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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-006684-36 | EudraCT Number | ||
| 5592-065 | Other Identifier | Merck |
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The purpose of this study is to collect pharmacokinetic (PK) information related to how well posaconazole tablet is distributed in the body and to determine the safety of this new formulation. The study consists of a Phase 1B study that includes participants with neutropenia undergoing chemotherapy for acute myelogenous leukemia (AML) or myelodysplasia (MDS) and a Phase 3 study that includes participants who are undergoing chemotherapy for AML or MDS and participants who are recipients of allogeneic hematopoietic stem cell transplant (HSCT).
Participants with a blood disease or cancer that can affect their infection-fighting white blood cells and those who have undergone a hematopoietic stem cell transplant (HSCT) and are receiving immunosuppressive therapy and have or are at risk of graft-vs-host disease (GVHD) are eligible for the study. These blood diseases and their treatments can weaken the immune system and may put individuals at high risk for a serious fungal infection of their internal organs or blood (invasive fungal infection). As these infections can be hard to detect early and can be life-threatening, many physicians believe that individuals diagnosed with these diseases should receive antifungal therapy to try to lower their risk of getting this type of infection.
Enrollment into this study will take place in several stages (parts). The determination of which part a participant will be in is based on which part is open at the site at the time of enrollment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Posaconazole 200 mg | Experimental | Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days |
|
| Posaconazole 300 mg | Experimental | Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Posaconazole 200 mg | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Average Concentration (Cavg) of Posaconazole Tablet | Posaconazole steady-state concentrations of posaconazole in the plasma reached after regular and repeated dosing were used to estimate pharmacokinetic (PK) parameters for each participant where Cavg was defined as area under the plasma concentration versus time curve divided by the dosing interval. Blood samples for the assessment of Cavg were collected on Day 1 and Day 8 predose and then at specified time points up to 24 hours postdose. | Predose on Day 1 up to 24 hours postdose on Day 8 |
| Minimum Concentration (Cmin) of Posaconazole Tablet | Cmin was defined as posaconazole trough level immediately before a participant received the dose of posaconazole tablets on the specified day. Trough (Cmin) level blood samples for determination of posaconazole in plasma were collected for all participants on Day 1, Day 2, Day 3, and Day 8. On Day 1, the trough level sample was collected the before the first dose of study drug. On Day 2, trough samples were collected approximately 12 hours after the second dose of study drug was administered on Day 1. On all subsequent days, trough samples were collected approximately 24 hours following the previous day's dose of study drug. | Predose on Day 1 up to 24 hours postdose on Day 8 |
| Maximum Concentration (Cmax) of Posaconazole Tablet | Blood samples for the assessment of Cmax were collected on Day 1 and Day 8 predose and then at specified time points up to 24 hours postdose. | Predose on Day 1 up to 24 hours postdose on Day 8 |
| Time to Maximum Concentration (Tmax) of Posaconazole Tablet | Blood samples for the assessment of Tmax were collected on Day 1 and Day 8 predose and then at specified time points up to 24 hours postdose. | Predose on Day 1 up to 24 hours postdose on Day 8 |
| Apparent Total Body Clearance (CL/F) for Posaconazole Tablet |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Surviving at Day 65 | Number of Participants Alive at Day 65 | Day 65 |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) | AEs are any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not considered related to this study drug. Treatment-emergent AEs are any events not present before starting study drug treatment or any events that were present before treatment that worsened in either intensity or frequency after exposure to study drug. |
Inclusion Criteria:
Exclusion Criteria:
- Female must not be pregnant, must not intend to become pregnant
during the study, and must not be nursing
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25049247 | Result | Duarte RF, Lopez-Jimenez J, Cornely OA, Laverdiere M, Helfgott D, Haider S, Chandrasekar P, Langston A, Perfect J, Ma L, van Iersel ML, Connelly N, Kartsonis N, Waskin H. Phase 1b study of new posaconazole tablet for prevention of invasive fungal infections in high-risk patients with neutropenia. Antimicrob Agents Chemother. 2014 Oct;58(10):5758-65. doi: 10.1128/AAC.03050-14. Epub 2014 Jul 21. | |
| Result | Cornely OA, Duarte RF, Haider S, Chandrasakar P, Helfgott D, Lopez J, Candoni A, Raad I, Laverdiere M, Langston A, Van Iersel M, Connelly N, Waskin H. Phase 3 Pharmacokinetics and Safety Study of Posaconazole Tablet in Patients at Risk for Invasive Fungal Infection. J Antimicrob Chemother. 2015;[e-pub 26Nov2015]. doi: 10.1093/jac/dkv380 | ||
| 36906440 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Posaconazole 200 mg | Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days |
| FG001 | Posaconazole 300 mg | Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Posaconazole 200 mg | Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days. |
| BG001 | Posaconazole 300 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 | Average Concentration (Cavg) of Posaconazole Tablet | Posaconazole steady-state concentrations of posaconazole in the plasma reached after regular and repeated dosing were used to estimate pharmacokinetic (PK) parameters for each participant where Cavg was defined as area under the plasma concentration versus time curve divided by the dosing interval. Blood samples for the assessment of Cavg were collected on Day 1 and Day 8 predose and then at specified time points up to 24 hours postdose. | The Cavg PK population included participants who met the inclusion/exclusion criteria, complied with protocol procedures including collection of specified PK and dosing parameters, had no major protocol violations, and had documented adherence to dosing and PK regimens through the Day 8 steady-state visit. | Posted | Mean | Standard Deviation | ng/mL | Predose on Day 1 up to 24 hours postdose on Day 8 |
|
Up to Day 65
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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 | Posaconazole 200 mg | Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
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| ID | Term |
|---|---|
| D009181 | Mycoses |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C101425 | posaconazole |
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| Posaconazole 300 mg |
| Drug |
|
|
Blood samples for the assessment of CL/F, the rate at which posaconazole was removed from the body, were collected on Day 1 and Day 8 predose and then at specified time points up to 24 hours postdose. |
| Predose on Day 1 up to 24 hours postdose on Day 8 |
| Up to Day 65 |
| Number of Participants With Treatment-Related AEs | AEs are any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not considered related to this study drug. Treatment-related AEs were considered by the investigator to be related to the study drug. | Up to Day 65 |
| Number of Participants Discontinuing Study Treatment Due to an AE | AEs are any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not considered related to this study drug. These AEs resulted in participants stopping study drug treatment. This measure includes participants who discontinued due to AEs and also includes treatment failures that were attributed to AEs. | Up to Day 28 |
| Derived |
| de Almeida C, Wong M, Kleijn HJ, Wrishko RE. Predicted Bezlotoxumab Exposure in Patients Who Have Received a Hematopoietic Stem Cell Transplant. Clin Ther. 2023 Apr;45(4):356-362. doi: 10.1016/j.clinthera.2023.02.006. Epub 2023 Mar 9. |
| 26612870 | Derived | Cornely OA, Duarte RF, Haider S, Chandrasekar P, Helfgott D, Jimenez JL, Candoni A, Raad I, Laverdiere M, Langston A, Kartsonis N, Van Iersel M, Connelly N, Waskin H. Phase 3 pharmacokinetics and safety study of a posaconazole tablet formulation in patients at risk for invasive fungal disease. J Antimicrob Chemother. 2016 Mar;71(3):718-26. doi: 10.1093/jac/dkv380. Epub 2015 Nov 26. |
| Withdrawal by Subject |
|
| Treatment Failure |
|
Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days
| OG001 | Posaconazole 300 mg | Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days |
|
|
| Primary | Minimum Concentration (Cmin) of Posaconazole Tablet | Cmin was defined as posaconazole trough level immediately before a participant received the dose of posaconazole tablets on the specified day. Trough (Cmin) level blood samples for determination of posaconazole in plasma were collected for all participants on Day 1, Day 2, Day 3, and Day 8. On Day 1, the trough level sample was collected the before the first dose of study drug. On Day 2, trough samples were collected approximately 12 hours after the second dose of study drug was administered on Day 1. On all subsequent days, trough samples were collected approximately 24 hours following the previous day's dose of study drug. | The Cmin PK population included participants who met the inclusion/exclusion criteria, complied with protocol procedures including collection of specified PK and dosing parameters, had no major protocol violations, and had documented adherence to dosing and PK regimens through the Day 8 steady-state visit. | Posted | Mean | Standard Deviation | ng/mL | Predose on Day 1 up to 24 hours postdose on Day 8 |
|
|
|
| Primary | Maximum Concentration (Cmax) of Posaconazole Tablet | Blood samples for the assessment of Cmax were collected on Day 1 and Day 8 predose and then at specified time points up to 24 hours postdose. | The Cmax PK population included participants who met the inclusion/exclusion criteria, complied with protocol procedures including collection of specified PK and dosing parameters, had no major protocol violations, and had documented adherence to dosing and PK regimens through the Day 8 steady-state visit. | Posted | Mean | Standard Deviation | ng/mL | Predose on Day 1 up to 24 hours postdose on Day 8 |
|
|
|
| Primary | Time to Maximum Concentration (Tmax) of Posaconazole Tablet | Blood samples for the assessment of Tmax were collected on Day 1 and Day 8 predose and then at specified time points up to 24 hours postdose. | The Tmax PK population included participants who met the inclusion/exclusion criteria, complied with protocol procedures including collection of specified PK and dosing parameters, had no major protocol violations, and had documented adherence to dosing and PK regimens through the Day 8 steady-state visit. | Posted | Median | Full Range | Hours | Predose on Day 1 up to 24 hours postdose on Day 8 |
|
|
|
| Primary | Apparent Total Body Clearance (CL/F) for Posaconazole Tablet | Blood samples for the assessment of CL/F, the rate at which posaconazole was removed from the body, were collected on Day 1 and Day 8 predose and then at specified time points up to 24 hours postdose. | The CL/F PK population included participants who met the inclusion/exclusion criteria, complied with protocol procedures including collection of specified PK and dosing parameters, had no major protocol violations, and had documented adherence to dosing and PK regimens through predose on the Day 8 steady-state visit. | Posted | Mean | Standard Deviation | L/hr | Predose on Day 1 up to 24 hours postdose on Day 8 |
|
|
|
| Other Pre-specified | Number of Participants Surviving at Day 65 | Number of Participants Alive at Day 65 | The safety population consisted of all participants who received at least one dose of study drug. | Posted | Number | Participants | Day 65 |
|
|
|
| Other Pre-specified | Number of Participants With Treatment-Emergent Adverse Events (AEs) | AEs are any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not considered related to this study drug. Treatment-emergent AEs are any events not present before starting study drug treatment or any events that were present before treatment that worsened in either intensity or frequency after exposure to study drug. | The safety population consisted of all participants who received at least one dose of study drug. | Posted | Number | Participants | Up to Day 65 |
|
|
|
| Other Pre-specified | Number of Participants With Treatment-Related AEs | AEs are any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not considered related to this study drug. Treatment-related AEs were considered by the investigator to be related to the study drug. | The safety population consisted of all participants who received at least one dose of study drug. | Posted | Number | Participants | Up to Day 65 |
|
|
|
| Other Pre-specified | Number of Participants Discontinuing Study Treatment Due to an AE | AEs are any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not considered related to this study drug. These AEs resulted in participants stopping study drug treatment. This measure includes participants who discontinued due to AEs and also includes treatment failures that were attributed to AEs. | The safety population consisted of all participants who received at least one dose of study drug. | Posted | Number | Participants | Up to Day 28 |
|
|
|
| 6 |
| 20 |
| 20 |
| 20 |
| EG001 | Posaconazole 300 mg | Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days | 69 | 210 | 186 | 210 |
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
|
| MICROANGIOPATHIC HAEMOLYTIC ANAEMIA | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
|
| SPLENIC HAEMORRHAGE | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
|
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
|
| THROMBOTIC THROMBOCYTOPENIC PURPURA | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
|
| CARDIAC ARREST | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| CARDIAC FAILURE | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| CARDIO-RESPIRATORY ARREST | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| CARDIOVASCULAR INSUFFICIENCY | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| LEFT VENTRICULAR FAILURE | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| MYOCARDIAL ISCHAEMIA | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| PERICARDITIS | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| ASCITES | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| ENTEROCOLITIS | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| HAEMATOCHEZIA | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| HAEMORRHOIDAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| NEUTROPENIC COLITIS | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| ASTHENIA | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| CHEST PAIN | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| DISEASE PROGRESSION | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| DRUG INTERACTION | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| GENERALISED OEDEMA | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| MULTI-ORGAN FAILURE | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| NON-CARDIAC CHEST PAIN | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| HEPATOTOXICITY | Hepatobiliary disorders | MedDRA 15.0 | Systematic Assessment |
|
| JAUNDICE | Hepatobiliary disorders | MedDRA 15.0 | Systematic Assessment |
|
| DRUG HYPERSENSITIVITY | Immune system disorders | MedDRA 15.0 | Systematic Assessment |
|
| GRAFT VERSUS HOST DISEASE | Immune system disorders | MedDRA 15.0 | Systematic Assessment |
|
| GRAFT VERSUS HOST DISEASE IN INTESTINE | Immune system disorders | MedDRA 15.0 | Systematic Assessment |
|
| BACTERIAL SEPSIS | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| CHOLECYSTITIS INFECTIVE | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| CLOSTRIDIUM DIFFICILE COLITIS | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| CYTOMEGALOVIRUS INFECTION | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| CYTOMEGALOVIRUS VIRAEMIA | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| DEVICE RELATED INFECTION | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| KLEBSIELLA INFECTION | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| LOWER RESPIRATORY TRACT INFECTION FUNGAL | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| LUNG INFECTION | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| NEUTROPENIC SEPSIS | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| PNEUMONIA | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| PNEUMONIA BACTERIAL | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| PNEUMONIA FUNGAL | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| PNEUMONIA RESPIRATORY SYNCYTIAL VIRAL | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| PSEUDOMONAL SEPSIS | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| SEPSIS | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| SEPTIC SHOCK | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| STAPHYLOCOCCAL SEPSIS | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| STREPTOCOCCAL SEPSIS | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| VIRAL INFECTION | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| ZYGOMYCOSIS | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| ALLERGIC TRANSFUSION REACTION | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| HUMERUS FRACTURE | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| TRANSPLANT FAILURE | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| BLOOD BILIRUBIN INCREASED | Investigations | MedDRA 15.0 | Systematic Assessment |
|
| BLOOD CREATININE INCREASED | Investigations | MedDRA 15.0 | Systematic Assessment |
|
| LIVER FUNCTION TEST ABNORMAL | Investigations | MedDRA 15.0 | Systematic Assessment |
|
| TRANSAMINASES INCREASED | Investigations | MedDRA 15.0 | Systematic Assessment |
|
| WEIGHT INCREASED | Investigations | MedDRA 15.0 | Systematic Assessment |
|
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
|
| METABOLIC ACIDOSIS | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
|
| ACUTE MYELOID LEUKAEMIA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
|
| LEUKAEMIA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
|
| POLYCYTHAEMIA VERA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
|
| T-CELL PROLYMPHOCYTIC LEUKAEMIA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| INTRACRANIAL PRESSURE INCREASED | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| LOSS OF CONSCIOUSNESS | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| SINUS HEADACHE | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| MAJOR DEPRESSION | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
|
| SUICIDAL IDEATION | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
|
| CYSTITIS HAEMORRHAGIC | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
|
| RENAL FAILURE | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
|
| RENAL FAILURE ACUTE | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
|
| RENAL FAILURE CHRONIC | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
|
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| PULMONARY OEDEMA | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| RESPIRATORY DISTRESS | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| HYPOTENSION | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
|
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
|
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
|
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
|
| BRADYCARDIA | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| TACHYCARDIA | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| ABDOMINAL DISTENSION | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| DYSPEPSIA | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| HAEMORRHOIDS | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| MOUTH HAEMORRHAGE | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| ORAL PAIN | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| RECTAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| ASTHENIA | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| CATHETER SITE ERYTHEMA | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| CHEST PAIN | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| CHILLS | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| FATIGUE | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| MUCOSAL INFLAMMATION | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| OEDEMA PERIPHERAL | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| CHOLESTASIS | Hepatobiliary disorders | MedDRA 15.0 | Systematic Assessment |
|
| HYPERBILIRUBINAEMIA | Hepatobiliary disorders | MedDRA 15.0 | Systematic Assessment |
|
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 15.0 | Systematic Assessment |
|
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 15.0 | Systematic Assessment |
|
| HAEMOGLOBIN DECREASED | Investigations | MedDRA 15.0 | Systematic Assessment |
|
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
|
| HYPOCALCAEMIA | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
|
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
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| HYPOMAGNESAEMIA | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
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| HYPOPHOSPHATAEMIA | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
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| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| DIZZINESS | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
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| ANXIETY | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
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| INSOMNIA | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
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| DYSURIA | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
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| HAEMATURIA | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
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| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
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| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
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| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
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| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
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| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
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| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| PETECHIAE | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| RASH | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| RASH MACULO-PAPULAR | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| HYPERTENSION | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
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| HYPOTENSION | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
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The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission.