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| Name | Class |
|---|---|
| MedImmune LLC | INDUSTRY |
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The primary objective of this study is to evaluate the safety and tolerability of MEDI-551 in Japanese patients with relapsed or refractory advanced B-cell malignancies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MEDI-551 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEDI-551 | Drug | MEDI-551 will be administered by intravenous infusion at dose of 2, 4 or 8 mg/kg once per week on Days 1 and 8 in the first cycle and then once every 28 days at the start of each subsequent cycle |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | From baseline to 30 days after the last dose of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose Limiting Toxicities | A MEDI-551 treatment-related AE of any toxicity grade that lead to an inability to receive a full cycle (2 doses) of MEDI-551, or, any Grade 3 or higher toxicity that could not be reasonably ascribed to another cause, such as disease progression or accident. | From baseline to 28 days after the first dose of study drug |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Fukuoka | Japan | ||||
| Research Site |
A total of 32 patients were enrolled into the study. Twelve patients were screen failures, thus 20 patients received MEDI-551.
First patient enrolled on 25 May 2011. Last patient last visit on 15 September 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | 2 mg/kg | MEDI-551 2 mg/kg |
| FG001 | 4 mg/kg | MEDI-551 4 mg/kg |
| FG002 | 8 mg/kg | MEDI-551 8 mg/kg |
| FG003 | 12 mg/kg | MEDI-551 12 mg/kg |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All patients who received at least 1 dose of MEDI-551.
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| ID | Title | Description |
|---|---|---|
| BG000 | 2 mg/kg | MEDI-551 2mg/kg |
| BG001 | 4 mg/kg | MEDI-551 4 mg/kg |
| BG002 |
| 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 Adverse Events | All patients who received at least 1 dose of MEDI-551. | Posted | Number | Participants | From baseline to 30 days after the last dose of study drug |
|
AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
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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 | 2 mg/kg | MEDI-551 2mg/kg |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Epiglottitis | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA Version 18.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | MedImmune, LLC | ClinicalTrialTransparency@astrazeneca.com |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C000609745 | inebilizumab |
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| Maximum Tolerated Dose | A dose was considered non-tolerated and dose escalation stopped if ≥2 of up to 6 evaluable patients experienced a DLT at any dose level. MTD is the last dose level before the non-tolerated dose. | From baseline to 28 days after the first dose of study drug |
| MEDI-551 Trough Concentration Levels at Day 0 (Pre-dose) | Lower limit of quantification for MEDI-551 was 0.1 μg/mL. | Day 0 (pre-dose) |
| MEDI-551 Trough Concentration Levels at Day 7 | Lower limit of quantification for MEDI-551 was 0.1 μg/mL. | Day 7 |
| MEDI-551 Trough Concentration Levels at Day 28 | Lower limit of quantification for MEDI-551 was 0.1 μg/mL. | Day 28 |
| MEDI-551 Trough Concentration Levels at Day 56 | Lower limit of quantification for MEDI-551 was 0.1 μg/mL. | Day 56 |
| MEDI-551 Trough Concentration Levels at Day84 | Lower limit of quantification for MEDI-551 was 0.1 μg/mL. | Day 84 |
| MEDI-551 Trough Concentration Levels at Day 112 | Lower limit of quantification for MEDI-551 was 0.1 μg/mL. | Day 112 |
| MEDI-551 Trough Concentration Levels at Day 140 | Lower limit of quantification for MEDI-551 was 0.1 μg/mL. | Day 140 |
| MEDI-551 Trough Concentration Levels at Day 168 | Lower limit of quantification for MEDI-551 was 0.1 μg/mL. | Day 168 |
| Anti-MEDI-551 Antibodies | Only 1 patient was tested positive for ADA at pre-dose of Cycle 1 Day 1. However, it was considered as false-positive because the titer value was close to the cut point, and this patient was tested negative for ADA at all subsequent cycles post-baseline. | From baseline to 30 days after the last dose of study drug |
| Number of Participants With Tumour Response in FL Patients | Tumour response is defined as complete remission (CR) or partial remission (PR) (Cheson BD et al 2007). CR: Nodal Masses: (a) FDG-avid or PET positive prior to therapy; mass of any size permitted if PET negative; (b) Variably FDG-avid or PET negative; regression to normal size on CT; Spleen, Liver: Not palpable, nodules disappeared. Bone Marrow: Infiltrate cleared on repeat biopsy; if indeterminate by morphology, immunohistochemistry should be negative. PR: Nodal Masses: ≥50% decrease in sum of the product of the diameters (SPD) of up to 6 largest dominant masses; no increase in size of other nodes; (a) FDG-avid or PET positive prior to therapy; ≥1 PET positive at previously involved site; (b) Variably FDG-avid or PET negative; regression on CT. Spleen, Liver: ≥50% decrease in SPD of nodules (for single nodule in greatest transverse diameter); no increase in size of liver or spleen. Bone Marrow: Irrelevant if positive prior to therapy; cell type should be specified. | From the baseline to 30 days after the last dose of study drug |
| Number of Participants With Tumour Response in DLBCL Patients | Tumour response is defined as complete remission (CR) or partial remission (PR) (Cheson BD et al 2007). CR: Nodal Masses: (a) FDG-avid or PET positive prior to therapy; mass of any size permitted if PET negative; (b) Variably FDG-avid or PET negative; regression to normal size on CT; Spleen, Liver: Not palpable, nodules disappeared. Bone Marrow: Infiltrate cleared on repeat biopsy; if indeterminate by morphology, immunohistochemistry should be negative. PR: Nodal Masses: ≥50% decrease in sum of the product of the diameters (SPD) of up to 6 largest dominant masses; no increase in size of other nodes; (a) FDG-avid or PET positive prior to therapy; ≥1 PET positive at previously involved site; (b) Variably FDG-avid or PET negative; regression on CT. Spleen, Liver: ≥50% decrease in SPD of nodules (for single nodule in greatest transverse diameter); no increase in size of liver or spleen. Bone Marrow: Irrelevant if positive prior to therapy; cell type should be specified. | From the baseline to 30 days after the last dose of study drug |
| Number of Participants With Tumour Response in CLL Patients | Tumour response is defined as complete remission (CR) or partial remission (PR) (Hallek M et al 2008). CR: all of the following criteria have to be met, and patients have to lack disease-related constitutional symptoms; Lymphadenopathy: None; Hepatomegaly: None; Splenomegaly: None; Blood lymphocytes: <4000/μL; Marrow: Normocellular, <30%lymphocytes, no B-lymphoid nodules, hypocellular marrow defines CR with incomplete marrow recovery; Platelet count: >100000/μL; Hemoglobin: >11.0 g/dL; Neutrophils: >1500/μL PR: at least 2 of the criteria of group A plus 1 of the criteria of group B have to be met. Group A: Lymphadenopathy: Decrease ≥50%; Hepatomegaly: Decrease ≥50%; Splenomegaly: Decrease ≥50%; Blood lymphocytes: Decrease ≥50% from baseline; Marrow: 50% reduction in marrow infiltrate, or B-lymphoid nodules. Group B: Platelet count: 100000/μL or increase ≥50% over baseline; Hemoglobin: >11.0 g/dL or increase ≥50% over baseline; Neutrophils: >1500/μL or >50% improvement over baseline. | From the baseline to 30 days after the last dose of study drug |
| Number of Participants With Tumour Response in MM Patients | Tumour response is defined as complete response (CR) or partial response (PR) (Durie M et al 2006). CR: Negative immunofixation on the serum and urine, and Disappearance of any soft tissue plasmacytomas and 5% or less plasma cells in bone marrow PR: ≥50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥90% or to <200mg per 24 h. If the serum and urine M-protein are unmeasurable, a ≥50% decrease in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria. If serum and urine M-protein are unmeasurable, and serum free light assay is also unmeasurable, ≥50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma cell percentage was ≥30%. In addition to the above listed criteria, if present at baseline, a ≥50% reduction in the size of soft tissue plasmacytomas is also required. | From the baseline to30 days after the last dose of study drug |
| Isehara-shi |
| Japan |
| Research Site | Nagoya | Japan |
| Death |
|
| 8 mg/kg |
MEDI-551 8 mg/kg |
| BG003 | 12 mg/kg | MEDI-551 12 mg/kg |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Disease Type | Disease Type (CLL: chronic lymphocytic leukemia, DLBCL: diffuse large B-cell lymphoma, FL: follicular lymphoma, MM: multiple myeloma) | Number | Participants |
|
| 12 mg/kg |
MEDI-551 12 mg/kg |
|
|
| Secondary | Number of Participants With Dose Limiting Toxicities | A MEDI-551 treatment-related AE of any toxicity grade that lead to an inability to receive a full cycle (2 doses) of MEDI-551, or, any Grade 3 or higher toxicity that could not be reasonably ascribed to another cause, such as disease progression or accident. | All subjects in the dose escalation phase who have received MEDI-551 at Day 1 and Day 8 and completed the safety follow-up through the dose-limiting toxicity (DLT) evaluation period (28 days), or who experienced a DLT. | Posted | Number | Participants | From baseline to 28 days after the first dose of study drug |
|
|
|
| Secondary | Maximum Tolerated Dose | A dose was considered non-tolerated and dose escalation stopped if ≥2 of up to 6 evaluable patients experienced a DLT at any dose level. MTD is the last dose level before the non-tolerated dose. | All subjects in the dose escalation phase who have received MEDI-551 at Day 1 and Day 8 and completed the safety follow-up through the dose-limiting toxicity (DLT) evaluation period (28 days), or who experienced a DLT. | Posted | Number | mg/kg | From baseline to 28 days after the first dose of study drug |
|
|
|
| Secondary | MEDI-551 Trough Concentration Levels at Day 0 (Pre-dose) | Lower limit of quantification for MEDI-551 was 0.1 μg/mL. | Patients who have trough concentration data at Day 0 (pre-dose) | Posted | Mean | Standard Deviation | μg/mL | Day 0 (pre-dose) |
|
|
|
| Secondary | MEDI-551 Trough Concentration Levels at Day 7 | Lower limit of quantification for MEDI-551 was 0.1 μg/mL. | Patients who have trough concentration data at Day 7 | Posted | Mean | Standard Deviation | μg/mL | Day 7 |
|
|
|
| Secondary | MEDI-551 Trough Concentration Levels at Day 28 | Lower limit of quantification for MEDI-551 was 0.1 μg/mL. | Patients who have trough concentration data at Day 28 | Posted | Mean | Standard Deviation | μg/mL | Day 28 |
|
|
|
| Secondary | MEDI-551 Trough Concentration Levels at Day 56 | Lower limit of quantification for MEDI-551 was 0.1 μg/mL. | Patients who have trough concentration data at Day 56 | Posted | Mean | Standard Deviation | μg/mL | Day 56 |
|
|
|
| Secondary | MEDI-551 Trough Concentration Levels at Day84 | Lower limit of quantification for MEDI-551 was 0.1 μg/mL. | Patients who have trough concentration data at Day 84 | Posted | Mean | Standard Deviation | μg/mL | Day 84 |
|
|
|
| Secondary | MEDI-551 Trough Concentration Levels at Day 112 | Lower limit of quantification for MEDI-551 was 0.1 μg/mL. | Patients who have trough concentration data at Day 112 | Posted | Mean | Standard Deviation | μg/mL | Day 112 |
|
|
|
| Secondary | MEDI-551 Trough Concentration Levels at Day 140 | Lower limit of quantification for MEDI-551 was 0.1 μg/mL. | Patients who have trough concentration data at Day 140 | Posted | Mean | Standard Deviation | μg/mL | Day 140 |
|
|
|
| Secondary | MEDI-551 Trough Concentration Levels at Day 168 | Lower limit of quantification for MEDI-551 was 0.1 μg/mL. | Patients who have trough concentration data at Day 168 | Posted | Mean | Standard Deviation | μg/mL | Day 168 |
|
|
|
| Secondary | Anti-MEDI-551 Antibodies | Only 1 patient was tested positive for ADA at pre-dose of Cycle 1 Day 1. However, it was considered as false-positive because the titer value was close to the cut point, and this patient was tested negative for ADA at all subsequent cycles post-baseline. | Patients who have at least one post-baseline sample for Anti-MEDI-551 antibodies. | Posted | Number | Participants | From baseline to 30 days after the last dose of study drug |
|
|
|
| Secondary | Number of Participants With Tumour Response in FL Patients | Tumour response is defined as complete remission (CR) or partial remission (PR) (Cheson BD et al 2007). CR: Nodal Masses: (a) FDG-avid or PET positive prior to therapy; mass of any size permitted if PET negative; (b) Variably FDG-avid or PET negative; regression to normal size on CT; Spleen, Liver: Not palpable, nodules disappeared. Bone Marrow: Infiltrate cleared on repeat biopsy; if indeterminate by morphology, immunohistochemistry should be negative. PR: Nodal Masses: ≥50% decrease in sum of the product of the diameters (SPD) of up to 6 largest dominant masses; no increase in size of other nodes; (a) FDG-avid or PET positive prior to therapy; ≥1 PET positive at previously involved site; (b) Variably FDG-avid or PET negative; regression on CT. Spleen, Liver: ≥50% decrease in SPD of nodules (for single nodule in greatest transverse diameter); no increase in size of liver or spleen. Bone Marrow: Irrelevant if positive prior to therapy; cell type should be specified. | All patients with FL who received at least 1 dose of MEDI-551 and completed at least 1 post-baseline disease assessment. | Posted | Number | Participants | From the baseline to 30 days after the last dose of study drug |
|
|
|
| Secondary | Number of Participants With Tumour Response in DLBCL Patients | Tumour response is defined as complete remission (CR) or partial remission (PR) (Cheson BD et al 2007). CR: Nodal Masses: (a) FDG-avid or PET positive prior to therapy; mass of any size permitted if PET negative; (b) Variably FDG-avid or PET negative; regression to normal size on CT; Spleen, Liver: Not palpable, nodules disappeared. Bone Marrow: Infiltrate cleared on repeat biopsy; if indeterminate by morphology, immunohistochemistry should be negative. PR: Nodal Masses: ≥50% decrease in sum of the product of the diameters (SPD) of up to 6 largest dominant masses; no increase in size of other nodes; (a) FDG-avid or PET positive prior to therapy; ≥1 PET positive at previously involved site; (b) Variably FDG-avid or PET negative; regression on CT. Spleen, Liver: ≥50% decrease in SPD of nodules (for single nodule in greatest transverse diameter); no increase in size of liver or spleen. Bone Marrow: Irrelevant if positive prior to therapy; cell type should be specified. | All patients with DLBCL who received at least 1 dose of MEDI-551 and completed at least 1 post-baseline disease assessment. | Posted | Number | Participants | From the baseline to 30 days after the last dose of study drug |
|
|
|
| Secondary | Number of Participants With Tumour Response in CLL Patients | Tumour response is defined as complete remission (CR) or partial remission (PR) (Hallek M et al 2008). CR: all of the following criteria have to be met, and patients have to lack disease-related constitutional symptoms; Lymphadenopathy: None; Hepatomegaly: None; Splenomegaly: None; Blood lymphocytes: <4000/μL; Marrow: Normocellular, <30%lymphocytes, no B-lymphoid nodules, hypocellular marrow defines CR with incomplete marrow recovery; Platelet count: >100000/μL; Hemoglobin: >11.0 g/dL; Neutrophils: >1500/μL PR: at least 2 of the criteria of group A plus 1 of the criteria of group B have to be met. Group A: Lymphadenopathy: Decrease ≥50%; Hepatomegaly: Decrease ≥50%; Splenomegaly: Decrease ≥50%; Blood lymphocytes: Decrease ≥50% from baseline; Marrow: 50% reduction in marrow infiltrate, or B-lymphoid nodules. Group B: Platelet count: 100000/μL or increase ≥50% over baseline; Hemoglobin: >11.0 g/dL or increase ≥50% over baseline; Neutrophils: >1500/μL or >50% improvement over baseline. | All patients with CLL who received at least 1 dose of MEDI-551 and completed at least 1 post-baseline disease assessment. | Posted | Number | Participants | From the baseline to 30 days after the last dose of study drug |
|
|
|
| Secondary | Number of Participants With Tumour Response in MM Patients | Tumour response is defined as complete response (CR) or partial response (PR) (Durie M et al 2006). CR: Negative immunofixation on the serum and urine, and Disappearance of any soft tissue plasmacytomas and 5% or less plasma cells in bone marrow PR: ≥50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥90% or to <200mg per 24 h. If the serum and urine M-protein are unmeasurable, a ≥50% decrease in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria. If serum and urine M-protein are unmeasurable, and serum free light assay is also unmeasurable, ≥50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma cell percentage was ≥30%. In addition to the above listed criteria, if present at baseline, a ≥50% reduction in the size of soft tissue plasmacytomas is also required. | All patients with MM who received at least 1 dose of MEDI-551 and completed at least 1 post-baseline disease assessment. | Posted | Number | Participants | From the baseline to30 days after the last dose of study drug |
|
|
|
| 1 |
| 3 |
| 3 |
| 3 |
| EG001 | 4 mg/kg | MEDI-551 4 mg/kg | 0 | 7 | 6 | 7 |
| EG002 | 8 mg/kg | MEDI-551 8 mg/kg | 0 | 4 | 4 | 4 |
| EG003 | 12 mg/kg | MEDI-551 12 mg/kg | 0 | 6 | 6 | 6 |
| White blood cell count decreased | Investigations | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Blood cholesterol increased | Investigations | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Proctalgia | Gastrointestinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Monarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Conjunctivitis allergic | Eye disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Eyelid oedema | Eye disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Cholesteatoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Sebaceous adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Calculus ureteric | Renal and urinary disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
Not provided
Not provided
| CTCAE Grade 3 or higher non-hematologic toxicity |
|
| CTCAE Grade 3 or higher hematologic toxicity |
|
| negative at all time points |
|