Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2016-001445-61 | EudraCT Number |
Not provided
Not provided
The study was stopped as per EMA waiver granted on 20July2018.
Not provided
Not provided
Not provided
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The purpose of this study is to compare the exposure of febuxostat in pediatric patients (≥6<18 years of age) and in adults suffering from hematological malignancies at intermediate to high risk of TLS and to compare the effect in terms of serum uric acid levels.
In the FLORET study it is planned to enroll 3 groups of patients in order to receive oral administration (film-coated tablets) of two different dose levels of febuxostat: children (from 6 to less than 12 years of age) will receive two different dose levels respectively; adolescents (from 12 to less than 18 years of age) will receive 80 and 120 mg/day respectively and adults (equal or major than 18 years of age) will receive 120 mg/day. The two dose levels for children and adolescents groups were to be sequentially administered, whereas the groups that will receive the first dose levels will simultaneously start the treatment at the study beginning. The individual treatment duration will be of 7 to 9 days, according to chemotherapy duration, as per Investigator's judgement.
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Febuxostat film-coated tablets 2x20 mg/QD for 7-9 days |
|
| Cohort 2 | Experimental | Febuxostat film-coated tablets 3x20 mg/QD for 7-9 days |
|
| Cohort 3 | Experimental | Febuxostat film-coated tablets 1x80 mg/QD for 7-9 days (Adenuric® 80 mg) |
|
| Cohort 4 | Experimental | Febuxostat film-coated tablets 1x120 mg/QD for 7-9 days (Adenuric® 120 mg) |
|
| Adults | Active Comparator | Febuxostat film-coated tablets 120 mg/QD for 7-9 days (Adenuric® 120 mg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Febuxostat | Drug | Intervention is orally administered to patients in this arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) Parameter: Apparent Clearance (CL/F) | Apparent clearance of febuxostat from Visit 2 (Day 2) to Evaluation Visit (Visit 8, Day 8) | 7 days |
| PK Parameter: Apparent Volume of Distribution (Vd/F) | Apparent volume of distribution of febuxostat from Visit 2 (Day 2) to Evaluation Visit (Visit 8, Day 8) | 7 days |
| PK Parameter: Absorption Rate Constant (Ka) | Absorption rate constant of febuxostat from Visit 2 (Day 2) to Evaluation Visit (Visit 8, Day 8) | 7 days |
| PK Parameter: Area Under Curve (AUC) | AUC of febuxostat from Visit 2 (Day 2) to Evaluation Visit (Visit 8, Day 8) | 7 days |
| PK Parameter: Maximum Plasma Concentration (Cmax) | Maximum plasma concentration of febuxostat from Visit 2 (Day 2) to Evaluation Visit (Visit 8, Day 8) | 7 days |
| PK Parameter: Tmax | Time to Cmax from Visit 2 (Day 2) to Evaluation Visit (Visit 8, Day 8) | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamic (PD) Parameter: Area Under the Curve of Serum Uric Acid (sUA) | Area under the curve of sUA from baseline (Visit 1, Day 1) to the Evaluation Visit (Visit 8, Day 8) (AUC sUA 1-8) | 8 days |
| Assessment of Laboratory Tumor Lysis Syndrome (LTLS) |
Not provided
Inclusion Criteria:
male and female children of 6 to less than 12 years of age, adolescents of 12 to less than 18 years of age and adults from 18 years:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Franco Locatelli, Prof, MD | IRCCS Ospedale Pediatrico Bambino Gesù, Piazza Sant'Onofrio, 4, 00165 Rome, IT | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Tsaritsa Yoanna | Sofia | 1527 | Bulgaria | |||
| Semmelweis Egyetem (paediatric) |
A total of 31 patients was screened, of whom 30 were enrolled and 28 completed the study regularly.
Two enrolled patients were withdrawn from study drug treatment.
The first patient was screened and enrolled on 27 Feb 2017. The last patient completed the study on 16 Jul 2018. The study was conducted at 17 sites in 4 European countries.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 | Febuxostat film-coated tablets 2x20 mg/QD for 7-9 days Febuxostat: Intervention is orally administered to patients in this arm. |
| FG001 | Cohort 2 | Febuxostat film-coated tablets 3x20 mg/QD for 7-9 days Febuxostat: Intervention is orally administered to patients in this arm. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Baseline Period |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 2, 2017 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Assessment of LTLS at Visit 1 (Day 1) and from Start of Chemotherapy (Visit 3, Day 3) to the Evaluation Visit (Visit 8, Day 8). LTLS is diagnosed if levels of 2 or more values of uric acid, potassium, phosphate or calcium are more than or less than normal at presentation or if they change by at least 25% from baseline. |
| 7 days |
| Assessment of Clinical Tumor Lysis Syndrome (CTLS) | Assessment of CTLS at Visit 1 (Day 1) and from Start of Chemotherapy (Visit 3, Day 3) to the Evaluation Visit (Visit 8, Day 8). CTLS is present when LTLS is accompanied by at least one of the following significant clinical complications: increased creatinine level ≥ 1.5 upper limit of normal, cardiac arrhythmia/sudden death or seizure. | 7 days |
| Assessment of Treatment Emergent Signs and Symptoms (TESS) | Assessment of incidence, severity (through Mild/Moderate/Severe scale), seriousness and treatment-causality of TESS from Screening Visit to End of Study Visit. Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. An adverse event was considered as TESS if it occured for the first time or if it worsened in terms of seriousness or severity after first study drug intake. | Estimated maximum time frame: 27 days |
| Assessment of Participants Affected by Treatment Emergent Signs and Symptoms (TESS) | Number of participants affected by TESS from Screening Visit to End of Study Visit. | Estimated maximum time frame: 27 days |
| Performance Status (PS) Evaluation | Quality of life was to be assessed by PS evaluation from Screening Visit to End of Study Visit. The Karnofsky Performance Status (KPS) scale was to be used for patients aged 16 years and older; the Lansky Play Performance Status (LPS) scale was to be used for patients aged less than 16 years. Both scales range from scores of 0 to 100 points at intervals of 10 where 0 points represent the worst outcome (KPS: 0 = death; LPS: 0 = unresponsive) and 100 points the best (KPS: 100 = normal, no complaints, no evidence of disease; LPS: 100 = fully active). | Estimated maximum time frame: 27 days |
| Budapest |
| 1083 |
| Hungary |
| Semmelweis Egyetem | Budapest | 1085 | Hungary |
| Debreceni Egyetem Klinikai Központ | Debrecen | 4032 | Hungary |
| SOC Oncologia Medica A - Centro di Riferimento Oncologico | Aviano | Pordenone | 33081 | Italy |
| Policlinico S. Orsola Malpighi | Bologna | 40138 | Italy |
| A.O.U.C. Azienda Ospedaliero - Universitaria Careggi | Florence | 50134 | Italy |
| Azienda Ospedaliero Universitaria Meyer | Florence | 50139 | Italy |
| Istituto G Gaslini Ospedale Pediatrico IRCCS | Genova | 16147 | Italy |
| Azienda Ospedaliero-Universitaria Pisana | Pisa | 56126 | Italy |
| IRCCS Ospedale Pediatrico Bambino Gesù | Rome | 00165 | Italy |
| Ospedale Infantile Regina Margherita | Torino | 10126 | Italy |
| Azienda Ospedaliera Universitaria Integrata di Verona | Verona | 37126 | Italy |
| Hospital de San Pedro de Alcantara | Cáceres | 10002 | Spain |
| Hospital General Universitario Gregorio Maranon | Madrid | 28007 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Hospital Universitari i Politècnic La Fe | Valencia | 46026 | Spain |
| FG002 | Cohort 3 | Febuxostat film-coated tablets 1x80 mg/QD for 7-9 days (Adenuric® 80 mg) Febuxostat: Intervention is orally administered to patients in this arm. |
| FG003 | Cohort 4 | Febuxostat film-coated tablets 1x120 mg/QD for 7-9 days (Adenuric® 120 mg) Febuxostat: Intervention is orally administered to patients in this arm. |
| FG004 | Adults | Febuxostat film-coated tablets 1x120 mg/QD for 7-9 days (Adenuric® 120 mg) Febuxostat: Intervention is orally administered to patients in this arm. |
| COMPLETED |
|
| NOT COMPLETED |
|
| Treatment Period |
|
|
DAY 1 before first febuxostat dosing.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 | Febuxostat film-coated tablets 2x20 mg/QD for 7-9 days Febuxostat: Intervention is orally administered to patients in this arm. |
| BG001 | Cohort 2 | Febuxostat film-coated tablets 3x20 mg/QD for 7-9 days Febuxostat: Intervention is orally administered to patients in this arm. |
| BG002 | Cohort 3 | Febuxostat film-coated tablets 1x80 mg/QD for 7-9 days (Adenuric® 80 mg) Febuxostat: Intervention is orally administered to patients in this arm. |
| BG003 | Cohort 4 | Febuxostat film-coated tablets 1x120 mg/QD for 7-9 days (Adenuric® 120 mg) Febuxostat: Intervention is orally administered to patients in this arm. |
| BG004 | Adults | Febuxostat film-coated tablets 1x120 mg/QD for 7-9 days (Adenuric® 120 mg) Febuxostat: Intervention is orally administered to patients in this arm. |
| BG005 | Total | Total of all reporting groups |
| 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 | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Weight | Mean | Standard Deviation | kg |
|
| 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 | Pharmacokinetic (PK) Parameter: Apparent Clearance (CL/F) | Apparent clearance of febuxostat from Visit 2 (Day 2) to Evaluation Visit (Visit 8, Day 8) | Data were not collected. | Posted | 7 days |
|
| |||||||||||||||||||||||||||||||
| Primary | PK Parameter: Apparent Volume of Distribution (Vd/F) | Apparent volume of distribution of febuxostat from Visit 2 (Day 2) to Evaluation Visit (Visit 8, Day 8) | Data were not collected. | Posted | 7 days |
| ||||||||||||||||||||||||||||||||
| Primary | PK Parameter: Absorption Rate Constant (Ka) | Absorption rate constant of febuxostat from Visit 2 (Day 2) to Evaluation Visit (Visit 8, Day 8) | Data were not collected. | Posted | 7 days |
| ||||||||||||||||||||||||||||||||
| Primary | PK Parameter: Area Under Curve (AUC) | AUC of febuxostat from Visit 2 (Day 2) to Evaluation Visit (Visit 8, Day 8) | Data were not collected. | Posted | 7 days |
| ||||||||||||||||||||||||||||||||
| Primary | PK Parameter: Maximum Plasma Concentration (Cmax) | Maximum plasma concentration of febuxostat from Visit 2 (Day 2) to Evaluation Visit (Visit 8, Day 8) | Data were not collected. | Posted | 7 days |
| ||||||||||||||||||||||||||||||||
| Primary | PK Parameter: Tmax | Time to Cmax from Visit 2 (Day 2) to Evaluation Visit (Visit 8, Day 8) | Data were not collected. | Posted | 7 days |
| ||||||||||||||||||||||||||||||||
| Secondary | Pharmacodynamic (PD) Parameter: Area Under the Curve of Serum Uric Acid (sUA) | Area under the curve of sUA from baseline (Visit 1, Day 1) to the Evaluation Visit (Visit 8, Day 8) (AUC sUA 1-8) | Data were not collected. | Posted | 8 days |
| ||||||||||||||||||||||||||||||||
| Secondary | Assessment of Laboratory Tumor Lysis Syndrome (LTLS) | Assessment of LTLS at Visit 1 (Day 1) and from Start of Chemotherapy (Visit 3, Day 3) to the Evaluation Visit (Visit 8, Day 8). LTLS is diagnosed if levels of 2 or more values of uric acid, potassium, phosphate or calcium are more than or less than normal at presentation or if they change by at least 25% from baseline. | Data were not collected. | Posted | 7 days |
| ||||||||||||||||||||||||||||||||
| Secondary | Assessment of Clinical Tumor Lysis Syndrome (CTLS) | Assessment of CTLS at Visit 1 (Day 1) and from Start of Chemotherapy (Visit 3, Day 3) to the Evaluation Visit (Visit 8, Day 8). CTLS is present when LTLS is accompanied by at least one of the following significant clinical complications: increased creatinine level ≥ 1.5 upper limit of normal, cardiac arrhythmia/sudden death or seizure. | Data were not collected. | Posted | 7 days |
| ||||||||||||||||||||||||||||||||
| Secondary | Assessment of Treatment Emergent Signs and Symptoms (TESS) | Assessment of incidence, severity (through Mild/Moderate/Severe scale), seriousness and treatment-causality of TESS from Screening Visit to End of Study Visit. Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. An adverse event was considered as TESS if it occured for the first time or if it worsened in terms of seriousness or severity after first study drug intake. | Safety population | Posted | Number | Events | Estimated maximum time frame: 27 days |
| ||||||||||||||||||||||||||||||
| Secondary | Assessment of Participants Affected by Treatment Emergent Signs and Symptoms (TESS) | Number of participants affected by TESS from Screening Visit to End of Study Visit. | Safety population | Posted | Number | participants | Estimated maximum time frame: 27 days |
| ||||||||||||||||||||||||||||||
| Secondary | Performance Status (PS) Evaluation | Quality of life was to be assessed by PS evaluation from Screening Visit to End of Study Visit. The Karnofsky Performance Status (KPS) scale was to be used for patients aged 16 years and older; the Lansky Play Performance Status (LPS) scale was to be used for patients aged less than 16 years. Both scales range from scores of 0 to 100 points at intervals of 10 where 0 points represent the worst outcome (KPS: 0 = death; LPS: 0 = unresponsive) and 100 points the best (KPS: 100 = normal, no complaints, no evidence of disease; LPS: 100 = fully active). | Data were not collected. | Posted | Estimated maximum time frame: 27 days |
|
Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
Not provided
| 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 | Febuxostat film-coated tablets 2x20 mg/QD for 7-9 days Febuxostat: Intervention is orally administered to patients in this arm. | 1 | 3 | 1 | 3 | 3 | 3 |
| EG001 | Cohort 2 | Febuxostat film-coated tablets 3x20 mg/QD for 7-9 days Febuxostat: Intervention is orally administered to patients in this arm. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Cohort 3 | Febuxostat film-coated tablets 1x80 mg/QD for 7-9 days (Adenuric® 80 mg) Febuxostat: Intervention is orally administered to patients in this arm. | 0 | 3 | 0 | 3 | 3 | 3 |
| EG003 | Cohort 4 | Febuxostat film-coated tablets 1x120 mg/QD for 7-9 days (Adenuric® 120 mg) Febuxostat: Intervention is orally administered to patients in this arm. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG004 | Adults | Febuxostat film-coated tablets 1x120 mg/QD for 7-9 days (Adenuric® 120 mg) Febuxostat: Intervention is orally administered to patients in this arm. | 0 | 24 | 5 | 24 | 20 | 24 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Enterobacter test positiv | Investigations | MedRA 19.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedRA 19.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedRA 19.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedRA 19.1 | Systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | MedRA 19.1 | Systematic Assessment |
| |
| Septioc shock | Infections and infestations | MedRA 19.1 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedRA 19.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hot flush | Vascular disorders | MedRA 19.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedRA 19.1 | Systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedRA 19.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedRA 19.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedRA 19.1 | Systematic Assessment |
| |
| Facial pain | General disorders | MedRA 19.1 | Systematic Assessment |
| |
| Inflammation | General disorders | MedRA 19.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedRA 19.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedRA 19.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedRA 19.1 | Systematic Assessment |
| |
| Pain | General disorders | MedRA 19.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedRA 19.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedRA 19.1 | Systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedRA 19.1 | Systematic Assessment |
| |
| ALT increased | Investigations | MedRA 19.1 | Systematic Assessment |
| |
| AST increased | Investigations | MedRA 19.1 | Systematic Assessment |
| |
| BP increased | Investigations | MedRA 19.1 | Systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedRA 19.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase | Investigations | MedRA 19.1 | Systematic Assessment |
| |
| Hemoglobin decreased | Investigations | MedRA 19.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedRA 19.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedRA 19.1 | Systematic Assessment |
| |
| White blood cell (WBC) count decreased | Investigations | MedRA 19.1 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedRA 19.1 | Systematic Assessment |
| |
| Extrasystoles | Cardiac disorders | MedRA 19.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedRA 19.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedRA 19.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedRA 19.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedRA 19.1 | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedRA 19.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedRA 19.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedRA 19.1 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedRA 19.1 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedRA 19.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedRA 19.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedRA 19.1 | Systematic Assessment |
| |
| Language disorder | Nervous system disorders | MedRA 19.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedRA 19.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedRA 19.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedRA 19.1 | Systematic Assessment |
| |
| Abdominal rigidity | Gastrointestinal disorders | MedRA 19.1 | Systematic Assessment |
| |
| Anorectal discomfort | Gastrointestinal disorders | MedRA 19.1 | Systematic Assessment |
| |
| Aphthous ulcer | Gastrointestinal disorders | MedRA 19.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedRA 19.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedRA 19.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedRA 19.1 | Systematic Assessment |
| |
| Faeces soft | Gastrointestinal disorders | MedRA 19.1 | Systematic Assessment |
| |
| Gingival swelling | Gastrointestinal disorders | MedRA 19.1 | Systematic Assessment |
| |
| Hematemesis | Gastrointestinal disorders | MedRA 19.1 | Systematic Assessment |
| |
| Hematochezia | Gastrointestinal disorders | MedRA 19.1 | Systematic Assessment |
| |
| Lip pain | Gastrointestinal disorders | MedRA 19.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedRA 19.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedRA 19.1 | Systematic Assessment |
| |
| Cold sweat | Skin and subcutaneous tissue disorders | MedRA 19.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedRA 19.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedRA 19.1 | Systematic Assessment |
| |
| Skin discolouration | Skin and subcutaneous tissue disorders | MedRA 19.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedRA 19.1 | Systematic Assessment |
| |
| Limb discomfort | Musculoskeletal and connective tissue disorders | MedRA 19.1 | Systematic Assessment |
| |
| Muscoskeletal pain | Musculoskeletal and connective tissue disorders | MedRA 19.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedRA 19.1 | Systematic Assessment |
| |
| Temporomandibular joint syndrome | Musculoskeletal and connective tissue disorders | MedRA 19.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedRA 19.1 | Systematic Assessment |
| |
| Fluid retention | Metabolism and nutrition disorders | MedRA 19.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedRA 19.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedRA 19.1 | Systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedRA 19.1 | Systematic Assessment |
| |
| Hypo HDL cholesterolaemia | Metabolism and nutrition disorders | MedRA 19.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedRA 19.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedRA 19.1 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedRA 19.1 | Systematic Assessment |
|
Data for all outcome measures were not collected due to the paucity of data in the minor patient population and in agreement with EMA with the exceptions of the secondary outcome Assessment of Treatment Emergent Signs and Symptoms (TESS).
Prior to submitting the results of this study for publication or presentation, the Investigator will allow the sponsor at least 60 days time to review and comment upon the publication manuscript. It is agreed, that the results of the study will not be submitted for presentation, abstract, poster exhibition, or publication by the investigator until the sponsor has reviewed/commented and agreed to any publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Angela Capriati, MD PhD - Corporate Director Clinical Sciences | Menarini Group | +39 055 5680 | 9990 | acapriati@menarini-ricerche.it |
| May 6, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D015275 | Tumor Lysis Syndrome |
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069465 | Febuxostat |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Physician Decision |
|
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Italy |
|
| Bulgaria |
|
| Spain |
|
| Adults |
Febuxostat film-coated tablets 120 mg/QD for 7-9 days (Adenuric® 120 mg) Febuxostat: Intervention is orally administered to patients in this arm. |
|
| Adults |
Febuxostat film-coated tablets 120 mg/QD for 7-9 days (Adenuric® 120 mg) Febuxostat: Intervention is orally administered to patients in this arm. |
|
Febuxostat film-coated tablets 120 mg/QD for 7-9 days (Adenuric® 120 mg) Febuxostat: Intervention is orally administered to patients in this arm. |
|
| Adults |
Febuxostat film-coated tablets 120 mg/QD for 7-9 days (Adenuric® 120 mg) Febuxostat: Intervention is orally administered to patients in this arm. |
|
Febuxostat film-coated tablets 120 mg/QD for 7-9 days (Adenuric® 120 mg) Febuxostat: Intervention is orally administered to patients in this arm. |
|
| OG004 |
| Adults |
Febuxostat film-coated tablets 1x120 mg/QD for 7-9 days (Adenuric® 120 mg) Febuxostat: Intervention is orally administered to patients in this arm. |
|
| OG004 | Adults | Febuxostat film-coated tablets 120 mg/QD for 7-9 days (Adenuric® 120 mg) Febuxostat: Intervention is orally administered to patients in this arm. |
|
| OG004 | Adults | Febuxostat film-coated tablets 120 mg/QD for 7-9 days (Adenuric® 120 mg) Febuxostat: Intervention is orally administered to patients in this arm. |
|
Febuxostat film-coated tablets 1x120 mg/QD for 7-9 days (Adenuric® 120 mg) Febuxostat: Intervention is orally administered to patients in this arm. |
| OG004 | Adults | Febuxostat film-coated tablets 1x120 mg/QD for 7-9 days (Adenuric® 120 mg) Febuxostat: Intervention is orally administered to patients in this arm. |
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| OG004 | Adults | Febuxostat film-coated tablets 1x120 mg/QD for 7-9 days (Adenuric® 120 mg) Febuxostat: Intervention is orally administered to patients in this arm. |
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| OG003 |
| Cohort 4 |
Febuxostat film-coated tablets 1x120 mg/QD for 7-9 days (Adenuric® 120 mg) Febuxostat: Intervention is orally administered to patients in this arm. |
| OG004 | Adults | Febuxostat film-coated tablets 120 mg/QD for 7-9 days (Adenuric® 120 mg) Febuxostat: Intervention is orally administered to patients in this arm. |
|