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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-024456-29 | EudraCT Number |
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The purpose is to investigate the maximum tolerated dose (MTD), safety and tolerability, pharmacokinetics and efficacy of BI 836826 monotherapy in patients with relapsed or refractory non-Hodgkin lymphoma with at least prior treatments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with relapsed or refractory NHL | Experimental | Adult patients with relapsed or refractory non-Hodgkin lymphoma of B cell origin after at least two prior treatments |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 836826 | Drug | Monotherapy with BI 836826 at escalating dose levels administered as an intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determination of the Maximum Tolerated Dose (MTD) Based on the Occurrence of Dose-limiting Toxicity (DLT) in First Cycle in Caucasian Patients | The primary objective of the dose-escalation part of this study was to determine the MTD of BI 836826 in caucasian patients. The MTD was to be defined on the basis of DLTs observed during the first 2 weeks of the 1st treatment course. In case of a delay of the second administration, evaluation of DLT was to be prolonged to 7 days after the second administration.. A DLT was defined as any drug-related non-haematological Adverse event (AE) of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or higher, except Infusion-related reaction (IRRs) associated with the administration of BI 836826. | From the first administration of trial medication to 7 days after the second administration, upto 36 days |
| Number of Subjects With Dose Limiting Toxicities (DLT) in First Cycle in Caucasian Patients | Number of subjects with Dose Limiting Toxicities (DLT) in first Cycle during the MTD evaluation period in caucasian patients with relapsed or refractory Non-Hodgkin lymphoma (NHL). | From the first administration of trial medication to 7 days after the second administration, up to 36 days |
| Measure | Description | Time Frame |
|---|---|---|
| Tumour Size Reduction | Tumour size reduction (lymph nodes, spleen, & liver nodules) defined as best percentage change from baseline in sum of products of diameter (SPD). Negative value represents decrease in tumour size, & positive value represents an increase in size. The tumour size of lymph nodes was to be measured as SPD of 2 perpendicular dimensions for up to 6 indicator lesions identified at baseline CT scan. Spleen & liver were to be described if considered enlarged at baseline by physical examination or CT scan. If nodules present in spleen &/or liver, was to be measured in 2 perpendicular dimensions. Median, 25th & 75th percentiles are calculated from unadjusted Kaplan-Meier curve for each treatment cohort. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| INS Paoli-Calmettes | Marseille | 13273 | France | |||
| HOP Lyon Sud |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32172489 | Derived | Kroschinsky F, Middeke JM, Janz M, Lenz G, Witzens-Harig M, Bouabdallah R, La Rosee P, Viardot A, Salles G, Kim SJ, Kim TM, Ottmann O, Chromik J, Quinson AM, von Wangenheim U, Burkard U, Berk A, Schmitz N. Phase I dose escalation study of BI 836826 (CD37 antibody) in patients with relapsed or refractory B-cell non-Hodgkin lymphoma. Invest New Drugs. 2020 Oct;38(5):1472-1482. doi: 10.1007/s10637-020-00916-3. Epub 2020 Mar 14. |
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All subjects were screened for eligibility to participate in trial. Subjects attended specialist sites to ensure that they (the subjects) met all implemented inclusion/exclusion criteria. Subjects were not to be entered to trial drug if any of the specific entry criteria was violated.
This was an open-label trial with a dose-escalation phase according to a modified 3+3 design.
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| ID | Title | Description |
|---|---|---|
| FG000 | BI 836826 1 mg iv (Caucasian Patients) | BI 836826 1 milligram (mg) was administered as an intravenous (iv) infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks. |
| FG001 | BI 836826 3 mg iv (Caucasian Patients) | BI 836826 3 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks. |
| FG002 | BI 836826 9 mg iv (Caucasian Patients) | BI 836826 9 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks. |
| FG003 | BI 836826 25 mg iv (Caucasian Patients) | BI 836826 25 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks. |
| FG004 | BI 836826 50 mg iv (Caucasian Patients) | BI 836826 50 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks. |
| FG005 | BI 836826 50mg iv (Korean Patients) | BI 836826 50 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in korean patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks. |
| FG006 | BI 836826 100 mg iv (Caucasian Patients) | BI 836826 100 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks. |
| FG007 | BI 836826 100 mg iv (Korean Patients) | BI 836826 100 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in korean patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks. |
| FG008 | BI 836826 150 mg iv (Caucasian Patients) | BI 836826 150 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks. |
| FG009 | BI 836826 200 mg iv (Caucasian Patients) | BI 836826 200 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Treated set (TS): Treated set (TS) consists of all patients who received at least 1 dose of BI 836826.
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| ID | Title | Description |
|---|---|---|
| BG000 | BI 836826 1 mg iv (Caucasian Patients) | BI 836826 1 milligram (mg) was administered as an intravenous (iv) infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Determination of the Maximum Tolerated Dose (MTD) Based on the Occurrence of Dose-limiting Toxicity (DLT) in First Cycle in Caucasian Patients | The primary objective of the dose-escalation part of this study was to determine the MTD of BI 836826 in caucasian patients. The MTD was to be defined on the basis of DLTs observed during the first 2 weeks of the 1st treatment course. In case of a delay of the second administration, evaluation of DLT was to be prolonged to 7 days after the second administration.. A DLT was defined as any drug-related non-haematological Adverse event (AE) of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or higher, except Infusion-related reaction (IRRs) associated with the administration of BI 836826. | Treated Set | Posted | Number | Milligram (mg) | From the first administration of trial medication to 7 days after the second administration, upto 36 days |
|
From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BI 836826 1 mg iv (Caucasian Patients) | BI 836826 1 milligram (mg) was administered as an intravenous (iv) infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 13, 2016 | Jun 30, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 28, 2017 | Jun 30, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| ID | Term |
|---|---|
| C000626798 | BI 836826 |
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| Computed tomography (CT) scan performed at screening, at Week 13, and at Week 25. |
| Best Overall Response Based on All Assessment | Best overall response was best response at any of CT scans and investigator assesment (incase the recent CT scan was not available). Response was assessed as follow according to the Standardized or Revised Response Criteria for Malignant Lymphoma from 1999.:
| Screening, Week 1, Week 4, Week 7, Week 8, Week 11, Week 14, Week 15, Week 18 and at End of Treatment (EOT) |
| Best Overall Response Based on Imaging Data | Best overall response based on imaging data. Response was assessed as follow according to the Standardized or Revised Response Criteria for Malignant Lymphoma from 1999.:
| Computed tomography (CT) scan performed at screening, at Week 13, and at Week 25. |
| Progression Free Survival (PFS) | PFS was defined as the time from first treatment with BI 836826 until disease progression or death from any cause. For disease progression one of the following criteria was required: • Any new lesion >1.5 centimeter (cm) in any axis • Increase of ≥50% from nadir in sum of product of diameter of any previously involved nodes or single nodes or the size of hepatic or splenic nodules. A lymph node with a diameter of the short axis of <1 cm had to increase by ≥50% and to a size of 1.5 x 1.5 cm or more than 1.5 cm in the long axis • Increase of ≥50% in the longest diameter of any single previously identified node >1 cm in its short axis. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment cohort. | from first treatment until disease progression or death from any cause, up to 12 months. |
| Failure Free Survival (FFS) | FFS was defined as the time from first treatment with BI 836826 until objective disease progression, death, or start of next Non-Hodgkin lymphoma (NHL) therapy.For disease progression one of the following criteria was required: • Any new lesion >1.5 centimeter (cm) in any axis • Increase of ≥50% from nadir in sum of product of diameter of any previously involved nodes or single nodes or the size of hepatic or splenic nodules. A lymph node with a diameter of the short axis of <1 cm had to increase by ≥50% and to a size of 1.5 x 1.5 cm or more than 1.5 cm in the long axis • Increase of ≥50% in the longest diameter of any single previously identified node >1 cm in its short axis. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment cohort. | from first treatment with BI 836826 until objective disease progression, death, or start of next NHL therapy, up to 12 months. |
| Pierre-Bénite |
| 69495 |
| France |
| Charité - Universitätsmedizin Berlin | Berlin | 12200 | Germany |
| Universitätsklinikum Carl Gustav Carus Dresden | Dresden | 01307 | Germany |
| Universitätsklinikum Frankfurt | Frankfurt am Main | 60590 | Germany |
| Universitätsmedizin Göttingen, Georg-August-Universität | Göttingen | 37075 | Germany |
| Asklepios Klinik St. Georg | Hamburg | 20099 | Germany |
| Universitätsklinikum Heidelberg | Heidelberg | 69120 | Germany |
| Universitätsklinikum Jena | Jena | 07740 | Germany |
| Universitätsklinikum Ulm | Ulm | 89081 | Germany |
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
| Samsung Medical Center | Seoul | 135-710 | South Korea |
| Other Adverse Event (Other than DLT) |
|
| Lost to Follow-up |
|
| Refused cont. medication |
|
| other than above |
|
| BG001 | BI 836826 3 mg iv (Caucasian Patients) | BI 836826 3 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks. |
| BG002 | BI 836826 9 mg iv (Caucasian Patients) | BI 836826 9 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks. |
| BG003 | BI 836826 25 mg iv (Caucasian Patients) | BI 836826 25 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks. |
| BG004 | BI 836826 50 mg iv (Caucasian Patients) | BI 836826 50 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks. |
| BG005 | BI 836826 50mg iv (Korean Patients) | BI 836826 50 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in korean patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks. |
| BG006 | BI 836826 100 mg iv (Caucasian Patients) | BI 836826 100 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks. |
| BG007 | BI 836826 100 mg iv (Korean Patients) | BI 836826 100 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in korean patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks. |
| BG008 | BI 836826 150 mg iv (Caucasian Patients) | BI 836826 150 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks. |
| BG009 | BI 836826 200 mg iv (Caucasian Patients) | BI 836826 200 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks. |
| BG010 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Ethinicity was not captured in this trial. | Count of Participants | Participants |
|
Caucasian patients were treated in the dose-escalation phase with BI 836826 as an intravenous infusion until the patient met criteria for stopping study medication during the MTD evaluation period. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
|
|
| Primary | Number of Subjects With Dose Limiting Toxicities (DLT) in First Cycle in Caucasian Patients | Number of subjects with Dose Limiting Toxicities (DLT) in first Cycle during the MTD evaluation period in caucasian patients with relapsed or refractory Non-Hodgkin lymphoma (NHL). | Treated Set | Posted | Count of Participants | Participants | From the first administration of trial medication to 7 days after the second administration, up to 36 days |
|
|
|
| Secondary | Tumour Size Reduction | Tumour size reduction (lymph nodes, spleen, & liver nodules) defined as best percentage change from baseline in sum of products of diameter (SPD). Negative value represents decrease in tumour size, & positive value represents an increase in size. The tumour size of lymph nodes was to be measured as SPD of 2 perpendicular dimensions for up to 6 indicator lesions identified at baseline CT scan. Spleen & liver were to be described if considered enlarged at baseline by physical examination or CT scan. If nodules present in spleen &/or liver, was to be measured in 2 perpendicular dimensions. Median, 25th & 75th percentiles are calculated from unadjusted Kaplan-Meier curve for each treatment cohort. | Treated set | Posted | Mean | Standard Deviation | Percentage | Computed tomography (CT) scan performed at screening, at Week 13, and at Week 25. |
|
|
|
| Secondary | Best Overall Response Based on All Assessment | Best overall response was best response at any of CT scans and investigator assesment (incase the recent CT scan was not available). Response was assessed as follow according to the Standardized or Revised Response Criteria for Malignant Lymphoma from 1999.:
| Treated set | Posted | Count of Participants | Participants | Screening, Week 1, Week 4, Week 7, Week 8, Week 11, Week 14, Week 15, Week 18 and at End of Treatment (EOT) |
|
|
|
| Secondary | Best Overall Response Based on Imaging Data | Best overall response based on imaging data. Response was assessed as follow according to the Standardized or Revised Response Criteria for Malignant Lymphoma from 1999.:
| Treated set | Posted | Count of Participants | Participants | Computed tomography (CT) scan performed at screening, at Week 13, and at Week 25. |
|
|
|
| Secondary | Progression Free Survival (PFS) | PFS was defined as the time from first treatment with BI 836826 until disease progression or death from any cause. For disease progression one of the following criteria was required: • Any new lesion >1.5 centimeter (cm) in any axis • Increase of ≥50% from nadir in sum of product of diameter of any previously involved nodes or single nodes or the size of hepatic or splenic nodules. A lymph node with a diameter of the short axis of <1 cm had to increase by ≥50% and to a size of 1.5 x 1.5 cm or more than 1.5 cm in the long axis • Increase of ≥50% in the longest diameter of any single previously identified node >1 cm in its short axis. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment cohort. | Treated set | Posted | Median | Inter-Quartile Range | days | from first treatment until disease progression or death from any cause, up to 12 months. |
|
|
|
| Secondary | Failure Free Survival (FFS) | FFS was defined as the time from first treatment with BI 836826 until objective disease progression, death, or start of next Non-Hodgkin lymphoma (NHL) therapy.For disease progression one of the following criteria was required: • Any new lesion >1.5 centimeter (cm) in any axis • Increase of ≥50% from nadir in sum of product of diameter of any previously involved nodes or single nodes or the size of hepatic or splenic nodules. A lymph node with a diameter of the short axis of <1 cm had to increase by ≥50% and to a size of 1.5 x 1.5 cm or more than 1.5 cm in the long axis • Increase of ≥50% in the longest diameter of any single previously identified node >1 cm in its short axis. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment cohort. | Treated set | Posted | Median | Inter-Quartile Range | days | from first treatment with BI 836826 until objective disease progression, death, or start of next NHL therapy, up to 12 months. |
|
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 1 |
| 1 |
| EG001 | BI 836826 3 mg iv (Caucasian Patients) | BI 836826 3 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks. | 0 | 4 | 3 | 4 | 4 | 4 |
| EG002 | BI 836826 9 mg iv (Caucasian Patients) | BI 836826 9 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks. | 1 | 3 | 2 | 3 | 3 | 3 |
| EG003 | BI 836826 25 mg iv (Caucasian Patients) | BI 836826 25 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks. | 1 | 4 | 1 | 4 | 4 | 4 |
| EG004 | BI 836826 50 mg iv (Caucasian Patients) | BI 836826 50 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks. | 2 | 6 | 5 | 6 | 6 | 6 |
| EG005 | BI 836826 50mg iv (Korean Patients) | BI 836826 50 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in korean patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks. | 1 | 7 | 4 | 7 | 7 | 7 |
| EG006 | BI 836826 100 mg iv (Caucasian Patients) | BI 836826 100 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks. | 1 | 6 | 5 | 6 | 6 | 6 |
| EG007 | BI 836826 100 mg iv (Korean Patients) | BI 836826 100 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in korean patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks. | 1 | 4 | 3 | 4 | 4 | 4 |
| EG008 | BI 836826 150 mg iv (Caucasian Patients) | BI 836826 150 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks. | 2 | 6 | 3 | 6 | 6 | 6 |
| EG009 | BI 836826 200 mg iv (Caucasian Patients) | BI 836826 200 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks. | 1 | 7 | 5 | 7 | 7 | 7 |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
|
| Atrial tachycardia | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Device related infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Escherichia bacteraemia | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Pulmonary mycosis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Pyelonephritis acute | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Malignant ascites | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
|
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
|
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
|
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
|
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
|
| Oropharyngeal neoplasm benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
|
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Neurological symptom | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
|
| Ureteric obstruction | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Chylothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Superior vena cava syndrome | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Lymph node pain | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Aortic valve calcification | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
|
| Coronary artery stenosis | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA 21.0 | Systematic Assessment |
|
| Middle ear effusion | Ear and labyrinth disorders | MedDRA 21.0 | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA 21.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | MedDRA 21.0 | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA 21.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Anal fissure | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Colitis microscopic | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Frequent bowel movements | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Gingival bleeding | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Oral disorder | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Proctalgia | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Drug intolerance | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Face oedema | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Facial pain | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Feeling hot | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Generalised oedema | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Oedema mucosal | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Swelling | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hypogammaglobulinaemia | Immune system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Angular cheilitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Candida infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Clostridium difficile colitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Cytomegalovirus infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Enterococcal infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Enterocolitis infectious | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Erysipelas | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Febrile infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Gastrointestinal infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Herpes virus infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Oesophageal candidiasis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Oral infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Vaginal infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Drug administration error | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Post procedural fever | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Radiation skin injury | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Bacterial test positive | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Blood calcium decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Body temperature increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| CD4 lymphocytes decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Cytomegalovirus test positive | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Prostatic specific antigen increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Troponin T increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Fluid imbalance | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Diastasis recti abdominis | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Tendon disorder | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Infected neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
|
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Dysaesthesia | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Polyneuropathy | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Post herpetic neuralgia | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
|
| Listless | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
|
| Stress | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
|
| Substance-induced psychotic disorder | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
|
| Azotaemia | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
|
| Calculus bladder | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
|
| Incontinence | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
|
| Polyuria | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pelvic pain | Reproductive system and breast disorders | MedDRA 21.0 | Systematic Assessment |
|
| Testicular swelling | Reproductive system and breast disorders | MedDRA 21.0 | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Dyspnoea at rest | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Throat tightness | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Dermatitis exfoliative generalised | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Circulatory collapse | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hypertensive crisis | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
| Varicose vein | Vascular disorders | MedDRA 21.0 | 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.
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
|
| liver nodules |
|
|
| spleen nodules |
|
| Complete remission unconfirmed |
|
| Partial remission |
|
| Stable disease |
|
| Progressive disease |
|
| Missing |
|
| Complete remission unconfirmed |
|
| Partial remission |
|
| Stable disease |
|
| Progressive disease |
|
| Missing |
|