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To confirm the safety of BIBF 1120 at a dose level up to 200 mg x 2/day (i.e., overseas recommended Phase III dose for combination treatment) with standard therapy of docetaxel (60 mg/m2 and 75 mg/m2) in Japanese advanced non small cell lung cancer (NSCLC) patients with stage IIIB/IV or recurrent after failure of first line chemotherapy and to determine the recommended dose for the Phase II trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIBF 1120 + docetaxel | Experimental | Low, medium and high dose of BIBF 1120 and 60 mg/m2, 75 mg/m2 docetaxel every 3 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIBF 1120 M + docetaxel M | Drug | BIBF 1120 Medium dose bid + docetaxel 60 mg/m2 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced Dose Limited Toxicity in Combination Therapy of Nintedanib and Docetaxel | Number of participants experienced Dose Limited Toxicity (DLT) in combination therapy of nintedanib and docetaxel. Maximum tolerated dose (MTD) of nintedanib combination with docetaxel were to be determined separately in the patient groups of body surface area (BSA) <1.5 m2 and BSA ≥1.5 m2. The MTD were to be determined as a combination of a dose equal to or less than 200 mg b.i.d. of nintedanib and 60 mg/m2 and 75 mg/m2 every 3 weeks of docetaxel at which either 0 out of 3, 1 out of 6, or 2 out of 6 patients experienced DLT. | During the first treatment course, up to 3 weeks |
| Adverse Events According to Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 for All Courses | Number of participants with adverse events according to Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 for all courses. The CTCAE grades are: 1 (mild AE), 2 (moderate AE), 3 (severe AE), 4 (life-threatening or disabling AE), 5 (death related to AE). | Between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Tumor Response | Number of participants with objective response defined as complete response (CR) or partial response (PR) according to the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0 | Pre-treatment, every 6 weeks from treatment course 3, end of treatment (up to 1367 days) |
| Disease Control |
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Inclusion criteria:
Histologically/cytologically confirmed, locally advanced/metastatic NSCLC of stage IIIB/IV or recurrent NSCLC (all histologies. Existence or nonexistence of measurable lesion according to RECIST is no object.)
Patients with one prior chemotherapy regimen including platinum-containing drug.
In case of recurrent disease, one additional prior regimen is allowed for adjuvant and/or neoadjuvant therapy. However monotherapy of EGFR-TKI (i.e. erlotinib/Tarceva® and gefitinib/Iressa®) is not counted as 'one regimen'.
Male or female patients age >=20 years and =<74 years at the enrolment.
Life expectancy of at least three (3) months after the start of administration of the investigational drug.
Eastern Cooperative Oncology Group (ECOG) [R01-0787] performance Score 0 or 1.
Patients retaining a significant physiological compensatory function and patients with sufficient baseline organ function as follows:
Written informed consent that is consistent with ICH-GCP guidelines.
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1199.29.002 Boehringer Ingelheim Investigational Site | Fukuoka, Fukuoka | Japan | ||||
| 1199.29.001 Boehringer Ingelheim Investigational Site |
In case a patient had to discontinue docetaxel for reasons other than progression disease, the patient could continue therapy with nintedanib if the patient had been treated with combination therapy with docetaxel during at least 4 treatment courses.
43 patients entered.1 patient was replaced because he did not take any nintedanib(Nin) due to new brain metastasis after completion of first administration of docetaxel. Accordingly,42 patients treated with at least 1 dose of Nin in combination with docetaxel.Patients started mono therapy phase after discontinued from combination therapy phase .
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| ID | Title | Description |
|---|---|---|
| FG000 | Nintedanib 100 mg + Docetaxel 60 mg/m2 | Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Combination Therapy Phase |
|
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| BIBF 1120 M + docetaxel H |
| Drug |
BIBF 1120 Medium dose bid + docetaxel 75mg/m2 |
|
| BIBF 1120 H + docetaxel H | Drug | BIBF 1120 HIgh dose bid + docetaxel 75 mg/m2 |
|
| BIBF 1120 L + docetaxel M | Drug | BIBF 1120 Low dose bid + docetaxel 60 mg/m2 |
|
| BIBF 1120 H + docetaxel M | Drug | BIBF 1120 HIgh dose bid + docetaxel 60 mg/m2 |
|
Number of participants with disease control, defined as complete response (CR) or partial response (PR) or stable disease (SD) according to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.0 |
| Pre-treatment, every 6 weeks from treatment course 3, end of treatment (up to 1367 days) |
| Progression-Free Survival (PFS) | For participants with known date of progression or death (of any cause): PFS [days] = earlier of date of progression or death - date the study treatment started + 1. For participants known to be alive without progression by the end of trial or follow-up visit: PFS (censored) [days] = date of last imaging when the participant is known to be progression-free and alive - date the study treatment started + 1. Progression is assessed according to RECIST version 1.0. | Pre-treatment, every 6 weeks from treatment course 3, end of treatment (up to 1367 days) |
| Time to Treatment Failure (TTF) | For participants with known date of discontinuation of the study treatment (or progression [not necessarily confirmed by tumour imaging; can also be based on any clinical sign of tumour progression] or death): TTF [days] = earlier of date of discontinuation of the study treatment, progression, or death - date the study treatment started + 1. For participants known to be alive without progression by the end of trial or follow-up visit: TTF (censored) [days] = date when the patient is known to be progression-free and alive - date the study treatment started + 1. Progression is assessed according to RECIST version 1.0. | Pre-treatment, every 6 weeks from treatment course 3, end of treatment (up to 1367 days) |
| Clinical Relevant Abnormalities in Laboratory Parameters | Number of participants with clinically relevant abnormalities in laboratory parameters reported as adverse events | Between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days |
| AUC0-inf of Nintedanib in Course 1 | AUC0-inf (area under the plasma concentration-time curve over the time interval from 0 extrapolated to infinity) after the first administration of nintedanib in course 1 | -0:05 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 7h, 10h and 23:55h after drug administration in course 1 |
| Cmax of Nintedanib in Course 1 | Cmax (maximum measured plasma concentration) after the first administration of nintedanib in course 1 | -0:05h before drug administration and 1h, 2h, 3h, 4h, 6h, 7h, 10h and 23:55h after drug administration in course 1 |
| AUC0-inf of Docetaxel in Course 1 | AUC0-inf (area under the plasma concentration-time curve over the time interval from 0 extrapolated to infinity) after the first administration of docetaxel in course 1 | -0:05h before drug administration and 1h, 1.5h, 2h, 3h, 4h, 7h, 23:55h and 47:55h after drug administration |
| Cmax of Docetaxel in Course 1 | Cmax (maximum measured plasma concentration) after the first administration of docetaxel in course 1 | -0:05h before drug administration and 1h, 1.5h, 2h, 3h, 4h, 7h, 23:55h and 47:55h after drug administration |
| AUC0-inf of Docetaxel in Course 2 | AUC0-inf (area under the plasma concentration-time curve over the time interval from 0 extrapolated to infinity) after the first administration of docetaxel in course 2. Docetaxel 50 mg/m2 patients were assigned to Docetaxel 60 mg/m2 in Cycle 1, but the dose was reduced to 50 mg/m2 in Cycle 2 as defined in the Clinical Trial Protocol. | -0:05h before drug administration and 1h, 1.5h, 2h, 3h, 4h, 7h, 23:55h and 47:55h after drug administration |
| Cmax of Docetaxel in Course 2 | Cmax (maximum measured plasma concentration) after the first administration of docetaxel in course 2. Docetaxel 50 mg/m2 patients were assigned to Docetaxel 60 mg/m2 in Cycle 1, but the dose was reduced to 50 mg/m2 in Cycle 2 as defined in the Clinical Trial Protocol. | -0:05h before drug administration and 1h, 1.5h, 2h, 3h, 4h, 7h, 23:55h and 47:55h after drug administration |
| Osaka-Sayamashi, Osaka |
| Japan |
| Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2) |
Patients with body surface area (BSA) <1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered. |
| FG002 | Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2) | Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered. |
| FG003 | Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA <1.5 m^2) | Patients with body surface area <1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered. |
| FG004 | Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2) | Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered. |
| FG005 | Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2) | Patients with body surface area <1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered. |
| FG006 | Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2) | Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered. |
| FG007 | Nintedanib 200 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2) | Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Mono Therapy Phase |
|
|
Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment
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| ID | Title | Description |
|---|---|---|
| BG000 | Nintedanib 100 mg + Docetaxel 60 mg/m2 | Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered. |
| BG001 | Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2) | Patients with body surface area (BSA) <1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered. |
| BG002 | Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2) | Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered. |
| BG003 | Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA <1.5 m^2) | Patients with body surface area <1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered. |
| BG004 | Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2) | Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered. |
| BG005 | Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2) | Patients with body surface area <1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered. |
| BG006 | Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2) | Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered. |
| BG007 | Nintedanib 200 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2) | Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered. |
| BG008 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Experienced Dose Limited Toxicity in Combination Therapy of Nintedanib and Docetaxel | Number of participants experienced Dose Limited Toxicity (DLT) in combination therapy of nintedanib and docetaxel. Maximum tolerated dose (MTD) of nintedanib combination with docetaxel were to be determined separately in the patient groups of body surface area (BSA) <1.5 m2 and BSA ≥1.5 m2. The MTD were to be determined as a combination of a dose equal to or less than 200 mg b.i.d. of nintedanib and 60 mg/m2 and 75 mg/m2 every 3 weeks of docetaxel at which either 0 out of 3, 1 out of 6, or 2 out of 6 patients experienced DLT. | Treated set (Patients eligible for DLT confirmation) | Posted | Number | Participants | During the first treatment course, up to 3 weeks |
|
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| |||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Adverse Events According to Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 for All Courses | Number of participants with adverse events according to Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 for all courses. The CTCAE grades are: 1 (mild AE), 2 (moderate AE), 3 (severe AE), 4 (life-threatening or disabling AE), 5 (death related to AE). | Treated set | Posted | Number | Participants | Between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Objective Tumor Response | Number of participants with objective response defined as complete response (CR) or partial response (PR) according to the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0 | Patients who were treated with nintedanib and had both baseline and at least one post-treatment tumour measurement by computed tomography (CT) image | Posted | Number | Participants | Pre-treatment, every 6 weeks from treatment course 3, end of treatment (up to 1367 days) |
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| Secondary | Disease Control | Number of participants with disease control, defined as complete response (CR) or partial response (PR) or stable disease (SD) according to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.0 | Patients who treated with nintedanib and had both baseline and at least one post-treated tumour measurement by computed tomography (CT) image | Posted | Number | Participants | Pre-treatment, every 6 weeks from treatment course 3, end of treatment (up to 1367 days) |
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| Secondary | Progression-Free Survival (PFS) | For participants with known date of progression or death (of any cause): PFS [days] = earlier of date of progression or death - date the study treatment started + 1. For participants known to be alive without progression by the end of trial or follow-up visit: PFS (censored) [days] = date of last imaging when the participant is known to be progression-free and alive - date the study treatment started + 1. Progression is assessed according to RECIST version 1.0. | Treated set | Posted | Median | 95% Confidence Interval | Days | Pre-treatment, every 6 weeks from treatment course 3, end of treatment (up to 1367 days) |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Treatment Failure (TTF) | For participants with known date of discontinuation of the study treatment (or progression [not necessarily confirmed by tumour imaging; can also be based on any clinical sign of tumour progression] or death): TTF [days] = earlier of date of discontinuation of the study treatment, progression, or death - date the study treatment started + 1. For participants known to be alive without progression by the end of trial or follow-up visit: TTF (censored) [days] = date when the patient is known to be progression-free and alive - date the study treatment started + 1. Progression is assessed according to RECIST version 1.0. | Treated set | Posted | Median | 95% Confidence Interval | Days | Pre-treatment, every 6 weeks from treatment course 3, end of treatment (up to 1367 days) |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Clinical Relevant Abnormalities in Laboratory Parameters | Number of participants with clinically relevant abnormalities in laboratory parameters reported as adverse events | Treated set | Posted | Number | Participants | Between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | AUC0-inf of Nintedanib in Course 1 | AUC0-inf (area under the plasma concentration-time curve over the time interval from 0 extrapolated to infinity) after the first administration of nintedanib in course 1 | Treated set (AUC0-inf could not be calculated in 5 patients because the elimination phase was not observed in plasma concentration-time profiles in these patients.) | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | -0:05 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 7h, 10h and 23:55h after drug administration in course 1 |
|
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| Secondary | Cmax of Nintedanib in Course 1 | Cmax (maximum measured plasma concentration) after the first administration of nintedanib in course 1 | Treated set | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | -0:05h before drug administration and 1h, 2h, 3h, 4h, 6h, 7h, 10h and 23:55h after drug administration in course 1 |
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| Secondary | AUC0-inf of Docetaxel in Course 1 | AUC0-inf (area under the plasma concentration-time curve over the time interval from 0 extrapolated to infinity) after the first administration of docetaxel in course 1 | Treated set (1 patient was replaced after completion of first administration of docetaxel and before any nintedanib intake. Pharmacokinetic (PK) sampling of docetaxel for this patient was done and included in PK analysis.) | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | -0:05h before drug administration and 1h, 1.5h, 2h, 3h, 4h, 7h, 23:55h and 47:55h after drug administration |
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| Secondary | Cmax of Docetaxel in Course 1 | Cmax (maximum measured plasma concentration) after the first administration of docetaxel in course 1 | Treated set (1 patient was replaced after completion of first administration of docetaxel and before any nintedanib intake. PK sampling of docetaxel for this patient was done and included in PK analysis.) | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | -0:05h before drug administration and 1h, 1.5h, 2h, 3h, 4h, 7h, 23:55h and 47:55h after drug administration |
|
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| Secondary | AUC0-inf of Docetaxel in Course 2 | AUC0-inf (area under the plasma concentration-time curve over the time interval from 0 extrapolated to infinity) after the first administration of docetaxel in course 2. Docetaxel 50 mg/m2 patients were assigned to Docetaxel 60 mg/m2 in Cycle 1, but the dose was reduced to 50 mg/m2 in Cycle 2 as defined in the Clinical Trial Protocol. | Treated set (AUC0-inf could not be calculated in 1 patient because the elimination phase was not observed in plasma concentration-time profile in this patient.) | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | -0:05h before drug administration and 1h, 1.5h, 2h, 3h, 4h, 7h, 23:55h and 47:55h after drug administration |
|
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| Secondary | Cmax of Docetaxel in Course 2 | Cmax (maximum measured plasma concentration) after the first administration of docetaxel in course 2. Docetaxel 50 mg/m2 patients were assigned to Docetaxel 60 mg/m2 in Cycle 1, but the dose was reduced to 50 mg/m2 in Cycle 2 as defined in the Clinical Trial Protocol. | Treated set | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | -0:05h before drug administration and 1h, 1.5h, 2h, 3h, 4h, 7h, 23:55h and 47:55h after drug administration |
|
|
between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nintedanib 100 mg + Docetaxel 60 mg/m2 | Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered. | 1 | 3 | 3 | 3 | ||
| EG001 | Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2) | Patients with body surface area (BSA) <1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered. | 4 | 7 | 7 | 7 | ||
| EG002 | Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2) | Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered. | 0 | 3 | 3 | 3 | ||
| EG003 | Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA <1.5 m^2) | Patients with body surface area <1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered. | 2 | 6 | 6 | 6 | ||
| EG004 | Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2) | Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered. | 4 | 7 | 7 | 7 | ||
| EG005 | Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2) | Patients with body surface area <1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered. | 0 | 3 | 3 | 3 | ||
| EG006 | Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2) | Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered. | 3 | 7 | 7 | 7 | ||
| EG007 | Nintedanib 200 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2) | Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered. | 1 | 6 | 6 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Brain cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Peritumoural oedema | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Conjunctivitis allergic | Eye disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Eye discharge | Eye disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Retinal haemorrhage | Eye disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Anal haemorrhage | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Gingival pain | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Periodontal disease | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Tongue discolouration | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Tooth disorder | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Eyelid infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Nail infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Oral infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Pulpitis dental | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Sunburn | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Blood albumin decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Blood calcium decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Blood chloride decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Blood uric acid increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Blood urine | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Blood urine present | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Prothrombin level decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Tri-iodothyronine free decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypercreatininaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypovitaminosis | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Visual field defect | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Nail bed bleeding | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Nail discolouration | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pigmentation disorder | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Skin induration | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Skin swelling | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Vasculitis | Vascular disorders | MedDRA 17.1 | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| Withdrawal by Subject |
|
| Adverse Event |
|
| Male |
|
Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered. |
| OG003 | Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA <1.5 m^2) | Patients with body surface area <1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered. |
| OG004 | Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2) | Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered. |
| OG005 | Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2) | Patients with body surface area <1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered. |
| OG006 | Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2) | Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered. |
| OG007 | Nintedanib 200 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2) | Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered. |
|
|
Patients administered a soft gelatin capsule of nintedanib 150 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
| OG003 | Nintedanib 200 mg + Docetaxel 60 mg/m2 | Patients administered a soft gelatin capsule of nintedanib 200 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered. |
| OG004 | Nintedanib 200 mg + Docetaxel 75 mg/m2 | Patients administered a soft gelatin capsule of nintedanib 200 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered. |
|
|
Patients administered a soft gelatin capsule of nintedanib 150 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
| OG003 | Nintedanib 200 mg + Docetaxel 60 mg/m2 | Patients administered a soft gelatin capsule of nintedanib 200 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered. |
| OG004 | Nintedanib 200 mg + Docetaxel 75 mg/m2 | Patients administered a soft gelatin capsule of nintedanib 200 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered. |
|
|
| Nintedanib 150 mg + Docetaxel 75 mg/m2 |
Patients administered a soft gelatin capsule of nintedanib 150 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered. |
| OG003 | Nintedanib 200 mg + Docetaxel 60 mg/m2 | Patients administered a soft gelatin capsule of nintedanib 200 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered. |
| OG004 | Nintedanib 200 mg + Docetaxel 75 mg/m2 | Patients administered a soft gelatin capsule of nintedanib 200 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered. |
|
|
| OG002 | Nintedanib 150 mg + Docetaxel 75 mg/m2 | Patients administered a soft gelatin capsule of nintedanib 150 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered. |
| OG003 | Nintedanib 200 mg + Docetaxel 60 mg/m2 | Patients administered a soft gelatin capsule of nintedanib 200 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered. |
| OG004 | Nintedanib 200 mg + Docetaxel 75 mg/m2 | Patients administered a soft gelatin capsule of nintedanib 200 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered. |
|
|
| OG003 | Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA <1.5 m^2) | Patients with body surface area <1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered. |
| OG004 | Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2) | Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered. |
| OG005 | Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2) | Patients with body surface area <1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered. |
| OG006 | Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2) | Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered. |
| OG007 | Nintedanib 200 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2) | Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered. |
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