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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-005033-39 | EudraCT Number |
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| Name | Class |
|---|---|
| Ono Pharmaceutical Co., Ltd. | INDUSTRY |
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The primary objective of the study is to evaluate the safety and tolerability of tirabrutinib (formerly ONO/GS-4059) given as monotherapy to participants with relapsed/refractory non-Hodgkin's lymphoma (NHL) and chronic lymphocytic leukemia (CLL).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tirabrutinib 20 mg Once Daily (CLL) | Experimental | Participants with relapsed/refractory chronic lymphocytic leukaemia (CLL) received tirabrutinib 20 mg once daily. |
|
| Tirabrutinib 40 mg Once Daily (CLL) | Experimental | Participants with relapsed/refractory CLL received tirabrutinib 40 mg once daily. |
|
| Tirabrutinib 80 mg Once Daily (CLL) | Experimental | Participants with relapsed/refractory CLL received tirabrutinib 80 mg once daily. |
|
| Tirabrutinib 160 mg Once Daily (CLL) | Experimental | Participants with relapsed/refractory CLL received tirabrutinib 160 mg once daily. |
|
| Tirabrutinib 320 mg Once Daily (CLL) | Experimental | Participants with relapsed/refractory CLL received tirabrutinib 320 mg once daily. |
|
| Tirabrutinib 400 mg Once Daily (CLL) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tirabrutinib | Drug | Capsules administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Experiencing Dose-Limiting Toxicities | Dose Limiting Toxicities (DLT) were defined as follows:
Any toxicity which in the opinion of the Investigator is attributed to a participant's underlying disease was not considered a DLT. | Day 1 through Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate | Overall response rate (ORR) was defined as the percentage of participants who achieve a best overall response of complete remission (CR, unconfirmed complete response (CRu), complete response with incomplete marrow recovery (CRi)) or partial remission (PR, nodal PR) during study as assessed by the investigator. ORR assessment was defined per following standardized criteria:
|
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU - Hopital Claude HURIEZ | Lille | 59037 | France | |||
| Centre hospitalier Lyon Sud |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27248633 | Result | Walter HS, Salles GA, Dyer MJ. New Agents to Treat Chronic Lymphocytic Leukemia. N Engl J Med. 2016 Jun 2;374(22):2185-6. doi: 10.1056/NEJMc1602674. No abstract available. | |
| 26542378 | Result | Walter HS, Rule SA, Dyer MJ, Karlin L, Jones C, Cazin B, Quittet P, Shah N, Hutchinson CV, Honda H, Duffy K, Birkett J, Jamieson V, Courtenay-Luck N, Yoshizawa T, Sharpe J, Ohno T, Abe S, Nishimura A, Cartron G, Morschhauser F, Fegan C, Salles G. A phase 1 clinical trial of the selective BTK inhibitor ONO/GS-4059 in relapsed and refractory mature B-cell malignancies. Blood. 2016 Jan 28;127(4):411-9. doi: 10.1182/blood-2015-08-664086. Epub 2015 Nov 5. |
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102 participants were screened.
Participants were enrolled at study sites in Europe. The first participant was screened on 17 August 2012. The last study visit occurred on 11 January 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tirabrutinib 20 mg Once Daily (CLL) | Participants with relapsed/refractory chronic lymphocytic leukaemia (CLL) received tirabrutinib 20 mg once daily. |
| FG001 | Tirabrutinib 40 mg Once Daily (CLL) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Experimental |
Participants with relapsed/refractory CLL received tirabrutinib 400 mg once daily. |
|
| Tirabrutinib 500 mg Once Daily (CLL) | Experimental | Participants with relapsed/refractory CLL received tirabrutinib 500 mg once daily. |
|
| Tirabrutinib 600 mg Once Daily (CLL) | Experimental | Participants with relapsed/refractory CLL received tirabrutinib 600 mg once daily. |
|
| Tirabrutinib 300 mg Twice Daily (CLL) | Experimental | Participants with relapsed/refractory CLL received tirabrutinib 300 mg twice daily. |
|
| Tirabrutinib 20 mg Once Daily (NHL) | Experimental | Participants with relapsed/refractory non-Hodgkin's lymphoma (NHL) received tirabrutinib 20 mg once daily. |
|
| Tirabrutinib 40 mg Once Daily (NHL) | Experimental | Participants with relapsed/refractory NHL received tirabrutinib 40 mg once daily. |
|
| Tirabrutinib 80 mg Once Daily (NHL) | Experimental | Participants with relapsed/refractory NHL received tirabrutinib 80 mg once daily. |
|
| Tirabrutinib 160 mg Once Daily (NHL) | Experimental | Participants with relapsed/refractory NHL received tirabrutinib 160 mg once daily. |
|
| Tirabrutinib 320 mg Once Daily (NHL) | Experimental | Participants with relapsed/refractory NHL received tirabrutinib 320 mg once daily. |
|
| Tirabrutinib 480 mg Once Daily (NHL) | Experimental | Participants with relapsed/refractory NHL received tirabrutinib 480 mg once daily. |
|
| Tirabrutinib 600 mg Once Daily (NHL) | Experimental | Participants with relapsed/refractory NHL received tirabrutinib 600 mg once daily. |
|
| Tirabrutinib 240 mg Twice Daily (NHL) | Experimental | Participants with relapsed/refractory NHL received tirabrutinib 240 mg twice daily. |
|
|
| Up to Cycle 37 (28 days for each cycle) plus 6-month intervals thereafter until disease progression (maximum: up to 39 months) |
| Pharmacokinetic (PK) Parameter: Cmax of Tirabrutinib | Cmax is defined as the maximum concentration of drug. | Pre-dose, then 30 minutes, 1, 2, 3, 4, 6, 8, 12 hours post-dose at Cycle 1, Day 28 |
| PK Parameter: AUCtau of Tirabrutinib | AUCtau is defined as concentration of drug over dosing interval. | Pre-dose, then 30 minutes, 1, 2, 3, 4, 6, 8, 12 hours post-dose at Cycle 1, Day 28 |
| Lyon |
| 69495 |
| France |
| CHU St Eloi | Montpellier | 34295 | France |
| University Hospital of Wales | Cardiff | CF14 4XW | United Kingdom |
| Leicester Royal Infirmary | Leicester | LE1 5WW | United Kingdom |
| Derriford Hospital | Plymouth | PL6 8DH | United Kingdom |
| Result | Fegan, C, Bagshawe J, Salles G, et al. The Bruton's tyrosine kinase (BTK) inhibitor ONO-4059: promising single agent activity and well tolerated in patients with high risk chronic lymphocytic leukaemia (CLL). Paper presented at: 56th American Society of Hematology Annual Meeting and Exposition; December 6-9, 2014; San Franscisco, CA. |
| Result | Morschhauser F, Terriou L, Dyer M, et al. The Bruton's tyrosine kinase (BTK) inhibitor ONO-4059: promising single agent activity in patients with relapsed and refractory NHL. Haematologica. 2014 Jun; 99: 150. |
Participants with relapsed/refractory CLL received tirabrutinib 40 mg once daily.
| FG002 | Tirabrutinib 80 mg Once Daily (CLL) | Participants with relapsed/refractory CLL received tirabrutinib 80 mg once daily. |
| FG003 | Tirabrutinib 160 mg Once Daily (CLL) | Participants with relapsed/refractory CLL received tirabrutinib 160 mg once daily. |
| FG004 | Tirabrutinib 320 mg Once Daily (CLL) | Participants with relapsed/refractory CLL received tirabrutinib 320 mg once daily. |
| FG005 | Tirabrutinib 400 mg Once Daily (CLL) | Participants with relapsed/refractory CLL received tirabrutinib 400 mg once daily. |
| FG006 | Tirabrutinib 500 mg Once Daily (CLL) | Participants with relapsed/refractory CLL received tirabrutinib 500 mg once daily. |
| FG007 | Tirabrutinib 600 mg Once Daily (CLL) | Participants with relapsed/refractory CLL received tirabrutinib 600 mg once daily. |
| FG008 | Tirabrutinib 300 mg Twice Daily (CLL) | Participants with relapsed/refractory CLL received tirabrutinib 300 mg twice daily. |
| FG009 | Tirabrutinib 20 mg Once Daily (NHL) | Participants with relapsed/refractory non-Hodgkin's lymphoma (NHL) received tirabrutinib 20 mg once daily. |
| FG010 | Tirabrutinib 40 mg Once Daily (NHL) | Participants with relapsed/refractory NHL received tirabrutinib 40 mg once daily. |
| FG011 | Tirabrutinib 80 mg Once Daily (NHL) | Participants with relapsed/refractory NHL received tirabrutinib 80 mg once daily. |
| FG012 | Tirabrutinib 160 mg Once Daily (NHL) | Participants with relapsed/refractory NHL received tirabrutinib 160 mg once daily. |
| FG013 | Tirabrutinib 320 mg Once Daily (NHL) | Participants with relapsed/refractory NHL received tirabrutinib 320 mg once daily. |
| FG014 | Tirabrutinib 480 mg Once Daily (NHL) | Participants with relapsed/refractory NHL received tirabrutinib 480 mg once daily. |
| FG015 | Tirabrutinib 600 mg Once Daily (NHL) | Participants with relapsed/refractory NHL received tirabrutinib 600 mg once daily. |
| FG016 | Tirabrutinib 240 mg Twice Daily (NHL) | Participants with relapsed/refractory NHL received tirabrutinib 240 mg twice daily. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Full Analysis Set included all the participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Tirabrutinib 20 mg Once Daily (CLL) | Participants with relapsed/refractory CLL received tirabrutinib 20 mg once daily. |
| BG001 | Tirabrutinib 40 mg Once Daily (CLL) | Participants with relapsed/refractory CLL received tirabrutinib 40 mg once daily. |
| BG002 | Tirabrutinib 80 mg Once Daily (CLL) | Participants with relapsed/refractory CLL received tirabrutinib 80 mg once daily. |
| BG003 | Tirabrutinib 160 mg Once Daily (CLL) | Participants with relapsed/refractory CLL received tirabrutinib 160 mg once daily. |
| BG004 | Tirabrutinib 320 mg Once Daily (CLL) | Participants with relapsed/refractory CLL received tirabrutinib 320 mg once daily. |
| BG005 | Tirabrutinib 400 mg Once Daily (CLL) | Participants with relapsed/refractory CLL received tirabrutinib 400 mg once daily. |
| BG006 | Tirabrutinib 500 mg Once Daily (CLL) | Participants with relapsed/refractory CLL received tirabrutinib 500 mg once daily. |
| BG007 | Tirabrutinib 600 mg Once Daily (CLL) | Participants with relapsed/refractory CLL received tirabrutinib 600 mg once daily. |
| BG008 | Tirabrutinib 300 mg Twice Daily (CLL) | Participants with relapsed/refractory CLL received tirabrutinib 300 mg twice daily. |
| BG009 | Tirabrutinib 20 mg Once Daily (NHL) | Participants with relapsed/refractory NHL received tirabrutinib 20 mg once daily. |
| BG010 | Tirabrutinib 40 mg Once Daily (NHL) | Participants with relapsed/refractory NHL received tirabrutinib 40 mg once daily. |
| BG011 | Tirabrutinib 80 mg Once Daily (NHL) | Participants with relapsed/refractory NHL received tirabrutinib 80 mg once daily. |
| BG012 | Tirabrutinib 160 mg Once Daily (NHL) | Participants with relapsed/refractory NHL received tirabrutinib 160 mg once daily. |
| BG013 | Tirabrutinib 320 mg Once Daily (NHL) | Participants with relapsed/refractory NHL received tirabrutinib 320 mg once daily. |
| BG014 | Tirabrutinib 480 mg Once Daily (NHL) | Participants with relapsed/refractory NHL received tirabrutinib 480 mg once daily. |
| BG015 | Tirabrutinib 600 mg Once Daily (NHL) | Participants with relapsed/refractory NHL received tirabrutinib 600 mg once daily. |
| BG016 | Tirabrutinib 240 mg Twice Daily (NHL) | Participants with relapsed/refractory NHL received tirabrutinib 240 mg twice daily. |
| BG017 | 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, Customized | Count of Participants | Participants | No |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| 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 | Percentage of Participants Experiencing Dose-Limiting Toxicities | Dose Limiting Toxicities (DLT) were defined as follows:
Any toxicity which in the opinion of the Investigator is attributed to a participant's underlying disease was not considered a DLT. | The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data for DLTs were summarized by dose level received by participants with NHL and CLL. | Posted | Number | percentage of participants | Day 1 through Day 28 |
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Response Rate | Overall response rate (ORR) was defined as the percentage of participants who achieve a best overall response of complete remission (CR, unconfirmed complete response (CRu), complete response with incomplete marrow recovery (CRi)) or partial remission (PR, nodal PR) during study as assessed by the investigator. ORR assessment was defined per following standardized criteria:
| The Full Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data for overall response rate were summarized by overall CLL group and NHL subgroup. | Posted | Number | percentage of participants | Up to Cycle 37 (28 days for each cycle) plus 6-month intervals thereafter until disease progression (maximum: up to 39 months) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetic (PK) Parameter: Cmax of Tirabrutinib | Cmax is defined as the maximum concentration of drug. | Participants in the PK Analysis Set (all participants who received at least 1 dose of study drug and had at least 1 nonmissing postdose concentration value for the corresponding analyte in plasma) with available data were analyzed. Per planned analysis, data for PK parameters were summarized by dose cohorts. | Posted | Mean | Standard Deviation | ng/mL | Pre-dose, then 30 minutes, 1, 2, 3, 4, 6, 8, 12 hours post-dose at Cycle 1, Day 28 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | PK Parameter: AUCtau of Tirabrutinib | AUCtau is defined as concentration of drug over dosing interval. | Participants in the PK Analysis Set with available data were analyzed. Per planned analysis, data for PK parameters were summarized by dose cohorts. | Posted | Mean | Standard Deviation | h*ng/mL | Pre-dose, then 30 minutes, 1, 2, 3, 4, 6, 8, 12 hours post-dose at Cycle 1, Day 28 |
|
Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
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 | Chronic Lymphocytic Leukaemia | Participants with relapsed/refractory CLL received tirabrutinib until disease progression or until the participant entered into a possible future tirabrutinib study. | 5 | 28 | 17 | 28 | 28 | 28 |
| EG001 | Non-Hodgkin's Lymphoma | Participants with relapsed/refractory NHL received tirabrutinib until disease progression or until the participant entered into a possible future tirabrutinib study. | 38 | 62 | 23 | 62 | 55 | 62 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Lymphocytic infiltration | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Spontaneous haematoma | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Ear haemorrhage | Ear and labyrinth disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Excessive cerumen production | Ear and labyrinth disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Inguinal hernia strangulated | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Oesophageal haemorrhage | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Small intestinal haemorrhage | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Adverse drug reaction | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Ill-defined disorder | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Campylobacter gastroenteritis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| H1n1 influenza | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Hepatitis E | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Herpes zoster oticus | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Lower respiratory tract infection bacterial | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Lower respiratory tract infection fungal | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Neutropenic infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pneumonia pneumococcal | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Cardiac function disturbance postoperative | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Colorectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Squamous cell carcinoma of lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Disorientation | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Calculus ureteric | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Myeloma cast nephropathy | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Purpura | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Eye haemorrhage | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Eye pruritus | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Glaucoma | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypogammaglobulinaemia | Immune system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Chronic sinusitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Eye infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Sinobronchitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Traumatic haematoma | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dysaesthesia | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Prostatomegaly | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Catarrh | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Rales | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Actinic keratosis | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Macule | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Purpura | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gilead Clinical Study Information Center | Gilead Sciences | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D015448 | Leukemia, B-Cell |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000608238 | tirabrutinib |
Not provided
Not provided
Not provided
| ≥ 65 years |
|
| Male |
|
| Asian |
|
| Other |
|
| NHL Subtype SLL |
Participants with NHL subtype small lymphocytic lymphoma (SLL) received tirabrutinib until disease progression or until the participant entered into a possible future tirabrutinib study. |
| OG003 | NHL Subtype WM | Participants with NHL subtype Waldenstrom macroglobulinemia (WM) received tirabrutinib until disease progression or until the participant entered into a possible future tirabrutinib study. |
| OG004 | NHL Subtype MZL | Participants with NHL subtype marginal zone lymphoma (MZL) received tirabrutinib until disease progression or until the participant entered into a possible future tirabrutinib study. |
| OG005 | NHL Subtype DLBCL | Participants with NHL subtype diffuse large B-cell lymphoma (DLBCL) received tirabrutinib until disease progression or until the participant entered into a possible future tirabrutinib study. |
| OG006 | NHL Subtype MCL | Participants with NHL subtype mantle cell lymphoma (MCL) received tirabrutinib until disease progression or until the participant entered into a possible future tirabrutinib study. |
|
|
Participants with relapsed/refractory CLL or NHL received tirabrutinib 160 mg once daily. |
| OG004 | Tirabrutinib 320 mg Once Daily (CLL or NHL) | Participants with relapsed/refractory CLL or NHL received tirabrutinib 320 mg once daily. |
| OG005 | Tirabrutinib 400 mg Once Daily (CLL) | Participants with relapsed/refractory CLL received tirabrutinib 400 mg once daily. |
| OG006 | Tirabrutinib 480 mg Once Daily (NHL) | Participants with relapsed/refractory NHL received tirabrutinib 480 mg once daily. |
| OG007 | Tirabrutinib 500 mg Once Daily (CLL) | Participants with relapsed/refractory CLL received tirabrutinib 500 mg once daily. |
| OG008 | Tirabrutinib 600 mg Once Daily (CLL or NHL) | Participants with relapsed/refractory CLL or NHL received tirabrutinib 600 mg once daily. |
| OG009 | Tirabrutinib 240 mg Twice Daily (NHL) | Participants with relapsed/refractory NHL received tirabrutinib 240 mg twice daily. |
| OG010 | Tirabrutinib 300 mg Twice Daily (CLL) | Participants with relapsed/refractory CLL received tirabrutinib 300 mg twice daily. |
|
|
| OG004 | Tirabrutinib 320 mg Once Daily (CLL or NHL) | Participants with relapsed/refractory CLL or NHL received tirabrutinib 320 mg once daily. |
| OG005 | Tirabrutinib 400 mg Once Daily (CLL) | Participants with relapsed/refractory CLL received tirabrutinib 400 mg once daily. |
| OG006 | Tirabrutinib 480 mg Once Daily (NHL) | Participants with relapsed/refractory NHL received tirabrutinib 480 mg once daily. |
| OG007 | Tirabrutinib 500 mg Once Daily (CLL) | Participants with relapsed/refractory CLL received tirabrutinib 500 mg once daily. |
| OG008 | Tirabrutinib 600 mg Once Daily (CLL or NHL) | Participants with relapsed/refractory CLL or NHL received tirabrutinib 600 mg once daily. |
| OG009 | Tirabrutinib 240 mg Twice Daily (NHL) | Participants with relapsed/refractory NHL received tirabrutinib 240 mg twice daily. |
| OG010 | Tirabrutinib 300 mg Twice Daily (CLL) | Participants with relapsed/refractory CLL received tirabrutinib 300 mg twice daily. |
|
|