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| Name | Class |
|---|---|
| Shin Poong Pharmaceutical Co. Ltd. | INDUSTRY |
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The primary trial objective is to determine the clinically effective dose of orally administered pyronaridine/artesunate (Pyramax®, PA) with a 3:1 ratio to treat adults with acute, symptomatic, uncomplicated P. falciparum malaria in South East Asia and Africa. Secondary trial objectives are to determine the safety of once-daily dosing for 3 days of PA and to explore possible ethnic differences in safety or efficacy.
This is a double-blind, multicentre, randomized, parallel group, dose-finding study of the efficacy, safety and tolerability of a once-daily 3-day regimen of PA with a 3:1 weight/weight ratio for patients with acute, symptomatic, uncomplicated P. falciparum malaria. Patients will be recruited from 5 to 7 study sites in endemic regions of South East Asia and Africa and will be randomized to 1 of 3 treatment groups differing in dosage, with 160 patients per group (n-480). Randomization will be balanced within each study site across all 3 study groups in pre-assigned treatment blocks.
The first dose will be administered on Day 0 and patients will remain hospitalized for at least 4 days whilst undertaking the 3-day regimen. Patients will remain near the study site for a minimum of 7 days or once fever and parasite clearance is confirmed (assessed by 3 negative readings of fever and/or slide).
The primary efficacy end point is the cure rate on Day 28 - the proportion of patients with PCR-corrected adequate clinical and parasitological response (ACPR). Despite this Day 28 end point, the relatively long half-life of pyronaridine necessitates follow-up until Day 42. In the case of adverse events reported and unresolved at Day 42, patients will be followed up for a further 30 days, or until resolution of the event.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pyronaridine/artesunate (6:2 mg/kg) | Experimental | pyronaridine tetraphosphate 6 mg/kg and artesunate 2 mg/kg |
|
| pyronaridine/artesunate (9:3 mg/kg) | Experimental | pyronaridine tetraphosphate 9 mg/kg and artesunate 3 mg/kg |
|
| pyronaridine/artesunate (12:4 mg/kg) | Experimental | pyronaridine tetraphsophate 12 mg/kg and artesunate 4 mg/kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pyronaridine/artesunate | Drug | Tablets of fixed dose combination of pyronaridine and artesunate at a ratio of 3:1. The tablets were taken daily for 3 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| PCR-Corrected ACPR at Day 28 | Percentage of subjects with PCR-corrected adequate clinical and parasitological response (ACPR) on Day 28, defined as absence of parasitaemia on Day 28 without the subject's meeting any of the criteria of early treatment failure, late clinical failure, or late parasitological failure | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| PCR-Corrected ACPR at Day 14 | Percentage of subjects with PCR-corrected adequate clinical and parasitological response (ACPR) on Day 14, defined as absence of parasitaemia on Day 14 without the subject's meeting any of the criteria of early treatment failure, late clinical failure, or late parasitological failure | Day 14 |
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Inclusion Criteria:
Male or female patients between the age of 15 and 60 years of age inclusive
Written informed consent, in accordance with local practice, provided by patient and/or parent/guardian/spouse. If the patient is unable to write, witnessed consent is permitted according to local ethical considerations
Absence of severe malnutrition (defined as the weight-for-height being below -3 standard deviations or <70% of the median of the NCHS/WHO normalized reference values)
Weight of between 35 kg and 75 kg inclusive
Presence of acute symptomatic uncomplicated P. falciparum malaria with a diagnosis confirmed by a positive blood smear with asexual forms of P. falciparum only (i.e. no mixed infection) plus history of fever within the previous 24 hours or a measured temperature of ≥37.5°C (depending on method of measurement):
Ability to swallow oral medication
Ability to comply with study visit schedule: patients will be hospitalised for at least 4 days and will be required to remain in the vicinity of the trial site for a minimum of 7 days or until clearance of fever and parasite for at least 24 hours, whichever is the later. The patient is to return to the study site or to make themselves available for all scheduled follow up visits, until discharge at Day 42.
Females must not be pregnant or lactating and be willing to take measures to not become pregnant during the study period
Willingness and ability to comply with the study protocol for the duration of the study
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sornchai Looareesuwan, MD | Hospital of Tropical Diseases, Mahidol University, Bangkok, Thailand | Principal Investigator |
| Duong Socheat, MD | Nat. Centre for Parasitol., Entomol. and Malaria Control, Phnom Penh, Cambodia | Principal Investigator |
| Emiliana Tjitra, PhD | Bethesda Hospital, Tomohon, North Sulawasi, Indonesia | Principal Investigator |
| Kalifa Bojang, MD | MRC Laboratories, Faraffeni, The Gambia | Principal Investigator |
| Patrice Piola, MD | Epicentre, Mbarara, Uganda | Principal Investigator |
| Oumar Gaye, MD | Centre de santé Roi Baudouin, Guediawaye, Senegal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pailin General Hospital | Pailin | Cambodia | ||||
| Bethesday Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23433102 | Derived | Duparc S, Borghini-Fuhrer I, Craft CJ, Arbe-Barnes S, Miller RM, Shin CS, Fleckenstein L. Safety and efficacy of pyronaridine-artesunate in uncomplicated acute malaria: an integrated analysis of individual patient data from six randomized clinical trials. Malar J. 2013 Feb 21;12:70. doi: 10.1186/1475-2875-12-70. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A: Pyronaridine/Artesunate (6:2 mg/kg) | Pyronaridine tetraphosphate 6 mg/kg and artesunate 2 mg/kg Pyronaridine/artesunate: Tablets of fixed dose combination of pyronaridine and artesunate at a ratio of 3:1 |
| FG001 | Group B: Pyronaridine/Artesunate (9:3 mg/kg) | Pyronaridine tetraphosphate 9 mg/kg and artesunate 3 mg/kg Pyronaridine/artesunate: Tablets of fixed dose combination of pyronaridine and artesunate at a ratio of 3:1 |
| FG002 | Group C: Pyronaridine/Artesunate (12:4 mg/kg) | Pyronaridine tetraphsophate 12 mg/kg and artesunate 4 mg/kg Pyronaridine/artesunate: Tablets of fixed dose combination of pyronaridine and artesunate at a ratio of 3:1 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A: Pyronaridine/Artesunate (6:2 mg/kg) | Pyronaridine tetraphosphate 6 mg/kg and artesunate 2 mg/kg Pyronaridine/artesunate: Tablets of fixed dose combination of pyronaridine and artesunate at a ratio of 3:1 |
| BG001 | Group B: Pyronaridine/Artesunate (9:3 mg/kg) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | One subject, who was randomized to the 12+4 mg/kg dose group, did not receive any study medication and was excluded from all populations. |
| 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 | PCR-Corrected ACPR at Day 28 | Percentage of subjects with PCR-corrected adequate clinical and parasitological response (ACPR) on Day 28, defined as absence of parasitaemia on Day 28 without the subject's meeting any of the criteria of early treatment failure, late clinical failure, or late parasitological failure | Subjects meeting the following: completed a full course of study medication and had known efficacy endpoints; no missed dose due to vomiting (except at D0); no concom. medication, except acetaminophen; no concom. disease that could have interfered with treatment outcome; no major protocol violation with respect to entry eligibility criteria. | Posted | Number | 90% Confidence Interval | percentage of subjects | Day 28 |
|
Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
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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 | Group A: Pyronaridine/Artesunate (6:2 mg/kg) | Pyronaridine tetraphosphate 6 mg/kg and artesunate 2 mg/kg Pyronaridine/artesunate: Tablets of fixed dose combination of pyronaridine and artesunate at a ratio of 3:1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure | Cardiac disorders | MedDRA 9.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 9.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephan Duparc, MD, Chief Medical Officer | Medicines for Malaria Venture (MMV) | +41 22 555 0300 | 351 | duparcs@mmv.org |
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| ID | Term |
|---|---|
| D016778 | Malaria, Falciparum |
| D008288 | Malaria |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
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| ID | Term |
|---|---|
| C000712628 | pyronaridine tetraphosphate, artesunate drug combination |
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|
| Parasite Clearance Time |
Parasite clearance time was defined as the time (in hours) from first dosing to the time of first blood draw with parasite clearance. Parasite clearance is defined as zero presence of parasites for two consecutive negative readings eight hours apart, with confirmed negative reading at 24 hours after the first negative slide |
| Thick blood slides were examined every 8 hours until at least 72 hours or until a negative smear was recorded |
| Fever Clearance Time | Fever clearance time was defined as the time (in hours) from first dosing to the first normal reading with fever clearance (2 consecutive assessments without fever (<37.5°C)). The method of temperature measurement was the same (ie, axillary, tympanic, oral or rectal) for each subject. Any subjects with a documented history of fever at inclusion, but who did not subsequently have a documented temperature reading >37.5°C during the 24 hours after initial dosing, were not included in this end point analysis. | Every 8 hours for at least 72 hours after the first dose |
| Parasite Clearance | Parasite clearance is defined as zero presence of parasites for 2 consecutive negative readings 8 hours apart, with confirmed negative reading at 24 hours after the first negative slide. The proportion of subjects with parasite clearance was summarized at Days 1, 2, and 3. | Days 1, 2, and 3 |
| Fever Clearance | Fever clearance was defined as a subject without fever for 2 consecutive assessments, plus confirmed normal temperature at 24 hours. The proportion of subjects with fever clearance was summarized at Days 1, 2, and 3. | Days 1, 2 and 3 |
| Adverse Events (AEs) | An AE was defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study | Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier |
| Tomohon |
| North Sulawesi |
| Indonesia |
| Centre de santé du roi Baudoin | Guédiawaye | Senegal |
| Faculty of Tropical Medicine, Mahidol University | Bangkok | Thailand |
| Farafenni Field Station, c/o MRC Laboratories | Farafenni | The Gambia |
| MSF Epicentre | Mbarara | Uganda |
| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Protocol Violation |
|
| No defiined |
|
Pyronaridine tetraphosphate 9 mg/kg and artesunate 3 mg/kg Pyronaridine/artesunate: Tablets of fixed dose combination of pyronaridine and artesunate at a ratio of 3:1 |
| BG002 | Group C: Pyronaridine/Artesunate (12:4 mg/kg) | Pyronaridine tetraphsophate 12 mg/kg and artesunate 4 mg/kg Pyronaridine/artesunate: Tablets of fixed dose combination of pyronaridine and artesunate at a ratio of 3:1 |
| BG003 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | One subject, who was randomized to the 12+4 mg/kg dose group, did not receive any study medication and was excluded from all populations. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | One subject, who was randomized to the 12+4 mg/kg dose group, did not receive any study medication and was excluded from all populations. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Group B: Pyronaridine/Artesunate (9:3 mg/kg) | Pyronaridine tetraphosphate 9 mg/kg and artesunate 3 mg/kg Pyronaridine/artesunate: Tablets of fixed dose combination of pyronaridine and artesunate at a ratio of 3:1 |
| OG002 | Group C: Pyronaridine/Artesunate (12:4 mg/kg) | Pyronaridine tetraphsophate 12 mg/kg and artesunate 4 mg/kg Pyronaridine/artesunate: Tablets of fixed dose combination of pyronaridine and artesunate at a ratio of 3:1 |
|
|
| Secondary | PCR-Corrected ACPR at Day 14 | Percentage of subjects with PCR-corrected adequate clinical and parasitological response (ACPR) on Day 14, defined as absence of parasitaemia on Day 14 without the subject's meeting any of the criteria of early treatment failure, late clinical failure, or late parasitological failure | Subjects meeting the following: completed a full course of study medication and had known efficacy endpoints; no missed dose due to vomiting (except at D0); no concom. medication, except acetaminophen; no concom. disease that could have interfered with treatment outcome; no major protocol violation with respect to entry eligibility criteria. | Posted | Number | 90% Confidence Interval | percentage of subjects | Day 14 |
|
|
|
| Secondary | Parasite Clearance Time | Parasite clearance time was defined as the time (in hours) from first dosing to the time of first blood draw with parasite clearance. Parasite clearance is defined as zero presence of parasites for two consecutive negative readings eight hours apart, with confirmed negative reading at 24 hours after the first negative slide | Subjects meeting the following: completed a full course of study medication and had known efficacy endpoints; no missed dose due to vomiting (except at D0); no concom. medication, except acetaminophen; no concom. disease that could have interfered with treatment outcome; no major protocol violation with respect to entry eligibility criteria. | Posted | Mean | Standard Deviation | hours | Thick blood slides were examined every 8 hours until at least 72 hours or until a negative smear was recorded |
|
|
|
| Secondary | Fever Clearance Time | Fever clearance time was defined as the time (in hours) from first dosing to the first normal reading with fever clearance (2 consecutive assessments without fever (<37.5°C)). The method of temperature measurement was the same (ie, axillary, tympanic, oral or rectal) for each subject. