mild AE which did not cause any significant problem, no dose adjustment required); grade 2 (moderate AE which caused problem that did not interfere significantly with usual activities or the clinical status, dose adjustment needed due to adverse event); grade 3 (severe AE which caused problem that interfered significantly with usual activities or the clinical status, study drug stopped due to adverse event); grade 4 (life threatening AE) and grade 5 (death). Treatment-emergent events were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. | Cycle 1 of Day 1 up to 28 days after the last dose of treatment |
| Number of Participants With Treatment Emergent Adverse Events (AEs) Based on Seriousness: Part 1 and Part 2 | AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Seriousness of an AE was assessed as serious adverse event (SAE) and non-serious adverse event (non-SAE). An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Non-SAE included all AE minus SAE. Treatment-emergent events were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. | Cycle 1 of Day 1 up to 28 days after the last dose of treatment |
| Time to Treatment-Emergent Adverse Events (AEs): Part 1 and Part 2 | Total time from onset of adverse event till the event is resolved. Treatment-emergent events were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. | Cycle 1 of Day 1 up to 28 days after the last dose of treatment |
| Number of Participants With Laboratory Abnormalities: Part 1 and Part 2 | Laboratory tests included hematology (hemoglobin, lymphocytes absolute [abs], neutrophils abs, platelets, white blood cells) and chemistry (alanine aminotransferase, alkaline phosphatase, amylase, aspartate aminotransferase, bilirubin, creatinine, hypercalcemia, hyperglycemia, hyperkalemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypokalemia, hyponatremia, hypophosphatemia, lipase). Assays were based on National Cancer Institute [NCI] Common Terminology Criteria for AE (CTCAE) grading scale for AEs (grade 1 [mild AE: did not cause any significant problem, no dose adjustment required]; grade 2 [moderate AE: caused problem that did not interfere significantly with usual activities or the clinical status, dose adjustment needed due to adverse event]; grade 3 [severe AE: caused problem that interfered significantly with usual activities or the clinical status, study drug stopped due to adverse event] and grade 4 [life threatening AE]). Overall data of the 4 grades is reported. | Cycle 1 of Day 1 up to 28 days after the last dose of treatment |
| Percentage of Participants With Objective Response: Part 1 and Part 2 | Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR defined as disappearance of all target lesions and non-target lesions. PR defined as >=30 % decrease in sum of the longest diameters (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non-target lesions. | Baseline then 6 weeks after Cycle 1 of Day1 thereafter every 6 weeks up to Day 490 |
| Percentage of Participants With Disease Control: Part 2 | Participants who achieved either a confirmed complete Response or confirmed partial response or a Stable disease lasting at least 12 weeks from the first dose was defined as achieving disease control. Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR: disappearance of all target lesions and non-target lesions. PR: >=30 % decrease in sum of the longest diameters (LD) of the target lesions taking as a reference the baseline sum LD and stable disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as a reference the smallest sum of the LD according to RECIST associated to non-progressive disease response for non-target lesions. Percentage of participants achieving disease control was calculated out of the participants participating in the exploratory phase. | Baseline then 6 weeks after Cycle 1 of Day1 thereafter every 6 weeks up to Day 490 |
| Time To Progression (TTP): Part 2 | Time in months from start of treatment to first documentation of objective tumor progression. TTP was calculated as (first event date or last known progression-free date minus the date of treatment plus 1) divided by 30.44. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD] per RECIST). PD: >=20% increase in the sum of the LD of the target lesions taking as a reference the smallest sum of the LD or the appearance of one or more new lesions and as unequivocal progression of existing non-target lesions, or the appearance of >=1 new lesions. TTP was calculated out of the participants participating in the exploratory phase. | Baseline then 6 weeks after Cycle 1 of Day1 thereafter every 6 weeks up to Day 490 |
| Volume of Distribution: Part 1 and Part 2 | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. As per planned analysis, volume of distribution was summarized if at least 3 participants had reportable value. | 0 hr (pre-dose),0.5,1,1.5,2,5,10,24 hr post-dose on Day (D) 1,3,5,8,11,15,22 of Cycle (C) 1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to cycle 12, 28 days after last dose for dose (up to 3 months after last dose for >=2 mg/kg arms) |
| 0 hr (pre dose), 1 hr post-dose C1D1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to C12 |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-03446962: Part 1 and Part 2 | 0 hr (pre-dose),0.5,1,1.5,2,5,10,24 hr post-dose on Day (D) 1,3,5,8,11,15,22 of Cycle (C) 1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to cycle 12, 28 days after last dose for dose (up to 3 months after last dose for >=2 mg/kg arms) |
| Area Under the Curve From Time Zero to Day 28 [AUC (0-28)]: Part 1 and Part 2 | AUC (0-28) = Area under the plasma concentration versus time curve from time zero (pre-dose) to Day 28 (0-28). | 0 hr (pre-dose),0.5,1,1.5,2,5,10,24 hr post-dose on Day (D) 1,3,5,8,11,15,22 of Cycle (C) 1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to cycle 12, 28 days after last dose for dose (up to 3 months after last dose for >=2 mg/kg arms) |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast): Part 1 and Part 2 | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). | 0 hr (pre-dose),0.5,1,1.5,2,5,10,24 hr post-dose on Day (D) 1,3,5,8,11,15,22 of Cycle (C) 1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to cycle 12, 28 days after last dose for dose (up to 3 months after last dose for >=2 mg/kg arms) |
| Systemic Clearance(CL): Part 1 and Part 2 | CL is a quantitative measure of the rate at which a drug substance is removed from the body. As per planned analysis, CL was summarized if at least 3 participants had reportable value. | 0 hr (pre-dose),0.5,1,1.5,2,5,10,24 hr post-dose on Day (D) 1,3,5,8,11,15,22 of Cycle (C) 1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to cycle 12, 28 days after last dose for dose (up to 3 months after last dose for >=2 mg/kg arms) |
| Plasma Decay Half-Life (t1/2): Part 1 and Part 2 | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. As per planned analysis, t1/2 was summarized if at least 3 participants had reportable value. | 0 hr (pre-dose),0.5,1,1.5,2,5,10,24 hr post-dose on Day (D) 1,3,5,8,11,15,22 of Cycle (C) 1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to cycle 12, 28 days after last dose for dose (up to 3 months after last dose for >=2 mg/kg arms) |
| Human Anti - Human Antibody (HAHA) Concentration: Part 1 and Part 2 | HAHA concentration was analyzed in blood samples for the evaluation of immunogenicity of PF-03446962. HAHA concentration was reported for samples above lower limit of quantification (>=4.32). | Baseline up to 3 months after last dose |
| Soluble Protein Biomarker [Angiopoietin-2 (Ang-2), Bone Morphogenetic Protein-9 (BMP-9), Chemokine (C-C Motif) Ligand 2 (CCL2)]: Part 1 and Part 2 | Plasma concentrations of soluble proteins (Ang-2, BMP-9, C-C motif) may be associated with tumor angiogenesis or tumor physiology and may correlate with efficacy or biological activity. | Baseline (pre-dose of C1D1), C1D1 6 hours post dosing, C1D22, C2D1, C3D1 and end of treatment (Day 490) |
| Soluble Protein Biomarker [Cluster of Differentiation 106 (CD106), Cluster of Differentiation 54 (CD54), Endoglin]: Part 1 and Part 2 | Plasma concentrations of soluble proteins (CD106, CD54 and Endoglin) may be associated with tumor angiogenesis or tumor physiology and may correlate with efficacy or biological activity. | Baseline (pre-dose of C1D1), C1D1 6 hours post dosing, C1D22, C2D1, C3D1 and end of treatment (Day 490) |
| Soluble Protein Biomarker [Placental Growth Factor (PLGF), Transforming Growth Beta 1 (TGFB1), Vascular Endothelial Growth Factor A (VEGF-A)]: Part 1 and Part 2 | Plasma concentrations of soluble proteins (PLGF, TGFB1, VEGF-A) may be associated with tumor angiogenesis or tumor physiology and may correlate with efficacy or biological activity. | Baseline (pre-dose of C1D1), C1D1 6 hours post dosing, C1D22, C2D1, C3D1 and end of treatment (Day 490) |
| Soluble Protein Biomarker [Vascular Endothelial Growth Factor C (VEGF-C), Vascular Endothelial Growth Factor-d (VEGF-d), Vascular Endothelial Growth Factor Receptor Type 1 (VEGFR1)]: Part 1 and Part 2 | Plasma concentrations of soluble proteins (VEGF-C, VEGF-d, VEGFR1) may be associated with tumor angiogenesis or tumor physiology and may correlate with efficacy or biological activity. | Baseline (pre-dose of C1D1), C1D1 6 hours post dosing, C1D22, C2D1, C3D1 and end of treatment (Day 490) |
| Soluble Protein Biomarker [Vascular Endothelial Growth Factor Receptor Type 2 (VEGFR2), Vascular Endothelial Growth Factor Receptor Type 3 (VEGFR3)]: Part 1 and Part 2 | Plasma concentrations of soluble proteins (VEGFR2, VEGFR3) may be associated with tumor angiogenesis or tumor physiology and may correlate with efficacy or biological activity. | Baseline (pre-dose of C1D1), C1D1 6 hours post dosing, C1D22, C2D1, C3D1 and end of treatment (Day 490) |
| Circulating Endothelial Cells (CEC)and Circulating Endothelial Progenitors (CEP): Part 1 and Part 2 | Circulating endothelial cells (CECs) are noninvasive marker of vascular damage, remodeling, and dysfunction. Blood samples for the assessment of CECs and circulating CEPs were collected to analyze effects of therapy on the number, viability/apoptotic state, and/or target activity/expression in CECs. Circulating Cells were classified as CEPs if cluster differentiation 133 positive cells (CD133+) were detected. | Baseline (pre-dose of C1D1), C1D1 6 hours post dosing, C1D22, C2D1, C3D1 and end of treatment (Day 490) |
| Charleston |
| South Carolina |
| 29425 |
| United States |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37212-3505 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| S.C Diagnostica Radiologica 2 | Milan | 20133 | Italy |
| S.C. Chirurgia Generale Indirizzo Oncologico 1 (epato-gastro-pancreatica) | Milan | 20133 | Italy |
| S.C. Medicina Oncologica I, Fondazione IRCCS Istituto Nazionale Tumori | Milan | 20133 | Italy |
| Dipartimento di Medicina | Milan | 20141 | Italy |
| UO di Oncologia ed Ematologia, Istituto Clinico Humanitas-Humanitas Cancer Center | Rozzano (MI) | 20089 | Italy |
| Seoul National University Hospital / Department of Internal Medicine | Seoul | 110-744 | South Korea |
| Derived |
| Goff LW, Cohen RB, Berlin JD, de Braud FG, Lyshchik A, Noberasco C, Bertolini F, Carpentieri M, Stampino CG, Abbattista A, Wang E, Borghaei H. A Phase I Study of the Anti-Activin Receptor-Like Kinase 1 (ALK-1) Monoclonal Antibody PF-03446962 in Patients with Advanced Solid Tumors. Clin Cancer Res. 2016 May 1;22(9):2146-54. doi: 10.1158/1078-0432.CCR-15-1622. Epub 2015 Dec 11. |
| Withdrawal by Subject |
|
| Adverse Event |
|
| Other |
|
| Death |
|
| global deterioration of health status |
|
| randomized but not treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | Recommended Phase 2 Dose (RP2D): Part 1 | RP2D was defined as the lower dose level to MTD based on the safety profile. | The MTD analysis set included all participants who were enrolled in the dose escalation part of the study and received at least 1 dose of study drug. | Posted | Number | mg/kg | Baseline up to 42 days after the start of each increased treatment dose |
|
|
|
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (AEs): Part 1 and Part 2 | An all causality AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Treatment-related AEs was any untoward medical occurrence in participant that was attributed to study drug. Treatment-emergent events were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. | Safety population included all enrolled participants who received at least one dose of study drug. | Posted | Number | participants | Cycle 1 of Day 1 up to 28 days after the last dose of treatment |
|
|
|
| Secondary | Number of Participants With Treatment Emergent Adverse Events (AEs) Based on Severity: Part 1 and Part 2 | AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to severity; Grade 0 (no change from normal); grade 1 (mild AE which did not cause any significant problem, no dose adjustment required); grade 2 (moderate AE which caused problem that did not interfere significantly with usual activities or the clinical status, dose adjustment needed due to adverse event); grade 3 (severe AE which caused problem that interfered significantly with usual activities or the clinical status, study drug stopped due to adverse event); grade 4 (life threatening AE) and grade 5 (death). Treatment-emergent events were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. | Safety population included all enrolled participants who received at least one dose of study drug. | Posted | Number | participants | Cycle 1 of Day 1 up to 28 days after the last dose of treatment |
|
|
|
| Secondary | Number of Participants With Treatment Emergent Adverse Events (AEs) Based on Seriousness: Part 1 and Part 2 | AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Seriousness of an AE was assessed as serious adverse event (SAE) and non-serious adverse event (non-SAE). An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Non-SAE included all AE minus SAE. Treatment-emergent events were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. | Safety population included all enrolled participants who received at least one dose of study drug. | Posted | Number | participants | Cycle 1 of Day 1 up to 28 days after the last dose of treatment |
|
|
|
| Secondary | Time to Treatment-Emergent Adverse Events (AEs): Part 1 and Part 2 | Total time from onset of adverse event till the event is resolved. Treatment-emergent events were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. | Data for timing was reported in individual participant listing for every adverse event (AE) and mentioned for description of narrative of Serious AEs but was not statistically summarized for analysis on the entire safety population, as planned. | Posted | Cycle 1 of Day 1 up to 28 days after the last dose of treatment |
|
|
| Secondary | Number of Participants With Laboratory Abnormalities: Part 1 and Part 2 | Laboratory tests included hematology (hemoglobin, lymphocytes absolute [abs], neutrophils abs, platelets, white blood cells) and chemistry (alanine aminotransferase, alkaline phosphatase, amylase, aspartate aminotransferase, bilirubin, creatinine, hypercalcemia, hyperglycemia, hyperkalemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypokalemia, hyponatremia, hypophosphatemia, lipase). Assays were based on National Cancer Institute [NCI] Common Terminology Criteria for AE (CTCAE) grading scale for AEs (grade 1 [mild AE: did not cause any significant problem, no dose adjustment required]; grade 2 [moderate AE: caused problem that did not interfere significantly with usual activities or the clinical status, dose adjustment needed due to adverse event]; grade 3 [severe AE: caused problem that interfered significantly with usual activities or the clinical status, study drug stopped due to adverse event] and grade 4 [life threatening AE]). Overall data of the 4 grades is reported. | Safety population included all enrolled participants who received at least one dose of study drug. | Posted | Number | participants | Cycle 1 of Day 1 up to 28 days after the last dose of treatment |
|
|
|
| Secondary | Percentage of Participants With Objective Response: Part 1 and Part 2 | Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR defined as disappearance of all target lesions and non-target lesions. PR defined as >=30 % decrease in sum of the longest diameters (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non-target lesions. | Response-evaluable set included all participants who received at least 1 dose of study drug with an adequate baseline tumor assessment. | Posted | Number | 90% Confidence Interval | percentage of participants | Baseline then 6 weeks after Cycle 1 of Day1 thereafter every 6 weeks up to Day 490 |
|
|
|
| Secondary | Percentage of Participants With Disease Control: Part 2 | Participants who achieved either a confirmed complete Response or confirmed partial response or a Stable disease lasting at least 12 weeks from the first dose was defined as achieving disease control. Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR: disappearance of all target lesions and non-target lesions. PR: >=30 % decrease in sum of the longest diameters (LD) of the target lesions taking as a reference the baseline sum LD and stable disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as a reference the smallest sum of the LD according to RECIST associated to non-progressive disease response for non-target lesions. Percentage of participants achieving disease control was calculated out of the participants participating in the exploratory phase. | Response-evaluable set included all participants who started Cycle 1 with an adequate baseline tumor assessment. | Posted | Number | 90% Confidence Interval | percentage of participants | Baseline then 6 weeks after Cycle 1 of Day1 thereafter every 6 weeks up to Day 490 |
|
|
|
| Secondary | Time To Progression (TTP): Part 2 | Time in months from start of treatment to first documentation of objective tumor progression. TTP was calculated as (first event date or last known progression-free date minus the date of treatment plus 1) divided by 30.44. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD] per RECIST). PD: >=20% increase in the sum of the LD of the target lesions taking as a reference the smallest sum of the LD or the appearance of one or more new lesions and as unequivocal progression of existing non-target lesions, or the appearance of >=1 new lesions. TTP was calculated out of the participants participating in the exploratory phase. | Safety population included all participants who received at least one dose of study drug. | Posted | Median | Full Range | months | Baseline then 6 weeks after Cycle 1 of Day1 thereafter every 6 weeks up to Day 490 |
|
|
|
| Other Pre-specified | Maximum Observed Serum Concentration (Cmax): Part 1 and Part 2 | Pharmacokinetic analysis set included all participants who received at least one dose of study drug and who had complete sampling for pharmacokinetic profiles for PF-03446962. | Posted | Geometric Mean | Standard Deviation | nanogram/milliliter (ng/mL) | 0 hr (pre-dose),0.5,1,1.5,2,5,10,24 hr post-dose on Day (D) 1,3,5,8,11,15,22 of Cycle (C) 1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to cycle 12, 28 days after last dose for dose (up to 3 months after last dose for >=2 mg/kg arms) |
|
|
|
| Other Pre-specified | Minimum Observed Serum Trough Concentration (Cmin): Part 1 and Part 2 | Pharmacokinetic analysis set included all participants who received at least one dose of study drug and who had complete sampling for pharmacokinetic profiles for PF-03446962. Here "N" (Number of participants analyzed) signifies those who were evaluable for the measure and "n" signifies those participants who were evaluable at specific time-point. | Posted | Geometric Mean | Standard Deviation | ng/mL | 0 hr (pre dose), 1 hr post-dose C1D1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to C12 |
|
|
|
| Other Pre-specified | Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-03446962: Part 1 and Part 2 | Pharmacokinetic analysis set included all participants who received at least one dose of study drug and who had complete sampling for pharmacokinetic profiles for PF-03446962. Here "N" (Number of participants analyzed) signifies those who were evaluable for the measure. | Posted | Median | Full Range | hour | 0 hr (pre-dose),0.5,1,1.5,2,5,10,24 hr post-dose on Day (D) 1,3,5,8,11,15,22 of Cycle (C) 1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to cycle 12, 28 days after last dose for dose (up to 3 months after last dose for >=2 mg/kg arms) |
|
|
|
| Other Pre-specified | Area Under the Curve From Time Zero to Day 28 [AUC (0-28)]: Part 1 and Part 2 | AUC (0-28) = Area under the plasma concentration versus time curve from time zero (pre-dose) to Day 28 (0-28). | Pharmacokinetic analysis set included all participants who received at least one dose of study drug and who had complete sampling for pharmacokinetic profiles for PF-03446962. Here "N" (Number of participants analyzed) signifies those who were evaluable for the measure. | Posted | Geometric Mean | Standard Deviation | nanogram*hour/milliliter (ng*hr/mL) | 0 hr (pre-dose),0.5,1,1.5,2,5,10,24 hr post-dose on Day (D) 1,3,5,8,11,15,22 of Cycle (C) 1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to cycle 12, 28 days after last dose for dose (up to 3 months after last dose for >=2 mg/kg arms) |
|
|
|
| Other Pre-specified | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast): Part 1 and Part 2 | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). | Pharmacokinetic analysis set included all participants who received at least one dose of study drug and who had complete sampling for pharmacokinetic profiles for PF-03446962. Here "N" (Number of participants analyzed) signifies those who were evaluable for the measure. | Posted | Geometric Mean | Standard Deviation | ng*hr/mL | 0 hr (pre-dose),0.5,1,1.5,2,5,10,24 hr post-dose on Day (D) 1,3,5,8,11,15,22 of Cycle (C) 1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to cycle 12, 28 days after last dose for dose (up to 3 months after last dose for >=2 mg/kg arms) |
|
|
|
| Other Pre-specified | Systemic Clearance(CL): Part 1 and Part 2 | CL is a quantitative measure of the rate at which a drug substance is removed from the body. As per planned analysis, CL was summarized if at least 3 participants had reportable value. | Pharmacokinetic analysis set included all participants who received at least one dose of study drug and who had complete sampling for pharmacokinetic profiles for PF-03446962. Here "N" (Number of participants analyzed) signifies those who were evaluable for the measure. | Posted | Geometric Mean | Standard Deviation | liter/hour (L/hr) | 0 hr (pre-dose),0.5,1,1.5,2,5,10,24 hr post-dose on Day (D) 1,3,5,8,11,15,22 of Cycle (C) 1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to cycle 12, 28 days after last dose for dose (up to 3 months after last dose for >=2 mg/kg arms) |
|
|
|
| Secondary | Volume of Distribution: Part 1 and Part 2 | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. As per planned analysis, volume of distribution was summarized if at least 3 participants had reportable value. | Pharmacokinetic analysis set included all participants who received at least one dose of study drug and who had complete sampling for pharmacokinetic profiles for PF-03446962. Here "N" (Number of participants analyzed) signifies those who were evaluable for the measure. | Posted | Geometric Mean | Standard Deviation | liter (L) | 0 hr (pre-dose),0.5,1,1.5,2,5,10,24 hr post-dose on Day (D) 1,3,5,8,11,15,22 of Cycle (C) 1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to cycle 12, 28 days after last dose for dose (up to 3 months after last dose for >=2 mg/kg arms) |
|
|
|
| Other Pre-specified | Plasma Decay Half-Life (t1/2): Part 1 and Part 2 | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. As per planned analysis, t1/2 was summarized if at least 3 participants had reportable value. | Pharmacokinetic analysis set included all participants who received at least one dose of study drug and who had complete sampling for pharmacokinetic profiles for PF-03446962. Here "N" (Number of participants analyzed) signifies those who were evaluable for the measure. | Posted | Mean | Standard Deviation | hours | 0 hr (pre-dose),0.5,1,1.5,2,5,10,24 hr post-dose on Day (D) 1,3,5,8,11,15,22 of Cycle (C) 1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to cycle 12, 28 days after last dose for dose (up to 3 months after last dose for >=2 mg/kg arms) |
|
|
|
| Other Pre-specified | Human Anti - Human Antibody (HAHA) Concentration: Part 1 and Part 2 | HAHA concentration was analyzed in blood samples for the evaluation of immunogenicity of PF-03446962. HAHA concentration was reported for samples above lower limit of quantification (>=4.32). | Statistical Data was not statistically summarized as majority of participants had concentration below the limit of quantification. | Posted | Baseline up to 3 months after last dose |
|
|
| Other Pre-specified | Soluble Protein Biomarker [Angiopoietin-2 (Ang-2), Bone Morphogenetic Protein-9 (BMP-9), Chemokine (C-C Motif) Ligand 2 (CCL2)]: Part 1 and Part 2 | Plasma concentrations of soluble proteins (Ang-2, BMP-9, C-C motif) may be associated with tumor angiogenesis or tumor physiology and may correlate with efficacy or biological activity. | Soluble protein biomarker analysis set included all participants who received at least one dose of study drug with a baseline (pre-dose C1D1) or screening biomarker result, and at least one on-treatment biomarker result for at least one biomarker. "n" signifies those participants who were evaluable at specific time-point. | Posted | Mean | Standard Deviation | picogram/milliliter (pg/mL) | Baseline (pre-dose of C1D1), C1D1 6 hours post dosing, C1D22, C2D1, C3D1 and end of treatment (Day 490) |
|
|
|
| Other Pre-specified | Soluble Protein Biomarker [Cluster of Differentiation 106 (CD106), Cluster of Differentiation 54 (CD54), Endoglin]: Part 1 and Part 2 | Plasma concentrations of soluble proteins (CD106, CD54 and Endoglin) may be associated with tumor angiogenesis or tumor physiology and may correlate with efficacy or biological activity. | Soluble protein biomarker analysis set included all participants who received at least one dose of study drug with a baseline (pre-dose C1D1) or screening biomarker result, and at least one on-treatment biomarker result for at least one biomarker. "n" signifies those participants who were evaluable at specific time-point. | Posted | Mean | Standard Deviation | pg/ml | Baseline (pre-dose of C1D1), C1D1 6 hours post dosing, C1D22, C2D1, C3D1 and end of treatment (Day 490) |
|
|
|
| Other Pre-specified | Soluble Protein Biomarker [Placental Growth Factor (PLGF), Transforming Growth Beta 1 (TGFB1), Vascular Endothelial Growth Factor A (VEGF-A)]: Part 1 and Part 2 | Plasma concentrations of soluble proteins (PLGF, TGFB1, VEGF-A) may be associated with tumor angiogenesis or tumor physiology and may correlate with efficacy or biological activity. | Soluble protein biomarker analysis set included all participants who received at least one dose of study drug with a baseline (pre-dose C1D1) or screening biomarker result, and at least one on-treatment biomarker result for at least one biomarker. "n" signifies those participants who were evaluable at specific time-point. | Posted | Mean | Standard Deviation | pg/ml | Baseline (pre-dose of C1D1), C1D1 6 hours post dosing, C1D22, C2D1, C3D1 and end of treatment (Day 490) |
|
|
|
| Other Pre-specified | Soluble Protein Biomarker [Vascular Endothelial Growth Factor C (VEGF-C), Vascular Endothelial Growth Factor-d (VEGF-d), Vascular Endothelial Growth Factor Receptor Type 1 (VEGFR1)]: Part 1 and Part 2 | Plasma concentrations of soluble proteins (VEGF-C, VEGF-d, VEGFR1) may be associated with tumor angiogenesis or tumor physiology and may correlate with efficacy or biological activity. | Soluble protein biomarker analysis set included all participants who received at least one dose of study drug with a baseline (pre-dose C1D1) or screening biomarker result, and at least one on-treatment biomarker result for at least one biomarker. "n" signifies those participants who were evaluable at specific time-point. | Posted | Mean | Standard Deviation | pg/ml | Baseline (pre-dose of C1D1), C1D1 6 hours post dosing, C1D22, C2D1, C3D1 and end of treatment (Day 490) |
|
|
|
| Other Pre-specified | Soluble Protein Biomarker [Vascular Endothelial Growth Factor Receptor Type 2 (VEGFR2), Vascular Endothelial Growth Factor Receptor Type 3 (VEGFR3)]: Part 1 and Part 2 | Plasma concentrations of soluble proteins (VEGFR2, VEGFR3) may be associated with tumor angiogenesis or tumor physiology and may correlate with efficacy or biological activity. | Soluble Protein Biomarker Analysis Set included all participants who received at least one dose of study drug with a baseline (pre-dose C1D1) or screening biomarker result, and at least one on-treatment biomarker result for at least one biomarker. "n" signifies those participants who were evaluable at specific time-point. | Posted | Mean | Standard Deviation | pg/ml | Baseline (pre-dose of C1D1), C1D1 6 hours post dosing, C1D22, C2D1, C3D1 and end of treatment (Day 490) |
|
|
|
| Other Pre-specified | Circulating Endothelial Cells (CEC)and Circulating Endothelial Progenitors (CEP): Part 1 and Part 2 | Circulating endothelial cells (CECs) are noninvasive marker of vascular damage, remodeling, and dysfunction. Blood samples for the assessment of CECs and circulating CEPs were collected to analyze effects of therapy on the number, viability/apoptotic state, and/or target activity/expression in CECs. Circulating Cells were classified as CEPs if cluster differentiation 133 positive cells (CD133+) were detected. | Data was reported in individual participant listings but not statistically summarized due to statistical constraints. | Posted | Baseline (pre-dose of C1D1), C1D1 6 hours post dosing, C1D22, C2D1, C3D1 and end of treatment (Day 490) |
|
|
| 24 |
| 68 |
| 68 |
| 68 |
| Atrial fibrillation | Cardiac disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Condition aggravated | General disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Disease progression | General disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Hepatitis acute | Hepatobiliary disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Infection | Infections and infestations | MedDRA v16.0 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA v16.0 | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA v16.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA v16.0 | Non-systematic Assessment |
|
| Blood albumin decreased | Investigations | MedDRA v16.0 | Non-systematic Assessment |
|
| Failure to thrive | Metabolism and nutrition disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Endometrial adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v16.0 | Non-systematic Assessment |
|
| Tumour necrosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v16.0 | Non-systematic Assessment |
|
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v16.0 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Suicide attempt | Psychiatric disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Embolism | Vascular disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Eye discharge | Eye disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Eyelid oedema | Eye disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Subileus | Gastrointestinal disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Pelvic mass | General disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Gallbladder disorder | Hepatobiliary disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Portal vein thrombosis | Hepatobiliary disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA v16.0 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA v16.0 | Non-systematic Assessment |
|
| Rhinovirus infection | Infections and infestations | MedDRA v16.0 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA v16.0 | Non-systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA v16.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA v16.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA v16.0 | Non-systematic Assessment |
|
| Periorbital haematoma | Injury, poisoning and procedural complications | MedDRA v16.0 | Non-systematic Assessment |
|
| Subcutaneous haematoma | Injury, poisoning and procedural complications | MedDRA v16.0 | Non-systematic Assessment |
|
| Ammonia increased | Investigations | MedDRA v16.0 | Non-systematic Assessment |
|
| Amylase increased | Investigations | MedDRA v16.0 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA v16.0 | Non-systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA v16.0 | Non-systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA v16.0 | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA v16.0 | Non-systematic Assessment |
|
| Blood potassium increased | Investigations | MedDRA v16.0 | Non-systematic Assessment |
|
| Breath sounds abnormal | Investigations | MedDRA v16.0 | Non-systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA v16.0 | Non-systematic Assessment |
|
| Heart rate increased | Investigations | MedDRA v16.0 | Non-systematic Assessment |
|
| Laboratory test abnormal | Investigations | MedDRA v16.0 | Non-systematic Assessment |
|
| Lipase increased | Investigations | MedDRA v16.0 | Non-systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA v16.0 | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA v16.0 | Non-systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA v16.0 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Gouty arthritis | Musculoskeletal and connective tissue disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Ataxia | Nervous system disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Scrotal oedema | Reproductive system and breast disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Testicular oedema | Reproductive system and breast disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Telangiectasia | Skin and subcutaneous tissue disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Intra-abdominal haematoma | Vascular disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Vasodilatation | Vascular disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Photopsia | Eye disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Vitreous floaters | Eye disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Cytokine release syndrome | Immune system disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Multiple allergies | Immune system disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA v16.0 | Non-systematic Assessment |
|
| Fungal oesophagitis | Infections and infestations | MedDRA v16.0 | Non-systematic Assessment |
|
| Infection | Infections and infestations | MedDRA v16.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA v16.0 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA v16.0 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA v16.0 | Non-systematic Assessment |
|
| Aspartate aminotransferase | Investigations | MedDRA v16.0 | Non-systematic Assessment |
|
| Blood albumin decreased | Investigations | MedDRA v16.0 | Non-systematic Assessment |
|
| Blood calcium decreased | Investigations | MedDRA v16.0 | Non-systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA v16.0 | Non-systematic Assessment |
|
| Blood potassium decreased | Investigations | MedDRA v16.0 | Non-systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA v16.0 | Non-systematic Assessment |
|
| Blood sodium decreased | Investigations | MedDRA v16.0 | Non-systematic Assessment |
|
| Blood uric acid increased | Investigations | MedDRA v16.0 | Non-systematic Assessment |
|
| Creatinine renal clearance decreased | Investigations | MedDRA v16.0 | Non-systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA v16.0 | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA v16.0 | Non-systematic Assessment |
|
| Weight increased | Investigations | MedDRA v16.0 | Non-systematic Assessment |
|
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Encephalopathy | Nervous system disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Psychotic disorder | Psychiatric disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Renal pain | Renal and urinary disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Pelvic pain | Reproductive system and breast disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Jugular vein thrombosis | Vascular disorders | MedDRA v16.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Treatment-related |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 5 |
