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To demonstrate that CT-P16 is similar to EU-Approved Avastin in terms of efficacy as determined by objective response rate (ORR) during the Induction Study Period
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT-P16 | Experimental | Drug: Bevacizumab 15mg/kg IV of CT-P16 will be administered every 3 weeks up to 6 cycles during the Induction Study Period and every 3 weeks until Progressive Disease (PD) or intolerable toxicity during the Maintenance Period. |
|
| Avastin | Active Comparator | Drug: Bevacizumab 15mg/kg IV of EU-approved Avastin will be administered every 3 weeks up to 6 cycles during the Induction Study Period and every 3 weeks until PD or intolerable toxicity during the Maintenance Period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT-P16 | Drug | 15mg/kg IV of CT-P16 every 3 weeks up to 6 cycles in the induction study period and every 3 weeks until PD occurs in the maintenance study period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) During the Induction Study Period From Central Review | The ORR was defined as the proportion of patients with a confirmed Best Overall Response (BOR) of CR or PR (the 'responder'). All other patients except responders were considered as non-responders, including patients without post-baseline tumor assessment. | Induction Study Period (around 18 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Response Duration From Central Review | Response duration was defined as time between initial response (CR or PR) that is confirmed by the subsequent assessment after study treatment administration and PD/recurrence or death from any cause, whichever occurs first. | Tumor assessments were assessed every 2 cycles during the Induction Study Period, every 3 cycles during the Maintenance Study Period, and at the EOT visit. The median follow-up time from randomization was 12.86 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chung-Ang University Hospital | Seoul | 06973 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40795416 | Derived | Andric Z, Moiseenko F, Makharadze T, Oleksiienko A, Yanez Ruiz E, Kim S, Ahn K, Park T, Ju H, Baek EH, Kwon S, Chang I, Kim S, Kim H, Lee E, Verschraegen C. Long-term results of a randomized controlled trial of biosimilar CT-P16 and reference bevacizumab in patients with metastatic or recurrent non-small cell lung cancer. Cancer Treat Res Commun. 2025;44:100970. doi: 10.1016/j.ctarc.2025.100970. Epub 2025 Jul 24. | |
| 36169807 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Avastin | Drug: Bevacizumab 15mg/kg IV of European Union (EU)-approved Avastin will be administered every 3 weeks up to 6 cycles during the Induction Study Period and every 3 weeks until Progressive Disease (PD) or intolerable toxicity during the Maintenance Period. Avastin: 15mg/kg IV of Avastin every 3 weeks up to 6 cycles in the induction study period and every 3 weeks until PD occurs in the maintenance study period. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Induction Study Period |
|
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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 14, 2019 | Apr 17, 2024 |
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| Avastin | Drug | 15mg/kg IV of Avastin every 3 weeks up to 6 cycles in the induction study period and every 3 weeks until PD occurs in the maintenance study period. |
|
| Time to Progression From Central Review | Time to progression was defined as time from randomization to determined PD/recurrence. | Tumor assessments were assessed every 2 cycles during the Induction Study Period, every 3 cycles during the Maintenance Study Period, and at the EOT visit. The median follow-up time from randomization was 12.86 months. |
| Progression Free Survival From Central Review | Progression-free survival was defined as time from randomization to determined PD/recurrence or death from any cause, whichever occurs first. | Tumor assessments were assessed every 2 cycles during the Induction Study Period, every 3 cycles during the Maintenance Study Period, and at the EOT visit. The median follow-up time from randomization was 12.86 months. |
| Overall Survival | Overall survival was defined as time from randomization to death from any cause. | Tumor assessments were assessed every 2 cycles during the Induction Study Period, every 3 cycles during the Maintenance Study Period, and at the EOT visit. The median follow-up time from randomization was 12.86 months. |
| Trough Serum Concentrations During the Induction Study Period | Pharmacokinetic samples were collected on Day 1 of each cycle (prior to the beginning of the study drug administration) in the Induction Study Period. | Induction Study Period. Pharmacokinetic samples were collected on Day 1 of each cycle in Induction Study Period. |
| Patients With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (NAb) at Anytime During the Whole Study Period | Immunogenicity was assessed on Day 1 of Cycle 1 (pre-dose), every 2 cycles during the Induction Study Period, and every 3 cycles during the Maintenance Study Period and End of Treatment (EOT) visit. In the Follow-Up Period, immunogenicity was assessed once at the first visit of the Follow-Up Period (ninth week). | Immunogenicity was assessed Day 1 of Cycle 1 (predose), every 2 cycles during the Induction Study Period, every 3 cycles during the Maintenance Study Period, EOT visit, and at the first visit of Follow-up period. |
| Derived |
| Verschraegen C, Andric Z, Moiseenko F, Makharadze T, Shevnya S, Oleksiienko A, Yanez Ruiz E, Kim S, Ahn K, Park T, Park S, Ju H, Ohe Y. Candidate Bevacizumab Biosimilar CT-P16 versus European Union Reference Bevacizumab in Patients with Metastatic or Recurrent Non-Small Cell Lung Cancer: A Randomized Controlled Trial. BioDrugs. 2022 Nov;36(6):749-760. doi: 10.1007/s40259-022-00552-8. Epub 2022 Sep 28. |
| FG001 | CT-P16 | Drug: Bevacizumab 15mg/kg IV of CT-P16 will be administered every 3 weeks up to 6 cycles during the Induction Study Period and every 3 weeks until PD or intolerable toxicity during the Maintenance Period. CT-P16: 15mg/kg IV of CT-P16 every 3 weeks up to 6 cycles in the induction study period and every 3 weeks until PD occurs in the maintenance study period. |
| COMPLETED |
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| NOT COMPLETED |
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| Maintenance Study Period |
|
ITT population: All randomized patients who were randomly assigned to study drug regardless of whether or not any study treatment dosing was completed.
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| ID | Title | Description |
|---|---|---|
| BG000 | CT-P16 | Drug: Bevacizumab 15mg/kg IV of CT-P16 will be administered every 3 weeks up to 6 cycles during the Induction Study Period and every 3 weeks until PD or intolerable toxicity during the Maintenance Period. CT-P16: 15mg/kg IV of CT-P16 every 3 weeks up to 6 cycles in the induction study period and every 3 weeks until PD occurs in the maintenance study period. |
| BG001 | Avastin | Drug: Bevacizumab 15mg/kg IV of EU-approved Avastin will be administered every 3 weeks up to 6 cycles during the Induction Study Period and every 3 weeks until PD or intolerable toxicity during the Maintenance Period. Avastin: 15mg/kg IV of Avastin every 3 weeks up to 6 cycles in the induction study period and every 3 weeks until PD occurs in the maintenance study period. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Disease Status | Count of Participants | Participants |
| ||||||||||||||||
| Eastern Cooperative Oncology Group (ECOG) Performance Status | A scale to assess a patient's disease status. 0 = Fully active, able to carry out all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity, but ambulatory and able to carry out work of light nature or sedentary nature; 2 = Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about > 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair > 50% of waking hours; 4 = Completely disabled, confined to bed or chair; 5 = Dead. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Objective Response Rate (ORR) During the Induction Study Period From Central Review | The ORR was defined as the proportion of patients with a confirmed Best Overall Response (BOR) of CR or PR (the 'responder'). All other patients except responders were considered as non-responders, including patients without post-baseline tumor assessment. | Intent-to-Treat (ITT) population: All randomized patients who were randomly assigned to study drug regardless of whether or not any study treatment dosing was completed. | Posted | Number | 95% Confidence Interval | percentage of responders | Induction Study Period (around 18 weeks) |
|
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Response Duration From Central Review | Response duration was defined as time between initial response (CR or PR) that is confirmed by the subsequent assessment after study treatment administration and PD/recurrence or death from any cause, whichever occurs first. | Patients who have confirmed BOR of CR or PR from ITT population (All randomized patients who were randomly assigned to study drug regardless of whether or not any study treatment dosing was completed). | Posted | Number | 95% Confidence Interval | Proportion of participants | Tumor assessments were assessed every 2 cycles during the Induction Study Period, every 3 cycles during the Maintenance Study Period, and at the EOT visit. The median follow-up time from randomization was 12.86 months. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Progression From Central Review | Time to progression was defined as time from randomization to determined PD/recurrence. | ITT population: All randomized patients who were randomly assigned to study drug regardless of whether or not any study treatment dosing was completed. | Posted | Number | 95% Confidence Interval | Proportion of participants | Tumor assessments were assessed every 2 cycles during the Induction Study Period, every 3 cycles during the Maintenance Study Period, and at the EOT visit. The median follow-up time from randomization was 12.86 months. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival From Central Review | Progression-free survival was defined as time from randomization to determined PD/recurrence or death from any cause, whichever occurs first. | ITT population: All randomized patients who were randomly assigned to study drug regardless of whether or not any study treatment dosing was completed. | Posted | Number | 95% Confidence Interval | Proportion of participants | Tumor assessments were assessed every 2 cycles during the Induction Study Period, every 3 cycles during the Maintenance Study Period, and at the EOT visit. The median follow-up time from randomization was 12.86 months. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall survival was defined as time from randomization to death from any cause. | ITT population: All randomized patients who were randomly assigned to study drug regardless of whether or not any study treatment dosing was completed. | Posted | Number | 95% Confidence Interval | Proportion of participants | Tumor assessments were assessed every 2 cycles during the Induction Study Period, every 3 cycles during the Maintenance Study Period, and at the EOT visit. The median follow-up time from randomization was 12.86 months. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Trough Serum Concentrations During the Induction Study Period | Pharmacokinetic samples were collected on Day 1 of each cycle (prior to the beginning of the study drug administration) in the Induction Study Period. | Pharmacokinetic (PK) population: all randomly assigned patients who received at least 1 full dose of study drug (CT-P16 or Avastin) and who had at least 1 post-treatment PK result. Patients who received incorrect treatment during the Induction Study Period were excluded from the PK population. | Posted | Mean | Standard Deviation | μg/L | Induction Study Period. Pharmacokinetic samples were collected on Day 1 of each cycle in Induction Study Period. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Patients With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (NAb) at Anytime During the Whole Study Period | Immunogenicity was assessed on Day 1 of Cycle 1 (pre-dose), every 2 cycles during the Induction Study Period, and every 3 cycles during the Maintenance Study Period and End of Treatment (EOT) visit. In the Follow-Up Period, immunogenicity was assessed once at the first visit of the Follow-Up Period (ninth week). | Safety Population: all randomly assigned patients who received at least 1 dose (partial or full) of study drug (CT-P16 or Avastin). Patients receiving at least 1 dose of CT-P16 at any time of during the treatment period were analyzed under the CT-P16 treatment group. Three patients who were randomized to Avastin treatment group were analyzed under the CT-P16 treatment group since the patients incorrectly received CT-P16 during the treatment period. | Posted | Number | participants | Immunogenicity was assessed Day 1 of Cycle 1 (predose), every 2 cycles during the Induction Study Period, every 3 cycles during the Maintenance Study Period, EOT visit, and at the first visit of Follow-up period. |
|
Adverse events were assessed from the date the informed consent form is signed until up to 28 days from last dose of study drug, regardless of the relationship to the study drug, regardless of the relationship to the study drug.
Three patients who were randomized to Avastin treatment group were analyzed under the CT-P16 treatment group since the patients incorrectly received CT-P16 during the treatment period.
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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 | CT-P16 | Drug: Bevacizumab 15mg/kg IV of CT-P16 will be administered every 3 weeks up to 6 cycles during the Induction Study Period and every 3 weeks until PD or intolerable toxicity during the Maintenance Period. CT-P16: 15mg/kg IV of CT-P16 every 3 weeks up to 6 cycles in the induction study period and every 3 weeks until PD occurs in the maintenance study period. | 24 | 345 | 69 | 345 | 332 | 345 |
| EG001 | Avastin | Drug: Bevacizumab 15mg/kg IV of EU-approved Avastin will be administered every 3 weeks up to 6 cycles during the Induction Study Period and every 3 weeks until PD or intolerable toxicity during the Maintenance Period. Avastin: 15mg/kg IV of Avastin every 3 weeks up to 6 cycles in the induction study period and every 3 weeks until PD occurs in the maintenance study period. | 25 | 344 | 73 | 344 | 320 | 344 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Splenic Infarction | Blood and lymphatic system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Acute Myocardial Infarction | Cardiac disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Angina Unstable | Cardiac disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Cardiac Arrest | Cardiac disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Cardiac Failure Acute | Cardiac disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Cardiac Failure Congestive | Cardiac disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Cardio-Respiratory Arrest | Cardiac disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Ventricular Fibrillation | Cardiac disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Anal Fistula | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Food Poisoning | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Gastric Haemorrhage | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Gastric Ulcer Haemorrhage | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Gastroduodenal Haemorrhage | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Gastrointestinal Toxicity | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Intestinal Obstruction | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Pancreatic Pseudocyst Rupture | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Pancreatitis Acute | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Pancreatitis Necrotising | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Hyperthermia Malignant | General disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Sudden Death | General disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Anaphylactic Reaction | Immune system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Anaphylactic Shock | Immune system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Contrast Media Reaction | Immune system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Abdominal Wall Abscess | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Abscess Limb | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| COVID-19 Pneumonia | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Infectious Pleural Effusion | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Lower Respiratory Tract Infection | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Lung Abscess | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Pneumonia Mycoplasmal | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Renal Abscess | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Respiratory Tract Infection Viral | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Craniocerebral Injury | Injury, poisoning and procedural complications | MedDRA version 24.0 | Systematic Assessment |
| |
| Femoral Neck Fracture | Injury, poisoning and procedural complications | MedDRA version 24.0 | Systematic Assessment |
| |
| Hip Fracture | Injury, poisoning and procedural complications | MedDRA version 24.0 | Systematic Assessment |
| |
| Infusion Related Reaction | Injury, poisoning and procedural complications | MedDRA version 24.0 | Systematic Assessment |
| |
| Laryngeal Nerve Dysfunction | Injury, poisoning and procedural complications | MedDRA version 24.0 | Systematic Assessment |
| |
| Neutrophil Count Decreased | Investigations | MedDRA version 24.0 | Systematic Assessment |
| |
| White Blood Cell Count Decreased | Investigations | MedDRA version 24.0 | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA version 24.0 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA version 24.0 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA version 24.0 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA version 24.0 | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA version 24.0 | Systematic Assessment |
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| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA version 24.0 | Systematic Assessment |
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| Tumour Lysis Syndrome | Metabolism and nutrition disorders | MedDRA version 24.0 | Systematic Assessment |
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| Type 2 Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Cancer Pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 24.0 | Systematic Assessment |
| |
| Cerebral Infarction | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Ischaemic Cerebral Infarction | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Ischaemic Stroke | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
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| Neurological Symptom | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Neuropathy Peripheral | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Partial Seizures | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Posterior Reversible Encephalopathy Syndrome | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Subarachnoid Haemorrhage | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA version 24.0 | Systematic Assessment |
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| Confusional State | Psychiatric disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | MedDRA version 24.0 | Systematic Assessment |
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| Renal Infarct | Renal and urinary disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Urinary Retention | Renal and urinary disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Cystocele | Reproductive system and breast disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Acute Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Oesophagobronchial Fistula | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Pharyngeal Disorder | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Pulmonary Haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Respiratory Distress | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| Dermatitis Allergic | Skin and subcutaneous tissue disorders | MedDRA version 24.0 | Systematic Assessment |
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| Accelerated Hypertension | Vascular disorders | MedDRA version 24.0 | Systematic Assessment |
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| Deep Vein Thrombosis | Vascular disorders | MedDRA version 24.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA version 24.0 | Systematic Assessment |
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| Hypertensive Crisis | Vascular disorders | MedDRA version 24.0 | Systematic Assessment |
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| Orthostatic Hypotension | Vascular disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA version 24.0 | Systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA version 24.0 | Systematic Assessment |
| |
| Gamma-Glutamyltransferase Increased | Investigations | MedDRA version 24.0 | Systematic Assessment |
| |
| Neutrophil Count Decreased | Investigations | MedDRA version 24.0 | Systematic Assessment |
| |
| Platelet Count Decreased | Investigations | MedDRA version 24.0 | Systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA version 24.0 | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
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| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
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| Neuropathy Peripheral | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
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| Peripheral Sensory Neuropathy | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
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| Proteinuria | Renal and urinary disorders | MedDRA version 24.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA version 24.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA version 24.0 | Systematic Assessment |
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Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Clinical Planning Department | Celltrion | 82328505000 | contact@celltrion.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 15, 2023 | Apr 17, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000077192 | Adenocarcinoma of Lung |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Male |
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| Asian |
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| Black or African American |
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| White or Caucasian |
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| Other |
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| Metastatic |
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| Grade 1 |
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| Log-binomial regression model including treatment groups (CT-P16 and EU-approved Avastin) as a fixed effect and region (EMEA vs. America vs. Asia), sex (female vs. male), disease status at baseline (recurrence vs. metastatic), and ECOG performance score at baseline (0 vs. 1) as covariates was used. | Risk Ratio (RR) | 1.0136 | 2-Sided | 90 | 0.8767 | 1.1719 | Equivalence | The similarity criterion had been set such that the confidence limits of the 90% confidence interval (CI) of the ratio of ORR from each treatment group was entirely bounded by the interval (0.7368, 1.3572). |
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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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Drug: Bevacizumab 15mg/kg IV of EU-approved Avastin will be administered every 3 weeks up to 6 cycles during the Induction Study Period and every 3 weeks until PD or intolerable toxicity during the Maintenance Period. Avastin: 15mg/kg IV of Avastin every 3 weeks up to 6 cycles in the induction study period and every 3 weeks until PD occurs in the maintenance study period. |
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