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| ID | Type | Description | Link |
|---|---|---|---|
| C4791010 | Other Identifier | Alias Study Number | |
| 2019-001386-33 | EudraCT Number |
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The Sponsor made a strategic decision to terminate the study, in order to prioritize a randomized comparative Phase 3 trial in the same indication. This decision was not based on any safety concerns
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This is a Phase 2, multicenter study to evaluate APX001 for the treatment of invasive fungal infections caused by Aspergillus spp. or rare molds (eg, Scedosporium spp., Fusarium spp., and Mucorales fungi).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A: fosmanogepix (APX001) | Experimental |
| |
| Cohort B: fosmanogepix (APX001) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fosmanogepix | Drug | IV and oral fosmanogepix |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Died After the First Dose of Study Drug Through Day 42 | Percentage of participants who died after first dose in the study through Day 42 were reported in this outcome measure. This outcome measure included all deaths from Day 1 through Day 42. | After first dose on Day 1 through Day 42 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Global Response Based on Data Review Committee (DRC) Assessment at End of Study Drug Treatment (EOST) | Global response was classified as treatment success (complete or partial response [CR or PR]) or treatment failure (stable response [SR], progression of fungal disease [PD], or death) as determined by DRC. CR: survival within prespecified period of observation (PPOB), resolution of all attributable (att) symptoms and signs of disease and radiological (rad) abnormalities, and mycological (myco) evidence of eradication of disease. PR: survival within POB, improvement in att symptoms and signs of disease and rad abnormalities, and evidence of clearance of cultures or reduction of fungal burden. SR: survival within PPOB, minor or no improvement in fungal disease but no evidence of progression based on composite of clinical, rad and myco criteria, PD or death. PD: evidence of progressive fungal disease based on composite of clinical, rad and myco criteria. Death: death during PPOB, regardless of attribution. Data is presented for EOST which could have preceded Day 42 for some participants. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc Engelhardt | Basilea Pharmaceutica International Ltd, Allschwil | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope (City of Hope National Medical Center, City of Hope Medical Center) | Duarte | California | 91010 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40203286 | Result | Hodges MR, Tawadrous M, Cornely OA, Thompson GR, Slavin MA, Maertens JA, Dadwal SS, Rahav G, Hazel S, Almas M, Jakate A, Pypstra R. Fosmanogepix for the Treatment of Invasive Mold Diseases Caused by Aspergillus Species and Rare Molds: A Phase 2, Open-Label Study (AEGIS). Clin Infect Dis. 2025 Dec 24;81(5):e302-e309. doi: 10.1093/cid/ciaf185. |
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Study was planned to be conducted in two parallel cohorts: Cohort A included participants with invasive mold infections (IMA) and an exploratory Cohort B was planned to include participants with invasive aspergillus, who had COVID-19 or Influenza A/B. The study was terminated early and no participants were enrolled in Cohort B; hence data is not reported for Cohort B in any section.
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| ID | Title | Description |
|---|---|---|
| FG000 | APX001 (Fosmanogepix): Cohort A | Eligible participants aged 18 years or older with invasive mold infections (IMI) and limited antifungal treatment options were included in this arm. On Day 1, participants received APX001 1000 milligram (mg) as a loading dose over 3 hours by intravenous (IV) infusion twice daily (BID). On Days 2 and 3, participants received APX001 600 mg as maintenance dose over 3 hours by IV infusion once daily (QD). From Day 4 till end of study treatment, for maintenance dose participants received either APX001 600 mg IV infusion QD over 3 hours or switched to APX001 800 mg orally QD on investigator discretion. Total treatment duration was maximum of 42 days. Participants had a follow-up visit at 4 weeks after last dose of study treatment and a follow-up telephone call was required on Day 84. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Phase |
|
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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 | Sep 29, 2020 | Mar 29, 2023 |
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| Any day from Day 1 until end of study treatment (any day up to Day 42) |
| Percentage of Participants With Treatment Success or Treatment Failure for Global Response Based on Data Review Committee (DRC) Assessment at End of Study Drug Treatment (EOST) | Global response was classified as treatment success (CR or PR) or treatment failure (SR, PD or death) as determined by DRC. CR: survival within prespecified POB, resolution of all attributable symptoms and signs of disease and rad abnormalities and myco evidence of eradication of disease. PR: survival within prespecified POB, improvement in attributable symptoms and signs of disease and rad abnormalities and evidence of clearance of cultures or reduction of fungal burden. SR: survival within prespecified POB, minor or no improvement in fungal disease, but no evidence of progression, based on composite of clinical, rad, and myco criteria, PD or death. PD: evidence of PD based on a composite of clinical, rad, and myco criteria. Death: death during prespecified period of evaluation, regardless of attribution. Percentage of participants with treatment success (CR, PR) and treatment failure (SR, PD, death) along with two-sided exact binomial 80% confidence interval is presented. | Any day from Day 1 until end of study treatment (any day up to Day 42) |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | An adverse event was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were events between first dose of study drug and up to 4 weeks post last dose of study treatment that were absent before treatment or that worsened relative to pretreatment state. An SAE was any untoward medical occurrence that occurred, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; was a congenital anomaly/birth defect and other important medical events. AEs included SAEs and all non-SAEs. | Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days) |
| Number of Participants With Clinically Significant Abnormality in Vital Signs | Vital signs included body temperature, blood pressure, heart rate, respiratory rate, and oxygen saturation. Number of participants with clinically significant abnormality in vital signs as judged by investigator were reported in this outcome measure. | Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days) |
| Number of Participants With Clinically Significant Abnormality in Laboratory Test Evaluations | Clinical laboratory assessments included serum chemistry (bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, creatinine, creatine kinase), hematology (including hemoglobin, hematocrit, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils and monocytes), coagulation (including Prothrombin time [PT]/ International normalized ratio [INR]), and urinalysis. Number of participants with clinically significant abnormality in any laboratory parameter as judged by investigator and reported as adverse events were presented. | Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days) |
| Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Findings | ECG parameters included PR interval, QRS interval, QT interval, QT interval corrected using the Fridericia's formula (QTcF), QT interval corrected using the Bazett's formula (QTcB), RR interval and heart rate. Number of participants with clinically significant abnormal ECG findings as judged by investigator were presented. | Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days) |
| Number of Participants With Clinically Significant Change From Baseline in Physical and Neurological Examinations | Physical examination included an assessment of general appearance, skin, eyes, heart, chest, abdomen, and a neurological examination. Components of the neurological examination included cranial nerve, sensory, and motor examination; reflex and gait testing; and coordination assessment. Clinically significant changes were judged by investigator. | Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days) |
| Plasma Concentrations of Fosmanogepix | Days 1, 2, 3, 4, 7: Pre-dose and 3 hours post-dose; Days 6, 13, 14: 3 hours post-dose, Day 15: pre-dose |
| IP Address : City of Hope Investigational Drug Services (IDS) |
| Duarte |
| California |
| 91010 |
| United States |
| Duke Department of Pharmacy/Investigational Drug Service (IDS) | Durham | North Carolina | 27710 | United States |
| Duke Medicine Pavilion | Durham | North Carolina | 27710 | United States |
| Duke University Medical Center (Duke South Clinic) | Durham | North Carolina | 27710 | United States |
| Duke University Medical Center(Duke Hospital) | Durham | North Carolina | 27710 | United States |
| Cliniques Universitaires de Bruxelles Hôpital Erasme - Department of Infectious Diseases | Brussels | 1070 | Belgium |
| UZ Leuven - Department of Haematology | Leuven | 3000 | Belgium |
| CHU UCL Namur - Mont- Godinne University Hospital - Intensive Care Unit | Yvoir | 5530 | Belgium |
| Klinikum Neuperlach, Klinik fur Hamatologie und Onkologie | München | Bavaria | 81737 | Germany |
| Universitätsmedizin der Johannes Gutenberg-Universität Mainz III | Mainz | 55131 | Germany |
| Pharmacy | Haifa | 3109601 | Israel |
| Rambam Medical Center | Haifa | 3109601 | Israel |
| Pharmacy | Ramat Gan | 5262160 | Israel |
| Sheba Medical Center, Tel Hashomer | Ramat Gan | 5262160 | Israel |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Follow-up Phase |
|
|
Safety population included all participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | APX001 (Fosmanogepix): Cohort A | Eligible participants aged 18 years or older with invasive mold infections (IMI) and limited antifungal treatment options were included in this arm. On Day 1, participants received APX001 1000 milligram (mg) as a loading dose over 3 hours by intravenous (IV) infusion twice daily (BID). On Days 2 and 3, participants received APX001 600 mg as maintenance dose over 3 hours by IV infusion once daily (QD). From Day 4 till end of study treatment, for maintenance dose participants received either APX001 600 mg IV infusion QD over 3 hours or switched to APX001 800 mg orally QD on investigator discretion. Total treatment duration was maximum of 42 days. Participants had a follow-up visit at 4 weeks after last dose of study treatment and a follow-up telephone call was required on Day 84. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 | Percentage of Participants Who Died After the First Dose of Study Drug Through Day 42 | Percentage of participants who died after first dose in the study through Day 42 were reported in this outcome measure. This outcome measure included all deaths from Day 1 through Day 42. | The modified Intent-to-Treat (mITT) population included all participants who entered in the study, received at least 1 dose of study drug, and had a diagnosis of proven or probable IMI confirmed by the DRC. | Posted | Number | 80% Confidence Interval | Percentage of participants | After first dose on Day 1 through Day 42 |
|
|
| |||||||||||||||||||||||||
| Secondary | Percentage of Participants With Global Response Based on Data Review Committee (DRC) Assessment at End of Study Drug Treatment (EOST) | Global response was classified as treatment success (complete or partial response [CR or PR]) or treatment failure (stable response [SR], progression of fungal disease [PD], or death) as determined by DRC. CR: survival within prespecified period of observation (PPOB), resolution of all attributable (att) symptoms and signs of disease and radiological (rad) abnormalities, and mycological (myco) evidence of eradication of disease. PR: survival within POB, improvement in att symptoms and signs of disease and rad abnormalities, and evidence of clearance of cultures or reduction of fungal burden. SR: survival within PPOB, minor or no improvement in fungal disease but no evidence of progression based on composite of clinical, rad and myco criteria, PD or death. PD: evidence of progressive fungal disease based on composite of clinical, rad and myco criteria. Death: death during PPOB, regardless of attribution. Data is presented for EOST which could have preceded Day 42 for some participants. | mITT population included all participants who entered in the study, received at least 1 dose of study drug, and had a diagnosis of proven or probable IMI confirmed by the DRC. | Posted | Number | Percentage of participants | Any day from Day 1 until end of study treatment (any day up to Day 42) |
| ||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Treatment Success or Treatment Failure for Global Response Based on Data Review Committee (DRC) Assessment at End of Study Drug Treatment (EOST) | Global response was classified as treatment success (CR or PR) or treatment failure (SR, PD or death) as determined by DRC. CR: survival within prespecified POB, resolution of all attributable symptoms and signs of disease and rad abnormalities and myco evidence of eradication of disease. PR: survival within prespecified POB, improvement in attributable symptoms and signs of disease and rad abnormalities and evidence of clearance of cultures or reduction of fungal burden. SR: survival within prespecified POB, minor or no improvement in fungal disease, but no evidence of progression, based on composite of clinical, rad, and myco criteria, PD or death. PD: evidence of PD based on a composite of clinical, rad, and myco criteria. Death: death during prespecified period of evaluation, regardless of attribution. Percentage of participants with treatment success (CR, PR) and treatment failure (SR, PD, death) along with two-sided exact binomial 80% confidence interval is presented. | mITT population included all participants who entered in the study, received at least 1 dose of study drug, and had a diagnosis of proven or probable IMI confirmed by the DRC. | Posted | Number | 80% Confidence Interval | Percentage of participants | Any day from Day 1 until end of study treatment (any day up to Day 42) |
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | An adverse event was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were events between first dose of study drug and up to 4 weeks post last dose of study treatment that were absent before treatment or that worsened relative to pretreatment state. An SAE was any untoward medical occurrence that occurred, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; was a congenital anomaly/birth defect and other important medical events. AEs included SAEs and all non-SAEs. | Safety population included all participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days) |
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically Significant Abnormality in Vital Signs | Vital signs included body temperature, blood pressure, heart rate, respiratory rate, and oxygen saturation. Number of participants with clinically significant abnormality in vital signs as judged by investigator were reported in this outcome measure. | Safety population included all participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days) |
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically Significant Abnormality in Laboratory Test Evaluations | Clinical laboratory assessments included serum chemistry (bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, creatinine, creatine kinase), hematology (including hemoglobin, hematocrit, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils and monocytes), coagulation (including Prothrombin time [PT]/ International normalized ratio [INR]), and urinalysis. Number of participants with clinically significant abnormality in any laboratory parameter as judged by investigator and reported as adverse events were presented. | Safety population included all participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days) |
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Findings | ECG parameters included PR interval, QRS interval, QT interval, QT interval corrected using the Fridericia's formula (QTcF), QT interval corrected using the Bazett's formula (QTcB), RR interval and heart rate. Number of participants with clinically significant abnormal ECG findings as judged by investigator were presented. | Safety population included all participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days) |
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically Significant Change From Baseline in Physical and Neurological Examinations | Physical examination included an assessment of general appearance, skin, eyes, heart, chest, abdomen, and a neurological examination. Components of the neurological examination included cranial nerve, sensory, and motor examination; reflex and gait testing; and coordination assessment. Clinically significant changes were judged by investigator. | Safety population included all participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days) |
| ||||||||||||||||||||||||||||
| Secondary | Plasma Concentrations of Fosmanogepix | The Pharmacokinetic (PK) Population included all participants who received any amount of study drug and had evaluable PK data. Here, "Number Analyzed" signifies participants evaluable at specified time points. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter | Days 1, 2, 3, 4, 7: Pre-dose and 3 hours post-dose; Days 6, 13, 14: 3 hours post-dose, Day 15: pre-dose |
|
|
For adverse events (SAEs and non-SAEs): Day 1 up to maximum of 31 days of follow up post last dose of study treatment, where maximum treatment duration was 42 days (maximum up to 73 days); for all-cause mortality: Throughout the study (Day 1 to Day 84)
Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of study drug.
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 | APX001 (Fosmanogepix): Cohort A | Eligible participants aged 18 years or older with invasive mold infections (IMI) and limited antifungal treatment options were included in this arm. On Day 1, participants received APX001 1000 milligram (mg) as a loading dose over 3 hours by intravenous (IV) infusion twice daily (BID). On Days 2 and 3, participants received APX001 600 mg as maintenance dose over 3 hours by IV infusion once daily (QD). From Day 4 till end of study treatment, for maintenance dose participants received either APX001 600 mg IV infusion QD over 3 hours or switched to APX001 800 mg orally QD on investigator discretion. Total treatment duration was maximum of 42 days. Participants had a follow-up visit at 4 weeks after last dose of study treatment and a follow-up telephone call was required on Day 84. | 9 | 21 | 13 | 21 | 21 | 21 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Sudden death | General disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Catheter site infection | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Device related sepsis | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Stenotrophomonas bacteraemia | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Eosinophilia | Blood and lymphatic system disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Euthyroid sick syndrome | Endocrine disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Anal incontinence | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Facial pain | General disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Inflammation | General disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Graft versus host disease | Immune system disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Graft versus host disease in gastrointestinal tract | Immune system disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Graft versus host disease in skin | Immune system disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Bacterial disease carrier | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Colonic abscess | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Enterococcal bacteraemia | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Escherichia bacteraemia | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Moraxella infection | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Pseudomonal sepsis | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA v25.1 | Non-systematic Assessment |
| |
| Febrile nonhaemolytic transfusion reaction | Injury, poisoning and procedural complications | MedDRA v25.1 | Non-systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA v25.1 | Non-systematic Assessment |
| |
| Skin injury | Injury, poisoning and procedural complications | MedDRA v25.1 | Non-systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA v25.1 | Non-systematic Assessment |
| |
| Vascular access site occlusion | Injury, poisoning and procedural complications | MedDRA v25.1 | Non-systematic Assessment |
| |
| Wound haemorrhage | Injury, poisoning and procedural complications | MedDRA v25.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Blood calcium decreased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Blood creatinine decreased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Blood sodium decreased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Drug level fluctuating | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Immunosuppressant drug level decreased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Spleen scan abnormal | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Sarcopenia | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Acute myeloid leukaemia refractory | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v25.1 | Non-systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Taste disorder | Nervous system disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Disorientation | Psychiatric disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Scrotal dermatitis | Reproductive system and breast disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Lung opacity | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Pleural thickening | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Purpura | Skin and subcutaneous tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Subclavian vein thrombosis | Vascular disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Rales | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | Non-systematic Assessment |
|
The Sponsor has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Basilea Pharmaceutica International Ltd, Allschwil | +41 79 701 0551 | marc.engelhardt@basilea.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 14, 2022 | Mar 29, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000072742 | Invasive Fungal Infections |
| D001228 | Aspergillosis |
| D000086382 | COVID-19 |
| D055732 | Pulmonary Aspergillosis |
| D009181 | Mycoses |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D008172 | Lung Diseases, Fungal |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
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