|
| Serious Adverse Events |
|
| Lymphocytes abs |
|
| Neutrophils abs |
|
| Platelets |
|
| White blood cells |
|
| Alanine Aminotransferase |
|
| Alkaline Phosphatase |
|
| Amylase |
|
| Aspartate Aminotransferase |
|
| Bilirubin |
|
| Creatinine |
|
| Hypercalcemia |
|
| Hyperglycemia |
|
| Hyperkalemia |
|
| Hypernatremia |
|
| Hypoalbuminemia |
|
| Hypocalcemia |
|
| Hypokalemia |
|
| Hyponatremia |
|
| Hypophosphatemia |
|
| Lipase |
|
| Hypoglycemia |
|
| Cycle 3 Day 1 (n=3, 2, 4, 3, 1, 4, 3, 1, 13) |
|
| Cycle 4 Day 1 (n=2, 2, 2, 3, 1, 4, 3, 1, 12) |
|
| Cycle 5 Day 1 (n= 1, 0, 2, 3, 1, 3, 3, 1, 12) |
|
| Cycle 6 Day 1 (n=0, 2, 2, 1, 1, 1, 1, 0, 7) |
|
| Cycle 7 Day 1 (n=0, 0, 2, 1, 1, 3, 1, 0, 7) |
|
| Cycle 8 Day 1 (n=0, 0, 2, 1, 1, 2, 1, 0, 5) |
|
| Cycle 9 Day 1 (n=0, 0, 2, 1, 1, 2, 1, 0, 4) |
|
| Cycle 10 Day 1 (n=0, 0, 1, 1, 1, 2, 1, 0, 3) |
|
| Cycle 11 Day 1 (n=0, 0, 0, 1, 1, 2, 1, 0, 3) |
|
| Cycle 12 Day 1 (n=0, 0, 0, 0, 1, 2, 1, 0, 2) |
|
| C1D16H: Ang-2 (n=4, 3, 6, 3, 4, 8, 7, 6, 24) |
|
| C1D22: Ang-2 (n=4, 5, 6, 3, 4, 6, 7, 5, 20) |
|
| C2D1: Ang-2 (n=3, 2, 6, 3, 4, 5, 5, 2, 20) |
|
| C3D1: Ang-2 (n=3, 2, 4, 3, 1, 4, 3, 1, 12) |
|
| EOT: Ang-2 (n=5, 5, 2, 3, 4, 4, 5, 5, 17) |
|
| Baseline: BMP-9 (n=5, 5, 6, 3, 4, 8, 7, 6, 24) |
|
| C1D16H: BMP-9 (n=4, 3, 6, 2, 4, 7, 7, 6, 23) |
|
| C1D22: BMP-9 (n=4, 5, 6, 2, 4, 5, 7, 5, 19) |
|
| C2D1: BMP-9 (n=3, 2, 6, 2, 4, 4, 5, 2, 20) |
|
| C3D1: BMP-9 (n=2, 2, 4, 2, 1, 3, 3, 1, 12) |
|
| EOT: BMP-9 (n=5, 5, 2, 2, 4, 4, 5, 5, 17) |
|
| Baseline: CCL2 (n=5, 5, 6, 3, 4, 8, 7, 6, 24) |
|
| C1D16H: CCL2 (n=4, 3, 6, 3, 4, 8, 7, 6, 24) |
|
| C1D22: CCL2 (n=4, 5, 6, 3, 4, 6, 7, 5, 20) |
|
| C2D1: CCL2 (n=3, 2, 6, 3, 4, 5, 5, 2, 20) |
|
| C3D1: CCL2 (n=3, 2, 4, 3, 1, 4, 3, 1, 12) |
|
| EOT: CCL2 (n=5, 5, 2, 3, 4, 4, 5, 5, 17) |
|
| C1D16H: CD106 (n= 4, 3, 6, 3, 4, 8, 7, 6, 24) |
|
| C1D22: CD106 (n= 4, 5, 6, 3, 4, 6, 7, 5, 20) |
|
| C2D1: CD106 (n= 3, 2, 6, 3, 4, 5, 5, 2, 20) |
|
| C3D1: CD106 (n= 3, 2, 4, 3, 1, 4, 3, 1, 12) |
|
| EOT: CD106 (n= 5, 5, 2, 3, 4, 4, 5, 5, 17) |
|
| Baseline: CD54 (n= 5, 5, 6, 3, 4, 8, 7, 6, 24) |
|
| C1D16H: CD54 (n= 4, 3, 6, 3, 4, 8, 7, 6, 24) |
|
| C1D22: CD54 (n= 4, 5, 6, 3, 4, 6, 7, 5, 20) |
|
| C2D1: CD54 (n= 3, 2, 6, 3, 4, 5, 5, 2, 20) |
|
| C3D1: CD54 (n= 3, 2, 4, 3, 1, 4, 3, 1, 12) |
|
| EOT: CD54 (n= 5, 5, 2, 3, 4, 4, 5, 5, 17) |
|
| Baseline: Endoglin (n= 5, 5, 6, 3, 4, 8, 7, 6, 24) |
|
| C1D16H: Endoglin (n= 4, 3, 6, 3, 4, 8, 7, 6, 24) |
|
| C1D22: Endoglin (n= 4, 5, 6, 3, 4, 6, 7, 5, 20) |
|
| C2D1: Endoglin (n= 3, 2, 6, 3, 4, 5, 5, 2, 20) |
|
| C3D1: Endoglin (n= 3, 2, 4, 3, 1, 4, 3, 1, 12) |
|
| EOT: Endoglin (n= 5, 5, 2, 3, 4, 4, 5, 5, 17) |
|
| C1D16H: PLGF (n=4, 3, 5, 3, 2, 7, 6, 5, 22) |
|
| C1D22: PLGF (n=4, 5, 6, 2, 3, 6, 6, 4, 18) |
|
| C2D1: PLGF (n=3, 2, 6, 1, 3, 4, 3, 2, 18) |
|
| C3D1: PLGF (n=3, 2, 3, 1, 1, 4, 2, 1, 10) |
|
| EOT: PLGF (n=5, 4, 2, 2, 2, 3, 2, 4, 14) |
|
| Baseline: TGFb1 (n=5, 5, 6, 3, 4, 8, 7, 6, 24) |
|
| C1D16H: TGFb1 (n=4, 3, 6, 3, 4, 8, 7, 6, 24) |
|
| C1D22: TGFb1 (n=4, 5, 6, 3, 4, 6, 7, 5, 20) |
|
| C2D1: TGFb1 (n=3, 2, 6, 3, 4, 5, 5, 2, 20) |
|
| C3D1: TGFb1 (n=3, 2, 4, 3, 1, 4, 3, 1, 12) |
|
| EOT: TGFb1 (n=5, 5, 2, 3, 4, 4, 5, 5, 17) |
|
| Baseline: VEGF-A (n=4, 5, 6, 3, 3, 8, 7, 6, 24) |
|
| C1D16H: VEGF-A (n=4, 3, 6, 3, 4, 8, 7, 6, 24) |
|
| C1D22: VEGF-A (n=4, 5, 6, 3, 4, 6, 7, 4, 20) |
|
| C2D1: VEGF-A (n=3, 2, 6, 3, 4, 5, 5, 2, 20) |
|
| C3D1: VEGF-A (n=3, 2, 4, 3, 1, 4, 3, 1, 12) |
|
| EOT: VEGF-A (n=5, 5, 2, 3, 4, 4, 5, 5, 17) |
|
| C1D16H: VEGF-C (n= 2, 2, 4, 2, 2, 5, 5, 4, 13) |
|
| C1D22: VEGF-C (n= 3, 5, 4, 2, 2, 4, 4, 4, 12) |
|
| C2D1: VEGF-C (n= 2, 1, 2, 1, 2, 4, 4, 1, 11) |
|
| C3D1: VEGF-C (n= 2, 1, 2, 0, 1, 3, 1, 0, 8) |
|
| EOT: VEGF-C (n= 5, 4, 0, 1, 2, 3, 4, 5, 10) |
|
| Baseline: VEGF-d (n= 5, 5, 6, 3, 4, 8, 7, 6, 24) |
|
| C1D16H: VEGF-d (n= 4, 3, 6, 3, 4, 8, 7, 6, 24) |
|
| C1D22: VEGF-d (n= 4, 5, 6, 3, 4, 6, 7, 5, 19) |
|
| C2D1: VEGF-d (n= 3, 2, 6, 3, 4, 5, 5, 2, 20) |
|
| C3D1: VEGF-d (n= 3, 2, 4, 3, 1, 4, 3, 1, 12) |
|
| EOT: VEGF-d (n= 5, 5, 2, 3, 4, 4, 5, 5, 17) |
|
| Baseline: VEGFR1 (n= 5, 5, 6, 3, 4, 7, 7, 6, 23) |
|
| C1D16H: VEGFR1 (n= 4, 3, 6, 3, 4, 8, 6, 6, 23) |
|
| C1D22: VEGFR1 (n= 4, 5, 6, 3, 3, 5, 7, 4, 20) |
|
| C2D1: VEGFR1 (n= 3, 1, 6, 3, 4, 5, 5, 2, 20) |
|
| C3D1: VEGFR1 (n= 3, 2, 4, 3, 1, 4, 2, 1, 12) |
|
| EOT: VEGFR1 (n= 5, 5, 2, 2, 4, 4, 4, 5, 17) |
|
| C1D16H: VEGFR2 (n= 4, 3, 6, 3, 4, 8, 7, 6, 24) |
|
| C1D22: VEGFR2 (n= 4, 5, 6, 3, 4, 6, 7, 5, 20) |
|
| C2D1: VEGFR2 (n= 3, 2, 6, 3, 4, 5, 5, 2, 20) |
|
| C3D1: VEGFR2 (n= 3, 2, 4, 3, 1, 4, 3, 1, 12) |
|
| EOT: VEGFR2 (n= 5, 5, 2, 3, 4, 4, 5, 5, 17) |
|
| Baseline: VEGFR3 (n= 5, 5, 6, 3, 4, 8, 7, 6, 24) |
|
| C1D16H: VEGFR3 (n= 4, 3, 6, 3, 4, 8, 7, 6, 24) |
|
| C1D22: VEGFR3 (n= 4, 5, 6, 3, 4, 6, 7, 5, 20) |
|
| C2D1: VEGFR3 (n= 3, 2, 6, 3, 4, 5, 5, 2, 20) |
|
| C3D1: VEGFR3 (n= 3, 2, 4, 3, 1, 4, 3, 1, 12) |
|
| EOT: VEGFR3 (n= 5, 5, 2, 3, 4, 4, 5, 5, 17) |
|