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| ID | Type | Description | Link |
|---|---|---|---|
| H9S-JE-JDCI | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to evaluate the safety and effect on the body of Tabalumab (LY2127399) in combination with bortezomib and dexamethasone in Japanese participants with relapsed or refractory multiple myeloma (MM).
The study has 3 cohorts. Cohort 2 and cohort 2-SC will be conducted in parallel with some data presented combined.
Cohort 1 - Participants will receive 100 mg Tabalumab (LY2127399) intravenously (IV), 1.3 milligram per square meter (mg/m^2) bortezomib IV, and 20 mg dexamethasone orally.
Cohort 2 - Participants will receive 300 mg Tabalumab (LY2127399) IV, 1.3 mg/m^2 bortezomib IV, and 20 mg dexamethasone orally.
Cohort 2-SC - Participants will receive 300 mg Tabalumab (LY2127399) IV, 1.3 mg/m^2 bortezomib subcutaneously (SC), and 20 mg dexamethasone orally.
Cohort 2-SC was added per protocol amendment in February 2013.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 100 mg Tabalumab+Bortezomib (BTZ)IV+Dexamethasone (Dex) | Experimental | Cohort 1. 100 mg tabalumab (LY2127399) intravenously (IV) on day 1 of each cycle, each cyle is 21 days. Bortezomib (BTZ), 1.3 milligram per square meter (mg/m^2), IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dexamethasone (Dex), 20 mg/day, on day of and day after BTZ. |
|
| 300 mg Tabalumab+BTZ IV+Dex | Experimental | Cohort 2. 300 mg tabalumab (LY2127399) IV on day 1 of each cycle, each cycle is 21 days. BTZ, 1.3 mg/m^2, IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dex, 20 mg/day, on day of and day after BTZ. |
|
| 300 mg Tabalumab+BTZ SC+Dex | Experimental | Cohort 2-SC. 300 mg tabalumab (LY2127399)IV on day 1 of each cycle, each cycle is 21 days. BTZ, 1.3 mg/m^2, subcutaneously (SC) on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dex, 20 mg/day, on day of and day after BTZ. Cohort 2-SC was added per protocol amendment in February 2013. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tabalumab | Biological | Administered IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With One or More Drug Related Adverse Events (AEs) or Any Serious AEs | A summary of other non-serious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section. | Baseline through 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) for Tabalumab (LY2127399) | Cycle 1, Day 1: 6 + or - hours after bortezomib (BTZ); Cycle 7, Day 1: immediately post BTZ dose and 2 hours after tabalumab | |
| Pharmacokinetics (PK): Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Plasma Concentration (AUC0-tlast) of Tabalumab (LY2127399) |
Not provided
Inclusion Criteria:
Have relapsed or refractory MM treated with at least 1 prior regimen. Prior therapy with bortezomib is allowed if there was previously at least a minimal response (MR).
Have measurable disease as defined by one or more of the following:
Have adequate organ function including:
Have an Eastern Cooperative Oncology Group performance status (ECOG PS) score of ≤ 2.
Have discontinued all previous therapies for cancer, including chemotherapy, surgery, and radiotherapy for at least 2 weeks (6 weeks for mitomycin-C or nitrosoureas) before study enrollment and recovered from the acute effects of therapy.
Males and females with reproductive potential: Must agree to use medically approved contraceptive precautions during the study and for 4 months following the last dose of study drug.
Females with childbearing potential: Must have had a negative urine or serum pregnancy test <7 days before the first dose of study drug.
Have an estimated life expectancy of ≥16 weeks, in the opinion of the investigator.
Exclusion Criteria:
Have received treatment within 30 days of the initial dose of study drug with an experimental agent for non-cancer indications that has not received regulatory approval for any indication.
Have one or more serious preexisting medical conditions that, in the opinion of the investigator, would preclude participation in this study.
Have an uncontrolled infection.
Females who are pregnant or breastfeeding.
Have known positive test results for human immunodeficiency virus (HIV), hepatitis B*, or hepatitis C antibodies (HCAb).
* Have evidence of or test positive for hepatitis B. A positive test for hepatitis B is defined as:
positive for hepatitis B surface antigen (HBsAg+). OR
positive for anti-hepatitis B core antibody and positive for hepatitis B deoxyribonucleic acid (HBV DNA).
OR
positive for anti-hepatitis B surface antibody (HBsAb+) and positive for hepatitis B deoxyribonucleic acid (HBV DNA).
Have ≥ Grade 2 peripheral neuropathy or any grade with pain as assessed using the Common Terminology Criteria for Adverse Events, version 4.03 (CTCAE v 4.03).
Have previously received an allogenic hematopoietic stem cell transplant.
Have previously received treatment with an experimental agent that targets B-cell activating factor (BAFF).
Have a corrected QT (QTc) interval >470 msec on their baseline electrocardiogram (ECG).
Have interstitial pneumonitis (interstitial pneumonia) or pulmonary fibrosis manifested as opacity on chest X-ray or computed tomography (CT) scan.
Have had another active malignancy within the past 5 years.
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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. | Aichi | 467-0001 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27350068 | Derived | Iida S, Ogiya D, Abe Y, Taniwaki M, Asou H, Maeda K, Uenaka K, Nagaoka S, Ishiki T, Conti I, Tobinai K. Dose-escalation study of tabalumab with bortezomib and dexamethasone in Japanese patients with multiple myeloma. Cancer Sci. 2016 Sep;107(9):1281-9. doi: 10.1111/cas.13000. Epub 2016 Sep 1. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 100 mg Tabalumab+BTZ IV+Dex | Cohort 1. 100 mg tabalumab (LY2127399)intravenously (IV) on day 1 of each cycle. Bortezomib (BTZ), 1.3 milligram per square meter (mg/m^2), IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dexamethasone (Dex), 20 mg/day, on day of and day after BTZ. |
| FG001 | 300 mg Tabalumab+ BTZ +Dex | Cohort 2. 300 mg tabalumab (LY2127399) IV on day 1 of each cycle. BTZ, 1.3 mg/m^2, IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dex, 20 mg/day, on day of and day after BTZ subcutaneously or intravenously (SC, IV respectively). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants who received at least 1 dose of study drug. 300 mg LY2127399 group administered BTZ IV or SC data were combined per protocol, BTZ was a supplemental therapy for participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | 100 mg Tabalumab+BTZ IV+Dex | Cohort 1. 100 mg tabalumab (LY2127399) intravenously (IV) on day 1 of each cycle. Bortezomib (BTZ), 1.3 milligram per square meter (mg/m^2), IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dexamethasone (Dex), 20 mg/day, on day of and day after BTZ. |
| 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 AEs | A summary of other non-serious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section. | All participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | No | Baseline through 8 months |
|
Not provided
300 mg tabalumab (LY2127399) group administered BTZ IV or SC data were combined per protocol, BTZ was a supplemental therapy for participants.
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 | 100 mg Tabalumab+BTZ IV+Dex | Cohort 1. 100 mg tabalumab (LY2127399) intravenously (IV) on day 1 of each cycle. Bortezomib (BTZ), 1.3 milligram per square meter (mg/m^2), IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dexamethasone (Dex), 20 mg/day, on day of and day after BTZ. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
300 mg tabalumab (LY2127399) group administered BTZ IV or SC data were combined per protocol in some instances as BTZ was a supplemental therapy for participants.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
Not provided
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| C575974 | tabalumab |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
Not provided
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Not provided
Not provided
Not provided
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|
| Bortezomib IV | Drug | Administered IV |
|
| Bortezomib SC | Drug | Administered SC |
|
| Dexamethasone | Drug | Administered orally |
|
| Cycle 1, Day 1: 6 + or - hours after bortezomib (BTZ); Cycle 7, Day 1: immediately post BTZ dose and 2 hours after tabalumab |
| Pharmacokinetics (PK): Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-∞) of Tabalumab (LY2127399) | Cycle 1, Day 1: 6 + or - hours after bortezomib (BTZ); Cycle 7, Day 1: immediately post BTZ dose and 2 hours after tabalumab |
| Number of Participants With Tumor Response (Tumor Response Rate) | Stringent Complete Response- Complete response in addition to normal free light chain ration and no clonal cells in bone marrow. Complete Response- no monoclonal protein (mp) in blood, no serum or urine mp, less than 5% plasma cells in bone marrow. Very Good Partial Response-more than 90% decrease in mp and urine protein. Partial Response- over 50% decrease in serum mp. Stable Disease- less than 25 percent decrease of monoclonal protein. Progressive Disease- 25% increase compared to lowest value of serum mp, urine mp, no measurable mp. | Baseline to disease progression (up to 421 days) |
| Duration of Response (DoR) | DoR is defined as the time from the date when the measurement criteria are met for CR, CRu, or PR (whichever status is recorded first) until the date of first observation of measured progressive disease. For responding participants who die without progressive disease (including death from study disease),DoR will be censored at the date of death. For responding participants not known to have died as of the data cut-off date and who do not have progressive disease, DoR will be censored at the last objective progression-free assessment date prior to the data cut-off date. | Time from Response until measured Progressive Disease (up to 455 days) |
| Time to Progression (TTP) | TTP is defined as the time from the date of study enrollment to the date of objectively determined progressive disease. TTP will be censored at the date of the last objective progression free disease assessment. | Baseline to date of Progressive Disease (up to 455 days) |
| Pharmacodynamics (PD): Change From Baseline in Absolute B-cell Count | Baseline through study completion (up to 455 days) |
| Pharmacodynamics (PD): Change From Baseline in B-cell Subset Fractions | CD19+ peripheral B-cells counts are based on the percentage of total leukocyte population and absolute cell counts. | Baseline, Cycle 1 and Cycle 7: prior to first tabalumab dose. |
| Japan |
| 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. | Fukuoka | 811-1395 | Japan |
| 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. | Kanagawa | 259-1193 | Japan |
| 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. | Kyoto | 602-0841 | Japan |
| 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. | Tokyo | 104-0045 | Japan |
| Progressive Disease |
|
| Death |
|
| 300 mg Tabalumab+BTZ +Dex |
Cohort 2. 300 mg tabalumab (LY2127399) IV on day 1 of each cycle. BTZ, 1.3 mg/m^2, IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dex, 20 mg/day, on day of and day after BTZ subcutaneously or intravenously (SC, IV respectively). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| 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 |
|
Cohort 2. 300 mg tabalumab (LY2127399) IV on day 1 of each cycle. BTZ, 1.3 mg/m^2, IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dex, 20 mg/day, on day of and day after BTZ subcutaneously or intravenously (SC, IV respectively). |
|
|
| Secondary | Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) for Tabalumab (LY2127399) | All participants who received at least 1 dose of any study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram per milliliter (μg/mL) | Cycle 1, Day 1: 6 + or - hours after bortezomib (BTZ); Cycle 7, Day 1: immediately post BTZ dose and 2 hours after tabalumab |
|
|
|
| Secondary | Pharmacokinetics (PK): Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Plasma Concentration (AUC0-tlast) of Tabalumab (LY2127399) | All participants who received at least 1 dose of any study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours times nanograms per milliliter | Cycle 1, Day 1: 6 + or - hours after bortezomib (BTZ); Cycle 7, Day 1: immediately post BTZ dose and 2 hours after tabalumab |
|
|
|
| Secondary | Pharmacokinetics (PK): Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-∞) of Tabalumab (LY2127399) | All participants who received at least 1 dose of any study drug and had evaluable PK data. Participants in the 300 mg tabalumab group may have received IV and SC BTZ and may be counted in the IV and SC group for analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Cycle 1, Day 1: 6 + or - hours after bortezomib (BTZ); Cycle 7, Day 1: immediately post BTZ dose and 2 hours after tabalumab |
|
|
|
| Secondary | Number of Participants With Tumor Response (Tumor Response Rate) | Stringent Complete Response- Complete response in addition to normal free light chain ration and no clonal cells in bone marrow. Complete Response- no monoclonal protein (mp) in blood, no serum or urine mp, less than 5% plasma cells in bone marrow. Very Good Partial Response-more than 90% decrease in mp and urine protein. Partial Response- over 50% decrease in serum mp. Stable Disease- less than 25 percent decrease of monoclonal protein. Progressive Disease- 25% increase compared to lowest value of serum mp, urine mp, no measurable mp. | All participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | No | Baseline to disease progression (up to 421 days) |
|
|
|
| Secondary | Duration of Response (DoR) | DoR is defined as the time from the date when the measurement criteria are met for CR, CRu, or PR (whichever status is recorded first) until the date of first observation of measured progressive disease. For responding participants who die without progressive disease (including death from study disease),DoR will be censored at the date of death. For responding participants not known to have died as of the data cut-off date and who do not have progressive disease, DoR will be censored at the last objective progression-free assessment date prior to the data cut-off date. | All participants who received at least 1 dose of study drug, 4 participants were censored from Cohort 1 and 5 participants from Cohort 2. 300 mg tabalumab group administered BTZ IV or SC data were combined per protocol, BTZ was a supplemental therapy for participants. | Posted | Number | months | Time from Response until measured Progressive Disease (up to 455 days) |
|
|
|
| Secondary | Time to Progression (TTP) | TTP is defined as the time from the date of study enrollment to the date of objectively determined progressive disease. TTP will be censored at the date of the last objective progression free disease assessment. | All participants who received at least 1 dose of study drug and didn't have AEs . 300 mg tabalumab group administered BTZ IV or SC data were combined per protocol, BTZ was a supplemental therapy for participants. Participants that were censored prior to PD and not included in analysis:100 mg tabalumab n=4, 300 mg tabalumab n=8. | Posted | Median | Full Range | months | Baseline to date of Progressive Disease (up to 455 days) |
|
|
|
| Secondary | Pharmacodynamics (PD): Change From Baseline in Absolute B-cell Count | Zero participants analyzed as no post baseline data collected. | Posted | Baseline through study completion (up to 455 days) |
|
|
| Secondary | Pharmacodynamics (PD): Change From Baseline in B-cell Subset Fractions | CD19+ peripheral B-cells counts are based on the percentage of total leukocyte population and absolute cell counts. | All participants who received at least 1 dose of study drug and had evaluable PD. 300 mg tabalumab IV and SC dose were analyzed together. | Posted | Mean | Standard Deviation | percentage of b-cell change | Baseline, Cycle 1 and Cycle 7: prior to first tabalumab dose. |
|
|
|
| 2 |
| 4 |
| 4 |
| 4 |
| EG001 | 300 mg Tabalumab+BTZ +Dex | Cohort 2. 300 mg tabalumab (LY2127399) IV on day 1 of each cycle. BTZ, 1.3 mg/m^2, IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dex, 20 mg/day, on day of and day after BTZ subcutaneously or intravenously (SC, IV respectively). | 8 | 12 | 12 | 12 |
| Ileus | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| Nerve compression | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Embolism | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Nephrogenic anaemia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA 18.1 | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA 18.1 | Systematic Assessment |
|
| Conjunctivitis allergic | Eye disorders | MedDRA 18.1 | Systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA 18.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Enteritis | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hypogammaglobulinaemia | Immune system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| Blood phosphorus decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hypermagnesaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Vagus nerve disorder | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
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| Purpura | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
Not provided
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| Cycle 7 Day 1 |
|
|
| Cycle 7 Day 1 |
|
|
| Cycle 7 Day 1 |
|
|
| Complete Response (CR) |
|
| Very Good Partial Response (VGPR) |
|
| Partial Response(PR) |
|
| Stable Disease(SD) |
|
| Progressive Disease |
|
| Cycle 1, Day 1 |
|
|
| Cycle 7, Day 1 |
|
|