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The purpose of the study is to demonstrate equivalence
Patients will receive CT-P6 or Herceptin every 3 weeks.
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT-P6 & Paclitaxel | Experimental | CT-P6 was administered at a loading dose of 8 mg/kg body weight by intravenous (IV) infusion over 90 minutes on Day 1, Cycle 1, then at 6 mg/kg repeated at 3-weekly intervals until disease progression, death or discontinuation. Paclitaxel was administered at a dose of 175 mg/m2 body surface area (BSA) as a continuous 3-hour IV infusion on the day following the first dose of study drug (CT-P6). If the first dose of study drug was well tolerated, subsequent doses of paclitaxel were given immediately after the next dose of study drug. Paclitaxel cycles were repeated every 3 weeks until disease progression, death or discontinuation. |
|
| Herceptin & Paclitaxel | Active Comparator | Herceptin was administered at a loading dose of 8 mg/kg body weight by IV infusion over 90 minutes on Day 1, Cycle 1, then at 6 mg/kg repeated at 3-weekly intervals until disease progression, death or discontinuation. Paclitaxel was administered at a dose of 175 mg/m2 BSA as a continuous 3-hour IV infusion on the day following the first dose of study drug (Herceptin). If the first dose of study drug was well tolerated, subsequent doses of paclitaxel were given immediately after the next dose of study drug. Paclitaxel cycles were repeated every 3 weeks until disease progression, death or discontinuation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT-P6 | Drug | Administered every 3 weeks |
| |
| Herceptin |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | Best Overall Response (BOR) was derived from the overall response across all time points until after Cycle 8 using Independent Tumor Review Committee (ITRC) data in the FAS. Objective Response Rate (ORR) was defined as the number of patients with a BOR of complete response (CR) or partial response (PR) divided by the number of patients in the corresponding population, as assessed by Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1. | 6 months (up to 24 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Progression | Time from randomization to determined progressive disease, as assessed by RECIST version 1.1. | Through study completion, approximately 40 months |
| Time to Response | Time from randomization to observed tumor response (Complete Response or Partial Response), as assessed by RECIST 1.1 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Investigational Site | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | South Korea |
A total of 475 patients initiated Main Study Treatment Period and were included in the Full Analysis Set (FAS).
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | CT-P6 | CT-P6 was administered at a loading dose of 8 mg/kg body weight by intravenous (IV) infusion over 90 minutes on Day 1, Cycle 1, then at 6 mg/kg repeated at 3-weekly intervals until disease progression, death or discontinuation. Paclitaxel was administered at a dose of 175 mg/m2 body surface area (BSA) as a continuous 3-hour IV infusion on the day following the first dose of study drug (CT-P6). If the first dose of study drug was well tolerated, subsequent doses of paclitaxel were given immediately after the next dose of study drug. Paclitaxel cycles were repeated every 3 weeks until disease progression, death or discontinuation. |
| FG001 | Herceptin | Herceptin was administered at a loading dose of 8 mg/kg body weight by IV infusion over 90 minutes on Day 1, Cycle 1, then at 6 mg/kg repeated at 3-weekly intervals until disease progression, death or discontinuation. Paclitaxel was administered at a dose of 175 mg/m2 BSA as a continuous 3-hour IV infusion on the day following the first dose of study drug (Herceptin). If the first dose of study drug was well tolerated, subsequent doses of paclitaxel were given immediately after the next dose of study drug. Paclitaxel cycles were repeated every 3 weeks until disease progression, death or discontinuation. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Main Study Treatment Period |
|
| |||||||||||||||||||||
| Treatment Period Beyond Cycle 8 |
|
All baseline characteristics of the Phase 3 study (CT-P6 3.1) listed below were analyzed in conjunction with those of the Phase 1/2b study (CT-P6 1.1).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | CT-P6 | CT-P6: 8 mg/kg for loading or 6 mg/kg for maintenance dose via IV infusion every 3 weeks. Paclitaxel: 175 mg/m2 BSA via IV infusion on the day following the first dose of study drug (CT-P6). Paclitaxel cycles were repeated every 3 weeks. |
| BG001 | Herceptin |
| 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 | Objective Response Rate | Best Overall Response (BOR) was derived from the overall response across all time points until after Cycle 8 using Independent Tumor Review Committee (ITRC) data in the FAS. Objective Response Rate (ORR) was defined as the number of patients with a BOR of complete response (CR) or partial response (PR) divided by the number of patients in the corresponding population, as assessed by Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1. | Full Analysis Set - consisted of all randomized patients who received any study drug and had at least one post-baseline assessment, with the exception of the patients who violated against Herceptin indication. All outcome measures of the Phase 3 study (CT-P6 3.1) were analyzed in conjunction with those of the Phase 1/2b study (CT-P6 1.1). | Posted | Count of Participants | Participants | 6 months (up to 24 weeks) |
|
Adverse event (AE) reporting was extended from date of informed consent until completion of the final visit (up to approximately 57 months).
At each level of summarization, patients were counted once if they reported one or more events.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CT-P6 | CT-P6: 8 mg/kg for loading or 6 mg/kg for maintenance dose via IV infusion every 3 weeks. Paclitaxel: 175 mg/m2 BSA via IV infusion on the day following the first dose of study drug (CT-P6). Paclitaxel cycles were repeated every 3 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (13.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (13.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Clinical Planning Department | Celltrion | 82328505000 | contact@celltrion.com |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000630847 | CT-P6 |
| D000068878 | Trastuzumab |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Administered every 3 weeks |
|
|
| Paclitaxel | Drug | Administered every 3 weeks |
|
| Through study completion, approximately 40 months |
| Progression Free Survival | Time from randomization to radiological progression or death from any cause, as assessed by RECIST 1.1 | Through study completion, approximately 40 months |
| Overall Survival | The number of days between the date of randomization and the date of death from any cause. | Through study completion, approximately 40 months |
| Safety Endpoints; Cardiotoxicity | Mean change from baseline to endpoint assessment in left ventricular ejection fraction (LVEF) (%) | Through study completion, approximately 40 months |
| Safety Endpoints; Immunogenicity | Assessed by the proportion of patients with development of antibodies to study drug (positive anti-drug antibody [ADA] results after the first study drug infusion) | During treatment, median of 13 cycles (every cycle is 3 weeks) |
| Pharmacokinetic Endpoints; Ctroughss | Trough concentration at steady state | predose and at 1.5 hours (end of infusion) of each cycle |
| Physician Decision |
|
| Withdrawal by Subject |
|
| Other Reason |
|
| Other |
|
| NOT COMPLETED |
|
|
Herceptin: 8 mg/kg for loading or 6 mg/kg for maintenance dose via IV infusion every 3 weeks. Paclitaxel: 175 mg/m2 BSA via IV infusion on the day following the first dose of study drug (Herceptin). Paclitaxel cycles were repeated every 3 weeks. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Childbearing Potential | Count of Participants | Participants |
|
| Height at Screening | Mean | Standard Deviation | cm |
|
| Weight at Screening | Mean | Standard Deviation | kg |
|
| BSA at Screening | Mean | Standard Deviation | m2 |
|
| Prior Chemotherapy | Count of Participants | Participants |
|
| ECOG performance status | Grade 0: Fully active, able to carry on all pre-disease performance without restriction. Grade 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. Grade 2: Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours. | Count of Participants | Participants |
|
| Karnofsky performance status | Category 1 (80-100 points): Able to carry on normal activity and to work; no special care needed. Category 2 (50-70 points): Unable to work; able to live at home and care for most personal needs; varying amount of assistance needed. | Count of Participants | Participants |
|
The ORR results for CT-P6 treatment group based on BOR during the Main Study Treatment Period (up to Cycle 8; 6 months) from the ITRC are presented below.
| OG001 | Herceptin | The ORR results for Herceptin treatment group based on BOR during the Main Study Treatment Period from the ITRC are presented below. |
|
|
|
| Secondary | Time to Progression | Time from randomization to determined progressive disease, as assessed by RECIST version 1.1. | Full Analysis Set (FAS) - consisted of all randomized patients who received any study drug and had at least one post-baseline assessment, with the exception of the patients who violated against Herceptin indication. All outcome measures of the Phase 3 study (CT-P6 3.1) were analyzed in conjunction with those of the Phase 1/2b study (CT-P6 1.1). | Posted | Median | 95% Confidence Interval | months | Through study completion, approximately 40 months |
|
|
|
| Secondary | Time to Response | Time from randomization to observed tumor response (Complete Response or Partial Response), as assessed by RECIST 1.1 | Full Analysis Set (FAS) - consisted of all randomized patients who received any study drug and had at least one post-baseline assessment, with the exception of the patients who violated against Herceptin indication. All outcome measures of the Phase 3 study (CT-P6 3.1) were analyzed in conjunction with those of the Phase 1/2b study (CT-P6 1.1). | Posted | Median | 95% Confidence Interval | months | Through study completion, approximately 40 months |
|
|
|
| Secondary | Progression Free Survival | Time from randomization to radiological progression or death from any cause, as assessed by RECIST 1.1 | Full Analysis Set (FAS) - consisted of all randomized patients who received any study drug and had at least one post-baseline assessment, with the exception of the patients who violated against Herceptin indication. All outcome measures of the Phase 3 study (CT-P6 3.1) were analyzed in conjunction with those of the Phase 1/2b study (CT-P6 1.1). | Posted | Median | 95% Confidence Interval | months | Through study completion, approximately 40 months |
|
|
|
| Secondary | Overall Survival | The number of days between the date of randomization and the date of death from any cause. | Full Analysis Set (FAS) - consisted of all randomized patients who received any study drug and had at least one post-baseline assessment, with the exception of the patients who violated against Herceptin indication. All outcome measures of the Phase 3 study (CT-P6 3.1) were analyzed in conjunction with those of the Phase 1/2b study (CT-P6 1.1). | Posted | Median | 95% Confidence Interval | months | Through study completion, approximately 40 months |
|
|
|
| Secondary | Safety Endpoints; Cardiotoxicity | Mean change from baseline to endpoint assessment in left ventricular ejection fraction (LVEF) (%) | Safety Analysis Set (SAF) - consisted of all patients in the FAS, analyzed as treated. All patients who received at least one dose of CT-P6 were analyzed under the CT-P6 treatment group. All other patients were analyzed under the Herceptin treatment group. All outcome measures of the Phase 3 study (CT-P6 3.1) were analyzed in conjunction with those of the Phase 1/2b study (CT-P6 1.1). | Posted | Mean | Standard Deviation | %; percent change in LVEF | Through study completion, approximately 40 months |
|
|
|
| Secondary | Safety Endpoints; Immunogenicity | Assessed by the proportion of patients with development of antibodies to study drug (positive anti-drug antibody [ADA] results after the first study drug infusion) | Safety Analysis Set (SAF) - consisted of all patients in the FAS, analyzed as treated. All patients who received at least one dose of CT-P6 were analyzed under the CT-P6 treatment group. All other patients were analyzed under the Herceptin treatment group. All outcome measures of the Phase 3 study (CT-P6 3.1) were analyzed in conjunction with those of the Phase 1/2b study (CT-P6 1.1). | Posted | Count of Participants | Participants | During treatment, median of 13 cycles (every cycle is 3 weeks) |
|
|
|
| Secondary | Pharmacokinetic Endpoints; Ctroughss | Trough concentration at steady state | PK Analysis Set (PKAS) - consisted of all FAS patients who had achieved steady state by the 8th cycle, which required 3 consecutive similar trough concentrations. All outcome measures of the Phase 3 study (CT-P6 3.1) were analyzed in conjunction with those of the Phase 1/2b study (CT-P6 1.1). | Posted | Mean | Standard Deviation | ug/mL | predose and at 1.5 hours (end of infusion) of each cycle |
|
|
|
| 8 |
| 244 |
| 34 |
| 244 |
| 227 |
| 244 |
| EG001 | Herceptin | Herceptin: 8 mg/kg for loading or 6 mg/kg for maintenance dose via IV infusion every 3 weeks. Paclitaxel: 175 mg/m2 BSA via IV infusion on the day following the first dose of study drug (Herceptin). Paclitaxel cycles were repeated every 3 weeks. | 8 | 231 | 39 | 231 | 214 | 231 |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (13.0) | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (13.0) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (13.0) | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
|
| Cardiac failure acute | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
|
| Left ventricular dysfunction | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Death | General disorders | MedDRA (13.0) | Systematic Assessment |
|
| Disease progression | General disorders | MedDRA (13.0) | Systematic Assessment |
|
| Inflammation | General disorders | MedDRA (13.0) | Systematic Assessment |
|
| Infusion related reaction | General disorders | MedDRA (13.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (13.0) | Systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA (13.0) | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (13.0) | Systematic Assessment |
|
| Hepatitis cholestatic | Hepatobiliary disorders | MedDRA (13.0) | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA (13.0) | Systematic Assessment |
|
| Acute tonsillitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Gangrene | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Malaria | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Neutropenic infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Concussion | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
|
| Radius fracture | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
|
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
|
| Endoscopic retrograde cholangiopancreatography | Investigations | MedDRA (13.0) | Systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA (13.0) | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
|
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Systematic Assessment |
|
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Systematic Assessment |
|
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Systematic Assessment |
|
| Brain oedema | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
|
| Metrorrhagia | Reproductive system and breast disorders | MedDRA (13.0) | Systematic Assessment |
|
| Vulval ulceration | Reproductive system and breast disorders | MedDRA (13.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Leukocytoclastic vasculitis | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
|
| Biliary drainage | Surgical and medical procedures | MedDRA (13.0) | Systematic Assessment |
|
| Cataract operation | Surgical and medical procedures | MedDRA (13.0) | Systematic Assessment |
|
| Extended radical mastectomy | Surgical and medical procedures | MedDRA (13.0) | Systematic Assessment |
|
| Mastectomy | Surgical and medical procedures | MedDRA (13.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (13.0) | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (13.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (13.0) | Systematic Assessment |
|
| Chills | General disorders | MedDRA (13.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (13.0) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (13.0) | Systematic Assessment |
|
| Pain | General disorders | MedDRA (13.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (13.0) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (13.0) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA (13.0) | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA (13.0) | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA (13.0) | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (13.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
|
Not provided
Not provided
| D017437 |
| Skin and Connective Tissue Diseases |
| 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 |
| ADA positive patients with a result at baseline visit |
|
|
| ADA positive patients with at least 1 result after the first infusion |
|
|