Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of the study is to investigate the safety, tolerability, efficacy and pharmacokinetics (PK) for Japanese hepatocellular carcinoma which are not amenable to curative surgery or loco regional therapy
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I | Experimental | patients with mild liver dysfunction according to their AST/ALT values and Child-Pugh score |
|
| Group II | Experimental | patients with moderate liver dysfunction according to their AST/ALT values and Child-Pugh score |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nintedanib high dose | Drug | twice daily oral dosing |
| |
| Nintedanib low dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose Limiting Toxicities to Determine Maximum Tolerated Dose (MTD) of Nintedanib | The MTD is based on the incidence of Dose Limiting Toxicities (DLTs). A drug-related AE was considered as a DLT if one of the following met: CTCAE grade 4 thrombocytopenia of any duration, CTCAE grade 4 neutropenia lasting for ≥8 days, CTCAE grade 4 febrile neutropenia of any duration, CTCAE grade 3 or 4 non-haematologic toxicity (with the following exception: Alopecia, Vomiting, nausea, or diarrhoea with no adequate supportive care, Transient electrolyte abnormality, which resolves spontaneously or can be corrected with appropriate treatment within 3 days, Liver toxicity), Liver enzyme toxicity of AST, ALT, alkaline phosphatase [ALP] elevation >5x ULN, or total bilirubin >3x ULN if baseline liver enzymes are within the normal range, or AST, ALT or ALP > baseline value + 4x ULN if the baseline value is elevated. The MTD was determined to be 200mg bid. | up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Objective Tumour Response According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 | Objective response (Complete response (CR) + Partial response (PR), regardless of confirmation) is derived from a patient's best objective response by RECIST. Best objective response is calculated based on the "overall" visit response from each assessment. Best objective response represents the best response a patient has had during their time in the study up until progression, last evaluable assessment in the absence of progression or the start of subsequent anti-cancer therapy. For patients whose progression event is death, best objective response will be calculated based on data up until the last evaluable RECIST assessment prior to death. |
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1199.120.001 Boehringer Ingelheim Investigational Site | Chuo-ku, Tokyo | Japan | ||||
| 1199.120.005 Boehringer Ingelheim Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27627050 | Derived | Okusaka T, Otsuka T, Ueno H, Mitsunaga S, Sugimoto R, Muro K, Saito I, Tadayasu Y, Inoue K, Loembe AB, Ikeda M. Phase I study of nintedanib in Japanese patients with advanced hepatocellular carcinoma and liver impairment. Cancer Sci. 2016 Dec;107(12):1791-1799. doi: 10.1111/cas.13077. Epub 2016 Dec 12. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Group I: Nintedanib 150mg Bid | Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 150mg twice daily |
| FG001 | Group I: Nintedanib 200mg Bid |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
twice daily oral dosing |
|
| Nintedanib medium dose | Drug | twice daily oral dosing |
|
| Nintedanib medium dose | Drug | twice daily oral dosing |
|
| Nintedanib high dose | Drug | twice daily oral dosing |
|
| up to 28 months |
| Progression Free Survival (PFS) | PFS is defined as the duration from start date of the study treatment to PD according to RECIST 1.0, or any death whichever occurs earlier. | up to 28 months |
| Time to Progression (TTP) | TTP is defined as the duration from the start date of the study treatment to PD according to RECIST 1.0. | up to 28 months |
| Number of Participants With Response by Alpha Fetoprotein (AFP) | Response by AFP is defined as 20% or more decline in AFP between the baseline value and the AFP value after three courses (12 weeks) of therapy. If patients only receive two courses of therapy the AFP value after two courses (8 weeks) will be used for the analysis. | up to 28 months |
| Fukuoka, Fukuoka |
| Japan |
| 1199.120.002 Boehringer Ingelheim Investigational Site | Kashiwa, Chiba | Japan |
| 1199.120.003 Boehringer Ingelheim Investigational Site | Nagoya, Aichi | Japan |
| 1199.120.004 Boehringer Ingelheim Investigational Site | Saga, Saga | Japan |
Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 200mg twice daily |
| FG002 | Group II: Nintedanib 100mg Bid | Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 100mg twice daily |
| FG003 | Group II: Nintedanib 150mg Bid | Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 x to <=5 upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 150mg twice daily |
| FG004 | Group II: Nintedanib 200mg Bid | Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 200mg twice daily |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Group I: Nintedanib 150mg Bid | Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 150mg twice daily |
| BG001 | Group I: Nintedanib 200mg Bid | Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 200mg twice daily |
| BG002 | Group II: Nintedanib 100mg Bid | Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 100mg twice daily |
| BG003 | Group II: Nintedanib 150mg Bid | Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 x to <=5 upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 150mg twice daily |
| BG004 | Group II: Nintedanib 200mg Bid | Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 200mg twice daily |
| 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, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | 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 | Number of Participants With Dose Limiting Toxicities to Determine Maximum Tolerated Dose (MTD) of Nintedanib | The MTD is based on the incidence of Dose Limiting Toxicities (DLTs). A drug-related AE was considered as a DLT if one of the following met: CTCAE grade 4 thrombocytopenia of any duration, CTCAE grade 4 neutropenia lasting for ≥8 days, CTCAE grade 4 febrile neutropenia of any duration, CTCAE grade 3 or 4 non-haematologic toxicity (with the following exception: Alopecia, Vomiting, nausea, or diarrhoea with no adequate supportive care, Transient electrolyte abnormality, which resolves spontaneously or can be corrected with appropriate treatment within 3 days, Liver toxicity), Liver enzyme toxicity of AST, ALT, alkaline phosphatase [ALP] elevation >5x ULN, or total bilirubin >3x ULN if baseline liver enzymes are within the normal range, or AST, ALT or ALP > baseline value + 4x ULN if the baseline value is elevated. The MTD was determined to be 200mg bid. | Patients from the MTD set: The MTD set contains only treated patients from the dose escalation that were not replaced for MTD determination. | Posted | Number | participants | up to 28 days |
|
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Objective Tumour Response According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 | Objective response (Complete response (CR) + Partial response (PR), regardless of confirmation) is derived from a patient's best objective response by RECIST. Best objective response is calculated based on the "overall" visit response from each assessment. Best objective response represents the best response a patient has had during their time in the study up until progression, last evaluable assessment in the absence of progression or the start of subsequent anti-cancer therapy. For patients whose progression event is death, best objective response will be calculated based on data up until the last evaluable RECIST assessment prior to death. | Treated Set (TS): The treated set includes all patients who were administered at least one dose of any study medication. | Posted | Number | participants | up to 28 months |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) | PFS is defined as the duration from start date of the study treatment to PD according to RECIST 1.0, or any death whichever occurs earlier. | Patients from TS | Posted | Median | Inter-Quartile Range | months | up to 28 months |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Progression (TTP) | TTP is defined as the duration from the start date of the study treatment to PD according to RECIST 1.0. | Patients from TS | Posted | Median | Inter-Quartile Range | months | up to 28 months |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Response by Alpha Fetoprotein (AFP) | Response by AFP is defined as 20% or more decline in AFP between the baseline value and the AFP value after three courses (12 weeks) of therapy. If patients only receive two courses of therapy the AFP value after two courses (8 weeks) will be used for the analysis. | Patients from TS and AFP evaluation (>20μg/L) at baseline and post-baseline AFP assessment after two or three courses. | Posted | Number | participants | up to 28 months |
|
up to 67 days
Not provided
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 | Group I: Nintedanib 150mg Bid | Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 150mg twice daily | 0 | 4 | 4 | 4 | ||
| EG001 | Group I: Nintedanib 200mg Bid | Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 200mg twice daily | 4 | 12 | 12 | 12 | ||
| EG002 | Group II: Nintedanib 100mg Bid | Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 100mg twice daily | 1 | 3 | 3 | 3 | ||
| EG003 | Group II: Nintedanib 150mg Bid | Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 x to <=5 upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 150mg twice daily | 2 | 4 | 4 | 4 | ||
| EG004 | Group II: Nintedanib 200mg Bid | Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 200mg twice daily | 3 | 7 | 7 | 7 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Immune thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Tumour embolism | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cheilitis | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Loose tooth | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Localised oedema | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Radiation oesophagitis | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Soft tissue injury | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Wound complication | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Blood uric acid increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Eosinophil count increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Parosmia | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Chromaturia | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Ketonuria | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Skin erosion | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
|
Other - Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C530716 | nintedanib |
Not provided
Not provided
Not provided
| Male |
|
| OG002 | Group II: Nintedanib 100mg Bid | Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 100mg twice daily |
| OG003 | Group II: Nintedanib 150mg Bid | Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 x to <=5 upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 150mg twice daily |
| OG004 | Group II: Nintedanib 200mg Bid | Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 200mg twice daily |
|
|
| Group II: Nintedanib 150mg Bid |
Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 x to <=5 upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 150mg twice daily |
| OG004 | Group II: Nintedanib 200mg Bid | Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 200mg twice daily |
|
|
| Group II: Nintedanib 150mg Bid |
Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 x to <=5 upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 150mg twice daily |
| OG004 | Group II: Nintedanib 200mg Bid | Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 200mg twice daily |
|
|
| OG003 | Group II: Nintedanib 150mg Bid | Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 x to <=5 upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 150mg twice daily |
| OG004 | Group II: Nintedanib 200mg Bid | Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 200mg twice daily |
|
|