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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-001132-38 | EudraCT Number |
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This is a Phase I, multi-centre, non-randomized, uncontrolled, open-label, dose escalating study of BI 836880 administered intravenously once a week. The eligible patient population will be patients with advanced solid tumors.
The primary objective of this trial is to determine the maximum tolerated dose (MTD) and recommended Phase II doses for BI 836880 in patients with solid tumors. Preliminary safety data will be evaluated as secondary objectives.
Subsequently, pharmacokinetic profile, pharmacodynamic changes in circulating biomarkers and Dynamic Contrast-Enhanced Magnetic Resonance Imaging ( DCE-MRI), anti-tumor activity and the immunogenicity of BI 836880 will be explored up to a total of 40 patients with advanced solid tumors.
Dose escalation will be guided by a Bayesian logistic regression model with over dose control (EWOC) using at least 2 patients per dose cohorts.
Safety criteria will be followed, including adverse events according to Common Terminology Criteria (CTCAE version 4.03), incidence of dose limiting toxicities, physical examination, vital signs, safety laboratory parameters and Eastern Cooperative Oncology Group (ECOG).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 40 mg BI 836880 | Experimental | 40 mg BI 836880 |
|
| 120 mg BI 836880 | Experimental | 120 mg BI 836880 |
|
| 150 mg BI 836880 | Experimental | 150 mg BI 836880 |
|
| 180 mg BI 836880 | Experimental | 180 mg BI 836880 |
|
| 240 mg BI 836880 | Experimental | 240 mg BI 836880 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 836880 | Drug | Solution for intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) | Determination of the maximum tolerated dose (MTD) in participants with advanced solid tumors. MTD was defined as the highest dose with less than 25% risk of true DLT rate being above 33% in the MTD evaluation period, and could be considered reached if the probability that the true DLT rate was in the target interval (16% to 33%) was sufficiently large during the MTD evaluation period. The MTD evaluation period was defined as 3 weeks after first administration of treatment. | First treatment cycle, 3 weeks from first administration of trial treatment (MTD evaluation period). |
| Number of Participants With Dose Limiting Toxicities (DLTs) in the Maximum Tolerated Dose (MTD) Evaluation Period | The following drug-related adverse events qualified as DLTs: Common Terminology Criteria for Adverse Events (CTCAE) grade 4 neutropenia >7 days or complicated by infection; grade >3 febrile neutropenia; grade = 4 thrombocytopenia; grade > 3 thrombocytopenia with bleeding; grade > 3 proteinuria > 3 non haematological toxicity except: Vomiting or diarrhea responding to supporting treatment, fatigue lasting for less than 4 days, transient grade 3 infusion reaction, any laboratory abnormality, which was considered not clinically relevant by the investigator or resolved spontaneously or could be resolved with appropriate treatment. Hypertension: increase of diastolic blood pressure (BP) by 15 mmHg, which could not be controlled by hypertensive medication and requires a dose reduction of BI 836880 for further treatment course. All related AE leading to an interruption of BI 836880 for more than 14 days until recovery to baseline. | First treatment cycle, 3 weeks from first administration of trial treatment (MTD evaluation period). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Drug-related Adverse Events (AEs) Leading to Dose Reduction or Discontinuation During the Treatment Period | Number of Participants with drug-related adverse Events (AEs) leading to dose reduction or discontinuation during the treatment period. | From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days. |
Not provided
Inclusion criteria:
1 Age >=18 years 2. Histologically confirmed malignancy which is locally advanced or metastatic solid tumor, and either refractory after standard therapy for the disease or for which standard therapy is not reliably effective e.g. patients do not tolerate or have contraindications to otherwise available standard therapy and tumour lesions evaluable for Dynamic contrast-enhanced (DCE)-MRI at MTD.
3. ECOG performance status <= 2 4. Adequate hepatic, renal and bone marrow functions as defined by the following criteria:
Total bilirubin within normal limits (<= 1.5x upper limit of normal (ULN) for patient with Gilberts syndrome)
Alanine amino transferase (ALT) and aspartate amino transferase (AST) <= 1.5x ULN (< 5x upper limit of normal (ULN) for patient known liver metastases)
Serum creatinine < 1.5x ULN
International normalized Ratio (INR) 0.8-1.2 or partial thromboplastin time (PTT) < 1.5x ULN
Absolute neutrophil count (ANC) > 1.5 109/L
Platelet count > 100x109/ L.
Haemoglobin > 10 g/dl (without transfusion within previous week) 5. Signed and dated written informed consent. 6. Life expectancy >= 3 months in the opinion of the investigator 7. Recovery from all reversible adverse events of previous anti-cancer therapies to baseline or CTCAE grade1, except for alopecia (any grade), sensory peripheral neuropathy CTCAE grade <= 2 or considered by the investigator as clinically not significant.
8. Male or female patients. Women of childbearing potential* must be ready and able to use highly effective methods of birth control per International Conference on Harmonisation [ICH M3(R2)] in combination with male condom as "double barrier", during the trial and for at least 6 months after the end of treatment with BI 836880, that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information.
Male patient must always use condoms when sexually active during the trial and for at least 6 months after the end of treatment with BI 836880.
*Women of childbearing potential are defined as: Any female who has experienced menarche and does not meet the criteria for "women not of childbearing potential" as described below.
Women not of childbearing potential are defined as:
Women who are postmenopausal (12 months with no menses without an alternative medical cause) or who are permanently sterilized (e.g., hysterectomy, bilateral oophorectomy or bilateral salpingectomy).
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CTR Georges-François Leclerc | Dijon | 21079 | France | |||
| Hospital Vall d'Hebron |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39402675 | Derived | Keller S, Kunz U, Schmid U, Beusmans J, Buchert M, He M, Jayadeva G, Le Tourneau C, Luedtke D, Niessen HG, Oum'hamed Z, Pleiner S, Wang X, Graeser R. Comprehensive biomarker and modeling approach to support dose finding for BI 836880, a VEGF/Ang-2 inhibitor. J Transl Med. 2024 Oct 14;22(1):934. doi: 10.1186/s12967-024-05612-x. | |
| 36108560 |
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Not provided
All subjects who were screened for eligibility to participate in the trial signed informed consent. Subject were assigned to the trial drug if the met all the inclusion and none of the exclusion criteria.
Abbreviations: AE = Adverse Event.
This was an open-label, non-randomised, uncontrolled, dose-escalating trial in patients with advanced solid tumors.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 40 mg BI 836880 | 40 milligram (mg) solution of BI 836880 was administered as once weekly intravenous infusion in 3 weeks treatment cycles. Participants continued treatment until disease progression or unacceptable toxicity. |
| FG001 | 120 mg BI 836880 | 120 mg solution of BI 836880 was administered as once weekly intravenous infusion in 3 weeks treatment cycles. Participants continued treatment until disease progression or unacceptable toxicity. |
| FG002 | 150 mg BI 836880 | 150 mg solution of BI 836880 was administered as once weekly intravenous infusion in 3 weeks treatment cycles. Participants continued treatment until disease progression or unacceptable toxicity. |
| FG003 | 180 mg BI 836880 | 180 mg solution of BI 836880 was administered as once weekly intravenous infusion in 3 weeks treatment cycles. Participants continued treatment until disease progression or unacceptable toxicity. |
| FG004 | 240 mg BI 836880 | 240 mg solution of BI 836880 was administered as once weekly intravenous infusion in 3 weeks treatment cycles. Participants continued treatment until disease progression or unacceptable toxicity. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Treated set: All patients who were treated with at least one single dose of BI 836880.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 40 mg BI 836880 | 40 milligram (mg) solution of BI 836880 was administered as once weekly intravenous infusion in 3 weeks treatment cycles. Participants continued treatment until disease progression or unacceptable toxicity. |
| BG001 | 120 mg BI 836880 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) | Determination of the maximum tolerated dose (MTD) in participants with advanced solid tumors. MTD was defined as the highest dose with less than 25% risk of true DLT rate being above 33% in the MTD evaluation period, and could be considered reached if the probability that the true DLT rate was in the target interval (16% to 33%) was sufficiently large during the MTD evaluation period. The MTD evaluation period was defined as 3 weeks after first administration of treatment. | Dose-finding cohort treated set: All patients enrolled in dose finding and confirmation of MTD cohort of the trial who were documented to have taken at least 1 dose of trial medication and were evaluable for MTD determination. | Posted | Number | Milligram (mg) | First treatment cycle, 3 weeks from first administration of trial treatment (MTD evaluation period). |
|
From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
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 | 40 mg BI 836880 | 40 milligram (mg) solution of BI 836880 was administered as once weekly intravenous infusion in 3 weeks treatment cycles. Participants continued treatment until disease progression or unacceptable toxicity. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Centre | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 13, 2019 | Sep 11, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 20, 2017 | Sep 11, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
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| Barcelona |
| 08035 |
| Spain |
| Le Tourneau C, Becker H, Claus R, Elez E, Ricci F, Fritsch R, Silber Y, Hennequin A, Tabernero J, Jayadeva G, Luedtke D, He M, Isambert N. Two phase I studies of BI 836880, a vascular endothelial growth factor/angiopoietin-2 inhibitor, administered once every 3 weeks or once weekly in patients with advanced solid tumors. ESMO Open. 2022 Oct;7(5):100576. doi: 10.1016/j.esmoop.2022.100576. Epub 2022 Sep 13. |
| Dose Limiting Toxicity |
|
| Other AE or clinical progression |
|
120 mg solution of BI 836880 was administered as once weekly intravenous infusion in 3 weeks treatment cycles. Participants continued treatment until disease progression or unacceptable toxicity. |
| BG002 | 150 mg BI 836880 | 150 mg solution of BI 836880 was administered as once weekly intravenous infusion in 3 weeks treatment cycles. Participants continued treatment until disease progression or unacceptable toxicity. |
| BG003 | 180 mg BI 836880 | 180 mg solution of BI 836880 was administered as once weekly intravenous infusion in 3 weeks treatment cycles. Participants continued treatment until disease progression or unacceptable toxicity. |
| BG004 | 240 mg BI 836880 | 240 mg solution of BI 836880 was administered as once weekly intravenous infusion in 3 weeks treatment cycles. Participants continued treatment until disease progression or unacceptable toxicity. |
| BG005 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
Participants were administered 40/ 120/ 150 / 180 /240 milligram (mg) solution of BI 836880 as once weekly intravenous infusion in 3 weeks treatment cycles. Participants continued treatment until disease progression or unacceptable toxicity.
|
|
| Primary | Number of Participants With Dose Limiting Toxicities (DLTs) in the Maximum Tolerated Dose (MTD) Evaluation Period | The following drug-related adverse events qualified as DLTs: Common Terminology Criteria for Adverse Events (CTCAE) grade 4 neutropenia >7 days or complicated by infection; grade >3 febrile neutropenia; grade = 4 thrombocytopenia; grade > 3 thrombocytopenia with bleeding; grade > 3 proteinuria > 3 non haematological toxicity except: Vomiting or diarrhea responding to supporting treatment, fatigue lasting for less than 4 days, transient grade 3 infusion reaction, any laboratory abnormality, which was considered not clinically relevant by the investigator or resolved spontaneously or could be resolved with appropriate treatment. Hypertension: increase of diastolic blood pressure (BP) by 15 mmHg, which could not be controlled by hypertensive medication and requires a dose reduction of BI 836880 for further treatment course. All related AE leading to an interruption of BI 836880 for more than 14 days until recovery to baseline. | Dose finding cohort treated set: All patients enrolled in dose finding and confirmation of MTD cohort of the trial who were documented to have taken at least 1 dose of trial medication and were evaluable for the MTD determination. | Posted | Count of Participants | Participants | First treatment cycle, 3 weeks from first administration of trial treatment (MTD evaluation period). |
|
|
|
| Secondary | Number of Participants With Drug-related Adverse Events (AEs) Leading to Dose Reduction or Discontinuation During the Treatment Period | Number of Participants with drug-related adverse Events (AEs) leading to dose reduction or discontinuation during the treatment period. | Treated Set: The treated set includes all participants enrolled in the Trial who were documented to have taken at least one dose of study medication. | Posted | Count of Participants | Participants | From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days. |
|
|
|
| 0 |
| 2 |
| 1 |
| 2 |
| 2 |
| 2 |
| EG001 | 120 mg BI 836880 | 120 mg solution of BI 836880 was administered as once weekly intravenous infusion in 3 weeks treatment cycles. Participants continued treatment until disease progression or unacceptable toxicity. | 0 | 5 | 3 | 5 | 5 | 5 |
| EG002 | 150 mg BI 836880 | 150 mg solution of BI 836880 was administered as once weekly intravenous infusion in 3 weeks treatment cycles. Participants continued treatment until disease progression or unacceptable toxicity. | 0 | 3 | 0 | 3 | 3 | 3 |
| EG003 | 180 mg BI 836880 | 180 mg solution of BI 836880 was administered as once weekly intravenous infusion in 3 weeks treatment cycles. Participants continued treatment until disease progression or unacceptable toxicity. | 0 | 11 | 6 | 11 | 11 | 11 |
| EG004 | 240 mg BI 836880 | 240 mg solution of BI 836880 was administered as once weekly intravenous infusion in 3 weeks treatment cycles. Participants continued treatment until disease progression or unacceptable toxicity. | 0 | 3 | 2 | 3 | 3 | 3 |
| EG005 | Total BI 836880 | Participants were administered 40/ 120/ 150 / 180 /240 milligram (mg) solution of BI 836880 as once weekly intravenous infusion in 3 weeks treatment cycles. Participants continued treatment until disease progression or unacceptable toxicity. | 0 | 24 | 12 | 24 | 24 | 24 |
| Intestinal perforation | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Subileus | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Abdominal infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
|
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Pulmonary alveolar haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Pulmonary arterial hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Proctalgia | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Localised oedema | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Xerosis | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Hepatocellular injury | Hepatobiliary disorders | MedDRA 22.1 | Systematic Assessment |
|
| Liver injury | Hepatobiliary disorders | MedDRA 22.1 | Systematic Assessment |
|
| Aspergillus infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
|
| Stoma site erythema | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Ejection fraction decreased | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Haemoglobin increased | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| International normalised ratio increased | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| QRS axis abnormal | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
|
| Oedema genital | Reproductive system and breast disorders | MedDRA 22.1 | Systematic Assessment |
|
| Pelvic pain | Reproductive system and breast disorders | MedDRA 22.1 | Systematic Assessment |
|
| Vulval oedema | Reproductive system and breast disorders | MedDRA 22.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Actinic keratosis | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Purpura | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
|
| Lymphoedema | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
|
| Peripheral vascular disorder | Vascular disorders | MedDRA 22.1 | 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.