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The study was terminated as part of the decision by Pfizer to halt its biosimilars programs in China.
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The current study will compare the efficacy, safety, pharmacokinetics and immunogenicity of PF-06439535 (CN) in combination with paclitaxel and carboplatin versus bevacizumab sourced from the European Union (bevacizumab-EU) with paclitaxel and carboplatin in Chinese participants with advanced non-squamous NSCLC in the first-line treatment setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | PF-06439535 (CN) + paclitaxel + carboplatin |
|
| Arm B | Active Comparator | Bevacizumab-EU + paclitaxel + carboplatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06439535 (CN) | Drug | 15 mg/kg, IV on day 1 of each 21 day cycle for up to 2 years, or until progression or unacceptable toxicity develops. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Objective Response | Objective response referred to complete response (CR) or partial response (PR) by Week 19 of the study in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 which was subsequently confirmed by Week 25. A participant achieved CR if both target and non-target lesions achieved CR, no new lesions; achieved PR if target lesions achieved CR or PR, non-target lesions were assessed as non-CR/non-PD (non-progressive disease), indeterminate or missing, and no new lesions. For target lesions, CR: complete disappearance of all target lesions, normal nodes (target nodes must decrease to normal size); PR: >= 30% decrease under baseline of the sum of diameters of all target measurable lesions. For non-target lesions, CR: disappearance of all non-target lesions and normalization of tumor marker levels and all lymph nodes must be normal in size; non-CR/non-PD: persistence of any non-target lesions and/or tumor marker level above the normal limits. | From Week 1 to Week 25 (25 Weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in Treatment Period | TEAE was defined as any adverse event that occurs after the beginning of the investigational product or any pre-existing adverse event (AE) that worsens after the beginning of the investigational product. Serious adverse events (SAE) were assessed by the investigator. Severity of AE was graded based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03: Grade 3-SEVERE AE; Grade 4-LIFE-THREATENING consequences; urgent intervention indicated; Grade 5-DEATH RELATED TO AE. |
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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 |
|---|---|---|---|---|---|---|
| Dongguan People's Hospital | Dongguan | Guangdong | 523059 | China | ||
| Affiliated Hospital of Hebei University |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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A total of 13 participants were screened, of which 5 were screen failure. Four participants were randomized into each of the PF-06439535 (CN) or bevacizumab (EU) groups. Sample size after termination is very small. To avoid the risk of participant re-identification, participant flow was reported in a single overall study period.
The study was terminated on 17 March 2021 by the Sponsor. This study was conducted in China.
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| ID | Title | Description |
|---|---|---|
| FG000 | PF-06439535 (CN) | Participants received PF-06439535 (CN) (starting dose of 15 mg/kg) plus paclitaxel (starting dose of 175 mg/m^2) and carboplatin (starting dose of area under the concentration versus time curve [AUC] 5 [max=750 mg]) for up to but not including 25 weeks, followed by PF-06439535 (CN) monotherapy up to 2 years from randomization. Paclitaxel, carboplatin and PF-06439535 (CN) were administered via intravenous (IV) infusion in order on 21-day cycles. |
| FG001 | Bevacizumab (EU) | Participants received bevacizumab (EU) (starting dose of 15 mg/kg) plus paclitaxel (starting dose of 175 mg/m^2) and carboplatin (starting dose of AUC 5 [max=750 mg]) for up to but not including 25 weeks, followed by PF-06439535 (CN) monotherapy up to 2 years from randomization. Paclitaxel, carboplatin and bevacizumab (EU) were administered via IV infusion in order on 21 day cycles. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PF-06439535 (CN) | Participants received PF-06439535 (CN) (starting dose of 15 mg/kg) plus paclitaxel (starting dose of 175 mg/m^2) and carboplatin (starting dose of AUC 5 [max=750 mg]) for up to but not including 25 weeks, followed by PF-06439535 (CN) monotherapy up to 2 years from randomization. Paclitaxel, carboplatin and PF-06439535 (CN) were administered via IV infusion in order on 21 day cycles. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Percentage of Participants Achieving Objective Response | Objective response referred to complete response (CR) or partial response (PR) by Week 19 of the study in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 which was subsequently confirmed by Week 25. A participant achieved CR if both target and non-target lesions achieved CR, no new lesions; achieved PR if target lesions achieved CR or PR, non-target lesions were assessed as non-CR/non-PD (non-progressive disease), indeterminate or missing, and no new lesions. For target lesions, CR: complete disappearance of all target lesions, normal nodes (target nodes must decrease to normal size); PR: >= 30% decrease under baseline of the sum of diameters of all target measurable lesions. For non-target lesions, CR: disappearance of all non-target lesions and normalization of tumor marker levels and all lymph nodes must be normal in size; non-CR/non-PD: persistence of any non-target lesions and/or tumor marker level above the normal limits. | The Intent-to-treat (ITT) population was defined as all participants who were randomized to study treatment. Data for analyzing endpoint were not collected. | Posted | From Week 1 to Week 25 (25 Weeks) |
From ICD through and up to 28 days after last dose of investigational product or prior to the start of new anticancer therapy, whichever occurred first (up to 311 days).
