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| ID | Type | Description | Link |
|---|---|---|---|
| I4T-IE-JVCA | Other Identifier | Eli Lilly and Company | |
| CP12-1032 | Other Identifier | ImClone Systems |
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The purpose of this study is to investigate whether there are no clinically significant pharmacokinetic effects of concomitant ramucirumab (IMC-1121B) on paclitaxel by investigating the pharmacokinetics (PK) of each in participants with advanced malignant solid tumors.
Part A of this study will investigate the potential of concomitant ramucirumab (IMC-1121B) to affect the pharmacokinetics of paclitaxel. Part B of this study will investigate the pharmacokinetics of ramucirumab (IMC-1121B) as monotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: ramucirumab (IMC-1121B) and paclitaxel | Experimental | Experimental: Part A: ramucirumab (IMC-1121B) and paclitaxel Cycle 1: paclitaxel administered on Day 1 of 2-week cycle. Cycle 2 and beyond : ramucirumab (IMC-1121B) administered on Day 1 and Day 15, paclitaxel administered on Day 1, Day 8 and Day 15 of 4-week cycle. |
|
| Part B: ramucirumab (IMC-1121B) and paclitaxel | Experimental | Cycle 1: ramucirumab (IMC-1121B) administered as monotherapy on Day 1 of 3-week cycle. Cycle 2 and beyond: ramucirumab (IMC-1121B) administered on Day 1 and Day 15, paclitaxel administered on Day 1, Day 8 and Day 15 of 4- week cycle. *After Cycle 1 (mandatory pharmacokinetic phase) is completed, participants may continue to receive ramucirumab (IMC-1121B) monotherapy or combination therapy with paclitaxel as described in Part A. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ramucirumab (IMC-1121B) | Biological | ramucirumab (IMC-1121B) 8 milligrams/kilogram (mg/kg) intravenous infusion, administered on Day 1and Day 15 of each 4-week cycle, unless otherwise specified. |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Pharmacokinetics - Dose-Normalized Area Under the Concentration Versus Time Curve of Paclitaxel From Time Zero to Infinity [AUC(0-∞)] in Cycle 1 | Dose-normalized AUC(0-∞) was calculated from AUC(0-∞) divided by the dose. Data presented are Geometric Least Squares (Geo LS) means. Geo LS means were adjusted for cycle, participant and random error. | Cycle 1: 0, 1, 1.5, 2, 5, 7, 24, 48, 72 and 168 hours post paclitaxel infusion |
| Part A: Pharmacokinetics - Dose-Normalized Area Under the Concentration Versus Time Curve of Paclitaxel From Time Zero to Infinity [AUC(0-∞)] in Cycle 2 | Dose-normalized AUC(0-∞) was calculated from AUC(0-∞) divided by the dose. Data presented are Geometric Least Squares (Geo LS) means. Geo LS means were adjusted for cycle, participant and random error. | Cycle 2: -1, 0, 1, 1.5, 2, 5, 7, 24, 48, 72, 96, 168, 264 and 336 hours post paclitaxel infusion |
| Part A: Pharmacokinetics - Dose-Normalized Maximum Observed Drug Concentration (Cmax) of Paclitaxel in Cycle 1 | Dose-normalized Cmax was calculated from Cmax divided by the dose. Data presented are Geometric Least Squares (Geo LS) means. Geo LS means were adjusted for cycle, participant and random error. | Cycle 1: 0,1, 1.5, 2, 5, 7, 24, 48, 72 and 168 hours post paclitaxel infusion |
| Part A: Pharmacokinetics - Dose-Normalized Maximum Observed Drug Concentration (Cmax) of Paclitaxel in Cycle 2 | Dose-normalized Cmax was calculated from Cmax divided by the dose. Data presented are Geometric Least Squares (Geo LS) means. Geo LS means were adjusted for cycle, participant and random error. | Cycle 2: -1, 0, 1, 1.5, 2, 5, 7, 24, 48, 72, 96, 168, 264 and 336 hours post paclitaxel infusion |
| Part B: Pharmacokinetics - Dose-Normalized Area Under the Concentration Versus Time Curve of Ramucirumab From Time Zero to Infinity [AUC(0-∞)] as Monotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Pharmacokinetics - Dose-Normalized Area Under the Concentration Versus Time Curve of Ramucirumab From Time Zero to Infinity [AUC(0-∞)] in the Presence of Paclitaxel | Dose-normalized AUC(0-∞) was calculated from AUC(0-∞) divided by the dose. | Cycle 2: 0, 1, 2, 2.5, 3, 6, 8, 25, 49, 73, 97, 169, 265 and 337 hours post ramucirumab infusion |
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Inclusion Criteria:
Exclusion Criteria:
Is receiving concomitant therapy with clinically relevant inhibitors or inducers of cytochrome P450, CYP2C8, CYP3AY and/or isoenzymes
Are currently enrolled in, or discontinued within the last 14 days from, a clinical trial involving an investigational product or non-approved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
Has received a monoclonal antibody within 42 days prior to first dose of study medication
Has received radiotherapy within 14 days prior to first dose of study medication
Has received cytotoxic chemotherapy within 21 days (6 weeks for nitrosoureas or mitomycin C) prior to first dose of study medication
Has a cardiac left ventricular ejection fraction (LVEF) not within institutional limits of normal on a multigated acquisition scan (MUGA) or echocardiogram
Is receiving concurrent treatment with another anticancer therapy, including chemotherapy, immunotherapy, hormonal therapy, radiation therapy, chemoembolization, targeted or other investigational anticancer therapy
Is receiving chronic therapy with nonsteroidal anti-inflammatory agents or other antiplatelet agents. Aspirin use at doses up to 325 milligrams/day (mg/day) and analgesic agents with no or low bleeding risk are permitted
Has a history of uncontrolled hereditary or acquired bleeding or thromboembolic disorders
Has experienced any arterial thromboembolic event, including myocardial infarction (MI), unstable angina stroke or transient ischemic attack (TIA), within 6 months prior to first dose of study medication
Has a history of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism during the 3 months prior to first dose of study medication
Has experienced a Grade 3 or 4 hemorrhagic event within 3 months prior to first dose of study medication
Has experienced peripheral neuropathy ≥ Grade 2 at any time prior to study entry
Has a bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection, Crohn's disease, ulcerative colitis, or chronic diarrhea
History of gastrointestinal perforation and / or fistulae within 6 months prior to randomization
Has an ongoing or active infection requiring treatment with intravenous antibiotics
Has a serious or nonhealing wound, peptic ulcer, or bone fracture within 28 days prior to first dose of study medication
Has uncontrolled hypertension
Has symptomatic congestive heart failure
Has known brain or leptomeningeal disease
Has known positive status for human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome-related illness
Has known active drug or alcohol abuse that would affect participant's ability to comply with study treatment
Has pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen
Has had major surgery within 28 days prior to first dose of study medication or subcutaneous venous access device implantation within 7 days prior to first dose of study medication
Has an elective or planned major surgery during the course of the trial
If a primary cancer is non-small-cell lung cancer (NSCLC), participant has intratumor cavitation, radiologically documented evidence of major blood vessel invasion or encasement by cancer, or proximity of cancer to major airways
Has received prior ramucirumab (IMC-1121B) therapy
The participant has:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ImClone Investigational Site | Ann Arbor | Michigan | 48109 | United States | ||
| ImClone Investigational Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A: Paclitaxel and Ramucirumab | Cycle 1: paclitaxel 80 milligrams/square meter (mg/m²) administered on Day 1 of 2-week cycle. Cycle 2 and beyond: ramucirumab (IMC-1121B) 8 milligrams/kilogram (mg/kg) administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle. |
| FG001 | Part B: Ramucirumab With or Without Paclitaxel | Cycle 1: ramucirumab (IMC-1121B) 8 mg/kg administered as monotherapy on Day 1 of 3-week cycle. Cycle 2 and beyond: ramucirumab (IMC-1121B) 8 mg/kg administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle. *After Cycle 1 (mandatory pharmacokinetic phase) is completed, participants may continue to receive ramucirumab (IMC-1121B) monotherapy or combination therapy with paclitaxel as described in Part A. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Part A: Paclitaxel and Ramucirumab | Cycle 1: paclitaxel 80 milligrams/square meter (mg/m²) administered on Day 1 of 2-week cycle. Cycle 2 and beyond: ramucirumab (IMC-1121B) 8 milligrams/kilogram (mg/kg) administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Part A: Pharmacokinetics - Dose-Normalized Area Under the Concentration Versus Time Curve of Paclitaxel From Time Zero to Infinity [AUC(0-∞)] in Cycle 1 | Dose-normalized AUC(0-∞) was calculated from AUC(0-∞) divided by the dose. Data presented are Geometric Least Squares (Geo LS) means. Geo LS means were adjusted for cycle, participant and random error. | All participants from Part A Cycle 1 and had sufficient concentration data to calculate paclitaxel AUC(0-∞). | Posted | Least Squares Mean | 90% Confidence Interval | nanograms*hour/milliliter/milligram | Cycle 1: 0, 1, 1.5, 2, 5, 7, 24, 48, 72 and 168 hours post paclitaxel infusion |
|
Baseline, up to 8 years
All participants who received at least one dose of study drug.
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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 | Part A: Paclitaxel Alone (Cycle 1) | Cycle 1: paclitaxel 80 milligrams/square meter (mg/m²) administered on Day 1 of 2-week cycle. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
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| ID | Term |
|---|---|
| D000096662 | Ramucirumab |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
| paclitaxel | Drug | paclitaxel 80 milligrams/square meter (mg/m²) intravenous infusion, administered on Days 1, 8 and 15 of each 4-week cycle, unless otherwise specified. |
|
Dose-normalized AUC(0-∞) was calculated from AUC(0-∞) divided by the dose. |
| Cycle 1: 0,1, 1.5, 2, 5, 7, 24, 48, 72,168, 264, 336, 408, and 504 hours post ramucirumab infusion |
| Part A: Pharmacokinetics - Dose-Normalized Maximum Observed Drug Concentration (Cmax) of Ramucirumab in the Presence of Paclitaxel | Dose-normalized Cmax was calculated from Cmax divided by the dose. | Cycle 2: 0, 1, 2, 2.5, 3, 6, 8, 25, 49, 73, 97, 169, 265 and 337 hours post ramucirumab infusion |
| Part A: Immunogenicity of Ramucirumab in Combination With Paclitaxel - Number of Participants With Anti-Ramucirumab Antibodies | Number of participants with positive treatment emergent anti-ramucirumab antibodies was summarized by treatment group. A treatment-emergent anti-drug antibodies (TEADA) sample was defined as: a post treatment sample with at least a 4-fold increase in titer from pre treatment sample; or 1:20 post treatment titer for participants that had no detectable ADA titer at baseline. | -1 hour on Day 1 of Cycle 2, and 30 days after last dose of study drug |
| Part B: Immunogenicity of Ramucirumab as Monotherapy - Number of Participants With Anti-Ramucirumab Antibodies | Number of participants with positive treatment emergent anti-ramucirumab antibodies was summarized by treatment group. A treatment-emergent anti-drug antibodies (TEADA) sample was defined as: a post treatment sample with at least a 4-fold increase in titer from pre treatment sample; or 1:20 post treatment titer for participants that had no detectable ADA titer at baseline. | 0 hour on Day 1 of Cycle 1, and 30 days after last dose of study drug |
| Detroit |
| Michigan |
| 48202 |
| United States |
| ImClone Investigational Site | New Brunswick | New Jersey | 08901 | United States |
| ImClone Investigational Site | Cleveland | Ohio | 44195 | United States |
| ImClone Investigational Site | Philadelphia | Pennsylvania | 19111 | United States |
| ImClone Investigational Site | Seattle | Washington | 98109 | United States |
| Withdrawal by Subject |
|
| Physician Decision |
|
| Part B: Ramucirumab With or Without Paclitaxel |
Cycle 1: ramucirumab (IMC-1121B) 8 mg/kg administered as monotherapy on Day 1 of 3-week cycle. Cycle 2 and beyond: ramucirumab (IMC-1121B) 8 mg/kg administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle. *After Cycle 1 (mandatory pharmacokinetic phase) is completed, participants may continue to receive ramucirumab (IMC-1121B) monotherapy or combination therapy with paclitaxel as described in Part A. |
| BG002 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Part A: Pharmacokinetics - Dose-Normalized Area Under the Concentration Versus Time Curve of Paclitaxel From Time Zero to Infinity [AUC(0-∞)] in Cycle 2 | Dose-normalized AUC(0-∞) was calculated from AUC(0-∞) divided by the dose. Data presented are Geometric Least Squares (Geo LS) means. Geo LS means were adjusted for cycle, participant and random error. | All participants from Part A Cycle 2 and had sufficient concentration data to calculate paclitaxel AUC(0-∞). | Posted | Least Squares Mean | 90% Confidence Interval | nanograms*hour/milliliter/milligram | Cycle 2: -1, 0, 1, 1.5, 2, 5, 7, 24, 48, 72, 96, 168, 264 and 336 hours post paclitaxel infusion |
|
|
|
|
| Primary | Part A: Pharmacokinetics - Dose-Normalized Maximum Observed Drug Concentration (Cmax) of Paclitaxel in Cycle 1 | Dose-normalized Cmax was calculated from Cmax divided by the dose. Data presented are Geometric Least Squares (Geo LS) means. Geo LS means were adjusted for cycle, participant and random error. | All participants from Part A Cycle 1 and had sufficient concentration data to calculate paclitaxel cmax. | Posted | Least Squares Mean | 90% Confidence Interval | nanograms/milliliter/milligram | Cycle 1: 0,1, 1.5, 2, 5, 7, 24, 48, 72 and 168 hours post paclitaxel infusion |
|
|
|
| Primary | Part A: Pharmacokinetics - Dose-Normalized Maximum Observed Drug Concentration (Cmax) of Paclitaxel in Cycle 2 | Dose-normalized Cmax was calculated from Cmax divided by the dose. Data presented are Geometric Least Squares (Geo LS) means. Geo LS means were adjusted for cycle, participant and random error. | All participants from Part A Cycle 2 and had sufficient concentration data to calculate paclitaxel cmax. | Posted | Least Squares Mean | 90% Confidence Interval | nanograms/milliliter/milligram | Cycle 2: -1, 0, 1, 1.5, 2, 5, 7, 24, 48, 72, 96, 168, 264 and 336 hours post paclitaxel infusion |
|
|
|
|
| Primary | Part B: Pharmacokinetics - Dose-Normalized Area Under the Concentration Versus Time Curve of Ramucirumab From Time Zero to Infinity [AUC(0-∞)] as Monotherapy | Dose-normalized AUC(0-∞) was calculated from AUC(0-∞) divided by the dose. | All participants who received ramucirumab and had sufficient concentration data to calculate ramucirumab AUC(0-∞) in Cycle 1 of Part B. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms*hour/milliliter/milligram | Cycle 1: 0,1, 1.5, 2, 5, 7, 24, 48, 72,168, 264, 336, 408, and 504 hours post ramucirumab infusion |
|
|
|
| Secondary | Part A: Pharmacokinetics - Dose-Normalized Area Under the Concentration Versus Time Curve of Ramucirumab From Time Zero to Infinity [AUC(0-∞)] in the Presence of Paclitaxel | Dose-normalized AUC(0-∞) was calculated from AUC(0-∞) divided by the dose. | All participants who received ramucirumab and paclitaxel and had sufficient concentration data to calculate ramucirumab AUC(0-∞) in Cycle 2 of Part A. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms*hour/milliliters/milligram | Cycle 2: 0, 1, 2, 2.5, 3, 6, 8, 25, 49, 73, 97, 169, 265 and 337 hours post ramucirumab infusion |
|
|
|
| Secondary | Part A: Pharmacokinetics - Dose-Normalized Maximum Observed Drug Concentration (Cmax) of Ramucirumab in the Presence of Paclitaxel | Dose-normalized Cmax was calculated from Cmax divided by the dose. | All participants who received ramucirumab and paclitaxel and had sufficient concentration data to calculate ramucirumab Cmax in Cycle 2 of Part A. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms/milliliter/milligram | Cycle 2: 0, 1, 2, 2.5, 3, 6, 8, 25, 49, 73, 97, 169, 265 and 337 hours post ramucirumab infusion |
|
|
|
| Secondary | Part A: Immunogenicity of Ramucirumab in Combination With Paclitaxel - Number of Participants With Anti-Ramucirumab Antibodies | Number of participants with positive treatment emergent anti-ramucirumab antibodies was summarized by treatment group. A treatment-emergent anti-drug antibodies (TEADA) sample was defined as: a post treatment sample with at least a 4-fold increase in titer from pre treatment sample; or 1:20 post treatment titer for participants that had no detectable ADA titer at baseline. | All participants from Part A Cycle 2, who received ramucirumab and paclitaxel and had data for anti-ramucirumab antibodies. | Posted | Count of Participants | Participants | No | -1 hour on Day 1 of Cycle 2, and 30 days after last dose of study drug |
|
|
|
| Secondary | Part B: Immunogenicity of Ramucirumab as Monotherapy - Number of Participants With Anti-Ramucirumab Antibodies | Number of participants with positive treatment emergent anti-ramucirumab antibodies was summarized by treatment group. A treatment-emergent anti-drug antibodies (TEADA) sample was defined as: a post treatment sample with at least a 4-fold increase in titer from pre treatment sample; or 1:20 post treatment titer for participants that had no detectable ADA titer at baseline. | All participants from Part B cycle 1, who received ramucirumab and had data for anti-ramucirumab antibodies. | Posted | Count of Participants | Participants | No | 0 hour on Day 1 of Cycle 1, and 30 days after last dose of study drug |
|
|
|
| 1 |
| 24 |
| 18 |
| 24 |
| EG001 | Part A: Paclitaxel + Ramucirumab (Cycle 2) | Cycle 2: ramucirumab (IMC-1121B) 8 milligrams/kilogram (mg/kg) administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle. | 6 | 21 | 21 | 21 |
| EG002 | Part B: Ramucirumab Alone (Cycle 1) | Cycle 1: ramucirumab (IMC-1121B) 8 mg/kg administered as monotherapy on Day 1 of 3-week cycle. | 0 | 16 | 8 | 16 |
| EG003 | Part B: Ramucirumab + Paclitaxel (Cycle 2) | Cycle 2 and beyond: ramucirumab (IMC-1121B) 8 mg/kg administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle. | 6 | 15 | 14 | 15 |
| Colitis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Acute hepatic failure | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Device related infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Depressed level of consciousness | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA 14.0 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 14.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Breath odour | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Defaecation urgency | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Application site dermatitis | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Catheter site inflammation | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Catheter site pain | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Face oedema | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Generalised oedema | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Impaired healing | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Thrombosis in device | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Catheter site cellulitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Rash pustular | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Breast pain | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
Investigators agreed to delay independently publishing or disclosing data, findings or conclusions from the study except as part of a multi-center publication. Upon study publication or if the draft publication is not produced within approximately 6 months of the final report of the study results, investigators may independently publish, subject to confidential information review/redaction by sponsor. The sponsor may request publication delay up to 90 days to seek patent protection.
| 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 |