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This study was an early-phase trial arranged into two phases. The Phase I portion was a dose-escalation study designed to assess the safety, tolerability and to identify the maximum tolerated dose of SB-743921 in patients with Non-Hodgkin Lymphoma and Hodgkin Lymphoma. Phase II was intended to assess the activity, safety and tolerability of SB-743921 in patients with Indolent and Aggressive Non-Hodgkin's Lymphomas exclusively. The Phase II portion of the study was not initiated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1 Dose Escalation | Experimental | Phase 1 dose escalation without and with GCSF support |
|
| Phase 2 Fixed Dose | Experimental | Phase 2 fixed dose based on Phase I findings stratified by NHL type |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SB-743921 | Drug | Phase 1: I.V. dose on Days 1 and 15 of a 28 day cycle starting at 2mg/m2 and increasing by 1 mg/m2 with possible prophylactic granulopoietic support until unacceptable toxicity develops. |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1: Determination of Maximum Tolerated Dose (MTD) First Without and Then With Administration of Prophylactic G-CSF. | Maximum Tolerated Dose (MTD) was determined by testing increasing doses in cohorts with at least 3 patients each. MTD reflects the highest dose of drug that did not cause dose limiting toxicity (DLT). | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Characterization of PK (Cmax) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 1 | Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose | |
| Characterization of PK (Tmax) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day1 |
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Inclusion Criteria: Phase 1: Patients with evaluable or measurable (by MRI or CT) Hodgkin's Disease or Non-Hodgkin's Lymphoma. Phase 2: Patients with Measurable Non-Hodgkin's Lymphomas (Indolent or Aggressive) only. - Patients with Indolent NHL must be relapsed or refractory to at least one prior line of therapy (CHOP, CVP, chlorambucil or fludaribine). Prior treatment with Rituximab is required. - Patients with Aggressive NHL refractory to (or relapsed from) at least one CHOP-based therapy who have had prior treatment with Rituximab and who are not candidates for high-dose chemotherapy or autologous stem cell transplantation. - ECOG performance status 0-2 - Autologous stem cell transplant recipients are eligible if 100 days have elapsed since procedure. Exclusion Criteria: Phase 1: History of prior radioimmunotherapy (Bexxar, Zevalin); These patients ARE permitted in the Phase 2 trial. - Current active malignancy besides NHL, except excised non-melanoma skin cancer, in-situ cervical or bladder cancer or early stage prostate cancer. - Patients with leptomeningeal of CNS lymphoma - Known allergy to and/or receipt of treatments contraindicated by administration of G-CSF - Patients with active Hepatitis B or C, or patients with HIV infection. - Pregnant or breast-feeding females. - Previous treatment with a KSP inhibitor
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| Name | Affiliation | Role |
|---|---|---|
| Owen O'Connor, M.D./Ph.D. | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States | ||
| Cornell University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25665464 | Derived | O'Connor OA, Gerecitano J, Van Deventer H, Hainsworth J, Zullo KM, Saikali K, Seroogy J, Wolff A, Escandon R. The addition of granulocyte-colony stimulating factor shifts the dose limiting toxicity and markedly increases the maximum tolerated dose and activity of the kinesin spindle protein inhibitor SB-743921 in patients with relapsed or refractory lymphoma: results of an international, multicenter phase I/II study. Leuk Lymphoma. 2015;56(9):2585-91. doi: 10.3109/10428194.2015.1004167. Epub 2015 Sep 11. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 2 mg/m2 Without GCSF | Phase 1 dose escalation cohort 1 without GCSF support |
| FG001 | 3 mg/m2 Without GCSF | Phase 1 dose escalation cohort 2 without GCSF support |
| FG002 | 4 mg/m2 Without GCSF | Phase 1 dose escalation cohort 3 without GCSF support |
| FG003 | 5 mg/m2 Without GCSF | Phase 1 dose escalation cohort 4 without GCSF support |
| FG004 | 6 mg/m2 Without GCSF | Phase 1 dose escalation cohort 5 without GCSF support |
| FG005 | 7 mg/m2 Without GCSF | Phase 1 dose escalation cohort 6 without GCSF support |
| FG006 | 6 mg/m2 With GCSF | Phase 1 dose escalation cohort 1 with GCSF support |
| FG007 | 7 mg/m2 With GCSF | Phase 1 dose escalation cohort 2 with GCSF support |
| FG008 | 8 mg/m2 With GCSF | Phase 1 dose escalation cohort 3 with GCSF support |
| FG009 | 9 mg/m2 With GCSF | Phase 1 dose escalation cohort 4 with GCSF support |
| FG010 | 10 mg/m2 With GCSF | Phase 1 dose escalation cohort 5 with GCSF support |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 2 mg/m2 Without GCSF | Phase 1 dose escalation cohort 1 without GCSF support |
| BG001 | 3 mg/m2 Without GCSF | Phase 1 dose escalation cohort 2 without GCSF support |
| 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 | Phase 1: Determination of Maximum Tolerated Dose (MTD) First Without and Then With Administration of Prophylactic G-CSF. | Maximum Tolerated Dose (MTD) was determined by testing increasing doses in cohorts with at least 3 patients each. MTD reflects the highest dose of drug that did not cause dose limiting toxicity (DLT). | Safety population; all patients who received at least 1 dose of study drug were included in the intent-to-treat/safety populations. Efficacy evaluable; any patient who received both cycles of treatment. | Posted | Number | mg/m2 | 28 days |
|
Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit.
Patients who received at least 1 dose of treatment were considered eligible for safety.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 2 mg/m2 Without GCSF | Phase 1 dose escalation cohort 1 without GCSF support |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sepsis | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (9.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Project Manager | Cytokinetics,Inc. | 650-624-2918 |
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| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D006689 | Hodgkin Disease |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| ID | Term |
|---|---|
| C557279 | SB 743921 |
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| SB-743921 | Drug | Phase 2: I.V. dose and regimen will be determined based on Phase 1 findings. |
|
| Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose |
| Characterization of PK (Clast) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 1 | Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose |
| Characterization of PK (AUClast) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 1 | Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose |
| Characterization of PK (Cmax) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 15 | Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose |
| Characterization of PK (Tmax) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 15 | Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose |
| Characterization of PK (Clast) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 15 | Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose |
| Characterization of PK (AUClast) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 15 | Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose |
| New York |
| New York |
| 10021 |
| United States |
| Memorial Sloan-Kettering Caner Center | New York | New York | 10021 | United States |
| Herbert Irving Comprehensive Cancer Center | New York | New York | 10032 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
| Sarah Cannon Cancer Research Institute | Nashville | Tennessee | 37203 | United States |
| Russian Medical Academy of Postgraduate Education | Moscow | 115478 | Russia |
| St. Petersburg State PAVLOV Medical University | Saint Petersburg | 197002 | Russia |
| BG002 | 4 mg/m2 Without GCSF | Phase 1 dose escalation cohort 3 without GCSF support |
| BG003 | 5 mg/m2 Without GCSF | Phase 1 dose escalation cohort 4 without GCSF support |
| BG004 | 6 mg/m2 Without GCSF | Phase 1 dose escalation cohort 5 without GCSF support |
| BG005 | 7 mg/m2 Without GCSF | Phase 1 dose escalation cohort 6 without GCSF support |
| BG006 | 6 mg/m2 With GCSF | Phase 1 dose escalation cohort 1 with GCSF support |
| BG007 | 7 mg/m2 With GCSF | Phase 1 dose escalation cohort 2 with GCSF support |
| BG008 | 8 mg/m2 With GCSF | Phase 1 dose escalation cohort 3 with GCSF support |
| BG009 | 9 mg/m2 With GCSF | Phase 1 dose escalation cohort 4 with GCSF support |
| BG010 | 10 mg/m2 With GCSF | Phase 1 dose escalation cohort 5 with GCSF support |
| BG011 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support |
| OG002 | Dose Escalation Cohort 3 4 mg/m2 (w/o GCSF) | Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support |
| OG003 | Dose Escalation Cohort 4 5 mg/m2 (w/o GCSF) | Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support |
| OG004 | Dose Escalation Cohort 5 6 mg/m2 (w/o GCSF) | Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support |
| OG005 | Dose Escalation Cohort 6 7 mg/m2 (w/o GCSF) | Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support |
| OG006 | Dose Escalation Cohort 1 6 mg/m2 (w/ GCSF) | Maximum Tolerated Dose (MTD) was determined by testing increasing doses with GCSF support |
| OG007 | Dose Escalation Cohort 2 7mg/m2 (w/GCSF) | Maximum Tolerated Dose (MTD) was determined by testing increasing doses with GCSF support |
| OG008 | Dose Escalation Cohort 3 8 mg/m2 (w/GCSF) | Maximum Tolerated Dose (MTD) was determined by testing increasing doses with GCSF support |
| OG009 | Dose Escalation Cohort 4 9 mg/m2 (w/GCSF) | Maximum Tolerated Dose (MTD) was determined by testing increasing doses with GCSF support |
| OG010 | Dose Escalation Cohort 5 10 mg/m2 (w/GCSF) | Maximum Tolerated Dose (MTD) was determined by testing increasing doses with GCSF support |
|
|
| Secondary | Characterization of PK (Cmax) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 1 | Posted | Mean | Standard Deviation | ng/mL | Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose |
|
|
|
| Secondary | Characterization of PK (Tmax) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day1 | Posted | Mean | Standard Deviation | hr | Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose |
|
|
|
| Secondary | Characterization of PK (Clast) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 1 | Posted | Mean | Standard Deviation | ng/mL | Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose |
|
|
|
| Secondary | Characterization of PK (AUClast) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 1 | Posted | Mean | Standard Deviation | hr*ng/mL | Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose |
|
|
|
| Secondary | Characterization of PK (Cmax) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 15 | Posted | Mean | Standard Deviation | ng/mL | Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose |
|
|
|
| Secondary | Characterization of PK (Tmax) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 15 | Posted | Mean | Standard Deviation | hr | Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose |
|
|
|
| Secondary | Characterization of PK (Clast) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 15 | Posted | Mean | Standard Deviation | ng/mL | Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose |
|
|
|
| Secondary | Characterization of PK (AUClast) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 15 | Posted | Mean | Standard Deviation | hr*ng/mL | Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose |
|
|
|
| 2 |
| 5 |
| 5 |
| 5 |
| EG001 | 3 mg/m2 Without GCSF | Phase 1 dose escalation cohort 2 without GCSF support | 0 | 6 | 6 | 6 |
| EG002 | 4 mg/m2 Without GCSF | Phase 1 dose escalation cohort 3 without GCSF support | 0 | 3 | 3 | 3 |
| EG003 | 5 mg/m2 Without GCSF | Phase 1 dose escalation cohort 4 without GCSF support | 0 | 6 | 6 | 6 |
| EG004 | 6 mg/m2 Without GCSF | Phase 1 dose escalation cohort 5 without GCSF support | 3 | 10 | 10 | 10 |
| EG005 | 7 mg/m2 Without GCSF | Phase 1 dose escalation cohort 6 without GCSF support | 1 | 9 | 8 | 9 |
| EG006 | 6 mg/m2 With GCSF | Phase 1 dose escalation cohort 1 with GCSF support | 1 | 4 | 4 | 4 |
| EG007 | 7 mg/m2 With GCSF | Phase 1 dose escalation cohort 2 with GCSF support | 1 | 3 | 3 | 3 |
| EG008 | 8 mg/m2 With GCSF | Phase 1 dose escalation cohort 3 with GCSF support | 0 | 3 | 3 | 3 |
| EG009 | 9 mg/m2 With GCSF | Phase 1 dose escalation cohort 4 with GCSF support | 1 | 7 | 7 | 7 |
| EG010 | 10 mg/m2 With GCSF | Phase 1 dose escalation cohort 5 with GCSF support | 3 | 7 | 7 | 7 |
| Clostridium infection | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
|
| Enterobacter bacteraemia | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
|
| Pneumococcal bacteraemia | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
|
| Staphyloccal infection | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (9.0) | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (9.0) | Systematic Assessment |
|
| Haemolytic anaemia | Blood and lymphatic system disorders | MedDRA (9.0) | Systematic Assessment |
|
| Heparin-induced thrombocytopenia | General disorders | MedDRA (9.0) | Systematic Assessment |
|
| Sudden death | General disorders | MedDRA (9.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA (9.0) | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA (9.0) | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (9.0) | Systematic Assessment |
|
| Procedural hypotension | Injury, poisoning and procedural complications | MedDRA (9.0) | Systematic Assessment |
|
| Malignant plural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Systematic Assessment |
|
| Eosinophilia | Blood and lymphatic system disorders | MedDRA (9.0) | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (9.0) | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (9.0) | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (9.0) | Systematic Assessment |
|
| Lymph node pain | Blood and lymphatic system disorders | MedDRA (9.0) | Systematic Assessment |
|
| Lymphocytosis | Blood and lymphatic system disorders | MedDRA (9.0) | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (9.0) | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (9.0) | Systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (9.0) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (9.0) | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
|
| Supraventricular extrasystoles | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
|
| Hypoacusis | Ear and labyrinth disorders | MedDRA (9.0) | Systematic Assessment |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA (9.0) | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA (9.0) | Systematic Assessment |
|
| Visual disturbance | Eye disorders | MedDRA (9.0) | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Lip ulceration | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Stomach discomfort | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (9.0) | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA (9.0) | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA (9.0) | Systematic Assessment |
|
| Chills | General disorders | MedDRA (9.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (9.0) | Systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA (9.0) | Systematic Assessment |
|
| Malaise | General disorders | MedDRA (9.0) | Systematic Assessment |
|
| Oedema | General disorders | MedDRA (9.0) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (9.0) | Systematic Assessment |
|
| Pain | General disorders | MedDRA (9.0) | Systematic Assessment |
|
| Performance status decreased | General disorders | MedDRA (9.0) | Systematic Assessment |
|
| Peripheral coldness | General disorders | MedDRA (9.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (9.0) | Systematic Assessment |
|
| Suprapubic pain | General disorders | MedDRA (9.0) | Systematic Assessment |
|
| Thirst | General disorders | MedDRA (9.0) | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (9.0) | Systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA (9.0) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
|
| Herpes virus infection | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
|
| Respiratory tract infection viral | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
|
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
|
| Incision site complication | Injury, poisoning and procedural complications | MedDRA (9.0) | Systematic Assessment |
|
| Sunburn | Injury, poisoning and procedural complications | MedDRA (9.0) | Systematic Assessment |
|
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA (9.0) | Systematic Assessment |
|
| Tracheal obstruction | Injury, poisoning and procedural complications | MedDRA (9.0) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (9.0) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA (9.0) | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA (9.0) | Systematic Assessment |
|
| Blood bicarbonate decreased | Investigations | MedDRA (9.0) | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA (9.0) | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA (9.0) | Systematic Assessment |
|
| Electrocardiogram QT corrected interval prolonged | Investigations | MedDRA (9.0) | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA (9.0) | Systematic Assessment |
|
| Urine colour abnormal | Investigations | MedDRA (9.0) | Systematic Assessment |
|
| Urine output decreased | Investigations | MedDRA (9.0) | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA (9.0) | Systematic Assessment |
|
| Acidosis | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
|
| Cachexia | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
|
| Hypermagnesaemia | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
|
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
|
| Polydipsia | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
|
| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
|
| Sacral pain | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
|
| Shoulder pain | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
|
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
|
| Dysarthria | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
|
| Neuropathy | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
|
| Parosmia | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
|
| Sinus headache | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (9.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (9.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (9.0) | Systematic Assessment |
|
| Libido decreased | Psychiatric disorders | MedDRA (9.0) | Systematic Assessment |
|
| Mental status changes | Psychiatric disorders | MedDRA (9.0) | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA (9.0) | Systematic Assessment |
|
| Neurogenic bladder | Renal and urinary disorders | MedDRA (9.0) | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA (9.0) | Systematic Assessment |
|
| Polyuria | Renal and urinary disorders | MedDRA (9.0) | Systematic Assessment |
|
| Urinary tract obstruction | Renal and urinary disorders | MedDRA (9.0) | Systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA (9.0) | Systematic Assessment |
|
| Vaginal discharge | Reproductive system and breast disorders | MedDRA (9.0) | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Systematic Assessment |
|
| Palmar erythema | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA (9.0) | Systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA (9.0) | Systematic Assessment |
|
| Vein discolouration | Vascular disorders | MedDRA (9.0) | Systematic Assessment |
|
Sponsor intends to publish the results of the trial in collaboration with the Investigators.
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |