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The purpose of this study is to determine whether a continuous infusion of Blinatumomab (MT103) is safe in the treatment of relapsed Non-Hodgkin's Lymphoma.
Furthermore, the study is intended to provide pharmacokinetic and pharmacodynamic data of Blinatumomab as well as to get first indication of tumour activity.
Non-Hodgkin's Lymphoma (NHL) represents the 6th most common cancer. Globally, around 165,000 new cases are diagnosed each year, with approximately 90,000 deaths per year. The vast majority of NHLs are B-cell derived (90%) and express common B-cell antigens such as CD19, CD20 and CD22. NHL can be divided into indolent (low-grade) and aggressive (high-grade) lymphomas. Still almost all patients with advanced stage indolent disease will die from their disease. Therefore, a high medical need exists to develop novel agents that further improve the survival of NHL patients.
Blinatumomab (MT103) is a bispecific antibody derivative, anti-CD19 x anti-CD3, designed to link B-cells and T-cells resulting in T-cell activation and a cytotoxic T-cell response against CD19+ cells. Data of prior phase I studies show evidence of biological activity in humans. In vitro and ex-vivo data suggest that a longterm presence of the drug in target tissues may provide antitumour activity.
The study investigates the safety and tolerability of different doses of Blinatumomab administration in a continuous infusion regimen. Maximum tolerated dose (MTD) will be defined in a classical 3+3 dose escalation regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blinatumomab | Experimental | Patients received blinatumomab as continuous intravenous infusion for 4 weeks. Participants with clinical benefit were permitted to continue for another 4 weeks for a total of 8 weeks. Participants with a clinical benefit 4 weeks after completion of the first cycle of treatment could also receive additional treatment approximately 3 months ater the end of infusion at the same dose level. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blinatumomab (MT103) | Biological | Doses from 0.5 to 120 µg/m^2/24hours by continuous intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | Participants reporting at least one occurence of any adverse event including clinical symptoms, laboratory abnormalities, serious adverse events, and treatment-limiting adverse events | From the first infusion of blinatumomab until the safety follow-up visit 2 weeks after end of the treatment period, including the consolidation and relapse periods. The median treatment duration was 33.24 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Concentration of Blinatumomab | The steady state serum concentration (Css), summarized as the observed concentrations collected at least 10 hours after the start of continuous intravenous infusion or within the sampling window at the end of infusion. Concentrations below the lower limit of quantitation (100 pg/mL) were excluded from analysis. | Up to 24 hours after the end of infusion. |
Not provided
Inclusion Criteria:
Patients with first or later relapse of histologically (World Health Organisation classification) confirmed:
Measurable disease (at least one lesion >= 1.5 cm) documented by computed tomography (CT) scan
Age >= 18 years
Eastern Cooperative Oncology Group (ECOG) performance status <=2
Life expectancy of at least 6 months
Ability to understand the patient information and informed consent form
Signed and dated written informed consent is available
B:T cell ratio (Fluorescence-Activated Cell Sorter [FACS] analysis results by central lab) available before study entry.
Exclusion Criteria:
Any other NHL not listed in inclusion criterion 1
Abnormal laboratory values as defined below:
Known or suspected central nervous system (CNS) involvement by NHL
a)History of or current relevant CNS pathology as epilepsy, seizure, paresis,aphasia, apoplexia, severe brain injuries, cerebellar disease, organic brain syndrome, psychosis b)Evidence for presence of inflammatory lesions and/or vasculitis on cerebral MRI
Autologous stem cell transplantation within 12 weeks prior to study entry
Allogeneic stem cell transplantation
Cancer chemotherapy within 4 weeks prior to study entry
Radiotherapy within 4 weeks prior to study entry
Treatment with rituximab within 4 weeks prior to study entry
Prior treatment with alemtuzumab 12 weeks prior to study entry
Treatment with any investigational agent within 12 weeks prior to study entry
Contraindication for any of the concomitant medications
Abnormal renal or hepatic function as defined below:
Indication of hypercoagulative state as defined below:
-antithrombin activity \
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| Name | Affiliation | Role |
|---|---|---|
| Ralf Bargou, MD, PhD | Medizinische Poliklinik der Julius-Maximilians-Universität Würzburg, Zentrum für Innere Medizin, Oberdürrbacherstr. 6 D-97080 Würzburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medizinische Klinik 5, Hämatologie & Internistische Onkologie, Universitätsklinikum Erlangen | Erlangen | 91054 | Germany | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34228983 | Derived | Nagele V, Zugmaier G, Goebeler ME, Viardot A, Bargou R, Kufer P, Klinger M. Relationship of T- and B-cell kinetics to clinical response in patients with relapsed/refractory non-Hodgkin lymphoma treated with blinatumomab. Exp Hematol. 2021 Aug;100:32-36. doi: 10.1016/j.exphem.2021.06.005. Epub 2021 Jul 3. | |
| 27209293 | Derived |
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Participants were enrolled into 20 different cohorts representing different dose levels, modes of administration (ramp, single-step, double-step, flat), or populations. To facilitate the analysis of the study, the different cohorts were grouped into six "dose groups" based on the dose that was intended to be given to a participant.
Participants were enrolled from 22 June 2004 through 18 July 2011
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| ID | Title | Description |
|---|---|---|
| FG000 | Blinatumomab ≤ 5 µg/m²/d | Participants received blinatumomab ≤ 5 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle. |
| FG001 | Blinatumomab 15 µg/m²/d | Participants received blinatumomab 15 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle. |
| FG002 | Blinatumomab 30 µg/m²/d | Participants received blinatumomab 30 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle. |
| FG003 | Blinatumomab 60 µg/m²/d Flat | Participants received blinatumomab 60 µg/m²/day without a lower dose as continuous intravenous infusion over 4-8 weeks in the first treatment cycle. |
| FG004 | Blinatumomab 60 µg/m²/d Step | Participants received blinatumomab 60 μg/m²/day as continuous intravenous infusion after initial lower doses of 5 and/or 15 μg/m²/day for a total treatment duration of 4-8 weeks in the first treatment cycle. |
| FG005 | Blinatumomab 90 µg/m²/d | Participants received blinatumomab 90 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Blinatumomab ≤ 5 µg/m²/d | Participants received blinatumomab ≤ 5 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle. |
| BG001 | Blinatumomab 15 µg/m²/d |
| 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 | Participants reporting at least one occurence of any adverse event including clinical symptoms, laboratory abnormalities, serious adverse events, and treatment-limiting adverse events | All participants who received at least one infusion of blinatumomab | Posted | Number | participants | From the first infusion of blinatumomab until the safety follow-up visit 2 weeks after end of the treatment period, including the consolidation and relapse periods. The median treatment duration was 33.24 days. |
|
From the first infusion of blinatumomab until the safety follow-up visit 2 weeks after end of the treatment period, including the consolidation and relapse periods. The median treatment duration was 33.24 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
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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 | Blinatumomab ≤ 5 µg/m²/d | Participants received blinatumomab ≤ 5 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 |
Not provided
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D012008 | Recurrence |
| D001733 | Bites and Stings |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| ID | Term |
|---|---|
| C510808 | blinatumomab |
| C568788 | N,N-dicyclohexyl-isoborneol-10-sulfonamide |
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| Objective Tumor Response According to the Cheson Criteria (Without Minimal Response) | Tumor response was defined according to the Cheson criteria and assessed after 4 and 8 weeks of study treatment using computed tomography (CT) scan (neck, thorax and abdomen/pelvic to assess nodal disease/organ enlargement due to nodal/diffuse infiltration), and bone marrow biopsy (to assess bone marrow infiltration). Best clinical response is defined as the best response achieved during the course of the study, with response defined as: Complete Response, Complete Response Unconfirmed, Partial Response, Stable Disease, and Progressive Disease. In this analysis minimal response is set to stable disease as intended in the response categories according to the Cheson criteria. An independent external review by a radiologist (computed tomography scans) and a pathologist (biopsies) was performed to confirm response status. If no post-baseline tumor assessment was available, the overall clinical response was set to not available. | Assessed after 4 and 8 weeks of treatment |
| Objective Tumor Response According to the Cheson Criteria (With Minimal Response) | Tumor response was defined according to the Cheson criteria and assessed after 4 and 8 weeks of study treatment using computed tomography (CT) scan (neck, thorax and abdomen/pelvic to assess nodal disease/organ enlargement due to nodal/diffuse infiltration), and bone marrow biopsy (to assess bone marrow infiltration). Minimal response was treated as a separate response category in this analysis. Best clinical response was defined as the best response achieved during the course of the study, whereby the following order was applied: Complete Response, Complete Response Unconfirmed, Partial Response, Minimal Response, Stable Disease, and Progressive Disease. If no post-baseline tumor assessment was available, the overall clinical response was set to not available. | Assessed after 4 and 8 weeks of treatment |
| Universitätsklinikum Essen, Klinik für Hämatologie, Medizinische Klinik und Poliklinik |
| Essen |
| 45147 |
| Germany |
| Universtätsklinkum Tübingen | Tübingen | 72076 | Germany |
| Universitätsklinikum Ulm, Abteilung Innere Medizin III | Ulm | 89081 | Germany |
| Medizinische Poliklinik der Julius-Maximilians-Universität Würzburg | Würzburg | 97080 | Germany |
| Zhu M, Wu B, Brandl C, Johnson J, Wolf A, Chow A, Doshi S. Blinatumomab, a Bispecific T-cell Engager (BiTE((R))) for CD-19 Targeted Cancer Immunotherapy: Clinical Pharmacology and Its Implications. Clin Pharmacokinet. 2016 Oct;55(10):1271-1288. doi: 10.1007/s40262-016-0405-4. |
| Lost to Follow-up |
|
| End of Study |
|
| Disease Progression |
|
| Other |
|
Participants received blinatumomab 15 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
| BG002 | Blinatumomab 30 µg/m²/d | Participants received blinatumomab 30 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle. |
| BG003 | Blinatumomab 60 µg/m²/d Flat | Participants received blinatumomab 60 µg/m²/day without a lower dose as continuous intravenous infusion over 4-8 weeks in the first treatment cycle. |
| BG004 | Blinatumomab 60 µg/m²/d Step | Participants received blinatumomab 60 μg/m²/day as continuous intravenous infusion after initial lower doses of 5 and/or 15 μg/m²/day for a total treatment duration of 4-8 weeks in the first treatment cycle. |
| BG005 | Blinatumomab 90 µg/m²/d | Participants received blinatumomab 90 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle. |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Participants received blinatumomab 15 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle. |
| OG002 | Blinatumomab 30 µg/m²/d | Participants received blinatumomab 30 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle. |
| OG003 | Blinatumomab 60 µg/m²/d Flat | Participants received blinatumomab 60 µg/m²/day without a lower dose as continuous intravenous infusion over 4-8 weeks in the first treatment cycle. |
| OG004 | Blinatumomab 60 µg/m²/d Step | Participants received blinatumomab 60 μg/m²/day as continuous intravenous infusion after initial lower doses of 5 and/or 15 μg/m²/day for a total treatment duration of 4-8 weeks in the first treatment cycle. |
| OG005 | Blinatumomab 90 µg/m²/d | Participants received blinatumomab 90 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle. |
|
|
| Secondary | Serum Concentration of Blinatumomab | The steady state serum concentration (Css), summarized as the observed concentrations collected at least 10 hours after the start of continuous intravenous infusion or within the sampling window at the end of infusion. Concentrations below the lower limit of quantitation (100 pg/mL) were excluded from analysis. | Participants who received blinatumomab and had available pharmacokinetic data | Posted | Mean | Standard Deviation | pg/mL | Up to 24 hours after the end of infusion. |
|
|
|
| Secondary | Objective Tumor Response According to the Cheson Criteria (Without Minimal Response) | Tumor response was defined according to the Cheson criteria and assessed after 4 and 8 weeks of study treatment using computed tomography (CT) scan (neck, thorax and abdomen/pelvic to assess nodal disease/organ enlargement due to nodal/diffuse infiltration), and bone marrow biopsy (to assess bone marrow infiltration). Best clinical response is defined as the best response achieved during the course of the study, with response defined as: Complete Response, Complete Response Unconfirmed, Partial Response, Stable Disease, and Progressive Disease. In this analysis minimal response is set to stable disease as intended in the response categories according to the Cheson criteria. An independent external review by a radiologist (computed tomography scans) and a pathologist (biopsies) was performed to confirm response status. If no post-baseline tumor assessment was available, the overall clinical response was set to not available. | All participants who received at least one infusion of blinatumomab | Posted | Number | participants | Assessed after 4 and 8 weeks of treatment |
|
|
|
| Secondary | Objective Tumor Response According to the Cheson Criteria (With Minimal Response) | Tumor response was defined according to the Cheson criteria and assessed after 4 and 8 weeks of study treatment using computed tomography (CT) scan (neck, thorax and abdomen/pelvic to assess nodal disease/organ enlargement due to nodal/diffuse infiltration), and bone marrow biopsy (to assess bone marrow infiltration). Minimal response was treated as a separate response category in this analysis. Best clinical response was defined as the best response achieved during the course of the study, whereby the following order was applied: Complete Response, Complete Response Unconfirmed, Partial Response, Minimal Response, Stable Disease, and Progressive Disease. If no post-baseline tumor assessment was available, the overall clinical response was set to not available. | All participants who received at least one infusion of blinatumomab | Posted | Number | participants | Assessed after 4 and 8 weeks of treatment |
|
|
|
| 8 |
| 12 |
| 12 |
| 12 |
| EG001 | Blinatumomab 15 µg/m²/d | Participants received blinatumomab 15 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle. | 10 | 13 | 13 | 13 |
| EG002 | Blinatumomab 30 µg/m²/d | Participants received blinatumomab 30 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle. | 6 | 6 | 6 | 6 |
| EG003 | Blinatumomab 60 µg/m²/d Flat | Participants received blinatumomab 60 µg/m²/day without a lower dose as continuous intravenous infusion over 4-8 weeks in the first treatment cycle. | 9 | 9 | 9 | 9 |
| EG004 | Blinatumomab 60 µg/m²/d Step | Participants received blinatumomab 60 μg/m²/day as continuous intravenous infusion after initial lower doses of 5 and/or 15 μg/m²/day for a total treatment duration of 4-8 weeks in the first treatment cycle. | 22 | 32 | 32 | 32 |
| EG005 | Blinatumomab 90 µg/m²/d | Participants received blinatumomab 90 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle. | 4 | 4 | 4 | 4 |
| EG006 | Blinatumomab Overall | All participants who received any dose of blinatumomab | 59 | 76 | 76 | 76 |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
|
| Apical granuloma | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Pneumoperitoneum | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Bacterial sepsis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Catheter site infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Device related infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Escherichia bacteraemia | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Lymph gland infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Muscle abscess | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Pneumocystis jiroveci pneumonia | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Soft tissue infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
|
| Blood uric acid increased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
|
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
|
| Non-Hodgkin's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
|
| Aphasia | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Ataxia | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Dysaesthesia | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Encephalopathy | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Hemiparesis | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Speech disorder | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| VIIth nerve paralysis | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
|
| Disorientation | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
|
| Hallucination, visual | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
|
| Mental disorder due to a general medical condition | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Venous thrombosis | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
|
| Basophilia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Eosinophilia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Monocytosis | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Splenomegaly | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
|
| Supraventricular extrasystoles | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
|
| Eustachian tube disorder | Ear and labyrinth disorders | MedDRA 14.1 | Systematic Assessment |
|
| Hypoacusis | Ear and labyrinth disorders | MedDRA 14.1 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 14.1 | Systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | MedDRA 14.1 | Systematic Assessment |
|
| Asthenopia | Eye disorders | MedDRA 14.1 | Systematic Assessment |
|
| Blepharitis | Eye disorders | MedDRA 14.1 | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA 14.1 | Systematic Assessment |
|
| Eye pruritus | Eye disorders | MedDRA 14.1 | Systematic Assessment |
|
| Eyelid irritation | Eye disorders | MedDRA 14.1 | Systematic Assessment |
|
| Eyelid oedema | Eye disorders | MedDRA 14.1 | Systematic Assessment |
|
| Ocular icterus | Eye disorders | MedDRA 14.1 | Systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA 14.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Paraesthesia oral | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Adverse drug reaction | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Catheter site haematoma | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Catheter site pain | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Face oedema | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Feeling abnormal | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Mucosal dryness | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Vessel puncture site haematoma | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 14.1 | Systematic Assessment |
|
| Hypogammaglobulinaemia | Immune system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Immunodeficiency | Immune system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Catheter site infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Clostridial infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Escherichia infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Genitourinary tract infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Herpes virus infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Tongue injury | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
|
| Wrong technique in drug usage process | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
|
| Activated partial thromboplastin time prolonged | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Activated partial thromboplastin time shortened | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Alanine aminotransferase abnormal | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Antithrombin III decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Aspartate aminotransferase abnormal | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Blood albumin decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Blood amylase increased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Blood bilirubin abnormal | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Blood calcium decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Blood chloride decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Blood creatine increased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Blood fibrinogen decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Blood fibrinogen increased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Blood immunoglobulin A decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Blood immunoglobulin E decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Blood immunoglobulin G decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Blood immunoglobulin G increased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Blood immunoglobulin M decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Blood potassium decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Blood pressure decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Blood sodium decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Blood uric acid increased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Blood urine | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| C-reactive protein abnormal | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Coagulation factor XII level decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Coagulation factor XIII level increased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Fibrin D dimer increased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Gamma-glutamyltransferase abnormal | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Haematocrit decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Haptoglobin decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Heart rate irregular | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Immunoglobulins decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| International normalised ratio increased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Mean cell haemoglobin concentration increased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Monocyte count decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Protein S decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Protein total decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Protein total increased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Protein urine present | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Prothrombin time prolonged | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Red blood cell count decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Urinary sediment abnormal | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
|
| Fluid retention | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
|
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
|
| Hypouricaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Allodynia | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Aphasia | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Apraxia | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Ataxia | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Cerebellar syndrome | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Disturbance in attention | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Dysarthria | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Intention tremor | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Polyneuropathy | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Speech disorder | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
|
| Communication disorder | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
|
| Emotional distress | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
|
| Bladder disorder | Renal and urinary disorders | MedDRA 14.1 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 14.1 | Systematic Assessment |
|
| Glycosuria | Renal and urinary disorders | MedDRA 14.1 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 14.1 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 14.1 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 14.1 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 14.1 | Systematic Assessment |
|
| Pelvic pain | Reproductive system and breast disorders | MedDRA 14.1 | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Palmar erythema | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Skin mass | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Stasis dermatitis | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
|
| Intra-abdominal haematoma | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
|
| Subclavian vein thrombosis | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
|
| Thrombophlebitis | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
|
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
| D014947 | Wounds and Injuries |
| Complete response unconfirmed |
|
| Partial response |
|
| Stable disease |
|
| Progressive disease |
|
| Not available |
|
| Complete response unconfirmed |
|
| Partial response |
|
| Minimal response |
|
| Stable disease |
|
| Progressive disease |
|
| Not available |
|