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| Name | Class |
|---|---|
| The Cleveland Clinic | OTHER |
| Case Comprehensive Cancer Center | OTHER |
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The purpose of this study is to evaluate the safety and efficacy of TRC105 in patients with recurrent or progressive glioblastoma after prior antiangiogenic therapy (including anti-VEGF therapy)
Angiogenesis plays a central role in the progression of solid cancer. TRC105 is an antibody to CD105, an important non-VEGF angiogenic target on proliferating endothelial cells. TRC105 inhibits angiogenesis, tumor growth and metastases in preclinical models. TRC105 has been well tolerated in patients with glioblastoma (GBM) as a single agent. The combination of TRC105 in combination with bevacizumab has demonstrated activity in bevacizumab refractory cancer patients. We hypothesize that TRC105 when administered with bevacizumab will have activity in GBM patients who progress on bevacizumab. By targeting a non-VEGF pathway, TRC105 has the potential to complement VEGF inhibition by bevacizumab, which could represent a major advance in GBM therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TRC105, Bevacizumab | Experimental | Single arm study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TRC105 | Drug | 10 mg/kg weekly by intravenous administration on Days 1, 8, 15 and 22 of each 28-day cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Median Overall Survival (OS) | Overall survival assessed by determination from time of informed consent on trial to the date of death of each patient enrolled in the trial | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Median Duration That Patients Remained Progression Free on Study | The median number of months that patients remained progression free was calculated using modified RANO criteria to determine progression. Modified RANO criteria is defined as follows: The largest cross-sectional area on the T1-weighted contrast-enhanced images was selected and measured in 2 dimensions with linear measures on the baseline MRI axial sequence. In addition, the largest cross-sectional area of a contiguous hyperintense lesion on FLAIR sequences was measured on the baseline MRI axial sequence. All subsequent scans were compared against these baseline measures (for both CE and FLAIR). New foci of FLAIR signal abnormality were recorded on each subsequent evaluation. Response was scored. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles Theuer, MD PhD | Tracon Pharmaceuticals Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Cincinnati | Cincinnati | Ohio | 45267 | United States | ||
| University Hospitals of Cleveland |
Not provided
Patients were screened and enrolled at 4 sites
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Carotuximab (TRC105), Bevacizumab | Single arm study Carotuximab (TRC105): 10 mg/kg weekly by intravenous administration on Days 1, 8, 15 and 22 of each 28-day cycle Bevacizumab: IV 10 mg/kg every 2 weeks |
| FG001 | Carotuximab (TRC105) | Single arm study Carotuximab (TRC105): 10 mg/kg weekly by intravenous administration on Days 1, 8, 15 and 22 of each 28-day cycle |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Patients who enrolled in the trial who received at least a portion of a dose were included
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | TRC105, Bevacizumab | Single arm study TRC105: 10 mg/kg weekly by intravenous administration on Days 1, 8, 15 and 22 of each 28-day cycle Bevacizumab: IV 10 mg/kg every 2 weeks |
| BG001 | TRC105 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Median |
| 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 | Median Overall Survival (OS) | Overall survival assessed by determination from time of informed consent on trial to the date of death of each patient enrolled in the trial | Patients treated with TRC105 and bevacizumab who expired. Overall survival was not captured in the monotherapy portion of the study. | Posted | Median | 95% Confidence Interval | months | 6 Months |
|
|
Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events (on average 4 months).
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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 | Carotuximab (TRC105), Bevacizumab | Single arm study Carotuximab (TRC105): 10 mg/kg weekly by intravenous administration on Days 1, 8, 15 and 22 of each 28-day cycle Bevacizumab: IV 10 mg/kg every 2 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | 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 |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Monitor | TRACON Pharmaceuticals | 8585500780 | ctheuer@traconpharma.com |
Not provided
| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
Not provided
Not provided
| ID | Term |
|---|---|
| C579557 | carotuximab |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
Not provided
A total of 6 initial patients were treated with 10 mg/kg of TRC105 monotherapy. All patients progressed within 2 months of initiating treatment, reflecting the rapid progression. Due to the lack of activity in this disease setting with TRC105 alone, the study was amended to treat patients with 10 mg/kg TRC105 weekly in combination with 10 mg/kg bevacizumab every two weeks.
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| Bevacizumab | Drug | IV |
|
|
| Patients are scanned every 8 weeks for approximately 6 months |
| Number of Participants With Adverse Events | Adverse event frequency per patient according to CTCAE version 4.0. | Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events, an average of 4 months |
| Number of Patients Who Respond to Study Treatment According to Modified RANO Criteria (Objective Response Rate (ORR)). | Number of patients who respond to study treatment according to modified RANO criteria was calculated (Objective Response Rate (ORR)). Modified RANO criteria is defined as follows: The largest cross-sectional area on the T1-weighted contrast-enhanced images was selected and measured in 2 dimensions with linear measures on the baseline MRI axial sequence. In addition, the largest cross-sectional area of a contiguous hyperintense lesion on FLAIR sequences was measured on the baseline MRI axial sequence. All subsequent scans were compared against these baseline measures (for both CE and FLAIR). New foci of FLAIR signal abnormality were recorded on each subsequent evaluation. Response was scored. | Patients are scanned every 8 weeks |
| Cleveland |
| Ohio |
| 44106 |
| United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
Single arm
TRC105: 10 mg/kg weekly by intravenous administration on Days 1, 8, 15 and 22 of each 28-day cycle
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Screening Karnofsky Score | Number | participants |
|
| Cancer Histology | Count of Participants | Participants |
|
| Number of Prior Regimens | Median | Full Range | prior regimens |
|
| Participants |
|
|
| Secondary | Median Duration That Patients Remained Progression Free on Study | The median number of months that patients remained progression free was calculated using modified RANO criteria to determine progression. Modified RANO criteria is defined as follows: The largest cross-sectional area on the T1-weighted contrast-enhanced images was selected and measured in 2 dimensions with linear measures on the baseline MRI axial sequence. In addition, the largest cross-sectional area of a contiguous hyperintense lesion on FLAIR sequences was measured on the baseline MRI axial sequence. All subsequent scans were compared against these baseline measures (for both CE and FLAIR). New foci of FLAIR signal abnormality were recorded on each subsequent evaluation. Response was scored. | Patients with at least 1 on study scan were included in the efficacy population. The number of months that patients remained progression free was calculated for 5 evaluable monotherapy patients and 14 evaluable combination therapy patients. | Posted | Median | 95% Confidence Interval | months | Patients are scanned every 8 weeks for approximately 6 months |
|
|
|
| Secondary | Number of Participants With Adverse Events | Adverse event frequency per patient according to CTCAE version 4.0. | Patients who received at least a portion of a dose of TRC105 and/or Bevacizumab | Posted | Count of Participants | Participants | Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events, an average of 4 months |
|
|
|
| Secondary | Number of Patients Who Respond to Study Treatment According to Modified RANO Criteria (Objective Response Rate (ORR)). | Number of patients who respond to study treatment according to modified RANO criteria was calculated (Objective Response Rate (ORR)). Modified RANO criteria is defined as follows: The largest cross-sectional area on the T1-weighted contrast-enhanced images was selected and measured in 2 dimensions with linear measures on the baseline MRI axial sequence. In addition, the largest cross-sectional area of a contiguous hyperintense lesion on FLAIR sequences was measured on the baseline MRI axial sequence. All subsequent scans were compared against these baseline measures (for both CE and FLAIR). New foci of FLAIR signal abnormality were recorded on each subsequent evaluation. Response was scored. | Nineteen patients had measurable disease at baseline and received at least one follow up scan and were evaluable for the secondary efficacy outcome measure of PFS by modified RANO criteria. None of the patients treated on this study had a reduction in tumor burden compared to baseline. | Posted | Count of Participants | Participants | Patients are scanned every 8 weeks |
|
|
|
| 1 |
| 16 |
| 6 |
| 16 |
| 16 |
| 16 |
| EG001 | Carotuximab (TRC105) | Single arm study Carotuximab (TRC105): 10 mg/kg weekly by intravenous administration on Days 1, 8, 15 and 22 of each 28-day cycle | 1 | 6 | 3 | 6 | 6 | 6 |
| Disease Progression | General disorders | MedDRA (14.1) | Systematic Assessment |
|
| Peripheral Oedema | General disorders | MedDRA (14.1) | Systematic Assessment |
|
| Periorbital Cellulitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
|
| Aphasia | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Cognitive Disorder | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Mental Impairment | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Transient Ischemic Attack | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Embolism | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA (14.1) | Systematic Assessment |
|
| Cushingoid | Endocrine disorders | MedDRA (14.1) | Systematic Assessment |
|
| Optic Neuropathy | Eye disorders | MedDRA (14.1) | Systematic Assessment |
|
| Photophobia | 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 |
|
| Breath Odour | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Defeacation Urgency | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Dry Mouth | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Faecal Incontinence | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Gingival Pain | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Oral Pain | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Periodontitis | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Tooth Impacted | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (14.1) | Systematic Assessment |
|
| Chest Pain | General disorders | MedDRA (14.1) | Systematic Assessment |
|
| Chills | General disorders | MedDRA (14.1) | Systematic Assessment |
|
| Disease Progression | General disorders | MedDRA (14.1) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (14.1) | Systematic Assessment |
|
| Feeling Hot | General disorders | MedDRA (14.1) | Systematic Assessment |
|
| Gait Disturbance | General disorders | MedDRA (14.1) | Systematic Assessment |
|
| Infusion Site Extravasation | General disorders | MedDRA (14.1) | Systematic Assessment |
|
| Localised Oedema | General disorders | MedDRA (14.1) | Systematic Assessment |
|
| Malaise | 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 |
|
| Pyrexia | General disorders | MedDRA (14.1) | Systematic Assessment |
|
| Periorbital Cellulitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
|
| Back Pain | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
|
| Head Injury | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
|
| Infusion Related Reaction | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
|
| Limb Injury | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
|
| Alanine Aminotransferase Increased | Investigations | MedDRA (14.1) | Systematic Assessment |
|
| Aspartate Aminotransferase Increased | Investigations | MedDRA (14.1) | Systematic Assessment |
|
| Cardiac Murmur | Investigations | MedDRA (14.1) | Systematic Assessment |
|
| Haemoglobin Decreased | Investigations | MedDRA (14.1) | Systematic Assessment |
|
| Lipase Increased | Investigations | MedDRA (14.1) | Systematic Assessment |
|
| Lymphocyte Count Decreased | Investigations | MedDRA (14.1) | Systematic Assessment |
|
| Platelet Count Decreased | Investigations | MedDRA (14.1) | Systematic Assessment |
|
| Protein Total Decreased | Investigations | MedDRA (14.1) | Systematic Assessment |
|
| Weight Decreased | Investigations | MedDRA (14.1) | Systematic Assessment |
|
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
|
| Vitamin D Deficiency | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
|
| Joint Stiffness | 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 |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
|
| Amnesia | 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 |
|
| Balance Disorder | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Clumsiness | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Cognitive Disorder | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Coordination Abnormal | 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 |
|
| Dysgeusia | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Hemianopia Homonymous | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Hypersomnia | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Hypogeusia | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Loss of Consciousness | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Loss of Proprioception | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Memory Impairment | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Mental Impairment | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Neurological Symptom | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Neuropathy Peripheral | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Somnolence | 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 |
|
| Anxiety | Psychiatric disorders | MedDRA (14.1) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (14.1) | Systematic Assessment |
|
| Disorientation | Psychiatric disorders | MedDRA (14.1) | Systematic Assessment |
|
| Flat Affect | Psychiatric disorders | MedDRA (14.1) | Systematic Assessment |
|
| Hallucination, visual | Psychiatric disorders | MedDRA (14.1) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (14.1) | Systematic Assessment |
|
| Bilirubinuria | Renal and urinary disorders | MedDRA (14.1) | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA (14.1) | Systematic Assessment |
|
| Micturition Urgency | Renal and urinary disorders | MedDRA (14.1) | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA (14.1) | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA (14.1) | Systematic Assessment |
|
| Renal Failure Acute | Renal and urinary disorders | MedDRA (14.1) | Systematic Assessment |
|
| Renal cyst | Renal and urinary disorders | MedDRA (14.1) | Systematic Assessment |
|
| Urinary Incontinence | Renal and urinary disorders | MedDRA (14.1) | Systematic Assessment |
|
| Urinary Retention | Renal and urinary 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 |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Nasal Discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Respiratory Tract Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Sinus Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Dermatitis Acneiform | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Systematic Assessment |
|
| Onychoclasis | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Systematic Assessment |
|
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Systematic Assessment |
|
| Skin Irritation | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Systematic Assessment |
|
| Embolism | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
|
| Epistaxis | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
|
| Gingival Bleeding | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
|
| Haemoptysis | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
|
| Telangiectasia | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
|
Not provided
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |