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| Name | Class |
|---|---|
| Spectrum Pharmaceuticals, Inc | INDUSTRY |
Open-label, multicentre, dose-escalation Phase I/II study to evaluate safety, efficacy, pharmacodynamics, and pharmacokinetics of the combination of PXD101 with doxorubicin administered q 3 weeks in patients with advanced solid tumours. Once the Maximum Tolerable Dose has been established, up to a total of 20-40 patients with Soft Tissue Sarcoma may be enrolled at the MTD dose level to examine efficacy and safety in this specific patient population. The trial is stopped if no more than 2 responses are seen among the first 20 of these patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: PXD101 and doxorubicin (BelDox) | Experimental | 5-day PXD101 IV schedule with dose escalation combined with 1 day doxorubicin dose escalation IV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PXD101 | Drug | Administered in combination with doxorubicin (BelDox) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) PXD101 | Maximum Tolerated Dose (MTD) of PXD101treatment | During Cohort 1 to 4, Cycle 1 only, up to 3 weeks |
| Maximum Tolerated Dose (MTD) of Doxorubicin | Maximum Tolerated Dose (MTD) of doxorubicin | During Cohort 1 to 4, Cycle 1 only, up to 3 weeks |
| Dose Limiting Toxicity (DLT) | Dose Limiting Toxicity (DLT) of PXD101 and doxorubicin combination treatment | Throughout study |
| Objective Response (CR and PR) | Measured by response rate using the RECIST (Response Evaluation Criteria in Solid Tumors) response criteria (response rate: Complete Response (CR) and Partial Response (PR)) following up to 6 cycles of treatment. | Throughout study, after every 2 cycles |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Response | Throughout study, after every 2 cycles | |
| Duration of Response | Throughout study, after every 2 cycles | |
| Time to Progression |
Not provided
Inclusion Criteria:
Signed consent of an IEC (Independent Ethics Committee)-approved Information consent form
A. For the dose escalation phase: Patients with histological or cytological confirmed solid tumours (including sarcomas), for which there is no known curative therapy B. For the MTD expansion phase: Patients with an established diagnosis of soft tissue sarcoma in need of first line chemotherapy and with measurable disease
Performance status (ECOG) ≤ 2
Life expectancy of at least 3 months
Age ≥ 18 years
Acceptable liver, renal and bone marrow function including the following:
Acceptable coagulation status: PT and APTT ([activated partial thromboplastin time ]) within ≤ 1.5 times upper limit of normal or in the therapeutic range if on anticoagulation.
A negative pregnancy test for women of childbearing potential. For men and women of child producing potential, the use of effective contraceptive methods during the study is required
Serum potassium within normal range
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| e-mail contact via enquires@topotarget.com | Valerio Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ã…rhus Hospital, Department of Oncology | Aarhus | DK-8000 C | Denmark | |||
| Herlev Hospital, Department of Oncology |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: BelDox IV (600/50) | PXD101 and doxorubicin: 5-day PXD101 600 mg/m² combined with doxorubicin 50 mg/m² |
| FG001 | Cohort 2: BelDox IV (600/75) | PXD101 and doxorubicin: 5-day PXD101 600 mg/m² combined with doxorubicin 75 mg/m² |
| FG002 | Cohort 3: BelDox IV (800/75) | PXD101 and doxorubicin: 5-day PXD101 800 mg/m² combined with doxorubicin 75 mg/m² |
| FG003 | Cohort 4: BelDox IV (1000/75) | PXD101 and doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m² |
| FG004 | MTD Expansion: BelDox IV (1000/75) | PXD101 and doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m² |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: BelDox IV (600/50) | PXD101 + doxorubicin: 5-day PXD101 600 mg/m² combined with doxorubicin 50 mg/m² |
| BG001 | Cohort 2: BelDox IV (600/75) | PXD101 + doxorubicin: 5-day PXD101 600 mg/m² combined with doxorubicin 75 mg/m² |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Maximum Tolerated Dose (MTD) PXD101 | Maximum Tolerated Dose (MTD) of PXD101treatment | Posted | Number | mg/m² | During Cohort 1 to 4, Cycle 1 only, up to 3 weeks |
|
|
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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 | Cohort 1: BelDox IV (600/50) | PXD101 + doxorubicin: 5-day PXD101 600 mg/m² combined with doxorubicin 50 mg/m² |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| PRS Administrator Gunilla Emanuelson | Topotarget A/S | +45 39 17 83 92 | enquiries@topotarget.com |
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| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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Not provided
| ID | Term |
|---|---|
| C487081 | belinostat |
| D004317 | Doxorubicin |
| ID | Term |
|---|---|
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
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| Doxorubicin | Drug | Administered in combination with PXD101 (BelDox) |
|
|
| Throughout study, after every 2 cycles |
| Disease Control Rate (CR or PR or SD) | The disease control rate, defined as best overall response of either objective response or stable disease (CR or PR or SD) following up to 6 cycles of treatment with confirmation according to the RECIST criteria | Throughout study, after every 2 cycles |
| Belinostat AUC (Time 0 to Last Measurement) | Measure the AUC of belinostat alone (Day 4 values) and in the presence of doxorubicin (Day 5 values) at the Maximum Tolerated Dose level: belinostat 1000 mg/m2 and doxorubicin 75 mg/m2 | Cycle 1, Day 4 and Day 5, pre-infusion, at end of infusion and at 5 min, 15 min, 30 min, 1 h, 2 h, 2 h and 15 min, 2 h and 30 min, 3 h, 4 h, 6 h, 8 h and 24 h post infusion |
| Belinostat Cmax | Measure the Cmax of belinostat alone (Day 4 values) and in the presence of doxorubicin (Day 5 values) at the Maximum Tolerated Dose level: belinostat 1000 mg/m2 and doxorubicin 75 mg/m2 | Cycle 1, Day 4 and Day 5, pre-infusion, at end of infusion and at 5 min, 15 min, 30 min, 1 h, 2 h, 2 h and 15 min, 2 h and 30 min, 3 h, 4 h, 6 h, 8 h and 24 h post infusion |
| Belinostat t½ | Measure the t½ of belinostat alone (Day 4 values) and in the presence of doxorubicin (Day 5 values) at the Maximum Tolerated Dose level: belinostat 1000 mg/m2 and doxorubicin 75 mg/m2 | Cycle 1, Day 4 and Day 5, pre-infusion, at end of infusion and at 5 min, 15 min, 30 min, 1 h, 2 h, 2 h and 15 min, 2 h and 30 min, 3 h, 4 h, 6 h, 8 h and 24 h post infusion |
| Herlev |
| DK-2730 |
| Denmark |
| The Royal Marsden NHS Trust, Cancer Research | Surrey | SM2 5PT Surrey | United Kingdom |
| Progressive disease |
|
| Withdrew consent |
|
| Death |
|
| Other |
|
| BG002 | Cohort 3: BelDox IV (800/75) | PXD101 + doxorubicin: 5-day PXD101 800 mg/m² combined with doxorubicin 75 mg/m² |
| BG003 | Cohort 4: BelDox IV (1000/75) | PXD101 + doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m² |
| BG004 | MTD Expansion: BelDox IV (1000/75) | PXD101 + doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m² |
| BG005 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Primary | Maximum Tolerated Dose (MTD) of Doxorubicin | Maximum Tolerated Dose (MTD) of doxorubicin | Posted | Number | mg/m2 | During Cohort 1 to 4, Cycle 1 only, up to 3 weeks |
|
|
|
| Secondary | Time to Response | Includes all 41 patients in the FAS population. 37 patients were censored due to no response, 23 in the Dose Escalation group and 14 in the MTD Expansion group. | Posted | Median | Full Range | months | Throughout study, after every 2 cycles |
|
|
|
| Secondary | Duration of Response | Includes only patients with response | Posted | Median | 95% Confidence Interval | Months | Throughout study, after every 2 cycles |
|
|
|
| Secondary | Time to Progression | Includes only patients with disease progression. | Posted | Median | 95% Confidence Interval | months | Throughout study, after every 2 cycles |
|
|
|
| Secondary | Disease Control Rate (CR or PR or SD) | The disease control rate, defined as best overall response of either objective response or stable disease (CR or PR or SD) following up to 6 cycles of treatment with confirmation according to the RECIST criteria | The full-analysis set (FAS) comprises all patients enrolled in the study and receiving at least one dose of study drug, and for whom at least one tumor assessment was performed post baseline. | Posted | Number | percentage of participants | Throughout study, after every 2 cycles |
|
|
|
| Primary | Dose Limiting Toxicity (DLT) | Dose Limiting Toxicity (DLT) of PXD101 and doxorubicin combination treatment | Posted | Number | Dose limiting toxicity | Throughout study |
|
|
|
| Primary | Objective Response (CR and PR) | Measured by response rate using the RECIST (Response Evaluation Criteria in Solid Tumors) response criteria (response rate: Complete Response (CR) and Partial Response (PR)) following up to 6 cycles of treatment. | The full-analysis set (FAS) comprises all patients enrolled in the study and receiving at least one dose of study drug, and for whom at least one tumor assessment was performed post baseline. | Posted | Number | percentage of participants | Throughout study, after every 2 cycles |
|
|
|
| Secondary | Belinostat AUC (Time 0 to Last Measurement) | Measure the AUC of belinostat alone (Day 4 values) and in the presence of doxorubicin (Day 5 values) at the Maximum Tolerated Dose level: belinostat 1000 mg/m2 and doxorubicin 75 mg/m2 | The pharmacokinetic population consisted of all patients who were dosed and had evaluable pharmacokinetic data. Dose level belinostat 1000 mg/m² and belinostat 1000 mg/m² plus doxorubicin 75 mg/m² is presented. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Cycle 1, Day 4 and Day 5, pre-infusion, at end of infusion and at 5 min, 15 min, 30 min, 1 h, 2 h, 2 h and 15 min, 2 h and 30 min, 3 h, 4 h, 6 h, 8 h and 24 h post infusion |
|
|
|
| Secondary | Belinostat Cmax | Measure the Cmax of belinostat alone (Day 4 values) and in the presence of doxorubicin (Day 5 values) at the Maximum Tolerated Dose level: belinostat 1000 mg/m2 and doxorubicin 75 mg/m2 | The pharmacokinetic population consisted of all patients who were dosed and had evaluable pharmacokinetic data. Dose level belinostat 1000 mg/m² and belinostat 1000 mg/m² plus doxorubicin 75 mg/m² is presented. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Cycle 1, Day 4 and Day 5, pre-infusion, at end of infusion and at 5 min, 15 min, 30 min, 1 h, 2 h, 2 h and 15 min, 2 h and 30 min, 3 h, 4 h, 6 h, 8 h and 24 h post infusion |
|
|
|
| Secondary | Belinostat t½ | Measure the t½ of belinostat alone (Day 4 values) and in the presence of doxorubicin (Day 5 values) at the Maximum Tolerated Dose level: belinostat 1000 mg/m2 and doxorubicin 75 mg/m2 | The pharmacokinetic population consisted of all patients who were dosed and had evaluable pharmacokinetic data. Dose level belinostat 1000 mg/m² and belinostat 1000 mg/m² plus doxorubicin 75 mg/m² is presented. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours | Cycle 1, Day 4 and Day 5, pre-infusion, at end of infusion and at 5 min, 15 min, 30 min, 1 h, 2 h, 2 h and 15 min, 2 h and 30 min, 3 h, 4 h, 6 h, 8 h and 24 h post infusion |
|
|
|
| 2 |
| 3 |
| 3 |
| 3 |
| EG001 | Cohort 2: BelDox IV (600/75) | PXD101 + doxorubicin: 5-day PXD101 600 mg/m² combined with doxorubicin 75 mg/m² | 4 | 7 | 7 | 7 |
| EG002 | Cohort 3: BelDox IV (800/75) | PXD101 + doxorubicin: 5-day PXD101 800 mg/m² combined with doxorubicin 75 mg/m² | 5 | 9 | 9 | 9 |
| EG003 | Cohort 4: BelDox IV (1000/75) | PXD101 + doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m² | 2 | 6 | 6 | 6 |
| EG004 | MTD Expansion: BelDox IV (1000/75) | PXD101 + doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m² | 10 | 16 | 16 | 16 |
| Thrombosis in device | General disorders | MedDRA | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Abdominal absecss | Infections and infestations | MedDRA | Systematic Assessment |
|
| Bacteriaemia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Disease progression | General disorders | MedDRA | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Device related infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Neutropenic sepsis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Myocardial ischaemia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Spinal cord compression | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Skin swelling | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
|
| Pain | General disorders | MedDRA | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA | Systematic Assessment |
|
| Chills | General disorders | MedDRA | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA | Systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA | Systematic Assessment |
|
| Thrombosis in device | General disorders | MedDRA | Systematic Assessment |
|
| Axillary pain | General disorders | MedDRA | Systematic Assessment |
|
| Catheter site pain | General disorders | MedDRA | Systematic Assessment |
|
| Catheter site swelling | General disorders | MedDRA | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA | Systematic Assessment |
|
| Disease progression | General disorders | MedDRA | Systematic Assessment |
|
| Extravasation | General disorders | MedDRA | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Abdominal distention | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Anal inflammation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Anal pruritus | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Defaecation urgency | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Eructation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Gastrooesophagal reflux disease | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Palatal disorder | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Rectal tenesmus | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Salivary hypersecretion | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Hair colour changes | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Intertrigo | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Skin swelling | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Vitiligo | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Rhinitis Allergic | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pulmonary Haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Yawning | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Neutrophil Count | Investigations | MedDRA | Systematic Assessment |
|
| Neutrophil Count Decreased | Investigations | MedDRA | Systematic Assessment |
|
| Blood Bilirubin | Investigations | MedDRA | Systematic Assessment |
|
| Blood Potassium Decreased | Investigations | MedDRA | Systematic Assessment |
|
| Blood Sodium Decreased | Investigations | MedDRA | Systematic Assessment |
|
| Electrocardiogram Qt Prolonged | Investigations | MedDRA | Systematic Assessment |
|
| Haemoglobin | Investigations | MedDRA | Systematic Assessment |
|
| Haemoglobin Decreased | Investigations | MedDRA | Systematic Assessment |
|
| Platelet Count Decreased | Investigations | MedDRA | Systematic Assessment |
|
| Weight Decreased | Investigations | MedDRA | Systematic Assessment |
|
| Activated Partial Thromboplastin Time Prolonged | Investigations | MedDRA | Systematic Assessment |
|
| Blood Potassium | Investigations | MedDRA | Systematic Assessment |
|
| Blood Pressure Increased | Investigations | MedDRA | Systematic Assessment |
|
| International Normalised Ratio Increased | Investigations | MedDRA | Systematic Assessment |
|
| Troponin | Investigations | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Cerebral Haematoma | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Neuropathy Peripheral | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Peripheral Motor Neuropathy | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Peripheral Sensory Neuropathy | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Spinal Cord Compression | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Device Related Infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Lung Infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Oral Candidiasis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Abdominal Abscess | Infections and infestations | MedDRA | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Herpes Zoster | Infections and infestations | MedDRA | Systematic Assessment |
|
| Neutropenic Sepsis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Subcutaneous Abscess | Infections and infestations | MedDRA | Systematic Assessment |
|
| Tinea Pedis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Wound Infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Muscle Rigidity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Soft Tissue Disorder | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Hot Flush | Vascular disorders | MedDRA | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA | Systematic Assessment |
|
| Deep Vein Thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA | Systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA | Systematic Assessment |
|
| Dry Eye | Eye disorders | MedDRA | Systematic Assessment |
|
| Lacrimation Increased | Eye disorders | MedDRA | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA | Systematic Assessment |
|
| Vision Blurred | Eye disorders | MedDRA | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Angina Pectoris | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Myocardial Ischaemia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Restlessness | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Urinary Retention | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Bladder Pain | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Bladder Spasm | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Micturition Urgency | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Renal Pain | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Open wound | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Cancer Pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Tumour Pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Erectile Dysfunction | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| Vaginal Haemorrhage | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
|
| Hepatic Steatosis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
| Abstains From Alcohol | Social circumstances | MedDRA | Systematic Assessment |
|
Not provided
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |