Neoplasms
Conditions
Brief summary
The primary objective of this trial is to evaluate the long-term safety of BIBF 1120 in terms of incidence and intensity of Adverse Events and changes in safety laboratory parameters. Secondary objectives are the collection of further safety data (vital signs), efficacy data and the determination of pharmacokinetic characteristics during long-term therapy with BIBF 1120.
Interventions
DRUGBIBF 1120
Sponsors
Boehringer Ingelheim
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female patients with advanced solid tumours who have completed a previous study with BIBF 1120. The patients should not have progression of their underlying tumour disease unless there is evidence for significant clinical benefit (e.g. symptom improvement) from treatment with BIBF 1120. 2. Age 18 years or older 3. Eastern Cooperative Oncology Group (ECOG, R01-0787) performance score \<= 2 4. Patients must have given written informed consent (which must be consistent with ICH-GCP and local legislation)
Exclusion criteria
1. Time elapsed from last administration of BIBF 1120 in the previous trial to start of treatment in the present trial exceeds four weeks 2. Presence of drug related toxicity \> grade 2 CTC from previous therapy with BIBF 1120 or presence of drug related continuous toxicity of grade 2 for seven or more consecutive days which would preclude ongoing chronic therapy with BIBF 1120 3. Active ulcers (gastro-intestinal tract, skin) 4. Major injuries and surgery within the past three weeks with incomplete wound healing 5. Hypersensitivity to BIBF 1120 or the excipients of the trial drug 6. Known secondary malignancy requiring therapy 7. Active infectious disease 8. Significant cardiovascular diseases (i.e. uncontrolled severe hypertension, unstable angina pectoris, history of myocardial infarction, congestive heart failure \> NYHA II) 9. Gastrointestinal disorders anticipated to interfere with the resorption of the study drug 10. Brain metastases requiring therapy 11. Absolute neutrophil count less than 1,500/mm3 12. Platelet count less than 100,000/mm3 13. Bilirubin greater than 1.5 mg/dl (\> 26 µmol/L) 14. Aspartate amino transferase (AST) and/or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal (if related to liver metastases greater than five times the upper limit of normal) 15. Serum creatinine greater than 2 mg/dl (\> 176 µmol/L) 16. Concomitant non-oncological diseases which are considered relevant for the evaluation of the safety of the trial drug 17. Chemo-, radio-, or immunotherapy within the past four weeks prior to treatment with the trial drug 18. Patients who are sexually active and unwilling to use a medically acceptable method of contraception 19. Pregnancy or lactation 20. Treatment with other investigational drugs or participation in another clinical trial within the past four weeks before start of therapy (visit 2) or concomitantly with this trial (except for a previous study with BIBF 1120) 21. Patients unable to comply with the protocol 22. Active alcohol or drug abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference From Baseline for Electrolytes | From signing the informed consent until end of treatment, up to 991 days | Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25. |
| Incidence and Intensity of Adverse Events With Highest CTCAE Grade 4 | From signing the informed consent until final follow-up, up to 991 days | All patients who had grade 4 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE). |
| Incidence and Intensity of Adverse Events With Highest CTCAE Grade 5 | From signing the informed consent until final follow-up, up to 991 days | All patients who had grade 5 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE). |
| Difference From Baseline for Liver Enzymes | From signing the informed consent until end of treatment, up to 991 days | Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25. |
| Difference From Baseline for Bilirubin, Creatinine and Glucose | From signing the informed consent until end of treatment, up to 991 days | Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25. |
| Difference From Baseline for Haemoglobin | From baseline until end of treatment, up to 991 days | Difference from baseline for Haemoglobin (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25. |
| Difference From Baseline for Haematology and Differentials Parameters | From signing the informed consent until end of treatment, up to 991 days | Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25. |
| Difference From Baseline for Coagulation Parameters | From signing the informed consent until end of treatment, up to 991 days | Difference from baseline (normalized value) in coagulation parameters Prothrombin time, international normalised ratio (PT-INR) and partial thromboplastin time. Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25. |
| Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | From signing the informed consent until final follow-up, up to 991 days | All patients who had grade 1 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE). |
| Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | From signing the informed consent until final follow-up, up to 991 days | All patients who had grade 2 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE). |
| Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | From signing the informed consent until final follow-up, up to 991 days | All patients who had grade 3 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pre-dose Concentration of Nintedanib in Plasma at Steady-state (Cpre,ss) | Just before drug administration every 28±7 days after day 29 | Cpre,ss represents the pre-dose concentration of Nintedanib in Plasma at steady-state at day 29 |
| Unconfirmed Best Overall Response | Baseline until end of treatment, up to 991 days | Unconfirmed best overall response assessed by RECIST (Response Evaluation Criteria In Solid Tumours) criteria (version 1.0). PD = Progressive disease. |
| Unconfirmed Best Objective Response | Baseline until end of treatment, up to 991 days | Unconfirmed best objective response assessed by RECIST (Response Evaluation Criteria In Solid Tumours) criteria (version 1.0) |
| Clinical Benefit | Baseline until end of treatment, up to 991 days | Clinical benefit was defined as the absence of disease progression (no PD or nonevaluable clinically progressive disease) determined by RECIST (version 1.0). |
| Confirmed Objective Response | Baseline until end of treatment, up to 991 days | Confirmed objective response assessed by RECIST (Response Evaluation Criteria In Solid Tumours) criteria (version 1.0) |
| Progression Free Survival | First drug administration (in previous trial) until end of treatment, up to 1230 days | Percentage of participants that experienced progression free survival (PFS), assessed by RECIST (Response Evaluation Criteria In Solid Tumours) (version 1.0), by day 1230. Progression was defined as progressive disease (PD) or non-evaluable clinically progressive disease. PFS was defined for patients without PD at screening as the time from first treatment with the trial drug in the previous trial until onset of PD or death, whatever comes earlier. Patients with PD could enter the trial if they showed signs of clinical benefit. For patients with PD at screening, the RECIST assessment at screening was used as a new baseline value and PFS was the time from first treatment with the trial drug in this trial until the onset of progressive disease in this trial or death, whatever comes first. |
| Clinically Relevant Abnormalities for Vital Signs | From baseline until final follow-up, up to 991 days | Clinically relevant abnormalities for Vital Signs (systolic blood pressure, diastolic blood pressure, and pulse rate). New abnormal findings or worsening of baseline conditions were reported as Adverse Events. |
Countries
France, Germany
Participant flow
Recruitment details
This was a multinational, open-label, uncontrolled, extension trial with Nintedanib in patients who had experienced a clinical benefit with Nintedanib (objective tumour response or disease stabilisation and/or symptom improvement) in either one out of five phase I or phase I/IIA clinical trials for advanced solid tumours at study entry.
Participants by arm
| Arm | Count |
|---|---|
| 50mg QD Patients were treated with 50 mg Nintedanib once daily in the morning. | 1 |
| 200mg QD Patients were treated with 200 mg Nintedanib once daily in the morning. | 1 |
| 100mg BID Patients were treated with 100 mg Nintedanib twice daily. | 4 |
| 150mg BID Patients were treated with 150 mg Nintedanib twice daily. | 9 |
| 200mg BID Patients were treated with 200 mg Nintedanib twice daily. | 6 |
| 250mg BID Patients were treated with 250 mg Nintedanib twice daily. | 19 |
| 300mg BID Patients were treated with 300 mg Nintedanib twice daily. | 1 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Overall Study | Dose limiting Toxicity (DLT) | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Other Adverse Event than DLT | 1 | 0 | 0 | 0 | 0 | 2 | 0 |
| Overall Study | Other reason not defined above | 0 | 0 | 1 | 0 | 1 | 1 | 0 |
| Overall Study | Progressive disease | 0 | 1 | 3 | 9 | 5 | 14 | 1 |
| Overall Study | Protocol Violation | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | 50mg QD | 200mg QD | 100mg BID | 150mg BID | 200mg BID | 250mg BID | 300mg BID | Total |
|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 75.0 years | 47.0 years | 65.5 years | 66.0 years | 63.5 years | 66.0 years | 67.0 years | 66.0 years |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 2 Participants | 2 Participants | 2 Participants | 1 Participants | 0 Participants | 8 Participants |
| Sex: Female, Male Male | 1 Participants | 0 Participants | 2 Participants | 7 Participants | 4 Participants | 18 Participants | 1 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 1 | 1 / 1 | 4 / 4 | 9 / 9 | 6 / 6 | 17 / 19 | 1 / 1 |
| serious Total, serious adverse events | 0 / 1 | 0 / 1 | 0 / 4 | 1 / 9 | 0 / 6 | 9 / 19 | 0 / 1 |
Outcome results
Primary
Difference From Baseline for Bilirubin, Creatinine and Glucose
Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.
Time frame: From signing the informed consent until end of treatment, up to 991 days
Population: Treated set.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| 50mg QD | Difference From Baseline for Bilirubin, Creatinine and Glucose | Creatinine | -0.1 mg/dL | Standard Error 0 |
| 50mg QD | Difference From Baseline for Bilirubin, Creatinine and Glucose | Bilirubin (total) | 0.5 mg/dL | Standard Error 0 |
| 50mg QD | Difference From Baseline for Bilirubin, Creatinine and Glucose | Glucose (N=1,1,3,9,4,14,1) | -60.0 mg/dL | Standard Error 0 |
| 200mg QD | Difference From Baseline for Bilirubin, Creatinine and Glucose | Bilirubin (total) | 0.0 mg/dL | Standard Error 0 |
| 200mg QD | Difference From Baseline for Bilirubin, Creatinine and Glucose | Glucose (N=1,1,3,9,4,14,1) | -2.2 mg/dL | Standard Error 0 |
| 200mg QD | Difference From Baseline for Bilirubin, Creatinine and Glucose | Creatinine | -0.3 mg/dL | Standard Error 0 |
| 100mg BID | Difference From Baseline for Bilirubin, Creatinine and Glucose | Creatinine | 0.0 mg/dL | Standard Error 0.2 |
| 100mg BID | Difference From Baseline for Bilirubin, Creatinine and Glucose | Glucose (N=1,1,3,9,4,14,1) | 28.9 mg/dL | Standard Error 126.1 |
| 100mg BID | Difference From Baseline for Bilirubin, Creatinine and Glucose | Bilirubin (total) | 0.0 mg/dL | Standard Error 0.2 |
| 150mg BID | Difference From Baseline for Bilirubin, Creatinine and Glucose | Creatinine | -0.1 mg/dL | Standard Error 0 |
| 150mg BID | Difference From Baseline for Bilirubin, Creatinine and Glucose | Bilirubin (total) | 0.0 mg/dL | Standard Error 0.3 |
| 150mg BID | Difference From Baseline for Bilirubin, Creatinine and Glucose | Glucose (N=1,1,3,9,4,14,1) | -11.3 mg/dL | Standard Error 75.1 |
| 200mg BID | Difference From Baseline for Bilirubin, Creatinine and Glucose | Glucose (N=1,1,3,9,4,14,1) | -76.5 mg/dL | Standard Error 75.9 |
| 200mg BID | Difference From Baseline for Bilirubin, Creatinine and Glucose | Creatinine | -0.1 mg/dL | Standard Error 0.2 |
| 200mg BID | Difference From Baseline for Bilirubin, Creatinine and Glucose | Bilirubin (total) | 0.1 mg/dL | Standard Error 0.1 |
| 250mg BID | Difference From Baseline for Bilirubin, Creatinine and Glucose | Creatinine | -0.1 mg/dL | Standard Error 0.3 |
| 250mg BID | Difference From Baseline for Bilirubin, Creatinine and Glucose | Bilirubin (total) | 0.1 mg/dL | Standard Error 0.3 |
| 250mg BID | Difference From Baseline for Bilirubin, Creatinine and Glucose | Glucose (N=1,1,3,9,4,14,1) | -23.3 mg/dL | Standard Error 52.2 |
| 300mg BID | Difference From Baseline for Bilirubin, Creatinine and Glucose | Creatinine | 0.0 mg/dL | Standard Error 0 |
| 300mg BID | Difference From Baseline for Bilirubin, Creatinine and Glucose | Bilirubin (total) | 0.0 mg/dL | Standard Error 0 |
| 300mg BID | Difference From Baseline for Bilirubin, Creatinine and Glucose | Glucose (N=1,1,3,9,4,14,1) | -40.0 mg/dL | Standard Error 0 |
Primary
Difference From Baseline for Coagulation Parameters
Difference from baseline (normalized value) in coagulation parameters Prothrombin time, international normalised ratio (PT-INR) and partial thromboplastin time. Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.
Time frame: From signing the informed consent until end of treatment, up to 991 days
Population: Treated set.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| 50mg QD | Difference From Baseline for Coagulation Parameters | PT-INR (N=1,1,3,7,5,14,1) | 0.1 sec | Standard Error 0 |
| 50mg QD | Difference From Baseline for Coagulation Parameters | Partial thromboplastin time (N=1,1,3,9,4,14,1) | 0.7 sec | Standard Error 0 |
| 200mg QD | Difference From Baseline for Coagulation Parameters | Partial thromboplastin time (N=1,1,3,9,4,14,1) | 2.6 sec | Standard Error 0 |
| 200mg QD | Difference From Baseline for Coagulation Parameters | PT-INR (N=1,1,3,7,5,14,1) | 0.1 sec | Standard Error 0 |
| 100mg BID | Difference From Baseline for Coagulation Parameters | Partial thromboplastin time (N=1,1,3,9,4,14,1) | -3.6 sec | Standard Error 6.7 |
| 100mg BID | Difference From Baseline for Coagulation Parameters | PT-INR (N=1,1,3,7,5,14,1) | 0.3 sec | Standard Error 0.6 |
| 150mg BID | Difference From Baseline for Coagulation Parameters | PT-INR (N=1,1,3,7,5,14,1) | 0.1 sec | Standard Error 0.1 |
| 150mg BID | Difference From Baseline for Coagulation Parameters | Partial thromboplastin time (N=1,1,3,9,4,14,1) | 1.9 sec | Standard Error 4.3 |
| 200mg BID | Difference From Baseline for Coagulation Parameters | Partial thromboplastin time (N=1,1,3,9,4,14,1) | 1.9 sec | Standard Error 4.3 |
| 200mg BID | Difference From Baseline for Coagulation Parameters | PT-INR (N=1,1,3,7,5,14,1) | 0.2 sec | Standard Error 0.5 |
| 250mg BID | Difference From Baseline for Coagulation Parameters | PT-INR (N=1,1,3,7,5,14,1) | -0.0 sec | Standard Error 0.1 |
| 250mg BID | Difference From Baseline for Coagulation Parameters | Partial thromboplastin time (N=1,1,3,9,4,14,1) | 1.5 sec | Standard Error 4.7 |
| 300mg BID | Difference From Baseline for Coagulation Parameters | PT-INR (N=1,1,3,7,5,14,1) | 0.1 sec | Standard Error 0 |
| 300mg BID | Difference From Baseline for Coagulation Parameters | Partial thromboplastin time (N=1,1,3,9,4,14,1) | -2.9 sec | Standard Error 0 |
Primary
Difference From Baseline for Electrolytes
Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.
Time frame: From signing the informed consent until end of treatment, up to 991 days
Population: Treated set.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| 50mg QD | Difference From Baseline for Electrolytes | Sodium (N=1,1,4,9,6,18,1) | 2.0 mmol/L | Standard Error 0 |
| 50mg QD | Difference From Baseline for Electrolytes | Potassium (N=1,1,4,9,6,18,1) | 0.2 mmol/L | Standard Error 0 |
| 200mg QD | Difference From Baseline for Electrolytes | Potassium (N=1,1,4,9,6,18,1) | -0.3 mmol/L | Standard Error 0 |
| 200mg QD | Difference From Baseline for Electrolytes | Sodium (N=1,1,4,9,6,18,1) | 1.0 mmol/L | Standard Error 0 |
| 100mg BID | Difference From Baseline for Electrolytes | Potassium (N=1,1,4,9,6,18,1) | -0.3 mmol/L | Standard Error 2.1 |
| 100mg BID | Difference From Baseline for Electrolytes | Sodium (N=1,1,4,9,6,18,1) | 3.3 mmol/L | Standard Error 5.2 |
| 150mg BID | Difference From Baseline for Electrolytes | Sodium (N=1,1,4,9,6,18,1) | 0.0 mmol/L | Standard Error 1.5 |
| 150mg BID | Difference From Baseline for Electrolytes | Potassium (N=1,1,4,9,6,18,1) | 0.1 mmol/L | Standard Error 0.4 |
| 200mg BID | Difference From Baseline for Electrolytes | Potassium (N=1,1,4,9,6,18,1) | -0.0 mmol/L | Standard Error 1.1 |
| 200mg BID | Difference From Baseline for Electrolytes | Sodium (N=1,1,4,9,6,18,1) | 1.5 mmol/L | Standard Error 6 |
| 250mg BID | Difference From Baseline for Electrolytes | Sodium (N=1,1,4,9,6,18,1) | -1.3 mmol/L | Standard Error 5.5 |
| 250mg BID | Difference From Baseline for Electrolytes | Potassium (N=1,1,4,9,6,18,1) | 0.1 mmol/L | Standard Error 0.9 |
| 300mg BID | Difference From Baseline for Electrolytes | Potassium (N=1,1,4,9,6,18,1) | 0.0 mmol/L | Standard Error 0 |
| 300mg BID | Difference From Baseline for Electrolytes | Sodium (N=1,1,4,9,6,18,1) | 5.0 mmol/L | Standard Error 0 |
Primary
Difference From Baseline for Haematology and Differentials Parameters
Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.
Time frame: From signing the informed consent until end of treatment, up to 991 days
Population: Treated set.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| 50mg QD | Difference From Baseline for Haematology and Differentials Parameters | Lymphocytes (N=1,1,4,9,4,17,1) | -0.6 10^9 /L | Standard Error 0 |
| 50mg QD | Difference From Baseline for Haematology and Differentials Parameters | Platelets | 42.2 10^9 /L | Standard Error 0 |
| 50mg QD | Difference From Baseline for Haematology and Differentials Parameters | White blood cell count | -1.1 10^9 /L | Standard Error 0 |
| 50mg QD | Difference From Baseline for Haematology and Differentials Parameters | Neutrophils (N=1,1,4,9,6,17,1) | -4.1 10^9 /L | Standard Error 0 |
| 200mg QD | Difference From Baseline for Haematology and Differentials Parameters | White blood cell count | -0.7 10^9 /L | Standard Error 0 |
| 200mg QD | Difference From Baseline for Haematology and Differentials Parameters | Neutrophils (N=1,1,4,9,6,17,1) | -4.7 10^9 /L | Standard Error 0 |
| 200mg QD | Difference From Baseline for Haematology and Differentials Parameters | Platelets | 11.1 10^9 /L | Standard Error 0 |
| 200mg QD | Difference From Baseline for Haematology and Differentials Parameters | Lymphocytes (N=1,1,4,9,4,17,1) | -0.4 10^9 /L | Standard Error 0 |
| 100mg BID | Difference From Baseline for Haematology and Differentials Parameters | Lymphocytes (N=1,1,4,9,4,17,1) | -0.1 10^9 /L | Standard Error 2 |
| 100mg BID | Difference From Baseline for Haematology and Differentials Parameters | Platelets | 1.0 10^9 /L | Standard Error 83.7 |
| 100mg BID | Difference From Baseline for Haematology and Differentials Parameters | White blood cell count | 0.2 10^9 /L | Standard Error 2.9 |
| 100mg BID | Difference From Baseline for Haematology and Differentials Parameters | Neutrophils (N=1,1,4,9,6,17,1) | 0.9 10^9 /L | Standard Error 3.7 |
| 150mg BID | Difference From Baseline for Haematology and Differentials Parameters | Neutrophils (N=1,1,4,9,6,17,1) | -1.0 10^9 /L | Standard Error 5.6 |
| 150mg BID | Difference From Baseline for Haematology and Differentials Parameters | Platelets | -2.5 10^9 /L | Standard Error 25.2 |
| 150mg BID | Difference From Baseline for Haematology and Differentials Parameters | White blood cell count | -0.8 10^9 /L | Standard Error 2.6 |
| 150mg BID | Difference From Baseline for Haematology and Differentials Parameters | Lymphocytes (N=1,1,4,9,4,17,1) | 1.0 10^9 /L | Standard Error 1.1 |
| 200mg BID | Difference From Baseline for Haematology and Differentials Parameters | White blood cell count | -0.1 10^9 /L | Standard Error 5.6 |
| 200mg BID | Difference From Baseline for Haematology and Differentials Parameters | Lymphocytes (N=1,1,4,9,4,17,1) | 0.0 10^9 /L | Standard Error 1.6 |
| 200mg BID | Difference From Baseline for Haematology and Differentials Parameters | Platelets | -38.1 10^9 /L | Standard Error 39.9 |
| 200mg BID | Difference From Baseline for Haematology and Differentials Parameters | Neutrophils (N=1,1,4,9,6,17,1) | -2.4 10^9 /L | Standard Error 10 |
| 250mg BID | Difference From Baseline for Haematology and Differentials Parameters | White blood cell count | 0.7 10^9 /L | Standard Error 2.9 |
| 250mg BID | Difference From Baseline for Haematology and Differentials Parameters | Platelets | 11.2 10^9 /L | Standard Error 65.9 |
| 250mg BID | Difference From Baseline for Haematology and Differentials Parameters | Lymphocytes (N=1,1,4,9,4,17,1) | 0.6 10^9 /L | Standard Error 0.6 |
| 250mg BID | Difference From Baseline for Haematology and Differentials Parameters | Neutrophils (N=1,1,4,9,6,17,1) | -0.5 10^9 /L | Standard Error 3 |
| 300mg BID | Difference From Baseline for Haematology and Differentials Parameters | White blood cell count | 0.0 10^9 /L | Standard Error 0 |
| 300mg BID | Difference From Baseline for Haematology and Differentials Parameters | Platelets | -27.1 10^9 /L | Standard Error 0 |
| 300mg BID | Difference From Baseline for Haematology and Differentials Parameters | Neutrophils (N=1,1,4,9,6,17,1) | -1.2 10^9 /L | Standard Error 0 |
| 300mg BID | Difference From Baseline for Haematology and Differentials Parameters | Lymphocytes (N=1,1,4,9,4,17,1) | 1.1 10^9 /L | Standard Error 0 |
Primary
Difference From Baseline for Haemoglobin
Difference from baseline for Haemoglobin (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.
Time frame: From baseline until end of treatment, up to 991 days
Population: Treated set.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| 50mg QD | Difference From Baseline for Haemoglobin | -1.8 g/dL | Standard Error 0 |
| 200mg QD | Difference From Baseline for Haemoglobin | 1.4 g/dL | Standard Error 0 |
| 100mg BID | Difference From Baseline for Haemoglobin | 0.4 g/dL | Standard Error 2.3 |
| 150mg BID | Difference From Baseline for Haemoglobin | 1.0 g/dL | Standard Error 1.3 |
| 200mg BID | Difference From Baseline for Haemoglobin | 1.2 g/dL | Standard Error 0.7 |
| 250mg BID | Difference From Baseline for Haemoglobin | -0.2 g/dL | Standard Error 2.1 |
| 300mg BID | Difference From Baseline for Haemoglobin | 1.1 g/dL | Standard Error 0 |
Primary
Difference From Baseline for Liver Enzymes
Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.
Time frame: From signing the informed consent until end of treatment, up to 991 days
Population: Treated set.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| 50mg QD | Difference From Baseline for Liver Enzymes | Aspartate aminotransferase | 14.3 U/L | Standard Error 0 |
| 50mg QD | Difference From Baseline for Liver Enzymes | Alanine aminotransferase | 10.6 U/L | Standard Error 0 |
| 50mg QD | Difference From Baseline for Liver Enzymes | Alkaline phosphatase | 127.0 U/L | Standard Error 0 |
| 200mg QD | Difference From Baseline for Liver Enzymes | Alanine aminotransferase | 6.6 U/L | Standard Error 0 |
| 200mg QD | Difference From Baseline for Liver Enzymes | Alkaline phosphatase | 11.9 U/L | Standard Error 0 |
| 200mg QD | Difference From Baseline for Liver Enzymes | Aspartate aminotransferase | 13.7 U/L | Standard Error 0 |
| 100mg BID | Difference From Baseline for Liver Enzymes | Alkaline phosphatase | -39.0 U/L | Standard Error 70.5 |
| 100mg BID | Difference From Baseline for Liver Enzymes | Aspartate aminotransferase | 9.6 U/L | Standard Error 18 |
| 100mg BID | Difference From Baseline for Liver Enzymes | Alanine aminotransferase | 0.6 U/L | Standard Error 11.1 |
| 150mg BID | Difference From Baseline for Liver Enzymes | Aspartate aminotransferase | 6.8 U/L | Standard Error 9.1 |
| 150mg BID | Difference From Baseline for Liver Enzymes | Alkaline phosphatase | -21.2 U/L | Standard Error 96.4 |
| 150mg BID | Difference From Baseline for Liver Enzymes | Alanine aminotransferase | -1.6 U/L | Standard Error 18.8 |
| 200mg BID | Difference From Baseline for Liver Enzymes | Alkaline phosphatase | -11.7 U/L | Standard Error 81 |
| 200mg BID | Difference From Baseline for Liver Enzymes | Aspartate aminotransferase | 4.3 U/L | Standard Error 41 |
| 200mg BID | Difference From Baseline for Liver Enzymes | Alanine aminotransferase | 9.1 U/L | Standard Error 45.4 |
| 250mg BID | Difference From Baseline for Liver Enzymes | Aspartate aminotransferase | 15.9 U/L | Standard Error 35.1 |
| 250mg BID | Difference From Baseline for Liver Enzymes | Alkaline phosphatase | 16.0 U/L | Standard Error 180.9 |
| 250mg BID | Difference From Baseline for Liver Enzymes | Alanine aminotransferase | 17.0 U/L | Standard Error 33.6 |
| 300mg BID | Difference From Baseline for Liver Enzymes | Alkaline phosphatase | 7.2 U/L | Standard Error 0 |
| 300mg BID | Difference From Baseline for Liver Enzymes | Alanine aminotransferase | 12.4 U/L | Standard Error 0 |
| 300mg BID | Difference From Baseline for Liver Enzymes | Aspartate aminotransferase | 7.6 U/L | Standard Error 0 |
Primary
Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1
All patients who had grade 1 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).
Time frame: From signing the informed consent until final follow-up, up to 991 days
Population: Treated set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Toothache | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Headache | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Gastrointestinal haemorrhage | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Vertigo | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Chills | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Flatulence | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Hyperglycaemia | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Cough | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Dry skin | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Muscle spasms | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Muscular weakness | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Abdominal distension | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Hot flush | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Hyperhidrosis | 100 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Sciatica | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Arthralgia | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Eye disorder | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Joint swelling | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Fatigue | 100 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Myalgia | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Xerosis | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Incontinence | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Conjunctivitis | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Eyelid oedema | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Rash maculo-papular | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Musculoskeletal chest pain | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Rash | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Musculoskeletal pain | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Sinus tachycardia | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Hypersensitivity | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Neck pain | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Chest pain | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Visual impairment | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Hepatic pain | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Pyrexia | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Haematuria | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Nasopharyngitis | 100 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Pain in extremity | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Carpal tunnel syndrome | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Gastric disorder | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Nail disorder | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Dysuria | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Diarrhoea | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Eye pain | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Vulvovaginal dryness | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Dyspepsia | 100 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Balance disorder | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Tooth discolouration | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Gastrointestinal infection | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Insomnia | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Urinary tract infection | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Arrhythmia | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Asthenia | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Alopecia | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Bronchitis | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Rales | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Nausea | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Viral infection | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Dizziness | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Adverse drug reaction | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Constipation | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Haemoptysis | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Haemorrhoids | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Vomiting | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Gastrooesophageal reflux disease | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Dyspnoea | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Anorexia | 100 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Dysgeusia | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Peripheral sensory neuropathy | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Anxiety | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Abdominal pain | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Pruritus | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Back pain | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Weight decreased | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Bone pain | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Conjunctivitis | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Dysgeusia | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Gastrooesophageal reflux disease | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Nasopharyngitis | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Tooth discolouration | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Dry skin | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Headache | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Joint swelling | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Asthenia | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Flatulence | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Weight decreased | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Xerosis | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Dizziness | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Rash maculo-papular | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Gastrointestinal infection | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Dyspepsia | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Back pain | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Bone pain | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Myalgia | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Arthralgia | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Sinus tachycardia | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Hyperglycaemia | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Muscular weakness | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Musculoskeletal chest pain | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Diarrhoea | 100 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Carpal tunnel syndrome | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Constipation | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Pyrexia | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Alopecia | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Bronchitis | 100 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Gastrointestinal haemorrhage | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Haemorrhoids | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Chest pain | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Vertigo | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Haemoptysis | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Toothache | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Cough | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Pruritus | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Hot flush | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Muscle spasms | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Visual impairment | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Incontinence | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Eye disorder | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Sciatica | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Chills | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Abdominal distension | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Rash | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Eyelid oedema | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Gastric disorder | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Anorexia | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Haematuria | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Neck pain | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Musculoskeletal pain | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Nail disorder | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Pain in extremity | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Dysuria | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Insomnia | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Vulvovaginal dryness | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Hepatic pain | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Adverse drug reaction | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Arrhythmia | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Balance disorder | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Rales | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Nausea | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Viral infection | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Urinary tract infection | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Fatigue | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Eye pain | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Peripheral sensory neuropathy | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Vomiting | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Anxiety | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Hyperhidrosis | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Abdominal pain | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Dyspnoea | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Hypersensitivity | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Cough | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Abdominal distension | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Balance disorder | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Dry skin | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Carpal tunnel syndrome | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Visual impairment | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Sciatica | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Dysuria | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Anorexia | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Eye pain | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Dyspnoea | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Rash maculo-papular | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Sinus tachycardia | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Hyperhidrosis | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Alopecia | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Diarrhoea | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Bronchitis | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Pyrexia | 25 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Haemorrhoids | 25 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Toothache | 25 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Muscle spasms | 25 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Incontinence | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Eye disorder | 25 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Conjunctivitis | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Eyelid oedema | 25 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Haematuria | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Neck pain | 25 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Pain in extremity | 25 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Musculoskeletal pain | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Insomnia | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Vulvovaginal dryness | 25 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Hepatic pain | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Arrhythmia | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Nausea | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Peripheral sensory neuropathy | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Vomiting | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Abdominal pain | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Dysgeusia | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Gastrooesophageal reflux disease | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Tooth discolouration | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Joint swelling | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Asthenia | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Xerosis | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Back pain | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Gastrointestinal infection | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Bone pain | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Dyspepsia | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Muscular weakness | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Arthralgia | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Musculoskeletal chest pain | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Hyperglycaemia | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Myalgia | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Dizziness | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Pruritus | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Weight decreased | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Headache | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Anxiety | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Urinary tract infection | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Rales | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Fatigue | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Nail disorder | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Rash | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Haemoptysis | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Chills | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Hot flush | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Vertigo | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Chest pain | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Constipation | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Flatulence | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Adverse drug reaction | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Gastric disorder | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Nasopharyngitis | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Hypersensitivity | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Gastrointestinal haemorrhage | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Viral infection | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Urinary tract infection | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Dysgeusia | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Vomiting | 22 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Dysuria | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Anxiety | 11 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Hepatic pain | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Eye pain | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Nausea | 33 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Anorexia | 11 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Arrhythmia | 11 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Sciatica | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Rales | 11 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Dry skin | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Peripheral sensory neuropathy | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Vulvovaginal dryness | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Pain in extremity | 11 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Insomnia | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Gastric disorder | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Nail disorder | 11 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Fatigue | 33 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Neck pain | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Chills | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Muscle spasms | 11 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Haematuria | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Musculoskeletal pain | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Rash | 11 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Carpal tunnel syndrome | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Gastrointestinal haemorrhage | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Eye disorder | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Bronchitis | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Incontinence | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Visual impairment | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Hot flush | 11 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Pyrexia | 11 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Gastrooesophageal reflux disease | 11 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Chest pain | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Toothache | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Cough | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Balance disorder | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Vertigo | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Conjunctivitis | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Abdominal distension | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Haemorrhoids | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Eyelid oedema | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Diarrhoea | 44 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Hypersensitivity | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Constipation | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Alopecia | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Hyperhidrosis | 11 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Hyperglycaemia | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Adverse drug reaction | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Musculoskeletal chest pain | 11 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Haemoptysis | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Rash maculo-papular | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Dyspepsia | 11 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Arthralgia | 11 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Muscular weakness | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Sinus tachycardia | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Myalgia | 11 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Pruritus | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Bone pain | 22 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Weight decreased | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Gastrointestinal infection | 11 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Xerosis | 11 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Nasopharyngitis | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Dizziness | 22 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Flatulence | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Dyspnoea | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Back pain | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Asthenia | 11 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Tooth discolouration | 11 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Viral infection | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Headache | 11 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Joint swelling | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Abdominal pain | 11 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Arrhythmia | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Anorexia | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Gastrooesophageal reflux disease | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Hepatic pain | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Dyspepsia | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Fatigue | 17 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Nasopharyngitis | 33 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Hyperhidrosis | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Diarrhoea | 50 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Pyrexia | 17 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Eyelid oedema | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Haemorrhoids | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Toothache | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Bronchitis | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Eye disorder | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Muscle spasms | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Neck pain | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Pain in extremity | 17 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Vulvovaginal dryness | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Nausea | 67 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Vomiting | 33 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Abdominal pain | 33 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Tooth discolouration | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Asthenia | 33 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Xerosis | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Gastrointestinal infection | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Bone pain | 17 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Arthralgia | 50 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Musculoskeletal chest pain | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Myalgia | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Dizziness | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Headache | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Anxiety | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Rales | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Nail disorder | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Rash | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Hot flush | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Vertigo | 17 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Constipation | 17 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Flatulence | 17 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Gastric disorder | 17 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Hypersensitivity | 17 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Viral infection | 17 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Musculoskeletal pain | 17 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Balance disorder | 17 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Carpal tunnel syndrome | 17 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Sciatica | 17 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Dysuria | 17 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Dyspnoea | 33 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Rash maculo-papular | 17 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Sinus tachycardia | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Eye pain | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Visual impairment | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Abdominal distension | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Gastrointestinal haemorrhage | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Adverse drug reaction | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Chest pain | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Chills | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Urinary tract infection | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Weight decreased | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Hyperglycaemia | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Muscular weakness | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Back pain | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Joint swelling | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Dysgeusia | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Peripheral sensory neuropathy | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Insomnia | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Haematuria | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Incontinence | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Cough | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Alopecia | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Dry skin | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Pruritus | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Conjunctivitis | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Haemoptysis | 0 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Cough | 5 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Viral infection | 0 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Hypersensitivity | 0 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Gastrointestinal haemorrhage | 5 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Gastric disorder | 0 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Flatulence | 11 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Fatigue | 0 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Adverse drug reaction | 5 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Constipation | 16 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Vertigo | 0 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Chest pain | 5 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Hot flush | 0 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Rash | 0 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Dyspepsia | 0 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Chills | 5 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Nail disorder | 0 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Hepatic pain | 5 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Rales | 0 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Anxiety | 0 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Urinary tract infection | 5 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Headache | 5 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Dizziness | 5 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Pruritus | 5 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Weight decreased | 11 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Myalgia | 0 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Musculoskeletal chest pain | 0 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Arthralgia | 5 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Bone pain | 0 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Muscular weakness | 11 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Gastrointestinal infection | 0 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Xerosis | 0 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Hyperglycaemia | 5 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Back pain | 5 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Asthenia | 5 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Tooth discolouration | 0 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Joint swelling | 5 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Gastrooesophageal reflux disease | 0 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Abdominal pain | 11 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Dysgeusia | 5 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Vomiting | 5 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Nausea | 21 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Haemoptysis | 0 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Peripheral sensory neuropathy | 5 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Vulvovaginal dryness | 0 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Pain in extremity | 5 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Conjunctivitis | 0 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Insomnia | 11 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Neck pain | 0 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Muscle spasms | 11 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Haematuria | 5 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Eye disorder | 0 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Bronchitis | 0 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Arrhythmia | 0 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Incontinence | 5 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Pyrexia | 5 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Toothache | 0 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Haemorrhoids | 5 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Abdominal distension | 5 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Diarrhoea | 37 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Hyperhidrosis | 5 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Alopecia | 5 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Anorexia | 16 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Rash maculo-papular | 0 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Nasopharyngitis | 5 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Sinus tachycardia | 5 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Dyspnoea | 0 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Dysuria | 0 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Eyelid oedema | 0 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Eye pain | 5 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Sciatica | 0 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Carpal tunnel syndrome | 0 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Dry skin | 5 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Visual impairment | 5 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Balance disorder | 0 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Musculoskeletal pain | 5 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Toothache | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Abdominal distension | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Vomiting | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Hypersensitivity | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Arrhythmia | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Gastric disorder | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Fatigue | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Dysuria | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Gastrointestinal haemorrhage | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Dysgeusia | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Flatulence | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Cough | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Constipation | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Nausea | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Diarrhoea | 100 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Vulvovaginal dryness | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Adverse drug reaction | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Vertigo | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Balance disorder | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Hot flush | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Dyspepsia | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Hyperhidrosis | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Chest pain | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Peripheral sensory neuropathy | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Rash | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Sciatica | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Nail disorder | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Pain in extremity | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Eyelid oedema | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Chills | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Neck pain | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Rales | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Musculoskeletal pain | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Hepatic pain | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Alopecia | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Anxiety | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Insomnia | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Headache | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Haemoptysis | 100 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Anorexia | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Urinary tract infection | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Muscle spasms | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Dizziness | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Dry skin | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Myalgia | 100 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Eye disorder | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Conjunctivitis | 100 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Weight decreased | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Nasopharyngitis | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Musculoskeletal chest pain | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Haematuria | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Arthralgia | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Pruritus | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Rash maculo-papular | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Bone pain | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Bronchitis | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Hyperglycaemia | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Eye pain | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Muscular weakness | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Gastrointestinal infection | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Pyrexia | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Dyspnoea | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Asthenia | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Visual impairment | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Incontinence | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Back pain | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Carpal tunnel syndrome | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Tooth discolouration | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Sinus tachycardia | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Gastrooesophageal reflux disease | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Xerosis | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Haemorrhoids | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Joint swelling | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Viral infection | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 | Abdominal pain | 0 percentage of participants |
Primary
Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2
All patients who had grade 2 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).
Time frame: From signing the informed consent until final follow-up, up to 991 days
Population: Treated set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Vomiting | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Deep vein thrombosis | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Headache | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Nausea | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Flatulence | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Parotitis | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Productive cough | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Bronchitis | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Osteolysis | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Osteoarthritis | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Diarrhoea | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Anorexia | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Abdominal pain upper | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Fatigue | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Gastrointestinal disorder | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Dehydration | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Musculoskeletal pain | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Groin pain | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Dyspnoea | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Phlebitis superficial | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Chest pain | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Anaemia | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Oedema peripheral | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Constipation | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Urinary tract infection | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Asthenia | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Musculoskeletal chest pain | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Neutropenia | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Gamma-glutamyltransferase increased | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Bone pain | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Gastrointestinal infection | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Peripheral sensory neuropathy | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Arthralgia | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Sciatica | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Cough | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Abdominal pain | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Weight decreased | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Haemoptysis | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Back pain | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Cough | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Oedema peripheral | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Constipation | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Nausea | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Abdominal pain | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Productive cough | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Musculoskeletal chest pain | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Parotitis | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Peripheral sensory neuropathy | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Headache | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Bronchitis | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Urinary tract infection | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Diarrhoea | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Flatulence | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Osteolysis | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Haemoptysis | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Osteoarthritis | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Neutropenia | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Asthenia | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Dehydration | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Weight decreased | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Abdominal pain upper | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Anorexia | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Fatigue | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Gamma-glutamyltransferase increased | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Gastrointestinal infection | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Gastrointestinal disorder | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Arthralgia | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Vomiting | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Dyspnoea | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Musculoskeletal pain | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Phlebitis superficial | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Groin pain | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Sciatica | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Chest pain | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Bone pain | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Deep vein thrombosis | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Back pain | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Anaemia | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Vomiting | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Sciatica | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Productive cough | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Neutropenia | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Oedema peripheral | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Gamma-glutamyltransferase increased | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Chest pain | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Peripheral sensory neuropathy | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Cough | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Anorexia | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Osteoarthritis | 25 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Musculoskeletal pain | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Flatulence | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Constipation | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Headache | 25 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Urinary tract infection | 25 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Arthralgia | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Weight decreased | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Musculoskeletal chest pain | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Bone pain | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Back pain | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Gastrointestinal infection | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Asthenia | 25 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Abdominal pain | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Anaemia | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Haemoptysis | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Dyspnoea | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Nausea | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Bronchitis | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Parotitis | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Osteolysis | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Diarrhoea | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Fatigue | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Abdominal pain upper | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Dehydration | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Gastrointestinal disorder | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Phlebitis superficial | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Groin pain | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Deep vein thrombosis | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Chest pain | 11 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Diarrhoea | 11 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Constipation | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Cough | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Abdominal pain upper | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Phlebitis superficial | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Urinary tract infection | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Weight decreased | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Back pain | 11 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Peripheral sensory neuropathy | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Haemoptysis | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Osteoarthritis | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Parotitis | 11 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Osteolysis | 11 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Gastrointestinal disorder | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Groin pain | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Anaemia | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Neutropenia | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Oedema peripheral | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Gamma-glutamyltransferase increased | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Dehydration | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Productive cough | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Deep vein thrombosis | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Fatigue | 22 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Anorexia | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Bronchitis | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Nausea | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Vomiting | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Abdominal pain | 11 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Asthenia | 11 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Gastrointestinal infection | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Bone pain | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Arthralgia | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Musculoskeletal chest pain | 11 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Headache | 11 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Flatulence | 11 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Musculoskeletal pain | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Sciatica | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Dyspnoea | 11 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Nausea | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Dehydration | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Arthralgia | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Gamma-glutamyltransferase increased | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Haemoptysis | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Weight decreased | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Bone pain | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Fatigue | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Constipation | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Musculoskeletal pain | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Cough | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Back pain | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Sciatica | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Abdominal pain | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Abdominal pain upper | 17 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Peripheral sensory neuropathy | 17 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Gastrointestinal infection | 17 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Asthenia | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Groin pain | 17 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Oedema peripheral | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Anorexia | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Deep vein thrombosis | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Flatulence | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Osteolysis | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Phlebitis superficial | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Diarrhoea | 33 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Gastrointestinal disorder | 17 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Chest pain | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Anaemia | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Parotitis | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Headache | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Neutropenia | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Bronchitis | 17 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Productive cough | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Dyspnoea | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Vomiting | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Osteoarthritis | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Musculoskeletal chest pain | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Urinary tract infection | 0 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Parotitis | 0 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Groin pain | 0 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Musculoskeletal pain | 5 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Deep vein thrombosis | 5 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Gastrointestinal disorder | 0 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Abdominal pain upper | 0 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Fatigue | 11 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Osteolysis | 0 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Anorexia | 11 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Diarrhoea | 21 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Sciatica | 11 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Bronchitis | 0 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Osteoarthritis | 0 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Nausea | 11 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Haemoptysis | 5 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Vomiting | 5 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Cough | 11 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Peripheral sensory neuropathy | 0 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Asthenia | 11 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Constipation | 5 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Gastrointestinal infection | 0 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Back pain | 0 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Weight decreased | 5 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Bone pain | 11 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Urinary tract infection | 5 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Arthralgia | 5 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Abdominal pain | 0 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Musculoskeletal chest pain | 0 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Chest pain | 0 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Headache | 0 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Phlebitis superficial | 5 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Dyspnoea | 11 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Flatulence | 0 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Oedema peripheral | 5 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Gamma-glutamyltransferase increased | 5 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Neutropenia | 5 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Dehydration | 5 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Anaemia | 5 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Productive cough | 5 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Constipation | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Chest pain | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Neutropenia | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Haemoptysis | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Deep vein thrombosis | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Dyspnoea | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Bronchitis | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Osteoarthritis | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Osteolysis | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Headache | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Diarrhoea | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Phlebitis superficial | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Groin pain | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Parotitis | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Dehydration | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Anorexia | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Abdominal pain upper | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Flatulence | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Gastrointestinal disorder | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Asthenia | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Back pain | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Oedema peripheral | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Sciatica | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Anaemia | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Gastrointestinal infection | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Urinary tract infection | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Peripheral sensory neuropathy | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Weight decreased | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Fatigue | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Vomiting | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Abdominal pain | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Musculoskeletal pain | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Bone pain | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Cough | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Productive cough | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Musculoskeletal chest pain | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Nausea | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Gamma-glutamyltransferase increased | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 | Arthralgia | 0 percentage of participants |
Primary
Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3
All patients who had grade 3 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).
Time frame: From signing the informed consent until final follow-up, up to 991 days
Population: Treated set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Convulsion | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Subileus | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Lymphopenia | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Renal failure | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Ileus | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Dyspnoea | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Urinary tract obstruction | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Gamma-glutamyltransferase increased | 100 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Vomiting | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Diarrhoea infectious | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Pneumonia | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Pleural effusion | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Haemorrhoids | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Diarrhoea | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Constipation | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Pleural effusion | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Haemorrhoids | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Constipation | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Ileus | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Gamma-glutamyltransferase increased | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Vomiting | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Urinary tract obstruction | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Renal failure | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Diarrhoea | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Convulsion | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Pneumonia | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Diarrhoea infectious | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Subileus | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Dyspnoea | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Lymphopenia | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Ileus | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Gamma-glutamyltransferase increased | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Lymphopenia | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Vomiting | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Pleural effusion | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Constipation | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Diarrhoea | 25 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Subileus | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Renal failure | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Haemorrhoids | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Diarrhoea infectious | 25 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Pneumonia | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Convulsion | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Dyspnoea | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Urinary tract obstruction | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Gamma-glutamyltransferase increased | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Diarrhoea | 11 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Diarrhoea infectious | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Dyspnoea | 11 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Ileus | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Urinary tract obstruction | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Lymphopenia | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Constipation | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Haemorrhoids | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Subileus | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Vomiting | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Pneumonia | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Convulsion | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Renal failure | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Pleural effusion | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Pleural effusion | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Lymphopenia | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Diarrhoea | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Gamma-glutamyltransferase increased | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Pneumonia | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Constipation | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Haemorrhoids | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Subileus | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Ileus | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Convulsion | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Diarrhoea infectious | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Renal failure | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Urinary tract obstruction | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Vomiting | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Dyspnoea | 0 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Diarrhoea infectious | 0 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Ileus | 5 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Subileus | 5 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Vomiting | 5 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Diarrhoea | 5 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Pneumonia | 5 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Gamma-glutamyltransferase increased | 0 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Convulsion | 5 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Lymphopenia | 5 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Pleural effusion | 5 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Renal failure | 11 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Urinary tract obstruction | 5 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Constipation | 5 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Dyspnoea | 5 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Haemorrhoids | 5 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Diarrhoea infectious | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Diarrhoea | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Constipation | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Renal failure | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Subileus | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Ileus | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Pneumonia | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Gamma-glutamyltransferase increased | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Lymphopenia | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Pleural effusion | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Vomiting | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Urinary tract obstruction | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Convulsion | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Haemorrhoids | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 | Dyspnoea | 0 percentage of participants |
Primary
Incidence and Intensity of Adverse Events With Highest CTCAE Grade 4
All patients who had grade 4 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).
Time frame: From signing the informed consent until final follow-up, up to 991 days
Population: Treated set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 4 | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 4 | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 4 | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 4 | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 4 | 0 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 4 | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 4 | 0 percentage of participants |
Primary
Incidence and Intensity of Adverse Events With Highest CTCAE Grade 5
All patients who had grade 5 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).
Time frame: From signing the informed consent until final follow-up, up to 991 days
Population: Treated set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 5 | Malignant neoplasm progression | 0 percentage of participants |
| 50mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 5 | Subdural Haematoma | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 5 | Subdural Haematoma | 0 percentage of participants |
| 200mg QD | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 5 | Malignant neoplasm progression | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 5 | Malignant neoplasm progression | 0 percentage of participants |
| 100mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 5 | Subdural Haematoma | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 5 | Malignant neoplasm progression | 0 percentage of participants |
| 150mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 5 | Subdural Haematoma | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 5 | Malignant neoplasm progression | 0 percentage of participants |
| 200mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 5 | Subdural Haematoma | 0 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 5 | Subdural Haematoma | 5 percentage of participants |
| 250mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 5 | Malignant neoplasm progression | 26 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 5 | Malignant neoplasm progression | 0 percentage of participants |
| 300mg BID | Incidence and Intensity of Adverse Events With Highest CTCAE Grade 5 | Subdural Haematoma | 0 percentage of participants |
Secondary
Clinical Benefit
Clinical benefit was defined as the absence of disease progression (no PD or nonevaluable clinically progressive disease) determined by RECIST (version 1.0).
Time frame: Baseline until end of treatment, up to 991 days
Population: Treated set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 50mg QD | Clinical Benefit | No | 0 percentage of participants |
| 50mg QD | Clinical Benefit | Yes | 100 percentage of participants |
| 200mg QD | Clinical Benefit | No | 0 percentage of participants |
| 200mg QD | Clinical Benefit | Yes | 100 percentage of participants |
| 100mg BID | Clinical Benefit | No | 0 percentage of participants |
| 100mg BID | Clinical Benefit | Yes | 100 percentage of participants |
| 150mg BID | Clinical Benefit | No | 0 percentage of participants |
| 150mg BID | Clinical Benefit | Yes | 100 percentage of participants |
| 200mg BID | Clinical Benefit | No | 0 percentage of participants |
| 200mg BID | Clinical Benefit | Yes | 100 percentage of participants |
| 250mg BID | Clinical Benefit | No | 11 percentage of participants |
| 250mg BID | Clinical Benefit | Yes | 89 percentage of participants |
| 300mg BID | Clinical Benefit | No | 0 percentage of participants |
| 300mg BID | Clinical Benefit | Yes | 100 percentage of participants |
Secondary
Clinically Relevant Abnormalities for Vital Signs
Clinically relevant abnormalities for Vital Signs (systolic blood pressure, diastolic blood pressure, and pulse rate). New abnormal findings or worsening of baseline conditions were reported as Adverse Events.
Time frame: From baseline until final follow-up, up to 991 days
Population: Treated set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 50mg QD | Clinically Relevant Abnormalities for Vital Signs | 0.0 percentage of participants |
| 200mg QD | Clinically Relevant Abnormalities for Vital Signs | 0.0 percentage of participants |
| 100mg BID | Clinically Relevant Abnormalities for Vital Signs | 0.0 percentage of participants |
| 150mg BID | Clinically Relevant Abnormalities for Vital Signs | 0.0 percentage of participants |
| 200mg BID | Clinically Relevant Abnormalities for Vital Signs | 0.0 percentage of participants |
| 250mg BID | Clinically Relevant Abnormalities for Vital Signs | 0.0 percentage of participants |
| 300mg BID | Clinically Relevant Abnormalities for Vital Signs | 0.0 percentage of participants |
Secondary
Confirmed Objective Response
Confirmed objective response assessed by RECIST (Response Evaluation Criteria In Solid Tumours) criteria (version 1.0)
Time frame: Baseline until end of treatment, up to 991 days
Population: Treated set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 50mg QD | Confirmed Objective Response | Unknown | 0 percentage of participants |
| 50mg QD | Confirmed Objective Response | Yes | 0 percentage of participants |
| 50mg QD | Confirmed Objective Response | No | 100 percentage of participants |
| 200mg QD | Confirmed Objective Response | Yes | 100 percentage of participants |
| 200mg QD | Confirmed Objective Response | No | 0 percentage of participants |
| 200mg QD | Confirmed Objective Response | Unknown | 0 percentage of participants |
| 100mg BID | Confirmed Objective Response | Unknown | 0 percentage of participants |
| 100mg BID | Confirmed Objective Response | No | 100 percentage of participants |
| 100mg BID | Confirmed Objective Response | Yes | 0 percentage of participants |
| 150mg BID | Confirmed Objective Response | No | 56 percentage of participants |
| 150mg BID | Confirmed Objective Response | Yes | 0 percentage of participants |
| 150mg BID | Confirmed Objective Response | Unknown | 44 percentage of participants |
| 200mg BID | Confirmed Objective Response | Yes | 0 percentage of participants |
| 200mg BID | Confirmed Objective Response | No | 100 percentage of participants |
| 200mg BID | Confirmed Objective Response | Unknown | 0 percentage of participants |
| 250mg BID | Confirmed Objective Response | No | 58 percentage of participants |
| 250mg BID | Confirmed Objective Response | Unknown | 42 percentage of participants |
| 250mg BID | Confirmed Objective Response | Yes | 0 percentage of participants |
| 300mg BID | Confirmed Objective Response | Unknown | 0 percentage of participants |
| 300mg BID | Confirmed Objective Response | Yes | 0 percentage of participants |
| 300mg BID | Confirmed Objective Response | No | 100 percentage of participants |
Secondary
Pre-dose Concentration of Nintedanib in Plasma at Steady-state (Cpre,ss)
Cpre,ss represents the pre-dose concentration of Nintedanib in Plasma at steady-state at day 29
Time frame: Just before drug administration every 28±7 days after day 29
Population: Treated set. No descriptive statistics could be calculated for the dosing groups 50 mg and 200 mg QD; 100 mg and 300 mg BID due to insufficient patients.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 150mg BID | Pre-dose Concentration of Nintedanib in Plasma at Steady-state (Cpre,ss) | 7.54 ng/mL | Geometric Coefficient of Variation 48.3 |
| 200mg BID | Pre-dose Concentration of Nintedanib in Plasma at Steady-state (Cpre,ss) | 11.8 ng/mL | Geometric Coefficient of Variation 33.5 |
| 250mg BID | Pre-dose Concentration of Nintedanib in Plasma at Steady-state (Cpre,ss) | 11.0 ng/mL | Geometric Coefficient of Variation 48.5 |
Secondary
Progression Free Survival
Percentage of participants that experienced progression free survival (PFS), assessed by RECIST (Response Evaluation Criteria In Solid Tumours) (version 1.0), by day 1230. Progression was defined as progressive disease (PD) or non-evaluable clinically progressive disease. PFS was defined for patients without PD at screening as the time from first treatment with the trial drug in the previous trial until onset of PD or death, whatever comes earlier. Patients with PD could enter the trial if they showed signs of clinical benefit. For patients with PD at screening, the RECIST assessment at screening was used as a new baseline value and PFS was the time from first treatment with the trial drug in this trial until the onset of progressive disease in this trial or death, whatever comes first.
Time frame: First drug administration (in previous trial) until end of treatment, up to 1230 days
Population: Treated set. Data for category
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 50mg QD | Progression Free Survival | Progression (RECIST) | 0 percentage of participants |
| 50mg QD | Progression Free Survival | Unknown | 0 percentage of participants |
| 50mg QD | Progression Free Survival | No progressive disease (RECIST) or death | 100 percentage of participants |
| 50mg QD | Progression Free Survival | Death | 0 percentage of participants |
| 200mg QD | Progression Free Survival | Unknown | 0 percentage of participants |
| 200mg QD | Progression Free Survival | Death | 0 percentage of participants |
| 200mg QD | Progression Free Survival | Progression (RECIST) | 100 percentage of participants |
| 200mg QD | Progression Free Survival | No progressive disease (RECIST) or death | 0 percentage of participants |
| 100mg BID | Progression Free Survival | Unknown | 0 percentage of participants |
| 100mg BID | Progression Free Survival | Progression (RECIST) | 25 percentage of participants |
| 100mg BID | Progression Free Survival | Death | 0 percentage of participants |
| 100mg BID | Progression Free Survival | No progressive disease (RECIST) or death | 75 percentage of participants |
| 150mg BID | Progression Free Survival | Progression (RECIST) | 11 percentage of participants |
| 150mg BID | Progression Free Survival | Death | 0 percentage of participants |
| 150mg BID | Progression Free Survival | Unknown | 45 percentage of participants |
| 150mg BID | Progression Free Survival | No progressive disease (RECIST) or death | 44 percentage of participants |
| 200mg BID | Progression Free Survival | Unknown | 0 percentage of participants |
| 200mg BID | Progression Free Survival | Progression (RECIST) | 33 percentage of participants |
| 200mg BID | Progression Free Survival | No progressive disease (RECIST) or death | 67 percentage of participants |
| 200mg BID | Progression Free Survival | Death | 0 percentage of participants |
| 250mg BID | Progression Free Survival | Progression (RECIST) | 42 percentage of participants |
| 250mg BID | Progression Free Survival | Unknown | 10 percentage of participants |
| 250mg BID | Progression Free Survival | No progressive disease (RECIST) or death | 16 percentage of participants |
| 250mg BID | Progression Free Survival | Death | 32 percentage of participants |
| 300mg BID | Progression Free Survival | Unknown | 0 percentage of participants |
| 300mg BID | Progression Free Survival | Progression (RECIST) | 100 percentage of participants |
| 300mg BID | Progression Free Survival | Death | 0 percentage of participants |
| 300mg BID | Progression Free Survival | No progressive disease (RECIST) or death | 0 percentage of participants |
Secondary
Unconfirmed Best Objective Response
Unconfirmed best objective response assessed by RECIST (Response Evaluation Criteria In Solid Tumours) criteria (version 1.0)
Time frame: Baseline until end of treatment, up to 991 days
Population: Treated set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 50mg QD | Unconfirmed Best Objective Response | No | 100 percentage of participants |
| 50mg QD | Unconfirmed Best Objective Response | Unknown | 0 percentage of participants |
| 50mg QD | Unconfirmed Best Objective Response | Yes | 0 percentage of participants |
| 200mg QD | Unconfirmed Best Objective Response | Yes | 100 percentage of participants |
| 200mg QD | Unconfirmed Best Objective Response | No | 0 percentage of participants |
| 200mg QD | Unconfirmed Best Objective Response | Unknown | 0 percentage of participants |
| 100mg BID | Unconfirmed Best Objective Response | Unknown | 0 percentage of participants |
| 100mg BID | Unconfirmed Best Objective Response | No | 100 percentage of participants |
| 100mg BID | Unconfirmed Best Objective Response | Yes | 0 percentage of participants |
| 150mg BID | Unconfirmed Best Objective Response | Yes | 0 percentage of participants |
| 150mg BID | Unconfirmed Best Objective Response | No | 56 percentage of participants |
| 150mg BID | Unconfirmed Best Objective Response | Unknown | 44 percentage of participants |
| 200mg BID | Unconfirmed Best Objective Response | Yes | 0 percentage of participants |
| 200mg BID | Unconfirmed Best Objective Response | No | 100 percentage of participants |
| 200mg BID | Unconfirmed Best Objective Response | Unknown | 0 percentage of participants |
| 250mg BID | Unconfirmed Best Objective Response | Unknown | 42 percentage of participants |
| 250mg BID | Unconfirmed Best Objective Response | Yes | 5 percentage of participants |
| 250mg BID | Unconfirmed Best Objective Response | No | 53 percentage of participants |
| 300mg BID | Unconfirmed Best Objective Response | No | 100 percentage of participants |
| 300mg BID | Unconfirmed Best Objective Response | Unknown | 0 percentage of participants |
| 300mg BID | Unconfirmed Best Objective Response | Yes | 0 percentage of participants |
Secondary
Unconfirmed Best Overall Response
Unconfirmed best overall response assessed by RECIST (Response Evaluation Criteria In Solid Tumours) criteria (version 1.0). PD = Progressive disease.
Time frame: Baseline until end of treatment, up to 991 days
Population: Treated set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 50mg QD | Unconfirmed Best Overall Response | Unknown | 0 percentage of participants |
| 50mg QD | Unconfirmed Best Overall Response | Partial response | 0 percentage of participants |
| 50mg QD | Unconfirmed Best Overall Response | Non-evaluable, clinically non-progressive disease | 0 percentage of participants |
| 50mg QD | Unconfirmed Best Overall Response | Complete response | 0 percentage of participants |
| 50mg QD | Unconfirmed Best Overall Response | Stable disease | 100 percentage of participants |
| 50mg QD | Unconfirmed Best Overall Response | PD or non-evaluable , clinically PD | 0 percentage of participants |
| 200mg QD | Unconfirmed Best Overall Response | Complete response | 100 percentage of participants |
| 200mg QD | Unconfirmed Best Overall Response | Non-evaluable, clinically non-progressive disease | 0 percentage of participants |
| 200mg QD | Unconfirmed Best Overall Response | Unknown | 0 percentage of participants |
| 200mg QD | Unconfirmed Best Overall Response | Partial response | 0 percentage of participants |
| 200mg QD | Unconfirmed Best Overall Response | PD or non-evaluable , clinically PD | 0 percentage of participants |
| 200mg QD | Unconfirmed Best Overall Response | Stable disease | 0 percentage of participants |
| 100mg BID | Unconfirmed Best Overall Response | PD or non-evaluable , clinically PD | 0 percentage of participants |
| 100mg BID | Unconfirmed Best Overall Response | Stable disease | 75 percentage of participants |
| 100mg BID | Unconfirmed Best Overall Response | Unknown | 0 percentage of participants |
| 100mg BID | Unconfirmed Best Overall Response | Non-evaluable, clinically non-progressive disease | 25 percentage of participants |
| 100mg BID | Unconfirmed Best Overall Response | Complete response | 0 percentage of participants |
| 100mg BID | Unconfirmed Best Overall Response | Partial response | 0 percentage of participants |
| 150mg BID | Unconfirmed Best Overall Response | PD or non-evaluable , clinically PD | 11 percentage of participants |
| 150mg BID | Unconfirmed Best Overall Response | Complete response | 0 percentage of participants |
| 150mg BID | Unconfirmed Best Overall Response | Partial response | 0 percentage of participants |
| 150mg BID | Unconfirmed Best Overall Response | Stable disease | 33 percentage of participants |
| 150mg BID | Unconfirmed Best Overall Response | Non-evaluable, clinically non-progressive disease | 11 percentage of participants |
| 150mg BID | Unconfirmed Best Overall Response | Unknown | 44 percentage of participants |
| 200mg BID | Unconfirmed Best Overall Response | Non-evaluable, clinically non-progressive disease | 83 percentage of participants |
| 200mg BID | Unconfirmed Best Overall Response | Partial response | 0 percentage of participants |
| 200mg BID | Unconfirmed Best Overall Response | PD or non-evaluable , clinically PD | 17 percentage of participants |
| 200mg BID | Unconfirmed Best Overall Response | Unknown | 0 percentage of participants |
| 200mg BID | Unconfirmed Best Overall Response | Stable disease | 0 percentage of participants |
| 200mg BID | Unconfirmed Best Overall Response | Complete response | 0 percentage of participants |
| 250mg BID | Unconfirmed Best Overall Response | Stable disease | 16 percentage of participants |
| 250mg BID | Unconfirmed Best Overall Response | Non-evaluable, clinically non-progressive disease | 5 percentage of participants |
| 250mg BID | Unconfirmed Best Overall Response | Partial response | 5 percentage of participants |
| 250mg BID | Unconfirmed Best Overall Response | PD or non-evaluable , clinically PD | 32 percentage of participants |
| 250mg BID | Unconfirmed Best Overall Response | Complete response | 0 percentage of participants |
| 250mg BID | Unconfirmed Best Overall Response | Unknown | 42 percentage of participants |
| 300mg BID | Unconfirmed Best Overall Response | Stable disease | 0 percentage of participants |
| 300mg BID | Unconfirmed Best Overall Response | Partial response | 0 percentage of participants |
| 300mg BID | Unconfirmed Best Overall Response | Unknown | 0 percentage of participants |
| 300mg BID | Unconfirmed Best Overall Response | Non-evaluable, clinically non-progressive disease | 0 percentage of participants |
| 300mg BID | Unconfirmed Best Overall Response | PD or non-evaluable , clinically PD | 100 percentage of participants |
| 300mg BID | Unconfirmed Best Overall Response | Complete response | 0 percentage of participants |