Not provided
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Due to low enrollment, the study was terminated early.
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The purpose of this study is to determine if the combination of X4P-001 plus nivolumab is safe and tolerable. Secondly, the study will investigate if adding X4P-001 to nivolumab treatment has an effect on the body and the cancer tumor, in participants receiving nivolumab but not exhibiting a radiological response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| X4P-001 Plus Nivolumab | Experimental | Participants will receive X4P-001 400 milligrams (mg) (as 4 capsules of 100 mg each) orally once daily in combination with nivolumab 240 mg intravenous (IV) infusion (over 60 minutes) every 2 weeks. Study medication will be administered in 28-day cycles and will continue until treatment-limiting toxicity or disease progression. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| X4P-001 | Drug | X4P-001 will be administered as per the dose and schedule specified in the arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Drug-related TEAEs: TEAEs with possible, probable, definite, or missing relationship to study medication (X4P-001 or Nivolumab). Serious AEs: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs were defined as events occurring on or after the first dose of study drug through 30 days after the last dose. Any TEAEs included both serious and non-serious TEAEs. A summary of other non-serious AEs and all serious AEs, regardless of causality, is located in Reported AE section. | From administration of first dose of study medication (Day 1) up to 30 days after last dose (up to 16 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of X4P-001 | Samples were to be analyzed for X4P-001 concentration using reversed-phase high performance liquid chromatography (RP-HPLC) with tandem mass spectrometry (MS) detection. | Predose (-30 minutes) on Day 1 of Cycle 1; predose (-10 minutes) on Days 8, 15, and 22 of Cycle 1, and Day 1 of Cycle 3; postdose at 60 and 90 minutes, and 2, 3 4, and 8 hours on Day 22 of Cycle 1 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chief Medical Officer | X4 Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington D.C. | District of Columbia | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33507454 | Derived | Choueiri TK, Atkins MB, Rose TL, Alter RS, Ju Y, Niland K, Wang Y, Arbeit R, Parasuraman S, Gan L, McDermott DF. A phase 1b trial of the CXCR4 inhibitor mavorixafor and nivolumab in advanced renal cell carcinoma patients with no prior response to nivolumab monotherapy. Invest New Drugs. 2021 Aug;39(4):1019-1027. doi: 10.1007/s10637-020-01058-2. Epub 2021 Jan 28. |
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| ID | Title | Description |
|---|---|---|
| FG000 | X4P-001 Plus Nivolumab | Participants received X4P-001 400 milligrams (mg) (as 4 capsules of 100 mg each) orally once daily in combination with nivolumab 240 mg intravenous (IV) infusion (over 60 minutes) every 2 weeks. Study medication was administered in 28-day cycles and continued until treatment-limiting toxicity or disease progression. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety population included all participants who received at least 1 dose of study medication.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | X4P-001 Plus Nivolumab | Participants received X4P-001 400 mg (as 4 capsules of 100 mg each) orally once daily in combination with nivolumab 240 mg IV infusion (over 60 minutes) every 2 weeks. Study medication was administered in 28-day cycles and continued until treatment-limiting toxicity or disease progression. |
| 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 Treatment-Emergent Adverse Events (TEAEs) | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Drug-related TEAEs: TEAEs with possible, probable, definite, or missing relationship to study medication (X4P-001 or Nivolumab). Serious AEs: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs were defined as events occurring on or after the first dose of study drug through 30 days after the last dose. Any TEAEs included both serious and non-serious TEAEs. A summary of other non-serious AEs and all serious AEs, regardless of causality, is located in Reported AE section. | Safety population included all participants who received at least 1 dose of study medication. | Posted | Count of Participants | Participants | From administration of first dose of study medication (Day 1) up to 30 days after last dose (up to 16 months) |
From administration of first dose of study medication (Day 1) up to 30 days after last dose (up to 16 months)
Safety population included all participants who received at least 1 dose of study medication.
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 | X4P-001 Plus Nivolumab | Participants received X4P-001 400 mg (as 4 capsules of 100 mg each) orally once daily in combination with nivolumab 240 mg IV infusion (over 60 minutes) every 2 weeks. Study treatment was administered in 28-day cycles and continued until treatment-limiting toxicity or disease progression. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
Due to low enrollment, the study was terminated early. Data for some pre-registered endpoints were therefore not collected or analysed and could not be reported.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | X4 Pharmacueticals | (857) 529-8300 | patientinfo@x4pharma.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 | Jul 5, 2017 | Aug 23, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 14, 2018 | Aug 23, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| C494414 | mavorixafor |
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
Not provided
Not provided
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| Nivolumab | Drug | Nivolumab will be administered as per the dose and schedule specified in the arm. |
|
|
| Area Under the Plasma Concentration Versus Time Curve (AUC) of X4P-001 | Samples were to be analyzed for X4P-001 concentration using RP-HPLC with tandem MS detection. | Predose (-30 minutes) on Day 1 of Cycle 1; predose (-10 minutes) on Days 8, 15, and 22 of Cycle 1, and Day 1 of Cycle 3; postdose at 60 and 90 minutes, and 2, 3 4, and 8 hours on Day 22 of Cycle 1 |
| Minimum Plasma Concentration (Cmin) of X4P-001 | Samples were to be analyzed for X4P-001 concentration using RP-HPLC with tandem MS detection. | Predose (-30 minutes) on Day 1 of Cycle 1; predose (-10 minutes) on Days 8, 15, and 22 of Cycle 1, and Day 1 of Cycle 3; postdose at 60 and 90 minutes, and 2, 3 4, and 8 hours on Day 22 of Cycle 1 |
| Time to Reach Cmax (Tmax) of X4P-001 | Samples were to be analyzed for X4P-001 concentration using RP-HPLC with tandem MS detection. | Predose (-30 minutes) on Day 1 of Cycle 1; predose (-10 minutes) on Days 8, 15, and 22 of Cycle 1, and Day 1 of Cycle 3; postdose at 60 and 90 minutes, and 2, 3 4, and 8 hours on Day 22 of Cycle 1 |
| Objective Response Rate (ORR): Percentage of Participants With Objective Response, Evaluated Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | ORR was defined as percentage of participants with best overall response of complete response (CR) or partial response (PR). CR: Disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) with a reduction in short axis to less than (<) 10 millimeters (mm). PR: At least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | From administration of first dose of study medication (Day 1) until disease progression, study completion or early termination (up to 15 months) |
| Duration of Objective Response (DOR), Evaluated Using RECIST Version 1.1 | DOR was defined as the time from first CR or PR whichever comes first until the time of disease progression by RECIST v1.1 or death due to any cause. CR: Disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) with a reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Disease progression: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum also demonstrated an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. The appearance of 1 or more new lesions was also considered progression. | Time from first CR or PR until the time of disease progression or death due to any cause (up to 15 months) |
| Time to Objective Response, Evaluated Using RECIST Version 1.1 | Time to objective response was defined as time from first administration of combination regimen to first CR or PR whichever comes first. CR: Disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) with a reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | From administration of first dose of study medication (Day 1) until first appearance of CR or PR (up to 15 months) |
| Disease Control Rate: Percentage of Participants With CR or PR or Stable Disease (SD), Evaluated Using RECIST Version 1.1 | Disease control rate was defined as percentage of participants with best overall response of CR or PR or SD. CR: Disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) with a reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study In addition to the relative increase of 20%, the sum also demonstrated an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. The appearance of 1 or more new lesions was also considered progression. | From administration of first dose of study medication (Day 1) until disease progression, study completion or early termination (up to 15 months) |
| Progression Free Survival (PFS), Evaluated Using RECIST Version 1.1 | PFS was defined as the time from first administration of study medication until objective tumor progression or death from any cause. Tumor progression: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study In addition to the relative increase of 20%, the sum also demonstrated an absolute increase of at least 5 mm. An unequivocal progression of existing non-target lesions or the appearance of 1 or more new lesions was also considered progression. | From administration of first dose of study medication (Day 1) until disease progression or death from any cause (up to 15 months) |
| Time to Progression (TTP), Evaluated Using RECIST Version 1.1 | TTP was defined as the time from first administration of study medication until objective tumor progression. Tumor progression: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study In addition to the relative increase of 20%, the sum also demonstrated an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions or the appearance of 1 or more new lesions was also considered progression. | From administration of first dose of study medication (Day 1) until disease progression (up to 15 months) |
| Boston |
| Massachusetts |
| United States |
| Hackensack | New Jersey | United States |
| Chapel Hill | North Carolina | United States |
| Study Termination |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | X4P-001 Plus Nivolumab | Participants received X4P-001 400 mg (as 4 capsules of 100 mg each) orally once daily in combination with nivolumab 240 mg IV infusion (over 60 minutes) every 2 weeks. Study medication was administered in 28-day cycles and continued until treatment-limiting toxicity or disease progression. |
|
|
| Secondary | Maximum Observed Plasma Concentration (Cmax) of X4P-001 | Samples were to be analyzed for X4P-001 concentration using reversed-phase high performance liquid chromatography (RP-HPLC) with tandem mass spectrometry (MS) detection. | The study was terminated and the pharmacokinetic (PK) samples collected could not be analyzed due to insufficient data available to assess the outcome measure as per the prespecified method of analysis. | Posted | Predose (-30 minutes) on Day 1 of Cycle 1; predose (-10 minutes) on Days 8, 15, and 22 of Cycle 1, and Day 1 of Cycle 3; postdose at 60 and 90 minutes, and 2, 3 4, and 8 hours on Day 22 of Cycle 1 |
|
|
| Secondary | Area Under the Plasma Concentration Versus Time Curve (AUC) of X4P-001 | Samples were to be analyzed for X4P-001 concentration using RP-HPLC with tandem MS detection. | The study was terminated and the PK samples collected could not be analyzed due to insufficient data available to assess the outcome measure as per the prespecified method of analysis. | Posted | Predose (-30 minutes) on Day 1 of Cycle 1; predose (-10 minutes) on Days 8, 15, and 22 of Cycle 1, and Day 1 of Cycle 3; postdose at 60 and 90 minutes, and 2, 3 4, and 8 hours on Day 22 of Cycle 1 |
|
|
| Secondary | Minimum Plasma Concentration (Cmin) of X4P-001 | Samples were to be analyzed for X4P-001 concentration using RP-HPLC with tandem MS detection. | The study was terminated and the PK samples collected could not be analyzed due to insufficient data available to assess the outcome measure as per the prespecified method of analysis. | Posted | Predose (-30 minutes) on Day 1 of Cycle 1; predose (-10 minutes) on Days 8, 15, and 22 of Cycle 1, and Day 1 of Cycle 3; postdose at 60 and 90 minutes, and 2, 3 4, and 8 hours on Day 22 of Cycle 1 |
|
|
| Secondary | Time to Reach Cmax (Tmax) of X4P-001 | Samples were to be analyzed for X4P-001 concentration using RP-HPLC with tandem MS detection. | The study was terminated and the PK samples collected could not be analyzed due to insufficient data available to as per the prespecified method of analysis. | Posted | Predose (-30 minutes) on Day 1 of Cycle 1; predose (-10 minutes) on Days 8, 15, and 22 of Cycle 1, and Day 1 of Cycle 3; postdose at 60 and 90 minutes, and 2, 3 4, and 8 hours on Day 22 of Cycle 1 |
|
|
| Secondary | Objective Response Rate (ORR): Percentage of Participants With Objective Response, Evaluated Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | ORR was defined as percentage of participants with best overall response of complete response (CR) or partial response (PR). CR: Disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) with a reduction in short axis to less than (<) 10 millimeters (mm). PR: At least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | Intent-to-treat (ITT) population included all participants who received at least 1 dose of study medication. | Posted | Number | 95% Confidence Interval | percentage of participants | From administration of first dose of study medication (Day 1) until disease progression, study completion or early termination (up to 15 months) |
|
|
|
| Secondary | Duration of Objective Response (DOR), Evaluated Using RECIST Version 1.1 | DOR was defined as the time from first CR or PR whichever comes first until the time of disease progression by RECIST v1.1 or death due to any cause. CR: Disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) with a reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Disease progression: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum also demonstrated an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. The appearance of 1 or more new lesions was also considered progression. | ITT population included all participants who received at least 1 dose of study medication. | Posted | Median | 95% Confidence Interval | months | Time from first CR or PR until the time of disease progression or death due to any cause (up to 15 months) |
|
|
|
| Secondary | Time to Objective Response, Evaluated Using RECIST Version 1.1 | Time to objective response was defined as time from first administration of combination regimen to first CR or PR whichever comes first. CR: Disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) with a reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | ITT population included all participants who received at least 1 dose of study medication. | Posted | Median | 95% Confidence Interval | months | From administration of first dose of study medication (Day 1) until first appearance of CR or PR (up to 15 months) |
|
|
|
| Secondary | Disease Control Rate: Percentage of Participants With CR or PR or Stable Disease (SD), Evaluated Using RECIST Version 1.1 | Disease control rate was defined as percentage of participants with best overall response of CR or PR or SD. CR: Disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) with a reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study In addition to the relative increase of 20%, the sum also demonstrated an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. The appearance of 1 or more new lesions was also considered progression. | ITT population included all participants who received at least 1 dose of study medication. | Posted | Number | 95% Confidence Interval | percentage of participants | From administration of first dose of study medication (Day 1) until disease progression, study completion or early termination (up to 15 months) |
|
|
|
| Secondary | Progression Free Survival (PFS), Evaluated Using RECIST Version 1.1 | PFS was defined as the time from first administration of study medication until objective tumor progression or death from any cause. Tumor progression: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study In addition to the relative increase of 20%, the sum also demonstrated an absolute increase of at least 5 mm. An unequivocal progression of existing non-target lesions or the appearance of 1 or more new lesions was also considered progression. | ITT population included all participants who received at least 1 dose of study medication. | Posted | Median | 95% Confidence Interval | months | From administration of first dose of study medication (Day 1) until disease progression or death from any cause (up to 15 months) |
|
|
|
| Secondary | Time to Progression (TTP), Evaluated Using RECIST Version 1.1 | TTP was defined as the time from first administration of study medication until objective tumor progression. Tumor progression: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study In addition to the relative increase of 20%, the sum also demonstrated an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions or the appearance of 1 or more new lesions was also considered progression. | ITT population included all participants who received at least 1 dose of study medication. | Posted | Median | 95% Confidence Interval | months | From administration of first dose of study medication (Day 1) until disease progression (up to 15 months) |
|
|
|
| 0 |
| 9 |
| 2 |
| 9 |
| 9 |
| 9 |
| Aspartate aminotransferase increased | Investigations | MedDRA 19.0 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 19.0 | Systematic Assessment |
|
| Autoimmune hepatitis | Hepatobiliary disorders | MedDRA 19.0 | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
|
| Embolism | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Anal incontinence | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Eructation | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA 19.0 | Systematic Assessment |
|
| Conjunctival hyperaemia | Eye disorders | MedDRA 19.0 | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA 19.0 | Systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | MedDRA 19.0 | Systematic Assessment |
|
| Photophobia | Eye disorders | MedDRA 19.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Dyspnoea Exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 19.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 19.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA 19.0 | Systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA 19.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 19.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
|
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 19.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 19.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 19.0 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 19.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 19.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
|
| Corneal abrasion | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
|
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
|
| Chronic kidney disease | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA 19.0 | Systematic Assessment |
|
| Ear congestion | Ear and labyrinth disorders | MedDRA 19.0 | Systematic Assessment |
|
| Hypoacusis | Ear and labyrinth disorders | MedDRA 19.0 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 19.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
|
Not provided
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |