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| ID | Type | Description | Link |
|---|---|---|---|
| 54179060WAL4001 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to evaluate the efficacy of ibrutinib based on overall response rate (ORR) (partial response [PR] or better) by investigator assessment per the modified Consensus Response Criteria from the Sixth International Workshop on Waldenstrom's Macroglobulinemia (IWWM) (NCCN 2019), in Chinese participants with relapsed or refractory waldenstrom's macroglobulinemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ibrutinib 420 milligram (mg) | Experimental | Participants will receive ibrutinib 420 mg once daily, continuously starting at Day 1 of Week 1 until disease progression or unacceptable toxicity, whichever occurs first. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibrutinib | Drug | Ibrutinib will be administered orally, once daily, at a dose of 420 mg (140 mg*3 capsules taken together at one time). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | ORR was defined as the percentage of participants who achieved partial response (PR) or better (VGPR) per the modified consensus response criteria from sixth International Workshop on Waldenstrom's Macroglobulinemia (IWWM) (National Comprehensive Cancer Network [NCCN], 2019). PR: greater than or equal to (>=) 50 percent (%) reduction of serum immunoglobulin M (IgM) from baseline, with reduction in lymphadenopathy/splenomegaly if present at baseline. Very Good Partial Response (VGPR): >=90% reduction of serum IgM from baseline or normal serum IgM values, with reduction in lymphadenopathy/splenomegaly if present at baseline. | From start of the treatment (Day 1) up to 49.3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Response Rate (CRR) | CRR was defined as the percentage of participants who achieved minor response (MR) or better according to the modified sixth IWWM (NCCN 2019) criteria as assessed by the investigator. MR: >=25% but less than (<) 50% reduction of serum IgM from baseline. | From start of the treatment (Day 1) up to 49.3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital of Jilin University | Changchun | 130021 | China | |||
| First affiliated Hospital of Zhejiang University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38079089 | Derived | Yi S, Cai Z, Hu Y, He A, Gao S, Li Q, Sha L, Zhang N, Ren Y, Gai X, Yang X, Qin R, Qiu L. Ibrutinib Efficacy, Safety, and Pharmacokinetics in Chinese Patients with Relapsed or Refractory Waldenstrom's Macroglobulinemia: A Multicenter, Single-Arm, Phase 4 Study. Adv Ther. 2024 Feb;41(2):672-685. doi: 10.1007/s12325-023-02720-w. Epub 2023 Dec 11. |
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The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.
As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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| ID | Title | Description |
|---|---|---|
| FG000 | Ibrutinib 420 mg | Participants with relapsed or refractory waldenstrom's macroglobulinemia received ibrutinib 420 milligrams (mg) (3*140 mg capsules) orally once daily from Day 1 of Week 1 until disease progression, unacceptable toxicity, whichever occurs first. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ibrutinib 420 mg | Participants with relapsed or refractory waldenstrom's macroglobulinemia received ibrutinib 420 milligrams (mg) (3*140 mg capsules) orally once daily from Day 1 of Week 1 until disease progression, unacceptable toxicity, whichever occurs first. |
| 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 | Overall Response Rate (ORR) | ORR was defined as the percentage of participants who achieved partial response (PR) or better (VGPR) per the modified consensus response criteria from sixth International Workshop on Waldenstrom's Macroglobulinemia (IWWM) (National Comprehensive Cancer Network [NCCN], 2019). PR: greater than or equal to (>=) 50 percent (%) reduction of serum immunoglobulin M (IgM) from baseline, with reduction in lymphadenopathy/splenomegaly if present at baseline. Very Good Partial Response (VGPR): >=90% reduction of serum IgM from baseline or normal serum IgM values, with reduction in lymphadenopathy/splenomegaly if present at baseline. | All treated analysis set included all enrolled participants who received at least 1 dose of study drug. | Posted | Number | 90% Confidence Interval | Percentage of Participants | From start of the treatment (Day 1) up to 49.3 months |
|
All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
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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 | Ibrutinib 420 mg | Participants with relapsed or refractory waldenstrom's macroglobulinemia received ibrutinib 420 milligrams (mg) (3*140 mg capsules) orally once daily from Day 1 of Week 1 until disease progression, unacceptable toxicity, whichever occurs first. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anal Abscess | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Executive Medical Director Onc | Janssen Research & Development, LLC | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.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 | Mar 25, 2020 | Mar 14, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 22, 2022 | Mar 14, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D008258 | Waldenstrom Macroglobulinemia |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| C551803 | ibrutinib |
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|
| Very Good Partial Response (VGPR) or Better Response Rate |
VGPR or better response rate was defined as the percentage of participants who achieved VGPR or better according to the modified sixth IWWM (NCCN 2019) criteria as assessed by the investigator. VGPR: >=90% reduction of serum IgM from baseline or normal serum IgM values, with reduction in lymphadenopathy/splenomegaly if present at baseline. |
| From start of the treatment (Day 1) up to 49.3 months |
| Duration of Response (DOR) | DOR: duration from date of initial documentation of response (PR/better) to date of first documented progressive disease(PD), death or date of censoring if applicable, for responders (PR/better), as assessed by investigator. VGPR/PR: >=90% reduction or normal serum IgM values (for VGPR) and >=50% (for PR) reduction of serum IgM, with reduction in lymphadenopathy/splenomegaly if present at baseline. PD(at least 1): >=25% IgM increase in serum IgM with >=500 milligrams per deciliters(mg/dL) increase from nadir(lowest serum IgM value at any time from baseline), confirmation needed if IgM was sole PD criterion; new lymph nodes >1.5 centimeters(cm), >=50% increase in nadir in sum of product of diameters; 50% increase in longest diameter of previously identified node >1cm in short axis; new splenomegaly; new extranodal disease; new/recurrent bone marrow involvement; new symptomatic disease(pleural effusion/Bing Neel syndrome/amyloidosis/light chain deposition/paraprotein mediated disorder). | From the date of first documented response up to date of first documented PD or death (Day 1 up to 49.3 months) |
| Time to Response (TTR) | TTR was defined as the time from the date of first dose to the date of initial documentation of a response (PR or better) for responders. PR: >=50% reduction of serum IgM from baseline, with reduction in lymphadenopathy/splenomegaly if present at baseline. VGPR: >=90% reduction of serum IgM from baseline or normal serum IgM values, with reduction in lymphadenopathy/splenomegaly if present at baseline. | From start of the treatment up to first documentation of PR or better (Day 1 up to 49.3 months) |
| Progression Free Survival (PFS) | PFS was defined as duration from the date of first dose to the date of disease progression or death, whichever occurs first, assessed according to the modified sixth IWWM (NCCN 2019) criteria. PD (at least 1 of the following): >=25% IgM increase in serum IgM with >=500 mg/dL increase from nadir (lowest serum IgM value at any time from baseline), confirmation needed if IgM was sole PD criterion; new lymph nodes >1.5 cm, >=50% increase in nadir in sum of product of diameters; 50% increase in longest diameter of previously identified node >1 cm in short axis; new splenomegaly; new extranodal disease; new/recurrent bone marrow involvement; new symptomatic disease (pleural effusion, Bing Neel syndrome, amyloidosis, light chain deposition, paraprotein mediated disorder). | From day of first dose (Day 1) until PD or death (up to 49.3 months) |
| Overall Survival (OS) | Overall survival was measured from the date of first dose to the date of the participant's death from any cause. | From day of first dose (Day 1) until death due to any cause (up to 49.3 months) |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Grade 3 or Higher TEAEs | An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs were defined as AEs occurring after the first dose of study drugs and within 30 days following the last dose of study drug or initiation of subsequent antineoplastic treatment, whichever occurred earlier. TEAEs were graded based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03 as Grade 1= Mild; Grade 2= Moderate; Grade 3= Severe; Grade 4= Life-threatening and Grade 5= Death. Number of participants with TEAEs and Grade 3 or higher TEAEs (included serious and non-serious events) were reported in this outcome measure. | From start of the treatment (Day 1) up to 30 days after last dose or initiation of subsequent antineoplastic treatment, whichever occurred first (Day 1 up to 45.9 months) |
| Plasma Concentration of Ibrutinib | Plasma concentrations of ibrutinib were reported. | Pre-dose on Day 1 of Weeks 1, 5 and 9 |
| Hangzhou |
| 310003 |
| China |
| Institute of Hematology and Blood Diseases Hospital | Tianjin | 300320 | China |
| Wuhan Union Hospital | Wuhan | 430023 | China |
| The Second Affiliated Hospital of Xi'an Jiaotong University | Xi'an | 710004 | China |
| Henan Cancer Hospital | Zhengzhou | 450008 | China |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
Participants with relapsed or refractory waldenstrom's macroglobulinemia received ibrutinib 420 milligrams (mg) (3*140 mg capsules) orally once daily from Day 1 of Week 1 until disease progression, unacceptable toxicity, whichever occurs first.
|
|
| Secondary | Clinical Response Rate (CRR) | CRR was defined as the percentage of participants who achieved minor response (MR) or better according to the modified sixth IWWM (NCCN 2019) criteria as assessed by the investigator. MR: >=25% but less than (<) 50% reduction of serum IgM from baseline. | All treated analysis set included all enrolled participants who received at least 1 dose of study drug. | Posted | Number | 90% Confidence Interval | Percentage of Participants | From start of the treatment (Day 1) up to 49.3 months |
|
|
|
| Secondary | Very Good Partial Response (VGPR) or Better Response Rate | VGPR or better response rate was defined as the percentage of participants who achieved VGPR or better according to the modified sixth IWWM (NCCN 2019) criteria as assessed by the investigator. VGPR: >=90% reduction of serum IgM from baseline or normal serum IgM values, with reduction in lymphadenopathy/splenomegaly if present at baseline. | All treated analysis set included all enrolled participants who received at least 1 dose of study drug. | Posted | Number | 90% Confidence Interval | Percentage of Participants | From start of the treatment (Day 1) up to 49.3 months |
|
|
|
| Secondary | Duration of Response (DOR) | DOR: duration from date of initial documentation of response (PR/better) to date of first documented progressive disease(PD), death or date of censoring if applicable, for responders (PR/better), as assessed by investigator. VGPR/PR: >=90% reduction or normal serum IgM values (for VGPR) and >=50% (for PR) reduction of serum IgM, with reduction in lymphadenopathy/splenomegaly if present at baseline. PD(at least 1): >=25% IgM increase in serum IgM with >=500 milligrams per deciliters(mg/dL) increase from nadir(lowest serum IgM value at any time from baseline), confirmation needed if IgM was sole PD criterion; new lymph nodes >1.5 centimeters(cm), >=50% increase in nadir in sum of product of diameters; 50% increase in longest diameter of previously identified node >1cm in short axis; new splenomegaly; new extranodal disease; new/recurrent bone marrow involvement; new symptomatic disease(pleural effusion/Bing Neel syndrome/amyloidosis/light chain deposition/paraprotein mediated disorder). | Analysis population included responders in all treated analysis set who achieved PR or better. | Posted | Median | 95% Confidence Interval | Months | From the date of first documented response up to date of first documented PD or death (Day 1 up to 49.3 months) |
|
|
|
| Secondary | Time to Response (TTR) | TTR was defined as the time from the date of first dose to the date of initial documentation of a response (PR or better) for responders. PR: >=50% reduction of serum IgM from baseline, with reduction in lymphadenopathy/splenomegaly if present at baseline. VGPR: >=90% reduction of serum IgM from baseline or normal serum IgM values, with reduction in lymphadenopathy/splenomegaly if present at baseline. | Analysis population included responders in all treated analysis set who achieved PR or better. | Posted | Median | 95% Confidence Interval | Months | From start of the treatment up to first documentation of PR or better (Day 1 up to 49.3 months) |
|
|
|
| Secondary | Progression Free Survival (PFS) | PFS was defined as duration from the date of first dose to the date of disease progression or death, whichever occurs first, assessed according to the modified sixth IWWM (NCCN 2019) criteria. PD (at least 1 of the following): >=25% IgM increase in serum IgM with >=500 mg/dL increase from nadir (lowest serum IgM value at any time from baseline), confirmation needed if IgM was sole PD criterion; new lymph nodes >1.5 cm, >=50% increase in nadir in sum of product of diameters; 50% increase in longest diameter of previously identified node >1 cm in short axis; new splenomegaly; new extranodal disease; new/recurrent bone marrow involvement; new symptomatic disease (pleural effusion, Bing Neel syndrome, amyloidosis, light chain deposition, paraprotein mediated disorder). | All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Here, 'N' (overall number of participants analyzed) refers to the number of participants evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | Months | From day of first dose (Day 1) until PD or death (up to 49.3 months) |
|
|
|
| Secondary | Overall Survival (OS) | Overall survival was measured from the date of first dose to the date of the participant's death from any cause. | All treated analysis set included all enrolled participants who received at least 1 dose of study drug. | Posted | Median | 95% Confidence Interval | Months | From day of first dose (Day 1) until death due to any cause (up to 49.3 months) |
|
|
|
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Grade 3 or Higher TEAEs | An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs were defined as AEs occurring after the first dose of study drugs and within 30 days following the last dose of study drug or initiation of subsequent antineoplastic treatment, whichever occurred earlier. TEAEs were graded based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03 as Grade 1= Mild; Grade 2= Moderate; Grade 3= Severe; Grade 4= Life-threatening and Grade 5= Death. Number of participants with TEAEs and Grade 3 or higher TEAEs (included serious and non-serious events) were reported in this outcome measure. | Safety analysis set included all enrolled participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | From start of the treatment (Day 1) up to 30 days after last dose or initiation of subsequent antineoplastic treatment, whichever occurred first (Day 1 up to 45.9 months) |
|
|
|
| Secondary | Plasma Concentration of Ibrutinib | Plasma concentrations of ibrutinib were reported. | Pharmacokinetics (PK) evaluable analysis set included all enrolled participants who received at least 1 dose of ibrutinib and had at least 1 available PK sample after treatment. Here, 'n' (number analyzed) signifies number of participants evaluable for specified time point. | Posted | Mean | Standard Deviation | Nanograms per milliliter (ng/mL) | Pre-dose on Day 1 of Weeks 1, 5 and 9 |
|
|
|
| 3 |
| 17 |
| 9 |
| 17 |
| 17 |
| 17 |
| Bacterial Prostatitis | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Covid-19 Pneumonia | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Orchitis | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Lumbar Vertebral Fracture | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Lung Squamous Cell Carcinoma Stage 0 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Haemorrhage Intracranial | Nervous system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Peripheral Sensory Neuropathy | Nervous system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Ureterolithiasis | Renal and urinary disorders | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Cardiac Failure | Cardiac disorders | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Ventricular Arrhythmia | Cardiac disorders | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Retinal Haemorrhage | Eye disorders | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Gastrointestinal Pain | Gastrointestinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Mouth Haemorrhage | Gastrointestinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Mouth Ulceration | Gastrointestinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Oedema Peripheral | General disorders | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Anal Abscess | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Bacterial Prostatitis | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Covid-19 | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Eye Infection | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Gingivitis | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Herpes Simplex | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Herpes Zoster | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Orchitis | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Head Injury | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Alanine Aminotransferase Increased | Investigations | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Aspartate Aminotransferase Increased | Investigations | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Blood Bilirubin Increased | Investigations | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Blood Creatinine Increased | Investigations | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Blood Lactate Dehydrogenase Increased | Investigations | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Blood Urea Increased | Investigations | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Hepatitis B DNA Assay Positive | Investigations | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Neutrophil Count Decreased | Investigations | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Platelet Count Decreased | Investigations | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Weight Decreased | Investigations | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Weight Increased | Investigations | MedDRA Version 26.1 | Non-systematic Assessment |
|
| White Blood Cell Count Decreased | Investigations | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Joint Swelling | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Ovarian Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Haemorrhage Intracranial | Nervous system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Peripheral Sensory Neuropathy | Nervous system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Renal Failure | Renal and urinary disorders | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Ureterolithiasis | Renal and urinary disorders | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Pharyngeal Haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Henoch-Schonlein Purpura | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Purpura | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Scalp Haematoma | Vascular disorders | MedDRA Version 26.1 | Non-systematic Assessment |
|
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will delay to allow for filing of a patent application.
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
|
| Predose Day 1 Week 9 |
|
|