To avoid risk re-identification of participants, data for extension period were reported in 1 arm as a total.
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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 | Treatment Period: PF-06439535 (CN) | Participants received PF-06439535 (CN) (starting dose of 15 mg/kg) plus paclitaxel (starting dose of 175 mg/m^2) and carboplatin (starting dose of AUC 5 [max=750 mg]) for up to but not including 25 weeks as treatment period, followed by PF-06439535 (CN) monotherapy up to 2 years from randomization as extension period. Paclitaxel, carboplatin and PF-06439535 (CN) were administered via IV infusion in order on 21-day cycles. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA v24.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v24.0 | Non-systematic Assessment |
The study was terminated on 17 March 2021 by the Sponsor. The decision to terminate this study was based on a business review of the biosimilars market and the Sponsor's global manufacturing network. This decision was not based on any safety or regulatory concerns with the treatment of participants with PF-06439535 (CN). The results reported are limited to safety, PK and immunogenicity, and only safety is summarized.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 27, 2019 | Apr 29, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 5, 2019 | Apr 29, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Bevacizumab-EU | Drug | 15 mg/kg, IV on day 1 of each 21 day cycle until disease progression, unacceptable toxicity or 25 weeks. At Week 25, the participants with clinical benefit will received PF-06439535 (CN) monotherapy for up to 2 years from randomization in this study |
|
|
| Paclitaxel | Drug | 175 mg/m2 via IV infusions on Day 1 of a 21-day cycle for each of at least 4 and no more than six (6) 21-day cycles. |
|
| Carboplatin | Drug | AUC 5 (max=750mg) via IV infusions on Day 1 of a 21-day cycle for each of at least 4 and no more than six (6) 21-day cycles. |
|
| From Day 1 to end of Cycle 8; 1 Cycle = 21 Days |
| Number of Participants With Anti-Drug Antibodies (ADA) | ADA have been evaluated in studies with bevacizumab in cancer patient populations. A sensitive and specific immunoassay for detecting ADA in human serum was used to analyze the ADA samples (blood samples for assessment of ADA collected at specified timepoints). | Pre-dose on Day 1 of Cycle 1 and Cycle 5, and before the last administration of the investigational product (up to Cycle 14 Day 1); 1 Cycle = 21 Days |
| Number of Participants With NAb | Blood samples for assessment of ADA and NAb were collected at specified time point. Samples that were determined positive for ADA were further characterized for NAb using a single validated NAb assay. | Pre-dose on Day 1 of Cycle 1 and Cycle 5, and before the last administration of the investigational product (up to Cycle 14 Day 1); 1 Cycle = 21 Days |
| Trough and Apparent Peak PF-06439535 (CN) and Bevacizumab (EU) Concentrations | The drug concentrations were determined using serum samples collected at the time points specified. | Pre-dose on Day 1 of Cycle 1 and Cycle 5, and before the last administration of the investigational product (up to Cycle 14 Day 1); 2.5 hours after initiation of bevacizumab infusion on Day 1 of Cycle 1 and Cycle 5; 1 Cycle = 21 Days |
| Number of Participants With TEAEs in Extension Period | Treatment emergent adverse event (TEAE) was defined as any adverse event that occurs after the beginning of the investigational product or any pre-existing adverse event that worsens after the beginning of the investigational product. Serious adverse events were assessed by the investigator. Severity of AE was graded based on NCI CTCAE version 4.03: Grade 3-SEVERE AE; Grade 4-LIFE-THREATENING consequences; urgent intervention indicated; Grade 5-DEATH RELATED TO AE. | Cycle 9 Day 1 up to End of Treatment (up to Cycle 14 Day 21); 1 Cycle = 21 Days |
| Baoding |
| Hebei |
| 071000 |
| China |
| Jinan Central Hospital | Jinan | Shandong | 250013 | China |
| Tianjin Medical University General Hospital | Tianjin | Tianjin Municipality | 300052 | China |
| BG001 | Bevacizumab (EU) | Participants received bevacizumab (EU) (starting dose of 15 mg/kg) plus paclitaxel (starting dose of 175 mg/m^2) and carboplatin (starting dose of AUC 5 [max=750 mg]) for up to but not including 25 weeks, followed by PF-06439535 (CN) monotherapy up to 2 years from randomization. Paclitaxel, carboplatin and bevacizumab (EU) were administered via IV infusion in order on 21 day cycles. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| ID | Title | Description |
|---|
| OG000 | PF-06439535 (CN) | Participants received PF-06439535 (CN) (starting dose of 15 mg/kg) plus paclitaxel (starting dose of 175 mg/m^2) and carboplatin (starting dose of AUC 5 [max=750 mg]) for up to but not including 25 weeks as treatment period, followed by PF-06439535 (CN) monotherapy up to 2 years from randomization as extension period. Paclitaxel, carboplatin and PF-06439535 (CN) were administered via IV infusion in order on 21 day cycles. |
| OG001 | Bevacizumab (EU) | Participants received bevacizumab (EU) (starting dose of 15 mg/kg) plus paclitaxel (starting dose of 175 mg/m^2) and carboplatin (starting dose of AUC 5 [max=750 mg]) for up to but not including 25 weeks as treatment period, followed by PF-06439535 (CN) monotherapy up to 2 years from randomization as extension period. Paclitaxel, carboplatin and bevacizumab (EU) were administered via IV infusion in order on 21 day cycles. |
|
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in Treatment Period | TEAE was defined as any adverse event that occurs after the beginning of the investigational product or any pre-existing adverse event (AE) that worsens after the beginning of the investigational product. Serious adverse events (SAE) were assessed by the investigator. Severity of AE was graded based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03: Grade 3-SEVERE AE; Grade 4-LIFE-THREATENING consequences; urgent intervention indicated; Grade 5-DEATH RELATED TO AE. | The safety population was defined as all participants who were randomized and received at least one dose of investigational product. | Posted | Count of Participants | Participants | From Day 1 to end of Cycle 8; 1 Cycle = 21 Days |
|
|
|
| Secondary | Number of Participants With Anti-Drug Antibodies (ADA) | ADA have been evaluated in studies with bevacizumab in cancer patient populations. A sensitive and specific immunoassay for detecting ADA in human serum was used to analyze the ADA samples (blood samples for assessment of ADA collected at specified timepoints). | All participants who were randomized and received at least 1 dose of investigational product were used for ADA and neutralizing antibody (NAb) analyses. The number of participants analyzed are those numbers with participants ADA samples tested. | Posted | Count of Participants | Participants | Pre-dose on Day 1 of Cycle 1 and Cycle 5, and before the last administration of the investigational product (up to Cycle 14 Day 1); 1 Cycle = 21 Days |
|
|
|
| Secondary | Number of Participants With NAb | Blood samples for assessment of ADA and NAb were collected at specified time point. Samples that were determined positive for ADA were further characterized for NAb using a single validated NAb assay. | All participants who were randomized and received at least one dose of investigational product were used for ADA and NAb analyses. NAb were not tested thus no data were reported. Only samples that were determined positive for ADA would be further characterized for NAb. | Posted | Pre-dose on Day 1 of Cycle 1 and Cycle 5, and before the last administration of the investigational product (up to Cycle 14 Day 1); 1 Cycle = 21 Days |
|
|
| Secondary | Trough and Apparent Peak PF-06439535 (CN) and Bevacizumab (EU) Concentrations | The drug concentrations were determined using serum samples collected at the time points specified. | Participants who were randomized and had at least 1 post dose drug concentration measurement, and had no major protocol deviations which influenced the pharmacokinetic (PK) assessment were included in the PK analysis. Data for analyzing endpoint were not collected. | Posted | Pre-dose on Day 1 of Cycle 1 and Cycle 5, and before the last administration of the investigational product (up to Cycle 14 Day 1); 2.5 hours after initiation of bevacizumab infusion on Day 1 of Cycle 1 and Cycle 5; 1 Cycle = 21 Days |
|
|
| Secondary | Number of Participants With TEAEs in Extension Period | Treatment emergent adverse event (TEAE) was defined as any adverse event that occurs after the beginning of the investigational product or any pre-existing adverse event that worsens after the beginning of the investigational product. Serious adverse events were assessed by the investigator. Severity of AE was graded based on NCI CTCAE version 4.03: Grade 3-SEVERE AE; Grade 4-LIFE-THREATENING consequences; urgent intervention indicated; Grade 5-DEATH RELATED TO AE. | The safety population was defined as all participants who were randomized and received at least one dose of investigational product. To avoid risk re-identification of participants, data for extension period were reported in 1 arm as a total. | Posted | Count of Participants | Participants | Cycle 9 Day 1 up to End of Treatment (up to Cycle 14 Day 21); 1 Cycle = 21 Days |
|
|
|
| 0 |
| 4 |
| 1 |
| 4 |
| 4 |
| 4 |
| EG001 | Treatment Period: Bevacizumab (EU) | Participants received bevacizumab (EU) (starting dose of 15 mg/kg) plus paclitaxel (starting dose of 175 mg/m^2) and carboplatin (starting dose of AUC 5 [max=750 mg]) for up to but not including 25 weeks as treatment period, followed by PF-06439535 (CN) monotherapy up to 2 years from randomization as extension period. Paclitaxel, carboplatin and bevacizumab (EU) were administered via IV infusion in order on 21-day cycles. | 0 | 4 | 2 | 4 | 4 | 4 |
| EG002 | Extension Period: PF-06439535 (CN) or Bevacizumab (EU) > PF-06439535 (CN) | Participants in extension period who received PF-06439535 (CN) or bevacizumab (EU) (starting dose of 15 mg/kg) plus paclitaxel (starting dose of 175 mg/m*2) and carboplatin (starting dose of AUC 5 [max=750mg]) for up to but not including 25 weeks as treatment period, followed by PF-06439535 (CN) monotherapy up to 2 years from randomization as extension period. Paclitaxel, carboplatin and PF-06439535 (CN) were administered via IV infusion in order on 21-day cycles. | 0 | 3 | 1 | 3 | 3 | 3 |
| Pyrexia | General disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Temperature intolerance | General disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA v24.0 | Non-systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA v24.0 | Non-systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA v24.0 | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA v24.0 | Non-systematic Assessment |
|
| Weight increased | Investigations | MedDRA v24.0 | Non-systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA v24.0 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Anaesthesia | Nervous system disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Neurotoxicity | Nervous system disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Merycism | Psychiatric disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA v24.0 | Non-systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA v24.0 | Non-systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA v24.0 | 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.
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
| Participants with all causalities AEs of maximum grade 3 or 4 |
|
| Participants with all causalities AEs of maximum grade 5 |
|
| Participants with PF-06439535 (CN) or bevacizumab (EU)-related AEs |
|
| Participants with PF-06439535 (CN) or bevacizumab (EU)-related SAEs |
|
| Participants with PF-06439535 (CN) or bevacizumab (EU)-related AEs of maximum grade 3 or 4 |
|
| Participants with PF-06439535 (CN) or bevacizumab (EU)-related AEs of maximum grade 5 |
|
| Cycle 5_Day 1_ADA Positive |
|
|
| End of Treatment Positive |
|
|
| Title | Measurements |
|---|---|
|
| Participants with all causality AEs of maximum grade 5 |
|
| Participants with PF-06439535 (CN) or bevacizumab (EU)-related AEs |
|
| Participants with PF-06439535 (CN) or bevacizumab (EU)-related SAEs |
|
| Participants with PF-06439535 (CN) or bevacizumab (EU)-related AEs of maximum grade 3 or 4 |
|
| Participants with PF-06439535 (CN) or bevacizumab (EU)-related AEs of maximum grade 5 |
|