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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-008304-41 | EudraCT Number | EudraCT |
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The primary objective of the current study is to investigate the Maximum Tolerated Dose (MTD) in terms of safety and tolerability of BI 6727 in combination with fixed dose BIBF 1120, in patients with advanced or metastatic solid tumours.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIBF 1120 and BI 6727 | Experimental | Finding Maximum Tolerated Dose of BI 6727 in combination with BIBF 1120 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 6727 | Drug | intravenous each 21 days |
| |
| BIBF 1120 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose Limiting Toxicities (DLTs) in the First Cycle for the Determination of the Maximum Tolerated Dose (MTD). | DLT was defined as:
| 28 days |
| Maximum Tolerated Dose (MTD) of Volasertib in Combination With Nintedanib | The MTD was determined using a 3+3 design with de-escalation. The MTD was defined as the highest dose level at which maximal 1 out of 6 patients experienced DLT in the first course of the escalation nd de-escalation phase. However, all DLT's occurring in the trial were considered for selection of the recommended dose for further development. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Drug Related Adverse Events | Number of participants with investigator-defined drug related adverse events. | From first study drug administration until 28 days after the last administration of any study medication, up to 485 days |
| Number of Participants With Dose Limiting Toxicities |
Not provided
Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1230.7.39002 Boehringer Ingelheim Investigational Site | Ancona | Italy | ||||
| 1230.7.39001 Boehringer Ingelheim Investigational Site |
Beginning after the first cycle of treatment, intra-patient dose escalations were allowed and could be repeated after every cycle. Intra-patient dose escalation was not allowed after the maximum tolerated dose (MTD) was determined.
An uncontrolled, open-label, dose escalation study in cohorts of patients following the '3+3 design with de-escalation'. After entering the study, cohorts of patients were sequentially allocated to the dose levels.
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| ID | Title | Description |
|---|---|---|
| FG000 | 100 mg Volasertib + 200 mg Nintedanib | Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 100 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day. Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2. |
| FG001 | 200 mg Volasertib + 200 mg Nintedanib | Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 200 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day. Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2. |
| FG002 | 300 mg Volasertib + 200 mg Nintedanib | Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 300 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day. Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2. |
| FG003 | 350 mg Volasertib + 200 mg Nintedanib | Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 350 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day. Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2. |
| FG004 | 400 mg Volasertib + 200 mg Nintedanib | Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 400 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Treated Set - All patients who received ≥1 dose of study medication were included in the treated set.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 100 mg Volasertib + 200 mg Nintedanib | Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 100 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day. Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2. |
| 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 | Number of Participants With Dose Limiting Toxicities (DLTs) in the First Cycle for the Determination of the Maximum Tolerated Dose (MTD). | DLT was defined as:
| Treated set. All patients who received ≥1 dose of study medication were included in the treated set. | Posted | Number | participants | 28 days |
|
All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 100 mg Volasertib + 200 mg Nintedanib | Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 100 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day. Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MEDDRA 16.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MEDDRA 16.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
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| ID | Term |
|---|---|
| C541363 | BI 6727 |
| C530716 | nintedanib |
Not provided
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| Drug |
oral continuously |
|
Number of participants with dose limiting toxicities (DLTs). DLT was defined as:
|
| From first study drug administration until 28 days after the last administration of any study medication, up to 485 days |
| Cmax of Volasertib | Maximum measured concentration (Cmax) in plasma of Volasertib in Cycle 1. | 0:05 h before start of Volasertib infusion and 1:00, 2:00, 3:00, 4:00, 8:00 and 24 h after start of Volasertib infusion |
| CL of Volasertib | Total plasma Clearance (CL) of Volasertib in Cycle 1. | 0:05 h before start of Volasertib infusion and 1:00, 2:00, 3:00, 4:00, 8:00 and 24 h after start of Volasertib infusion |
| Vss of Volasertib | Volume of distribution at steady state (Vss) of Volasertib in Cycle 1. | 0:05 h before start of Volasertib infusion and 1:00, 2:00, 3:00, 4:00, 8:00 and 24 h after start of Volasertib infusion |
| Cmax of Nintedanib | Maximum measured concentration (Cmax) of Nintedanib in Cycle 1. 400 mg Volasertib + 200 mg Nintedanib group is not displayed due to data only being available for one patient. | 5 min before Nintedanib administration in the morning and 1:00, 2:00, 3:00, 4:00, 6:00 h after administration on Day 9 |
| AUC(0-6h) of Nintedanib | Area under the concentration-time curve (AUC) of Nintedanib over the time interval 0 to 6 hours in Cycle 1. 400 mg Volasertib + 200 mg Nintedanib group is not displayed due to data only being available for one patient. | 5 min before Nintedanib administration in the morning and 1:00, 2:00, 3:00, 4:00, 6:00 h after administration on Day 9 |
| Tmax of Nintedanib | Time from dosing to the maximum measured concentration, Cmax, of Nintedanib (tmax) in Cycle 1. 400 mg Volasertib + 200 mg Nintedanib group is not displayed due to data only being available for one patient. | 5 min before Nintedanib administration in the morning and 1:00, 2:00, 3:00, 4:00, 6:00 h after administration on Day 9 |
| Number of Patients With Best Overall Response | Best overall response based on response evaluation criteria in solid tumors (RECIST) version 1.1. Best overall response is defined as the best overall response (complete response, partial response, stable disease, progressive disease or not evaluable) since the start of treatment. | Tumor assessment was performed at screening and every 2nd course until earliest time of progression, death or end of treatment. |
| Number of Patients With Objective Response (OR) | Objective tumor response based on response evaluation criteria in solid tumors (RECIST) version 1.1. OR is defined as complete response (CR) or partial response (PR) as best response throughout the study. | Tumor assessment was performed at screening and every 2nd course until earliest time of progression, death or end of treatment. |
| Number of Patients With Disease Control | Disease control based on response evaluation criteria in solid tumors (RECIST) version 1.1. Disease control is defined as complete response (CR), partial response (PR) or stable disease (SD) as best response throughout the study. | Tumor assessment was performed at screening and every 2nd course until earliest time of progression, death or end of treatment. |
| Duration of Disease Control | Disease control based on response evaluation criteria in solid tumors (RECIST) version 1.1. Patients who had a best overall tumour response of complete response (CR), partial response (PR) or stable disease (SD) were assessed to show disease control. | Tumor assessment was performed at screening and every 2nd course until earliest time of progression, death or end of treatment. |
| Progression Free Survival (PFS) | PFS is defined as the time from start of treatment with study medication to tumour progression or death whichever occurs first. Tumour response was to be documented using appropriate techniques such as magnetic resonance imaging (MRI) or computer tomography (CT). | Tumor assessment was performed at screening and every 2nd course until earliest time of progression, death or end of treatment. |
| Milan |
| Italy |
| Dose-limiting toxicity |
|
| Withdrawal by Subject |
|
| Other not stated above |
|
| BG001 | 200 mg Volasertib + 200 mg Nintedanib | Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 200 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day. Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2. |
| BG002 | 300 mg Volasertib + 200 mg Nintedanib | Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 300 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day. Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2. |
| BG003 | 350 mg Volasertib + 200 mg Nintedanib | Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 350 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day. Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2. |
| BG004 | 400 mg Volasertib + 200 mg Nintedanib | Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 400 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day. |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | 200 mg Volasertib + 200 mg Nintedanib | Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 200 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day. Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2. |
| OG002 | 300 mg Volasertib + 200 mg Nintedanib | Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 300 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day. Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2. |
| OG003 | 350 mg Volasertib + 200 mg Nintedanib | Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 350 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day. Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2. |
| OG004 | 400 mg Volasertib + 200 mg Nintedanib | Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 400 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day. |
|
|
| Secondary | Number of Participants With Drug Related Adverse Events | Number of participants with investigator-defined drug related adverse events. | Treated Set. | Posted | Number | participants | From first study drug administration until 28 days after the last administration of any study medication, up to 485 days |
|
|
|
| Secondary | Number of Participants With Dose Limiting Toxicities | Number of participants with dose limiting toxicities (DLTs). DLT was defined as:
| Treated Set. | Posted | Number | participants | From first study drug administration until 28 days after the last administration of any study medication, up to 485 days |
|
|
|
| Secondary | Cmax of Volasertib | Maximum measured concentration (Cmax) in plasma of Volasertib in Cycle 1. | Pharmacokinetic (PK) analysis set. The PK analysis set included all patients who took at least 1 dose of study medication and provided at least 1 blood sample following drug administration. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 0:05 h before start of Volasertib infusion and 1:00, 2:00, 3:00, 4:00, 8:00 and 24 h after start of Volasertib infusion |
|
|
|
| Secondary | CL of Volasertib | Total plasma Clearance (CL) of Volasertib in Cycle 1. | PK analysis set. | Posted | Geometric Mean | Geometric Coefficient of Variation | mL/min | 0:05 h before start of Volasertib infusion and 1:00, 2:00, 3:00, 4:00, 8:00 and 24 h after start of Volasertib infusion |
|
|
|
| Secondary | Vss of Volasertib | Volume of distribution at steady state (Vss) of Volasertib in Cycle 1. | PK analysis set. | Posted | Geometric Mean | Geometric Coefficient of Variation | L | 0:05 h before start of Volasertib infusion and 1:00, 2:00, 3:00, 4:00, 8:00 and 24 h after start of Volasertib infusion |
|
|
|
| Secondary | Cmax of Nintedanib | Maximum measured concentration (Cmax) of Nintedanib in Cycle 1. 400 mg Volasertib + 200 mg Nintedanib group is not displayed due to data only being available for one patient. | PK analysis set. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 5 min before Nintedanib administration in the morning and 1:00, 2:00, 3:00, 4:00, 6:00 h after administration on Day 9 |
|
|
|
| Secondary | AUC(0-6h) of Nintedanib | Area under the concentration-time curve (AUC) of Nintedanib over the time interval 0 to 6 hours in Cycle 1. 400 mg Volasertib + 200 mg Nintedanib group is not displayed due to data only being available for one patient. | PK analysis set. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | 5 min before Nintedanib administration in the morning and 1:00, 2:00, 3:00, 4:00, 6:00 h after administration on Day 9 |
|
|
|
| Secondary | Tmax of Nintedanib | Time from dosing to the maximum measured concentration, Cmax, of Nintedanib (tmax) in Cycle 1. 400 mg Volasertib + 200 mg Nintedanib group is not displayed due to data only being available for one patient. | PK analysis set. | Posted | Median | Full Range | h | 5 min before Nintedanib administration in the morning and 1:00, 2:00, 3:00, 4:00, 6:00 h after administration on Day 9 |
|
|
|
| Secondary | Number of Patients With Best Overall Response | Best overall response based on response evaluation criteria in solid tumors (RECIST) version 1.1. Best overall response is defined as the best overall response (complete response, partial response, stable disease, progressive disease or not evaluable) since the start of treatment. | Treated Set. | Posted | Number | participants | Tumor assessment was performed at screening and every 2nd course until earliest time of progression, death or end of treatment. |
|
|
|
| Secondary | Number of Patients With Objective Response (OR) | Objective tumor response based on response evaluation criteria in solid tumors (RECIST) version 1.1. OR is defined as complete response (CR) or partial response (PR) as best response throughout the study. | Treated Set. | Posted | Number | participants | Tumor assessment was performed at screening and every 2nd course until earliest time of progression, death or end of treatment. |
|
|
|
| Primary | Maximum Tolerated Dose (MTD) of Volasertib in Combination With Nintedanib | The MTD was determined using a 3+3 design with de-escalation. The MTD was defined as the highest dose level at which maximal 1 out of 6 patients experienced DLT in the first course of the escalation nd de-escalation phase. However, all DLT's occurring in the trial were considered for selection of the recommended dose for further development. | Treated Set. All patients who received >= 1 dose of study medication. | Posted | Number | mg | 28 days |
|
|
|
| Secondary | Number of Patients With Disease Control | Disease control based on response evaluation criteria in solid tumors (RECIST) version 1.1. Disease control is defined as complete response (CR), partial response (PR) or stable disease (SD) as best response throughout the study. | Treated Set. | Posted | Number | participants | Tumor assessment was performed at screening and every 2nd course until earliest time of progression, death or end of treatment. |
|
|
|
| Secondary | Duration of Disease Control | Disease control based on response evaluation criteria in solid tumors (RECIST) version 1.1. Patients who had a best overall tumour response of complete response (CR), partial response (PR) or stable disease (SD) were assessed to show disease control. | All patients of the treated set that were assessed to show disease control. | Posted | Median | Full Range | days | Tumor assessment was performed at screening and every 2nd course until earliest time of progression, death or end of treatment. |
|
|
|
| Secondary | Progression Free Survival (PFS) | PFS is defined as the time from start of treatment with study medication to tumour progression or death whichever occurs first. Tumour response was to be documented using appropriate techniques such as magnetic resonance imaging (MRI) or computer tomography (CT). | Treated Set. | Posted | Median | Full Range | days | Tumor assessment was performed at screening and every 2nd course until earliest time of progression, death or end of treatment. |
|
|
|
| 0 |
| 3 |
| 3 |
| 3 |
| EG001 | 200 mg Volasertib + 200 mg Nintedanib | Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 200 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day. Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2. | 0 | 4 | 4 | 4 |
| EG002 | 300 mg Volasertib + 200 mg Nintedanib | Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 300 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day. Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2. | 5 | 13 | 13 | 13 |
| EG003 | 350 mg Volasertib + 200 mg Nintedanib | Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 350 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day. Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2. | 2 | 8 | 8 | 8 |
| EG004 | 400 mg Volasertib + 200 mg Nintedanib | Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 400 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day. | 1 | 2 | 2 | 2 |
| Neutropenia | Blood and lymphatic system disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 16.0 | Systematic Assessment |
|
| Metastases to meninges | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 16.0 | Systematic Assessment |
|
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 16.0 | Systematic Assessment |
|
| Bladder obstruction | Renal and urinary disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Thrombocytosis | Blood and lymphatic system disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Atrial thrombosis | Cardiac disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Thyroid disorder | Endocrine disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Abdominal hernia | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Oesophageal pain | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Asthenia | General disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Chest pain | General disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Chills | General disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Fatigue | General disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Hypertransaminasaemia | Hepatobiliary disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
|
| Herpes simplex | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
|
| Tracheitis | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
|
| Viral uveitis | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
|
| Contrast media reaction | Injury, poisoning and procedural complications | MEDDRA 16.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MEDDRA 16.0 | Systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | MEDDRA 16.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MEDDRA 16.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MEDDRA 16.0 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MEDDRA 16.0 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MEDDRA 16.0 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MEDDRA 16.0 | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MEDDRA 16.0 | Systematic Assessment |
|
| Breath sounds abnormal | Investigations | MEDDRA 16.0 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MEDDRA 16.0 | Systematic Assessment |
|
| Glomerular filtration rate increased | Investigations | MEDDRA 16.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MEDDRA 16.0 | Systematic Assessment |
|
| Transaminases increased | Investigations | MEDDRA 16.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 16.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Epilepsy | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Muscle contractions involuntary | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Post herpetic neuralgia | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Pulmonary microemboli | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Skin haemorrhage | Skin and subcutaneous tissue disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MEDDRA 16.0 | Systematic Assessment |
|
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Partial Response |
|
| Stable Disease |
|
| Progressive Disease |
|
| Not Evaluable |
|
| Missing |
|
| Missing |
|