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| ID | Type | Description | Link |
|---|---|---|---|
| I4T-CR-JVBU | Other Identifier | Eli Lilly and Company |
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This trial is testing ramucirumab (LY3009806) administered to Chinese participants with advanced solid tumors that are resistant to standard therapy or for whom no standard therapy is available. The purpose of this study is to evaluate how safe ramucirumab is and whether it causes any side effects. The study will also measure how much ramucirumab gets into the blood stream and how long it takes the body to get rid of it.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ramucirumab | Experimental | Ramucirumab administered intravenously (IV) at escalating doses (6 milligrams per kilogram [mg/kg] up to 10 mg/kg) every 2-3 weeks for 6 weeks (1 Cycle). Treatment may continue until discontinuation criterion is met. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ramucirumab | Biological | Administered IV. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious Adverse Events (SAEs) | A summary of AEs and SAEs considered by the investigator to be drug-related is located in the Reported Adverse Events module. An AE is summarized if the onset date is on or after the first dose of study drug and within 30 days after the last dose, or it occurred before the first dose of study drug and worsened while on the therapy. | Baseline through Study Completion (Up to 12 Weeks) |
| Pharmacokinetics: Maximum Concentration (Cmax) of Ramucirumab | Cycle 1 & 2: Predose, End of Infusion, 0.5 hour (h) ,1h, 2h, 4h, 8h, 24h, 48h,72h or 96h, 168h, 264h, and 336h Postdose (and 504h Postdose Cohort 2 only) | |
| Pharmacokinetics: Minimum Concentration (Cmin) of Ramucirumab | Cycle 2-5: Predose | |
| Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of Ramucirumab | Cycle 1 analysis performed: Area Under the Concentration-Time Curve Zero to Infinity (AUC[0-∞]); Cycle 2 analysis performed: Area Under the Concentration-Time Curve Over the Dosing Interval at Steady State (AUC[τ,ss]) | Cycle 1 & 2: Predose, End of Infusion, 0.5 hour (h) ,1h, 2h, 4h, 8h, 24h, 48h,72h or 96h, 168h, 264h, and 336h Postdose (and 504h Postdose Cohort 2 only) |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response | Participants achieved an objective response if they had a best overall response of complete response (CR) or partial response (PR). According to RECIST v1.1, CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels (if tumor markers were initially above the upper limit of normal); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. For each participant who is not known to have died or to have had objective progression of disease as of the data-inclusion cut-off date for a particular analysis, duration of tumor response was to be censored at the date of the participant's last objective tumor assessment prior to that cut-off date. |
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Inclusion Criteria:
Exclusion Criteria:
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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 |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Shanghai | 200032 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28465370 | Derived | Cao J, Ji D, Chen Z, Shen W, Wang J, Li B, Chi H, Long A, Gao L, Li J. Phase I Dose-Escalation Study of Ramucirumab in Chinese Patients with Advanced Solid Tumors. Oncologist. 2017 Jun;22(6):638-e56. doi: 10.1634/theoncologist.2017-0137. Epub 2017 May 2. |
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Participant study completion is defined as a participant either completing all 6 cycles of study drug or discontinuing study drug due to dose-limiting toxicities (DLT), then completing all required End-of-Therapy and End-of-Study assessments.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 - 6 mg/kg/2w Ramucirumab | 6 milligram per kilogram (mg/kg) ramucirumab administered intravenously (IV) every 2 weeks (w) for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 2. After Cycle 1 treatment, participants who had an objective response or stable disease were permitted to receive ramucirumab at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met. |
| FG001 | Cohort 2 - 10 mg/kg/3w Ramucirumab | 10 mg/kg ramucirumab administered IV every 3 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 3. After Cycle 1 treatment, participants who had an objective response or stable disease were permitted to receive ramucirumab at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met. |
| FG002 | Cohort 3 - 8 mg/kg/2w Ramucirumab | 8 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle). After Cycle 1 treatment, participants who had an objective response or stable disease were permitted to receive ramucirumab at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All randomized participants who received at least one dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 - 6 mg/kg/2w Ramucirumab | 6 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle) followed by dose escalation to Cohort 2. When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 2. |
| BG001 |
| 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 | Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious Adverse Events (SAEs) | A summary of AEs and SAEs considered by the investigator to be drug-related is located in the Reported Adverse Events module. An AE is summarized if the onset date is on or after the first dose of study drug and within 30 days after the last dose, or it occurred before the first dose of study drug and worsened while on the therapy. | All enrolled participants who received at least one dose of study drug. | Posted | Number | Participants | Baseline through Study Completion (Up to 12 Weeks) |
|
Not provided
Not provided
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 | Cohort 1 - 6mg/kg/2w Ramucirumab | 6mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 2. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
Not provided
| ID | Term |
|---|---|
| D000096662 | Ramucirumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
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| Time Between Meeting Response Criteria and Progressive Disease or Death Due to Any Cause (Up to 10 Weeks) |
| Duration of Stable Disease (SD) | Duration of SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum of diameters while on study. SD is measured at the start of the study drug until progressive disease or death due to any cause, whichever is first. Censoring occurred if a participant did not have a complete baseline disease assessment, initiated on another anti-cancer therapy (censored at the date of the last complete objective progression-free disease assessment before initiation of the new therapy), was not known to have died or had objective progression as of the data inclusion cutoff date for analysis. | Baseline to Progressive Disease or Death Due to Any Cause (Up to 10 Weeks) |
| Time to Disease Progression | Time to progressive disease was measured from the start of study drug until progressive disease. Censoring occurred if a participant did not have a complete baseline disease assessment, initiated on another anti-cancer therapy (censored at the date of the last complete objective progression-free disease assessment before initiation of the new therapy), was not known to have died or had objective progression as of the data inclusion cutoff date for analysis. | Baseline to Progressive Disease (Up to 10 Weeks) |
| Number of Participants With Anti-Ramucirumab Antibodies | A sample will be considered positive for circulating anti-ramucirumab antibodies if it exhibits a post-baseline antibody level that exceeds the upper 95% confidence interval of the mean determined from the normal anti-ramucirumab level seen in healthy untreated individuals. A participant will be considered to have an anti-ramucirumab response if there are 2 consecutive positive samples or if the final sample tested is positive. | Cycle 1: Pre-infusion, Cycle 2: Pre-infusion, Cycle 3: Pre-infusion |
| Number of Participants With Best Objective Response (BOR) | Participants achieved disease control if they had a BOR of CR, PR or SD. Progressive Disease (PD) and those participants which were Not Evaluable (NE) were also reported. According to RECIST v1.1, CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels (if tumor markers were initially above the upper limit of normal); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. SD was neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started. | Baseline to Progressive Disease or Participant Stopped Study (Up to 10 Weeks) |
| China |
| Cohort 2 - 10 mg/kg/3w Ramucirumab |
10 mg/kg ramucirumab administered IV every 3 weeks for 6 weeks (one cycle) followed by dose escalation to Cohort 3. When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 3. |
| BG002 | Cohort 3 - 8 mg/kg/2w Ramucirumab | 8 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle). |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
| OG001 | Cohort 2: 10 mg/kg/3w Ramucirumab | 10 mg/kg ramucirumab administered IV every 3 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 3. |
| OG002 | Cohort 3: 8 mg/kg/2w Ramucirumab | 8 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle). |
|
|
| Primary | Pharmacokinetics: Maximum Concentration (Cmax) of Ramucirumab | All enrolled participants who received at least one dose of study drug and had evaluable Cmax pharmacokinetics (PK) data. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram/milliliter (µg/mL) | Cycle 1 & 2: Predose, End of Infusion, 0.5 hour (h) ,1h, 2h, 4h, 8h, 24h, 48h,72h or 96h, 168h, 264h, and 336h Postdose (and 504h Postdose Cohort 2 only) |
|
|
|
| Primary | Pharmacokinetics: Minimum Concentration (Cmin) of Ramucirumab | All enrolled participants who received at least one dose of study drug and had evaluable Cmin PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | µg/mL | Cycle 2-5: Predose |
|
|
|
| Primary | Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of Ramucirumab | Cycle 1 analysis performed: Area Under the Concentration-Time Curve Zero to Infinity (AUC[0-∞]); Cycle 2 analysis performed: Area Under the Concentration-Time Curve Over the Dosing Interval at Steady State (AUC[τ,ss]) | All enrolled participants who received at least one dose of study drug and had evaluable AUC(0-∞) for Cycle 1 and AUC(τ,ss) for Cycle 2 PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | Microgram*day/milliliter (µg*day/mL) | Cycle 1 & 2: Predose, End of Infusion, 0.5 hour (h) ,1h, 2h, 4h, 8h, 24h, 48h,72h or 96h, 168h, 264h, and 336h Postdose (and 504h Postdose Cohort 2 only) |
|
|
|
| Secondary | Duration of Response | Participants achieved an objective response if they had a best overall response of complete response (CR) or partial response (PR). According to RECIST v1.1, CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels (if tumor markers were initially above the upper limit of normal); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. For each participant who is not known to have died or to have had objective progression of disease as of the data-inclusion cut-off date for a particular analysis, duration of tumor response was to be censored at the date of the participant's last objective tumor assessment prior to that cut-off date. | All enrolled participants who received at least one dose of study drug. There were no participants censored due to no CR or PR responses. | Posted | Median | 95% Confidence Interval | Months | Time Between Meeting Response Criteria and Progressive Disease or Death Due to Any Cause (Up to 10 Weeks) |
|
|
|
| Secondary | Duration of Stable Disease (SD) | Duration of SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum of diameters while on study. SD is measured at the start of the study drug until progressive disease or death due to any cause, whichever is first. Censoring occurred if a participant did not have a complete baseline disease assessment, initiated on another anti-cancer therapy (censored at the date of the last complete objective progression-free disease assessment before initiation of the new therapy), was not known to have died or had objective progression as of the data inclusion cutoff date for analysis. | All enrolled participants who received at least one dose of study drug and had evaluable SD data. Participants censored for Cohort 1, 2, and 3: 3, 2, and 1, respectively. | Posted | Median | 95% Confidence Interval | Months | Baseline to Progressive Disease or Death Due to Any Cause (Up to 10 Weeks) |
|
|
|
| Secondary | Time to Disease Progression | Time to progressive disease was measured from the start of study drug until progressive disease. Censoring occurred if a participant did not have a complete baseline disease assessment, initiated on another anti-cancer therapy (censored at the date of the last complete objective progression-free disease assessment before initiation of the new therapy), was not known to have died or had objective progression as of the data inclusion cutoff date for analysis. | All enrolled participants who received at least one dose of study drug. Censoring for Cohort 1, 2 and 3: 3, 2 and 2, respectively. | Posted | Median | 95% Confidence Interval | Months | Baseline to Progressive Disease (Up to 10 Weeks) |
|
|
|
| Secondary | Number of Participants With Anti-Ramucirumab Antibodies | A sample will be considered positive for circulating anti-ramucirumab antibodies if it exhibits a post-baseline antibody level that exceeds the upper 95% confidence interval of the mean determined from the normal anti-ramucirumab level seen in healthy untreated individuals. A participant will be considered to have an anti-ramucirumab response if there are 2 consecutive positive samples or if the final sample tested is positive. | All enrolled participants who received at least one dose of study drug and had evaluable immunogenicity data. | Posted | Number | Participants | Cycle 1: Pre-infusion, Cycle 2: Pre-infusion, Cycle 3: Pre-infusion |
|
|
|
| Secondary | Number of Participants With Best Objective Response (BOR) | Participants achieved disease control if they had a BOR of CR, PR or SD. Progressive Disease (PD) and those participants which were Not Evaluable (NE) were also reported. According to RECIST v1.1, CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels (if tumor markers were initially above the upper limit of normal); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. SD was neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started. | All enrolled participants who received at least one dose of study drug. | Posted | Number | Participants | Baseline to Progressive Disease or Participant Stopped Study (Up to 10 Weeks) |
|
|
|
| 1 |
| 6 |
| 6 |
| 6 |
| EG001 | Cohort 2 - 10mg/kg/3w Ramucirumab | 10mg/kg ramucirumab administered IV every 3 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 3. | 2 | 10 | 10 | 10 |
| EG002 | Cohort 3 - 8mg/kg/2w Ramucirumab | 8mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle). | 1 | 12 | 12 | 12 |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
|
| Extrasystoles | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
|
| Ventricular arrhythmia | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA 17.1 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 17.1 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 17.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Gastrointestinal pain | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Gingival bleeding | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Gingival pain | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Oral dysaesthesia | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Face oedema | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Facial pain | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Gallbladder pain | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
|
| Hepatic pain | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
|
| Contrast media allergy | Immune system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Vaginal infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| Amylase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| Electrocardiogram st segment abnormal | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| Electrocardiogram t wave abnormal | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| Glucose urine present | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| Red blood cell count decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| White blood cells urine positive | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Haemangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Hemiparesis | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
|
| Renal failure chronic | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
|
| Urinary tract obstruction | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
|
| Urinary tract pain | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
|
| Menstruation irregular | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Laryngeal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Nail discolouration | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
|
Not provided
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
|
|
| Cycle 4 (n = 1, 2, 4) |
|
| Cycle 5 (n = 0, 3, 4) |
|
|
|
| Stable Disease (SD) |
|
| Progressive Disease (PD) |
|
| Not Evaluable (NE) |
|