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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-006288-36 | EudraCT Number | EudraCT |
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A phase II trial to assess the impact of afatinib (BIBW 2992) on the heart (QTcF) and the effectiveness of afatinib (BIBW 2992) in treating certain cancers. Cancers studied will include glioblastoma and cancers which have spread to the brain (metastases).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monotherapy | Experimental | BIBW 2992 high dose, once daily, continuous, monotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIBW 2992 | Drug | patients to receive continuous oral daily dosing of BIBW 2992 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response (OR) | OR is defined as complete response and partial response (PR) and was assessed according to the Macdonald criteria for glioblastomas and brain metastases and according to Response Evaluation Criteria in Solid Tumours version 1.0 (RECIST) for solid tumours (excluding glioblastomas). | Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter. |
| Average Time-matched QT Corrected by the Fridericia Formula (QTcF) Change From Baseline to Day 14 | Average time-matched QT corrected by the Fridericia formula (QTcF) change from baseline to day 14 over 1 to 24 hours following administration of afatinib. | The day before the first drug dose (baseline) and the day 14. Electrocardiograms (ECG) were performed at time point 0 and 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 10 h, 24 h thereafter. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | PFS was defined as the time from the first treatment to the occurrence of tumour progression or death, whichever came first. It was assessed according to the Macdonald criteria for glioblastomas and brain metastases and according to RECIST for solid tumours (excluding glioblastomas) as well as by the investigators assessment. Median time results from unstratified Kaplan-Meier estimates. |
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Inclusion criteria:
For patients with Glioma and brain metastases the following additional inclusion criteria should apply:
Exclusion criteria:
Major exclusion criteria; 9. Radiotherapy within the past 2 weeks prior to treatment with the trial drug. 10. Chemo-, hormone- (other than megestrol acetate or steroids required for maintenance non-cancer therapy) or immunotherapy within the past 4 weeks before first drug administration.
11. Patients not completely recovered from any therapy-related toxicities from previous chemo-, hormone-, immuno-, or radiotherapies to CTC < Grade 1. Prior chemotherapy is allowed if completed at least 4 weeks prior to first trial treatment (6 weeks for mitomycin C or nitrosoureas) and the patient has recovered from the acute toxicities of that therapy.
12. Prior treatment with EGFR targeting therapies or treatment with EGFR- or HER2 inhibiting drugs within the past four weeks before start of therapy or concomitantly with this trial.
15. History of clinically significant or uncontrolled cardiac disease, including congestive heart failure, angina, myocardial infarction, arrhythmia, including New York Heart Association (NYHA) functional classification of 3.
16. Cardiac left ventricular function with resting ejection fraction < 50% measured by multigated blood pool imaging of the heart (MUGA scan) or Echocardiogram.
17. QTcF- interval > 470 ms at screening. 18. PR-interval > 230 ms at screening. 19. QRS-interval >120 ms at screening. 20. ST-segment and T/U-wave abnormalities at screening, as will be assessed by a cardiology specialist of a central lab.
21. Absolute neutrophil count (ANC) < 1,500/mm3. 22. Platelet count < 100,000 / mm3. 23. Bilirubin > 1.5 mg / dl (>26 micro mol / L, SI unit equivalent). Aspartate amino transferase (AST) or alanine amino transferase (ALT) > or equal to three times the upper limit of normal (if related to liver metastases > five times the upper limit of normal).
24. Serum creatinine > 1.5 times of the upper normal limit or calculated/measured creatinine clearance > or equal to 45 ml / min.
25. Patients with known Interstitial Lung Disease (ILD) For Patients with glioma and brain metastases additional exclusion criteria apply;
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1200.24.4403 Boehringer Ingelheim Investigational Site | Guildford | United Kingdom | ||||
| 1200.24.4402 Boehringer Ingelheim Investigational Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Patients | Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Patients | Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Objective Response (OR) | OR is defined as complete response and partial response (PR) and was assessed according to the Macdonald criteria for glioblastomas and brain metastases and according to Response Evaluation Criteria in Solid Tumours version 1.0 (RECIST) for solid tumours (excluding glioblastomas). | Treated Set (TS). TS consisted of all patients who received at least one dose of trial medication. | Posted | Number | Participants with OR | Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter. |
|
First administration of trial medication until 28 days after last administration of trial medication
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Patients | Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ocular effect | Eye disorders | MedDRA 14.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077716 | Afatinib |
| ID | Term |
|---|---|
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter. |
| Overall Survival (OS) | Overall survival (OS) is defined as time from start of treatment to death. | Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter. |
| Disease Control | Disease control was defined as CR, PR or stable disease (SD) and was assessed according to the Macdonald criteria for glioblastomas and brain metastases and according to RECIST for solid tumours (excluding glioblastomas). | Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter. |
| Duration of Disease Control (DC) | Duration of Disease control (DC). DC was defined as CR, PR or stable disease (SD) and was assessed according to the Macdonald criteria for glioblastomas and brain metastases and according to RECIST for solid tumours (excluding glioblastomas). | Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter. |
| Patients With Notable Findings in QTcF on Day 14 | Notable findings are defined as a QTcF>500 ms or an increase in QTcF of >60ms. | Day 14 |
| Patients With Clinically Relevant Findings in ECG on Day 14 | Patients with clinically relevant findings in Electrocardiogram data (ECG) on day 14. | Day 14 |
| Time-matched QTcF Changes From Baseline to Day 14 at Each Time-point | Individual QTcF measurements at each time-point. Response was defined as the change from baseline. Analysis adjusted for baseline using a mixed model. | Baseline and day 14 (at 1, 2, 3, 4, 5, 6, 7, 10, 24 hours post-dose ) |
| Average Time-matched QT Change From Baseline to Day 14 | Average time-matched QT change from baseline to day 14 over 1 to 24 hours following administration of afatinib. | The day before the first drug dose (baseline) and the day 14. Electrocardiograms (ECG) were performed at time point 0 and 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 10 h, 24 h thereafter. |
| Patients With Notable Findings in QT on Day 14 | Number of Patients with notable findings in QT on day 14. Notable findings are defined as a QT>500 ms. | Day 14 |
| Average Time-matched Heart Rate Change From Baseline to Day 14. | Average time-matched heart rate change from baseline to day 14. | The day before the first drug dose (baseline) and the day 14. |
| Highest CTC Grade for Adverse Events | Highest Common Terminology Criteria (CTC) grade for adverse events | First administration of trial medication until 28 days after last administration of trial medication |
| Area Under Curve 0-24 Hours (AUC0-24) on Day 1 | AUC0-24 represents the area under the concentration curve of afatinib in plasma from 0 to 24 hours on Day 1. | 0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 1 |
| Maximum Concentration (Cmax) | Cmax represents the maximum measured concentration of afatinib in plasma on Day 1. | 0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 1 |
| Time From Dosing to the Maximum Concentration (Tmax) | tmax represents the time from dosing to the maximum concentration of afatinib in plasma on Day 1. | 0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 1 |
| Area Under Curve of Afatinib Over a Uniform Dosing Interval Tau at Steady State (AUCtau,ss) | AUCtau,ss represents the area under the concentration curve of afatinib in plasma over a uniform dosing interval tau (24h) at steady state (Day14). | 0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 14 |
| Maximum Concentration of Afatinib in Plasma at Steady State (Cmax,ss) | Cmax,ss represents the maximum measured concentration of afatinib in plasma at steady state (Day 14). | 0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 14 |
| Time From Dosing to the Maximum Concentration of Afatinib in Plasma at Steady State (Tmax,ss) | tmax,ss represents the time from dosing to the maximum concentration of afatinib in plasma at steady state (Day 14). | 0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 14 |
| Accumulation Ratio of AUC Values (R_A,AUC) | R_A,AUC represents the accumulation ratio of AUC values after multiple dose administration over a uniform dosing interval t between days 1 and 14 | 0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 1 and 14 |
| Accumulation Ratio of AUC Values (R_A,Cmax) | R_A,Cmax represents the accumulation ratio of Cmax values after multiple dose administration over a uniform dosing interval t between days 1 and 14 | 0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 1 and 14 |
| Percentage Peak Trough Fluctuation (PTF) | PTF represents the percentage peak trough fluctuation. PTF is defined as difference between maximum and minimum concentration at steady state divided by the average concentration multiplied with 100 to report as percentage. | 0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 14 |
| London |
| United Kingdom |
| 1200.24.4404 Boehringer Ingelheim Investigational Site | London | United Kingdom |
| 1200.24.4401 Boehringer Ingelheim Investigational Site | Sutton | United Kingdom |
| Other |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | Average Time-matched QT Corrected by the Fridericia Formula (QTcF) Change From Baseline to Day 14 | Average time-matched QT corrected by the Fridericia formula (QTcF) change from baseline to day 14 over 1 to 24 hours following administration of afatinib. | All patients in TS who had at least 1 time-matched pair of QT measurements available from baseline and from Day 14 of treatment. | Posted | Mean | Standard Error | ms | The day before the first drug dose (baseline) and the day 14. Electrocardiograms (ECG) were performed at time point 0 and 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 10 h, 24 h thereafter. |
|
|
|
| Secondary | Progression-free Survival (PFS) | PFS was defined as the time from the first treatment to the occurrence of tumour progression or death, whichever came first. It was assessed according to the Macdonald criteria for glioblastomas and brain metastases and according to RECIST for solid tumours (excluding glioblastomas) as well as by the investigators assessment. Median time results from unstratified Kaplan-Meier estimates. | All patients from TS who progressed or died. | Posted | Median | 95% Confidence Interval | weeks | Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter. |
|
|
|
| Secondary | Overall Survival (OS) | Overall survival (OS) is defined as time from start of treatment to death. | TS. | Posted | Median | 95% Confidence Interval | weeks | Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter. |
|
|
|
| Secondary | Disease Control | Disease control was defined as CR, PR or stable disease (SD) and was assessed according to the Macdonald criteria for glioblastomas and brain metastases and according to RECIST for solid tumours (excluding glioblastomas). | TS. | Posted | Number | Participants | Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter. |
|
|
|
| Secondary | Duration of Disease Control (DC) | Duration of Disease control (DC). DC was defined as CR, PR or stable disease (SD) and was assessed according to the Macdonald criteria for glioblastomas and brain metastases and according to RECIST for solid tumours (excluding glioblastomas). | TS. | Posted | Median | 95% Confidence Interval | weeks | Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter. |
|
|
|
| Secondary | Patients With Notable Findings in QTcF on Day 14 | Notable findings are defined as a QTcF>500 ms or an increase in QTcF of >60ms. | All patients from TS with data for QTcF on day 14 | Posted | Number | Participants | Day 14 |
|
|
|
| Secondary | Patients With Clinically Relevant Findings in ECG on Day 14 | Patients with clinically relevant findings in Electrocardiogram data (ECG) on day 14. | All patients from TS with data for ECG on day 14 | Posted | Number | Participants | Day 14 |
|
|
|
| Secondary | Time-matched QTcF Changes From Baseline to Day 14 at Each Time-point | Individual QTcF measurements at each time-point. Response was defined as the change from baseline. Analysis adjusted for baseline using a mixed model. | All patients in TS who had at least 1 time-matched pair of QT measurements available from either Day1 or Day 14 of treatment. | Posted | Mean | Standard Error | ms | Baseline and day 14 (at 1, 2, 3, 4, 5, 6, 7, 10, 24 hours post-dose ) |
|
|
|
| Secondary | Average Time-matched QT Change From Baseline to Day 14 | Average time-matched QT change from baseline to day 14 over 1 to 24 hours following administration of afatinib. | All patients in TS who had at least 1 time-matched pair of QT measurements available from baseline and from Day 14 of treatment. | Posted | Mean | Standard Error | ms | The day before the first drug dose (baseline) and the day 14. Electrocardiograms (ECG) were performed at time point 0 and 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 10 h, 24 h thereafter. |
|
|
|
| Secondary | Patients With Notable Findings in QT on Day 14 | Number of Patients with notable findings in QT on day 14. Notable findings are defined as a QT>500 ms. | All patients from TS with data for QTcF on day 14 | Posted | Number | Participants | Day 14 |
|
|
|
| Secondary | Average Time-matched Heart Rate Change From Baseline to Day 14. | Average time-matched heart rate change from baseline to day 14. | All patients in TS who had at least 1 time-matched pair of QT measurements available from baseline and from Day 14 of treatment. | Posted | Mean | Standard Error | bpm | The day before the first drug dose (baseline) and the day 14. |
|
|
|
| Secondary | Highest CTC Grade for Adverse Events | Highest Common Terminology Criteria (CTC) grade for adverse events | All patients from TS with adverse events | Posted | Number | Participants | First administration of trial medication until 28 days after last administration of trial medication |
|
|
|
| Secondary | Area Under Curve 0-24 Hours (AUC0-24) on Day 1 | AUC0-24 represents the area under the concentration curve of afatinib in plasma from 0 to 24 hours on Day 1. | TS. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | 0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 1 |
|
|
|
| Secondary | Maximum Concentration (Cmax) | Cmax represents the maximum measured concentration of afatinib in plasma on Day 1. | TS. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 1 |
|
|
|
| Secondary | Time From Dosing to the Maximum Concentration (Tmax) | tmax represents the time from dosing to the maximum concentration of afatinib in plasma on Day 1. | TS. | Posted | Median | Full Range | hours | 0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 1 |
|
|
|
| Secondary | Area Under Curve of Afatinib Over a Uniform Dosing Interval Tau at Steady State (AUCtau,ss) | AUCtau,ss represents the area under the concentration curve of afatinib in plasma over a uniform dosing interval tau (24h) at steady state (Day14). | TS. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | 0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 14 |
|
|
|
| Secondary | Maximum Concentration of Afatinib in Plasma at Steady State (Cmax,ss) | Cmax,ss represents the maximum measured concentration of afatinib in plasma at steady state (Day 14). | TS. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 14 |
|
|
|
| Secondary | Time From Dosing to the Maximum Concentration of Afatinib in Plasma at Steady State (Tmax,ss) | tmax,ss represents the time from dosing to the maximum concentration of afatinib in plasma at steady state (Day 14). | Subset of TS, restricted to patients with adequate protocol compliance, i.e. patients without important protocol violations. | Posted | Median | Full Range | hours | 0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 14 |
|
|
|
| Secondary | Accumulation Ratio of AUC Values (R_A,AUC) | R_A,AUC represents the accumulation ratio of AUC values after multiple dose administration over a uniform dosing interval t between days 1 and 14 | Subset of TS, restricted to patients with adequate protocol compliance, i.e. patients without important protocol violations. | Posted | Geometric Mean | Geometric Coefficient of Variation | ratio | 0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 1 and 14 |
|
|
|
| Secondary | Accumulation Ratio of AUC Values (R_A,Cmax) | R_A,Cmax represents the accumulation ratio of Cmax values after multiple dose administration over a uniform dosing interval t between days 1 and 14 | Subset of TS, restricted to patients with adequate protocol compliance, i.e. patients without important protocol violations. | Posted | Geometric Mean | Geometric Coefficient of Variation | ratio | 0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 1 and 14 |
|
|
|
| Secondary | Percentage Peak Trough Fluctuation (PTF) | PTF represents the percentage peak trough fluctuation. PTF is defined as difference between maximum and minimum concentration at steady state divided by the average concentration multiplied with 100 to report as percentage. | Subset of TS, restricted to patients with adequate protocol compliance, i.e. patients without important protocol violations. | Posted | Geometric Mean | Geometric Coefficient of Variation | percentage of peak trough fluctuation | 0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 14 |
|
|
|
| 34 |
| 60 |
| 58 |
| 60 |
| Cardiac arrest | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Myocardial ischaemia | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Nausea/Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Peritoneal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Rectal cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
|
| Renal disorder | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Renal insufficency | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Rash/acne | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Ureteric obstruction | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Nausea/Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Nail effect | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Fatigue | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Rash/acne | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| Title | Measurements |
|---|---|
|
| Time-point 4:00 h (N=49) |
|
| Time-point 5:00 h (N=49) |
|
| Time-point 6:00 h (N=49) |
|
| Time-point 7:00 h (N=48) |
|
| Time-point 10:00 h (N=49) |
|
| Time-point 24:00 h (N=48) |
|
| Title | Measurements |
|---|
|
| Grade 4 |
|
| Grade 5 |
|