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To investigate safety, tolerability, maximum tolerated dose of volasertib in Japanese patients with AML
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Volasertib | Experimental | Patient to receive escalating dose of volasertib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Volasertib | Drug | Patient to receive volasertib |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose Limiting Toxicities (DLT) in Cycle 1 for the Determination of the Maximum Tolerated Dose (MTD) of Volasertib | Primary objective for this trial was to identify the MTD of volasertib. The MTD was defined as the highest dose level at which DLTs were reported in at most 2 in 6 evaluable patients during cycle 1. In this outcome measure the number of participants with DLTs in cycle 1 is presented. | From first administration of trial drug up to 28 days |
| MTD of Volasertib | Primary objective for this trial was to identify the MTD of volasertib. The MTD was defined as the highest dose level at which DLTs were reported in at most 2 in 6 evaluable patients during cycle 1. In this outcome measure the MTD is presented. | From first administration of trial drug up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Best Response by Complete Remission (CR) | The secondary outcome best response will be presented by the CR, CR with incomplete blood count recovery (CRi) and partial remission (PR). In this outcome measure the CR will be presented. The criteria for the CR are: Bone marrow blasts less than 5%; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count (ANC) >1.0 × 10^9/Litre (L) (1000/microlitre (μL)); platelet count >100 × 10^9/L (100 000/μL); independence of red cell transfusions. |
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Inclusion criteria:
Patients with diagnosis of AML (except for acute promyelocytic leukemia, APL) according to the World Health Organization definition and with one of the following features at screening
Male or female patients of age >/= 18 years at the time of informed consent
Eastern Cooperative Oncology Group performance status score 0 - 2 at screening
Signed written informed consent consistent with Japanese Good Clinical Practice.
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boehringer Ingelheim Investigational Site | Chuo-ku, Tokyo | Japan | ||||
| Boehringer Ingelheim Investigational Site |
Patients with written informed consent underwent screening within (≤) 14 days before starting the volasertib treatment. Eligible patients were enrolled and treated as soon as possible or within (≤)14 days after obtaining informed consent.
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| ID | Title | Description |
|---|---|---|
| FG000 | V 350 mg | Patients received 350 milligram (mg) of volasertib (V) as monotherapy on Days 1 and 15 of a 28-day cycle via intravenous (i.v.) drip infusion over 2 hours. |
| FG001 | V 400 mg | Patients received 400 mg of volasertib as monotherapy on Days 1 and 15 of a 28-day cycle via i.v. drip infusion over 2 hours. |
| FG002 | V 450 mg | Patients received 450 mg of volasertib as monotherapy on Days 1 and 15 of a 28-day cycle via i.v. drip infusion over 2 hours. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Treated Set (TS): All patients that received at least 1 dose of the trial medication were defined as the treated set.
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| ID | Title | Description |
|---|---|---|
| BG000 | V 350 mg | Patients received 350 milligram (mg) of volasertib (V) as monotherapy on Days 1 and 15 of a 28-day cycle via intravenous (i.v.) drip infusion over 2 hours. |
| BG001 | V 400 mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Dose Limiting Toxicities (DLT) in Cycle 1 for the Determination of the Maximum Tolerated Dose (MTD) of Volasertib | Primary objective for this trial was to identify the MTD of volasertib. The MTD was defined as the highest dose level at which DLTs were reported in at most 2 in 6 evaluable patients during cycle 1. In this outcome measure the number of participants with DLTs in cycle 1 is presented. | Treated Set | Posted | Number | Participants | From first administration of trial drug up to 28 days |
|
From inclusion into the study to 21 days after last drug administration (up to 507 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 | V 350 mg | Patients received 350 milligram (mg) of Volasertib (V) as monotherapy on Days 1 and 15 of a 28-day cycle via intravenous (i.v.) drip infusion over 2 hours. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.0 | 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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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C541363 | BI 6727 |
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| From first administration of trial drug up to 486 days |
| Best Response by CRi | The secondary outcome best response will be presented by the CR, CRi and PR. In this outcome measure the CRi will be presented. The criteria for the CRi are: All CR criteria are met except for residual neutropenia (<1.0 × 10^9/L [1000/μL]) or thrombocytopenia (<100 × 10^9/L [100 000/μL]). | From first administration of trial drug up to 486 days |
| Best Response by PR | The secondary outcome best response will be presented by the CR, CRi and PR. In this outcome measure the PR is presented. The criteria for the PR are: All haematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%. | From first administration of trial drug up to 486 days |
| Remission Duration | The remission duration is the time from the date of achieving CR or CRi until relapse for patients with documented CR or CRi. | From first administration of trial drug up to 486 days |
| Isehara, Kanagawa |
| Japan |
| Boehringer Ingelheim Investigational Site | Maebashi, Gunma, | Japan |
| Boehringer Ingelheim Investigational Site | Nagasaki, Nagasaki | Japan |
| Boehringer Ingelheim Investigational Site | Nagoya-shi, Aichi | Japan |
| Boehringer Ingelheim Investigational Site | Yoshida-gun, Fukui | Japan |
| Not specified above |
|
Patients received 400 mg of volasertib as monotherapy on Days 1 and 15 of a 28-day cycle via i.v. drip infusion over 2 hours.
| BG002 | V 450 mg | Patients received 450 mg of volasertib as monotherapy on Days 1 and 15 of a 28-day cycle via i.v. drip infusion over 2 hours. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Patients received 400 mg of volasertib as monotherapy on Days 1 and 15 of a 28-day cycle via i.v. drip infusion over 2 hours. |
| OG002 | V 450 mg | Patients received 450 mg of volasertib as monotherapy on Days 1 and 15 of a 28-day cycle via i.v. drip infusion over 2 hours. |
|
|
| Secondary | Best Response by Complete Remission (CR) | The secondary outcome best response will be presented by the CR, CR with incomplete blood count recovery (CRi) and partial remission (PR). In this outcome measure the CR will be presented. The criteria for the CR are: Bone marrow blasts less than 5%; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count (ANC) >1.0 × 10^9/Litre (L) (1000/microlitre (μL)); platelet count >100 × 10^9/L (100 000/μL); independence of red cell transfusions. | Treated Set | Posted | Number | Participants | From first administration of trial drug up to 486 days |
|
|
|
| Primary | MTD of Volasertib | Primary objective for this trial was to identify the MTD of volasertib. The MTD was defined as the highest dose level at which DLTs were reported in at most 2 in 6 evaluable patients during cycle 1. In this outcome measure the MTD is presented. | Treated Set | Posted | Number | milligram (mg) | From first administration of trial drug up to 28 days |
|
|
|
| Secondary | Best Response by CRi | The secondary outcome best response will be presented by the CR, CRi and PR. In this outcome measure the CRi will be presented. The criteria for the CRi are: All CR criteria are met except for residual neutropenia (<1.0 × 10^9/L [1000/μL]) or thrombocytopenia (<100 × 10^9/L [100 000/μL]). | Treated Set | Posted | Number | Participants | From first administration of trial drug up to 486 days |
|
|
|
| Secondary | Best Response by PR | The secondary outcome best response will be presented by the CR, CRi and PR. In this outcome measure the PR is presented. The criteria for the PR are: All haematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%. | Treated Set | Posted | Number | Participants | From first administration of trial drug up to 486 days |
|
|
|
| Secondary | Remission Duration | The remission duration is the time from the date of achieving CR or CRi until relapse for patients with documented CR or CRi. | Treated Set, patient with remissions | Posted | Mean | Standard Deviation | Days | From first administration of trial drug up to 486 days |
|
|
|
| 3 |
| 7 |
| 7 |
| 7 |
| EG001 | V 400 mg | Patients received 400 mg of Volasertib as monotherapy on Days 1 and 15 of a 28-day cycle via i.v. drip infusion over 2 hours. | 0 | 4 | 4 | 4 |
| EG002 | V 450 mg | Patients received 450 mg of Volasertib as monotherapy on Days 1 and 15 of a 28-day cycle via i.v. drip infusion over 2 hours. | 4 | 8 | 8 | 8 |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Cushingoid | Endocrine disorders | MedDRA 18.0 | Systematic Assessment |
|
| Photophobia | Eye disorders | MedDRA 18.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Cheilosis | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Gingival pain | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Gingival ulceration | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Lip dry | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Lip erosion | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Periodontal disease | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Proctalgia | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Catheter site erosion | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Catheter site pain | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Soft tissue inflammation | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Thirst | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 18.0 | Systematic Assessment |
|
| Anal abscess | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Bacillus bacteraemia | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Gingivitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Neutropenic infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Parotitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Periodontitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Soft tissue infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Subcutaneous abscess | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Urethritis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Allergic transfusion reaction | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
|
| Bite | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
|
| Foreign body in eye | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
|
| Subcutaneous haematoma | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
|
| Transfusion reaction | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
|
| Activated partial thromboplastin time abnormal | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| Blood potassium increased | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| International normalised ratio | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| Urine output decreased | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
|
| Calculus bladder | Renal and urinary disorders | MedDRA 18.0 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 18.0 | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA 18.0 | Systematic Assessment |
|
| Scrotal oedema | Reproductive system and breast disorders | MedDRA 18.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Haemorrhage subcutaneous | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Purpura | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Skin induration | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Urticaria chronic | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
|
| Vascular pain | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
|
| Vasculitis | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
|
Other - 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.
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |