Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The trial will be performed to evaluate whether BI 2536 may be effective in the treatment of advanced or metastatic NSCLC of stage IIIB or IV in patients who relapsed after or failed first-line therapy. A secondary aim is to identify the most suitable dosage schedule for the further Phase II and III clinical programme of BI 2536. To achieve this objective two dosage schedules are compared.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 200 milligram (mg) of BI 2536 | Experimental | Day 1 |
|
| 50 milligram (mg) of BI 2536 | Experimental | Day 1, 2, and 3 |
|
| 60 milligram (mg) of BI 2536 | Experimental | Day 1, 2, and 3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 2536 | Drug | Intravenous Infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Tumour Response Evaluated According to the Response Evaluation Criteria in Solid Tumours (RECIST 1.0) by Central Review of the Tumour Images | The best overall response was the best response recorded from start of treatment until the participant progressed, received any other anti-tumour therapy, died or until the individual participant's end of trial. Number of participants with 'Objective tumour response evaluated according to RECIST 1.0 by central review of the tumour images = Yes' are reported. Objective response is complete response (disappearance of all target lesions) or partial response (at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter). Changes in tumour measurements were confirmed by repeat assessments that had to be performed 6 weeks after the criteria for response had been first met. | assessed at baseline, then every 6 weeks (every second treatment course) until disease progression or start of any other anti-tumour therapy or death or individual participant's end of trial, up to 533 days |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | Progression-free survival defined as time from date of randomisation until "date of imaging indicating progressive disease (PD) as assessed by the independent central imaging review (according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.0)" or "date of investigator assessment of clinical progression" or "date of progressive disease recorded during the follow-up period" or "death date", whatever comes first. Participants without documented progression at the time of analysis were censored at the date of the last visit. Per RECIST version 1.0 for target lesions and assessed by Computed Tomography (CT)-scan or Magnetic Resonance Imaging (MRI): PD, At least a 20% increase in the sum of the longest diameter (SoD) of target lesions taking as reference the smallest SoD of target lesions recorded since the treatment started or the appearance of one or more new lesions. |
Not provided
Inclusion Criteria:
male or female patients aged 18 years or older with histologically or cytologically confirmed advanced or metastatic NSCLC of stage IIIB or IV, who relapsed or failed prior first-line chemotherapy for advanced or metastatic disease. At least one tumour lesion must be present that can accurately be measured by magnetic resonance imaging (MRI), or computed tomography (CT) in at least one dimension (longest diameter to be recorded) as 20 mm or greater with conventional techniques or as 10 mm or greater with spiral CT scan. Life expectancy of at least three months; Eastern co-operative oncology group (ECOG) performance score of 2 or less and written informed consent which must be consistent with international conference on harmonisation good clinical practice (ICH-GCP) and local legislation
Exclusion Criteria:
persistence of toxicities of prior anti cancer therapies which are deemed to be clinically relevant, known secondary malignancy requiring therapy, brain metastases which are symptomatic or require therapy, absolute neutrophil count less than 1,500/mm3, platelet count less than 100,000/mm3, haemoglobin less than 9 mg/dl, aspartate amino transferase (AST) or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal, or AST or ALT greater than 5 times the upper limit of normal in case of known liver metastases, bilirubin greater than 1.5 mg/dl, serum creatinine greater than 2.0 mg/dl, concomitant intercurrent illnesses that would limit compliance with trial requirement or which are considered relevant for the evaluation of the efficacy or safety of the trial drug, chemo-, hormone- or immunotherapy within the past four weeks or within less than four half-life times of the previous drug prior to treatment with the trial drug (whatever is the longest period), radiotherapy within the past four weeks prior to treatment with the trial drug, men or women who are sexually active and unwilling to use a medically acceptable method of contraception during the trial, pregnancy or lactation, treatment with any other investigational drug within the past four weeks or within less than four half-life times of the investigational drug before treatment with the trial drug (whatever is the longest period), patient unable to comply with the protocol, patients who are considered eligible by the investigator for other second-line chemotherapy, radiotherapy or immunotherapy, patients who have received more than two lines of prior anti-tumour therapy for advanced or metastatic non small cell lung cancer
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1216.9.49002 Boehringer Ingelheim Investigational Site | Freiburg im Breisgau | Germany | ||||
| 1216.9.49007 Boehringer Ingelheim Investigational Site |
Not provided
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Abbreviation: Common Terminology Criteria for Adverse Events version 3.0 (CTCAE)
An open-label, randomized, parallel-group, phase II clinical trial to investigate the efficacy, safety and pharmacokinetics of a single dose of 200 milligram (mg) BI 2536 administered intravenously in comparison to 50 / 60 mg BI 2536 administered intravenously on days 1, 2 and 3 in patients with advanced or metastatic non small cell lung cancer.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 200 Milligram (mg) BI 2536 (Day 1) | A single dose of 200 mg BI 2536 on day one of each treatment course (comprising 21 days including the day of administration) was administered as an intravenous infusion over a period of 60 minutes. Each participant was planned to receive at least 2 treatment courses, in case of clinical benefit (i.e., at least stable disease and acceptable tolerability) the participants could continue therapy. Trial drug administration was stopped temporarily in case of dose limiting toxicity (DLT). Participants could continue therapy only if recovery from DLT occurred and only with a dose reduced by up to 50 mg. Dose reduction was allowed only once for a participant during the whole trial. If a participant had experienced a second episode of DLT with the reduced dose or had not recovered from DLT then the participant was withdrawn from the trial. A participant who continued therapy with BI 2536 beyond course 2 could be treated with a higher dose in case of non-progression and good tolerability. |
| FG001 | 50 Milligram BI 2536 (Day 1 - Day 3) | A single dose of 50 mg BI 2536 on days 1, 2 and 3 of each treatment course (comprising 21 days including the days of administration) was administered as an intravenous infusion over a period of 60 minutes. Each participant was planned to receive at least 2 treatment courses, in case of clinical benefit (i.e., at least stable disease and acceptable tolerability) the participants could continue therapy with the trial drug. Trial drug administration was stopped temporarily in case of dose limiting toxicity (DLT). Participants could continue therapy only if recovery from DLT (to CTCAE levels which allowed further therapy) occurred and only with a dose reduced by up to 10 mg. Dose reduction was allowed only once for a participant during the whole trial. If a participant had experienced a second episode of DLT with the reduced dose or the participant had not recovered from DLT then the participant was withdrawn from the trial. A participant who continued therapy with BI 2536 beyond course 2 could be treated with a higher dose in case of non-progression and good tolerability. |
| FG002 | 60 Milligram BI 2536 (Day 1 - Day 3) | After implementation of protocol amendment 2 a single dose of 60 mg BI 2536 on days 1, 2 and 3 of each treatment course (comprising 21 days including the days of administration) was administered as an intravenous infusion over a period of 60 minutes. Each participant was planned to receive at least 2 treatment courses, in case of clinical benefit (i.e., at least stable disease and acceptable tolerability) the participants could continue therapy with the trial drug. Trial drug administration was stopped temporarily in case of dose limiting toxicity (DLT). Participants could continue therapy only if recovery from DLT (to CTCAE levels which allowed further therapy) occurred and only with a dose reduced by up to 10 mg. Dose reduction was allowed only once for a participant during the whole trial. If a participant had experienced a second episode of DLT with the reduced dose or the participant had not recovered from DLT then the participant was withdrawn from the trial. A participant who continued therapy with BI 2536 beyond course 2 could be treated with a higher dose in case of non-progression and good tolerability. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The Treated Set comprised all participants who received at least one application of the BI drug BI 2536 including treated patients who were not randomized.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 200 Milligram (mg) BI 2536 (Day 1) | A single dose of 200 mg BI 2536 on day one of each treatment course (comprising 21 days including the day of administration) was administered as an intravenous infusion over a period of 60 minutes. Each participant was planned to receive at least 2 treatment courses, in case of clinical benefit (i.e., at least stable disease and acceptable tolerability) the participants could continue therapy. Trial drug administration was stopped temporarily in case of dose limiting toxicity (DLT). Participants could continue therapy only if recovery from DLT occurred and only with a dose reduced by up to 50 mg. Dose reduction was allowed only once for a participant during the whole trial. If a participant had experienced a second episode of DLT with the reduced dose or had not recovered from DLT then the participant was withdrawn from the trial. A participant who continued therapy with BI 2536 beyond course 2 could be treated with a higher dose in case of non-progression and good tolerability. |
| 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 Tumour Response Evaluated According to the Response Evaluation Criteria in Solid Tumours (RECIST 1.0) by Central Review of the Tumour Images | The best overall response was the best response recorded from start of treatment until the participant progressed, received any other anti-tumour therapy, died or until the individual participant's end of trial. Number of participants with 'Objective tumour response evaluated according to RECIST 1.0 by central review of the tumour images = Yes' are reported. Objective response is complete response (disappearance of all target lesions) or partial response (at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter). Changes in tumour measurements were confirmed by repeat assessments that had to be performed 6 weeks after the criteria for response had been first met. | The Treated Set comprised all participants who received at least one application of the BI drug BI 2536 including treated participants who were not randomized. | Posted | Number | Number of Participants | assessed at baseline, then every 6 weeks (every second treatment course) until disease progression or start of any other anti-tumour therapy or death or individual participant's end of trial, up to 533 days |
For Serious and Other Adverse Events: On-treatment period, that is, from first administration of the trial drug until 3 weeks after the last administration of the trial drug, up to 428 days. For All-Cause Mortality: On-treatment period + Follow-up period, up to 599 days.
All participants who received at least one dose of BI 2536 were included in the safety analyses.
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 | 200 Milligram (mg) BI 2536 (Day 1) | A single dose of 200 mg BI 2536 on day one of each treatment course (comprising 21 days including the day of administration) was administered as an intravenous infusion over a period of 60 minutes. Each participant was planned to receive at least 2 treatment courses, in case of clinical benefit (i.e., at least stable disease and acceptable tolerability) the participants could continue therapy with the trial drug. Trial drug administration was stopped temporarily in case of dose limiting toxicity (DLT). Participants could continue therapy only if recovery from DLT (to CTCAE levels which allowed further therapy) occurred and only with a dose reduced by up to 50 mg. Dose reduction was allowed only once for a participant during the whole trial. If a participant had experienced a second episode of DLT with the reduced dose or the participant had not recovered from DLT then the participant was withdrawn from the trial. A participant who continued therapy with BI 2536 beyond course 2 could be treated with a higher dose in case of non-progression and good tolerability. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim , Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
Not provided
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C518477 | BI 2536 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| every 6 weeks (every second treatment course), up to 419 days |
| Overall Survival | Overall survival defined as time from date of randomisation until date of death from any cause. Participants alive at the time of analysis were censored at the date of the last trial visit or last date of follow-up, whatever came last. | every 6 weeks (every second treatment course), up to 599 days |
| Duration of Overall Response | For participants who showed an overall tumour response of complete response (CR, disappearance of all target lesions) or partial response (PR, at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter), 'duration of overall response' was defined as the time from the first date where measurement criteria were met for CR or PR (whichever was first recorded) until the first date that recurrent or progressive disease (PD) was objectively documented (taking as reference for PD the smallest measurements recorded since the treatment started). Tumour response was evaluated based on local radiological images according to RECIST version 1.0 (agreed upon by independent review). The number of participants with an CR or PR who experienced the event 'recurrent or PD' is reported instead of the time-to-event data with unit of time as the number analyzed was too small to perform a Kaplan-Meier analysis. | assessed at baseline, then every 6 weeks (every second treatment course) until disease progression or start of any other anti-tumour therapy or death or individual participant's end of trial, up to 533 days |
| Objective Tumour Response Evaluated According to the Response Evaluation Criteria in Solid Tumours (RECIST 1.0) by Investigator | The best overall response was the best response recorded from start of treatment until the participant progressed, received any other anti-tumour therapy, died or until the individual participant's end of trial. 'Objective tumour response evaluated according to RECIST 1.0 by investigator' is 'Yes' if the best overall response is either complete response (CR, disappearance of all target lesions) or partial response (PR, at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter). Otherwise it is 'No'. To be assigned a status of 'partial response' or 'complete response', changes in tumour measurements were confirmed by repeat assessments that had to be performed six weeks after the criteria for response had been first met. Number of participants with 'Objective tumour response evaluated according to RECIST 1.0 by investigator = Yes' are reported. | assessed at baseline, then every 6 weeks (every second treatment course) until disease progression or start of any other anti-tumour therapy or death or individual participant's end of trial, up to 533 days |
| Time-to-deterioration for Symptom Score 'Cough' Assessed on Question 1 on the Lung Cancer Module QLQ LC13 of the European Organization for Research and Treatment Quality of Life (QoL) Questionnaire (EORTC QLQ) C30 Version 3.0 | Time to deterioration for cough [days] was defined as the time from randomization to deterioration in score for the symptom 'cough'. Participants were considered to have deteriorated if a 10-point increase from the baseline score at any time point after baseline was observed. Participants who died before deteriorating were analyzed as having deteriorated at the time of death. Participants with disease progression without deterioration in score were censored at the time of the last scale measurement. Participants with no QoL assessments were censored at day 1. The score for symptom 'cough' was based on Question 1 on the lung cancer module QLQ LC13 of the EORTC QLQ C30 Version 3.0. A linear transformation was used to standardize the raw scores, so that scores range from 0 to 100. A high score represents a higher ("worse") level of the symptom 'cough'. | baseline and every 3 weeks (prior to the first administration of BI 2536 in a treatment course comprising 3 weeks), up to 539 days |
| Time-to-deterioration for Symptom Score 'Dyspnoea' Assessed on the Composite of Questions 3-5 on the Lung Cancer Module QLQ LC13 of the European Organization for Research and Treatment Quality of Life (QoL) Questionnaire (EORTC QLQ) C30 Version 3.0 | Time to deterioration for dyspnoea [days] was defined as the time from randomization to deterioration in score for the symptom 'dyspnoea'. Participants were considered to have deteriorated if a 10-point increase from the baseline score at any time point after baseline was observed. Participants who died before deteriorating were analyzed as having deteriorated at the time of death. Participants with disease progression without deterioration in score were censored at the time of the last scale measurement. Participants with no QoL assessments were censored at day 1. The score for symptom 'dyspnoea' was based on the composite of Questions 3-5 on the lung cancer module QLQ LC13 of the EORTC QLQ C30 Version 3.0. A linear transformation was used to standardize the raw scores, so that scores range from 0 to 100. A high score represents a higher ("worse") level of the symptom 'dyspnoea'. | baseline and every 3 weeks (prior to the first administration of BI 2536 in a treatment course comprising 3 weeks), up to 539 days |
| Time-to-deterioration for Symptom Score 'Pain' Assessed on the Composite of Questions 9 and 19 of the European Organization for Research and Treatment Quality of Life (QoL) Questionnaire (EORTC QLQ) C30 Version 3.0 | Time to deterioration for pain [days] was defined as the time from randomization to deterioration in score for the symptom 'pain'. Participants were considered to have deteriorated if a 10-point increase from the baseline score at any time point after baseline was observed. Participants who died before deteriorating were analyzed as having deteriorated at the time of death. Participants with disease progression without deterioration in score were censored at the time of the last scale measurement. Participants with no QoL assessments will be censored at day 1. The score for symptom 'pain' was based on the composite of Questions 9 and 19 of the EORTC QLQ C30 Version 3.0. A linear transformation was used to standardize the raw scores, so that scores range from 0 to 100. A high score represents a higher ("worse") level of the symptom 'pain'. | baseline and every 3 weeks (prior to the first administration of BI 2536 in a treatment course comprising 3 weeks), up to 539 days |
| BI 2536 Plasma Concentrations After Intravenous Infusion of 200 Milligram BI 2536 on Day 1 in Treatment Course 1 | BI 2536 plasma concentrations after intravenous infusion of 200 milligram BI 2536 on day 1 in treatment course 1. Geometric Coefficient of Variation reported in percentage [%]. | on day 1 in treatment course 1: 0.5 hour (h) , 1 h, 2 h, 4 h, 120 h post-dose (planned times) |
| BI 2536 Plasma Concentrations After Intravenous Infusion of 50 / 60 Milligram BI 2536 on Day 1 in Treatment Course 1 | BI 2536 plasma concentrations after intravenous infusion of 50 / 60 milligram BI 2536 on day 1 in treatment course 1. Geometric Coefficient of Variation reported in percentage [%]. | on day 1 in treatment course 1: 1 hour (h), 2 h, 23.92 h, 25 h, 47.92 h, 48.5 h, 49 h, 50 h, 52 h, 120 h post-dose (planned times) |
| Incidence of Adverse Events Categorized by Common Terminology Criteria for Adverse Events (CTCAE) Grades | Number of participants with adverse events categorized by "common terminology criteria for adverse events (CTCAE) grades (version 3.0)" are reported. | On-treatment period, that is, from first administration of the trial drug until 3 weeks after the last administration of the trial drug, up to 428 days |
| Incidence of Dose Limiting Toxicity (DLT) | Dose limiting toxicity was defined as drug related common terminology criteria for adverse events (CTCAE) grade 3 or greater non haematological toxicity (excluding untreated nausea, vomiting or diarrhoea) or drug related CTCAE grade 4 neutropenia for seven or more days and / or complicated by infection or CTCAE grade 4 thrombocytopenia. Number of participants with DLT is reported. | On-treatment period, that is, from first administration of the trial drug until 3 weeks after the last administration of the trial drug, up to 428 days |
| Number of Participants With Neutropenia of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or 4 | Number of participants with neutropenia of common terminology criteria for adverse events (CTCAE) grade 3 or 4. | On-treatment period, that is, from first administration of the trial drug until 3 weeks after the last administration of the trial drug, up to 428 days |
| Number of Participants With Thrombocytopenia of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or 4 | Number of participants with thrombocytopenia of common terminology criteria for adverse events (CTCAE) grade 3 or 4. | On-treatment period, that is, from first administration of the trial drug until 3 weeks after the last administration of the trial drug, up to 428 days |
| Change From Baseline in Systolic/Diastolic Blood Pressure at Individual Participant's End-of-trial Visit | Change from baseline in systolic/diastolic blood pressure at individual participant's end-of-trial visit. | baseline, date of individual participant's end of trial visit which was 533 days after start of treatment at the latest |
| Change From Baseline in Pulse Rate at Individual Participant's End-of-trial Visit | Change from baseline in pulse rate at individual participant's end-of-trial visit. | baseline, date of individual participant's end of trial visit which was 533 days after start of treatment at the latest |
| Gauting |
| Germany |
| 1216.9.49008 Boehringer Ingelheim Investigational Site | Großhansdorf | Germany |
| 1216.9.49001 Boehringer Ingelheim Investigational Site | Heidelberg | Germany |
| 1216.9.49004 Boehringer Ingelheim Investigational Site | Mainz | Germany |
| 1216.9.49005 Boehringer Ingelheim Investigational Site | Mainz | Germany |
| 1216.9.49003 Boehringer Ingelheim Investigational Site | Wiesbaden | Germany |
| Adverse Event other than Dose Limiting Toxicity |
|
| Not treated with BI 2536 |
|
| Investigator's and participant's decision to stop treatment with BI 2536 after 6 cycles |
|
| Investigator's and participant's decision to stop treatment with BI 2536 |
|
| Investigator's decision to stop treatment with BI 2536 after 6 cycles |
|
| Investigator's decision to stop treatment with BI 2536 |
|
| Participant's decision to stop treatment with BI 2536 after 6 cycles |
|
| Participant's decision to stop treatment with BI 2536 |
|
| Increase of tumour markers |
|
| Bone metastasis |
|
| BG001 | 50 Milligram BI 2536 (Day 1 - Day 3) | A single dose of 50 mg BI 2536 on days 1, 2 and 3 of each treatment course (comprising 21 days including the days of administration) was administered as an intravenous infusion over a period of 60 minutes. Each participant was planned to receive at least 2 treatment courses, in case of clinical benefit (i.e., at least stable disease and acceptable tolerability) the participants could continue therapy with the trial drug. Trial drug administration was stopped temporarily in case of dose limiting toxicity (DLT). Participants could continue therapy only if recovery from DLT (to CTCAE levels which allowed further therapy) occurred and only with a dose reduced by up to 10 mg. Dose reduction was allowed only once for a participant during the whole trial. If a participant had experienced a second episode of DLT with the reduced dose or the participant had not recovered from DLT then the participant was withdrawn from the trial. A participant who continued therapy with BI 2536 beyond course 2 could be treated with a higher dose in case of non-progression and good tolerability. |
| BG002 | 60 Milligram BI 2536 (Day 1 - Day 3) | After implementation of protocol amendment 2 a single dose of 60 mg BI 2536 on days 1, 2 and 3 of each treatment course (comprising 21 days including the days of administration) was administered as an intravenous infusion over a period of 60 minutes. Each participant was planned to receive at least 2 treatment courses, in case of clinical benefit (i.e., at least stable disease and acceptable tolerability) the participants could continue therapy with the trial drug. Trial drug administration was stopped temporarily in case of dose limiting toxicity (DLT). Participants could continue therapy only if recovery from DLT (to CTCAE levels which allowed further therapy) occurred and only with a dose reduced by up to 10 mg. Dose reduction was allowed only once for a participant during the whole trial. If a participant had experienced a second episode of DLT with the reduced dose or the participant had not recovered from DLT then the participant was withdrawn from the trial. A participant who continued therapy with BI 2536 beyond course 2 could be treated with a higher dose in case of non-progression and good tolerability. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | 200 Milligram (mg) BI 2536 (Day 1) | A single dose of 200 mg BI 2536 on day one of each treatment course (comprising 21 days including the day of administration) was administered as an intravenous infusion over a period of 60 minutes. Each participant was planned to receive at least 2 treatment courses, in case of clinical benefit (i.e., at least stable disease and acceptable tolerability) the participants could continue therapy. Trial drug administration was stopped temporarily in case of dose limiting toxicity (DLT). Participants could continue therapy only if recovery from DLT occurred and only with a dose reduced by up to 50 mg. Dose reduction was allowed only once for a participant during the whole trial. If a participant had experienced a second episode of DLT with the reduced dose or had not recovered from DLT then the participant was withdrawn from the trial. A participant who continued therapy with BI 2536 beyond course 2 could be treated with a higher dose in case of non-progression and good tolerability. |
| OG001 | 50 Milligram BI 2536 (Day 1 - Day 3) | A single dose of 50 mg BI 2536 on days 1, 2 and 3 of each treatment course (comprising 21 days including the days of administration) was administered as an intravenous infusion over a period of 60 minutes. Each participant was planned to receive at least 2 treatment courses, in case of clinical benefit (i.e., at least stable disease and acceptable tolerability) the participants could continue therapy with the trial drug. Trial drug administration was stopped temporarily in case of dose limiting toxicity (DLT). Participants could continue therapy only if recovery from DLT (to CTCAE levels which allowed further therapy) occurred and only with a dose reduced by up to 10 mg. Dose reduction was allowed only once for a participant during the whole trial. If a participant had experienced a second episode of DLT with the reduced dose or the participant had not recovered from DLT then the participant was withdrawn from the trial. A participant who continued therapy with BI 2536 beyond course 2 could be treated with a higher dose in case of non-progression and good tolerability. |
| OG002 | 60 Milligram BI 2536 (Day 1 - Day 3) | After implementation of protocol amendment 2 a single dose of 60 mg BI 2536 on days 1, 2 and 3 of each treatment course (comprising 21 days including the days of administration) was administered as an intravenous infusion over a period of 60 minutes. Each participant was planned to receive at least 2 treatment courses, in case of clinical benefit (i.e., at least stable disease and acceptable tolerability) the participants could continue therapy with the trial drug. Trial drug administration was stopped temporarily in case of dose limiting toxicity (DLT). Participants could continue therapy only if recovery from DLT (to CTCAE levels which allowed further therapy) occurred and only with a dose reduced by up to 10 mg. Dose reduction was allowed only once for a participant during the whole trial. If a participant had experienced a second episode of DLT with the reduced dose or the participant had not recovered from DLT then the participant was withdrawn from the trial. A participant who continued therapy with BI 2536 beyond course 2 could be treated with a higher dose in case of non-progression and good tolerability. |
| OG003 | Combination of Treatment Group "50 mg BI 2536 (Day 1 - Day 3)" and "60 mg BI 2536 (Day 1 - Day 3)" | A single dose of 50 mg or 60 mg (following implementation of protocol amendment 2) on days 1, 2 and 3 of each treatment course (comprising 21 days including the days of administration) was administered as an intravenous infusion over a period of 60 minutes. Each participant was planned to receive at least 2 treatment courses, in case of clinical benefit (i.e., at least stable disease and acceptable tolerability) the participants could continue therapy with the trial drug. Trial drug administration was stopped temporarily in case of dose limiting toxicity (DLT). Participants could continue therapy only if recovery from DLT (to CTCAE levels which allowed further therapy) occurred and only with a dose reduced by up to 10 mg. Dose reduction was allowed only once for a participant during the whole trial. If a participant had experienced a second episode of DLT with the reduced dose or the participant had not recovered from DLT then the participant was withdrawn from the trial. A participant who continued therapy with BI 2536 beyond course 2 could be treated with a higher dose in case of non-progression and good tolerability. |
|
|
|
| Secondary | Progression Free Survival | Progression-free survival defined as time from date of randomisation until "date of imaging indicating progressive disease (PD) as assessed by the independent central imaging review (according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.0)" or "date of investigator assessment of clinical progression" or "date of progressive disease recorded during the follow-up period" or "death date", whatever comes first. Participants without documented progression at the time of analysis were censored at the date of the last visit. Per RECIST version 1.0 for target lesions and assessed by Computed Tomography (CT)-scan or Magnetic Resonance Imaging (MRI): PD, At least a 20% increase in the sum of the longest diameter (SoD) of target lesions taking as reference the smallest SoD of target lesions recorded since the treatment started or the appearance of one or more new lesions. | The Treated Set comprised all participants who received at least one application of the BI drug BI 2536 including treated participants who were not randomized. | Posted | Median | 95% Confidence Interval | days | every 6 weeks (every second treatment course), up to 419 days |
|
|
|
|
| Secondary | Overall Survival | Overall survival defined as time from date of randomisation until date of death from any cause. Participants alive at the time of analysis were censored at the date of the last trial visit or last date of follow-up, whatever came last. | The Treated Set comprised all participants who received at least one application of the BI drug BI 2536 including treated participants who were not randomized. | Posted | Median | 95% Confidence Interval | days | every 6 weeks (every second treatment course), up to 599 days |
|
|
|
|
| Secondary | Duration of Overall Response | For participants who showed an overall tumour response of complete response (CR, disappearance of all target lesions) or partial response (PR, at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter), 'duration of overall response' was defined as the time from the first date where measurement criteria were met for CR or PR (whichever was first recorded) until the first date that recurrent or progressive disease (PD) was objectively documented (taking as reference for PD the smallest measurements recorded since the treatment started). Tumour response was evaluated based on local radiological images according to RECIST version 1.0 (agreed upon by independent review). The number of participants with an CR or PR who experienced the event 'recurrent or PD' is reported instead of the time-to-event data with unit of time as the number analyzed was too small to perform a Kaplan-Meier analysis. | All participants who received at least one application of the BI drug BI 2536 (including treated participants who were not randomized) and who showed an 'overall tumour response of complete response or partial response'. | Posted | Count of Participants | Participants | assessed at baseline, then every 6 weeks (every second treatment course) until disease progression or start of any other anti-tumour therapy or death or individual participant's end of trial, up to 533 days |
|
|
|
| Secondary | Objective Tumour Response Evaluated According to the Response Evaluation Criteria in Solid Tumours (RECIST 1.0) by Investigator | The best overall response was the best response recorded from start of treatment until the participant progressed, received any other anti-tumour therapy, died or until the individual participant's end of trial. 'Objective tumour response evaluated according to RECIST 1.0 by investigator' is 'Yes' if the best overall response is either complete response (CR, disappearance of all target lesions) or partial response (PR, at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter). Otherwise it is 'No'. To be assigned a status of 'partial response' or 'complete response', changes in tumour measurements were confirmed by repeat assessments that had to be performed six weeks after the criteria for response had been first met. Number of participants with 'Objective tumour response evaluated according to RECIST 1.0 by investigator = Yes' are reported. | All participants who received at least one application of the BI drug BI 2536 (including treated participants who were not randomized) and had at least one post-baseline response evaluation. | Posted | Number | Number of Participants | assessed at baseline, then every 6 weeks (every second treatment course) until disease progression or start of any other anti-tumour therapy or death or individual participant's end of trial, up to 533 days |
|
|
|
| Secondary | Time-to-deterioration for Symptom Score 'Cough' Assessed on Question 1 on the Lung Cancer Module QLQ LC13 of the European Organization for Research and Treatment Quality of Life (QoL) Questionnaire (EORTC QLQ) C30 Version 3.0 | Time to deterioration for cough [days] was defined as the time from randomization to deterioration in score for the symptom 'cough'. Participants were considered to have deteriorated if a 10-point increase from the baseline score at any time point after baseline was observed. Participants who died before deteriorating were analyzed as having deteriorated at the time of death. Participants with disease progression without deterioration in score were censored at the time of the last scale measurement. Participants with no QoL assessments were censored at day 1. The score for symptom 'cough' was based on Question 1 on the lung cancer module QLQ LC13 of the EORTC QLQ C30 Version 3.0. A linear transformation was used to standardize the raw scores, so that scores range from 0 to 100. A high score represents a higher ("worse") level of the symptom 'cough'. | The Treated Set comprised all participants who received at least one application of the BI drug BI 2536 including treated participants who were not randomized. | Posted | Median | 95% Confidence Interval | days | baseline and every 3 weeks (prior to the first administration of BI 2536 in a treatment course comprising 3 weeks), up to 539 days |
|
|
|
|
| Secondary | Time-to-deterioration for Symptom Score 'Dyspnoea' Assessed on the Composite of Questions 3-5 on the Lung Cancer Module QLQ LC13 of the European Organization for Research and Treatment Quality of Life (QoL) Questionnaire (EORTC QLQ) C30 Version 3.0 | Time to deterioration for dyspnoea [days] was defined as the time from randomization to deterioration in score for the symptom 'dyspnoea'. Participants were considered to have deteriorated if a 10-point increase from the baseline score at any time point after baseline was observed. Participants who died before deteriorating were analyzed as having deteriorated at the time of death. Participants with disease progression without deterioration in score were censored at the time of the last scale measurement. Participants with no QoL assessments were censored at day 1. The score for symptom 'dyspnoea' was based on the composite of Questions 3-5 on the lung cancer module QLQ LC13 of the EORTC QLQ C30 Version 3.0. A linear transformation was used to standardize the raw scores, so that scores range from 0 to 100. A high score represents a higher ("worse") level of the symptom 'dyspnoea'. | The Treated Set comprised all participants who received at least one application of the BI drug BI 2536 including treated participants who were not randomized. | Posted | Median | 95% Confidence Interval | days | baseline and every 3 weeks (prior to the first administration of BI 2536 in a treatment course comprising 3 weeks), up to 539 days |
|
|
|
|
| Secondary | Time-to-deterioration for Symptom Score 'Pain' Assessed on the Composite of Questions 9 and 19 of the European Organization for Research and Treatment Quality of Life (QoL) Questionnaire (EORTC QLQ) C30 Version 3.0 | Time to deterioration for pain [days] was defined as the time from randomization to deterioration in score for the symptom 'pain'. Participants were considered to have deteriorated if a 10-point increase from the baseline score at any time point after baseline was observed. Participants who died before deteriorating were analyzed as having deteriorated at the time of death. Participants with disease progression without deterioration in score were censored at the time of the last scale measurement. Participants with no QoL assessments will be censored at day 1. The score for symptom 'pain' was based on the composite of Questions 9 and 19 of the EORTC QLQ C30 Version 3.0. A linear transformation was used to standardize the raw scores, so that scores range from 0 to 100. A high score represents a higher ("worse") level of the symptom 'pain'. | The Treated Set comprised all participants who received at least one application of the BI drug BI 2536 including treated participants who were not randomized. | Posted | Median | 95% Confidence Interval | days | baseline and every 3 weeks (prior to the first administration of BI 2536 in a treatment course comprising 3 weeks), up to 539 days |
|
|
|
|
| Secondary | BI 2536 Plasma Concentrations After Intravenous Infusion of 200 Milligram BI 2536 on Day 1 in Treatment Course 1 | BI 2536 plasma concentrations after intravenous infusion of 200 milligram BI 2536 on day 1 in treatment course 1. Geometric Coefficient of Variation reported in percentage [%]. | The Treated Set comprised all participants who received at least one application of the BI drug BI 2536 including treated participants that were not randomized. Plasma concentrations below the limit of quantification were not used. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram / milliliter (ng/mL) | on day 1 in treatment course 1: 0.5 hour (h) , 1 h, 2 h, 4 h, 120 h post-dose (planned times) |
|
|
|
| Secondary | BI 2536 Plasma Concentrations After Intravenous Infusion of 50 / 60 Milligram BI 2536 on Day 1 in Treatment Course 1 | BI 2536 plasma concentrations after intravenous infusion of 50 / 60 milligram BI 2536 on day 1 in treatment course 1. Geometric Coefficient of Variation reported in percentage [%]. | The Treated Set comprised all participants who received at least one application of the BI drug BI 2536 including treated participants who were not randomized. Plasma concentrations below the limit of quantification were not used. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram / milliliter (ng/mL) | on day 1 in treatment course 1: 1 hour (h), 2 h, 23.92 h, 25 h, 47.92 h, 48.5 h, 49 h, 50 h, 52 h, 120 h post-dose (planned times) |
|
|
|
| Secondary | Incidence of Adverse Events Categorized by Common Terminology Criteria for Adverse Events (CTCAE) Grades | Number of participants with adverse events categorized by "common terminology criteria for adverse events (CTCAE) grades (version 3.0)" are reported. | The Treated Set comprised all participants who received at least one application of the BI drug BI 2536 including treated participants who were not randomized. | Posted | Number | Participants | On-treatment period, that is, from first administration of the trial drug until 3 weeks after the last administration of the trial drug, up to 428 days |
|
|
|
| Secondary | Incidence of Dose Limiting Toxicity (DLT) | Dose limiting toxicity was defined as drug related common terminology criteria for adverse events (CTCAE) grade 3 or greater non haematological toxicity (excluding untreated nausea, vomiting or diarrhoea) or drug related CTCAE grade 4 neutropenia for seven or more days and / or complicated by infection or CTCAE grade 4 thrombocytopenia. Number of participants with DLT is reported. | The Treated Set comprised all participants who received at least one application of the BI drug BI 2536 including treated participants who were not randomized. | Posted | Number | Participant | On-treatment period, that is, from first administration of the trial drug until 3 weeks after the last administration of the trial drug, up to 428 days |
|
|
|
| Secondary | Number of Participants With Neutropenia of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or 4 | Number of participants with neutropenia of common terminology criteria for adverse events (CTCAE) grade 3 or 4. | The Treated Set comprised all participants who received at least one application of the BI drug BI 2536 including treated participants who were not randomized. Participants with laboratory values that were out of range for CTCAE grading and were deemed possible clinically significant abnormal were excluded from the analyses. | Posted | Number | Number of Participants | On-treatment period, that is, from first administration of the trial drug until 3 weeks after the last administration of the trial drug, up to 428 days |
|
|
|
| Secondary | Number of Participants With Thrombocytopenia of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or 4 | Number of participants with thrombocytopenia of common terminology criteria for adverse events (CTCAE) grade 3 or 4. | The Treated Set comprised all participants who received at least one application of the BI drug BI 2536 including treated participants who were not randomized. Participants with laboratory values that were out of range for CTCAE grading and were deemed possible clinically significant abnormal were excluded from the analyses. | Posted | Number | Number of Participants | On-treatment period, that is, from first administration of the trial drug until 3 weeks after the last administration of the trial drug, up to 428 days |
|
|
|
| Secondary | Change From Baseline in Systolic/Diastolic Blood Pressure at Individual Participant's End-of-trial Visit | Change from baseline in systolic/diastolic blood pressure at individual participant's end-of-trial visit. | All participants who received at least one application of the BI drug BI 2536 (including treated patients who were not randomized) and for whom data were collected for this endpoint at the end-of-trial visit. | Posted | Mean | Standard Deviation | millimetre of mercury (mmHg) | baseline, date of individual participant's end of trial visit which was 533 days after start of treatment at the latest |
|
|
|
| Secondary | Change From Baseline in Pulse Rate at Individual Participant's End-of-trial Visit | Change from baseline in pulse rate at individual participant's end-of-trial visit. | All participants who received at least one application of the BI drug BI 2536 (including treated patients who were not randomized) and for whom data were collected for this endpoint at the end-of-trial visit. | Posted | Mean | Standard Deviation | beats per minute (bpm) | baseline, date of individual participant's end of trial visit which was 533 days after start of treatment at the latest |
|
|
|
| 35 |
| 48 |
| 20 |
| 48 |
| 44 |
| 48 |
| EG001 | 50 Milligram BI 2536 (Day 1 - Day 3) | A single dose of 50 mg BI 2536 on days 1, 2 and 3 of each treatment course (comprising 21 days including the days of administration) was administered as an intravenous infusion over a period of 60 minutes. Each participant was planned to receive at least 2 treatment courses, in case of clinical benefit (i.e., at least stable disease and acceptable tolerability) the participants could continue therapy with the trial drug. Trial drug administration was stopped temporarily in case of dose limiting toxicity (DLT). Participants could continue therapy only if recovery from DLT (to CTCAE levels which allowed further therapy) occurred and only with a dose reduced by up to 10 mg. Dose reduction was allowed only once for a participant during the whole trial. If a participant had experienced a second episode of DLT with the reduced dose or the participant had not recovered from DLT then the participant was withdrawn from the trial. A participant who continued therapy with BI 2536 beyond course 2 could be treated with a higher dose in case of non-progression and good tolerability. | 20 | 26 | 8 | 26 | 24 | 26 |
| EG002 | 60 Milligram BI 2536 (Day 1 - Day 3) | After implementation of protocol amendment 2 a single dose of 60 mg BI 2536 on days 1, 2 and 3 of each treatment course (comprising 21 days including the days of administration) was administered as an intravenous infusion over a period of 60 minutes. Each participant was planned to receive at least 2 treatment courses, in case of clinical benefit (i.e., at least stable disease and acceptable tolerability) the participants could continue therapy with the trial drug. Trial drug administration was stopped temporarily in case of dose limiting toxicity (DLT). Participants could continue therapy only if recovery from DLT (to CTCAE levels which allowed further therapy) occurred and only with a dose reduced by up to 10 mg. Dose reduction was allowed only once for a participant during the whole trial. If a participant had experienced a second episode of DLT with the reduced dose or the participant had not recovered from DLT then the participant was withdrawn from the trial. A participant who continued therapy with BI 2536 beyond course 2 could be treated with a higher dose in case of non-progression and good tolerability. | 16 | 21 | 12 | 21 | 19 | 21 |
| EG003 | Combination of Treatment Group "50 mg BI 2536 (Day 1 - Day 3)" and "60 mg BI 2536 (Day 1 - Day 3)" | A single dose of 50 mg or 60 mg (following implementation of protocol amendment 2) on days 1, 2 and 3 of each treatment course (comprising 21 days including the days of administration) was administered as an intravenous infusion over a period of 60 minutes. Each participant was planned to receive at least 2 treatment courses, in case of clinical benefit (i.e., at least stable disease and acceptable tolerability) the participants could continue therapy with the trial drug. Trial drug administration was stopped temporarily in case of dose limiting toxicity (DLT). Participants could continue therapy only if recovery from DLT (to CTCAE levels which allowed further therapy) occurred and only with a dose reduced by up to 10 mg. Dose reduction was allowed only once for a participant during the whole trial. If a participant had experienced a second episode of DLT with the reduced dose or the participant had not recovered from DLT then the participant was withdrawn from the trial. A participant who continued therapy with BI 2536 beyond course 2 could be treated with a higher dose in case of non-progression and good tolerability. | 36 | 47 | 20 | 47 | 43 | 47 |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Cardiopulmonary failure | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Right ventricular failure | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Tracheo-oesophageal fistula | Congenital, familial and genetic disorders | MedDRA 11.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Multi-organ failure | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Tracheal stenosis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Catheter removal | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
|
| Circulatory collapse | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Venous thrombosis limb | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 11.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Injection site phlebitis | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Iatrogenic injury | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Polyneuropathy | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Skin reaction | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Thrombophlebitis | Vascular disorders | MedDRA 11.0 | 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.
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
|
| 2 hour post-dose (planned time) |
|
|
| 4 hour post-dose (planned time) |
|
|
| 120 hour post-dose (planned time) |
|
|
| 2 hour post-dose (planned time) |
|
|
| 23.92 hour post-dose (planned time) |
|
|
| 25 hour post-dose (planned time) |
|
|
| 47.92 hour post-dose (planned time) |
|
|
| 48.5 hour post-dose (planned time) |
|
|
| 49 hour post-dose (planned time) |
|
|
| 50 hour post-dose (planned time) |
|
|
| 52 hour post-dose (planned time) |
|
|
| 120 hour post-dose (planned time) |
|
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 5 |
|
| Change from baseline in diastolic blood pressure |
|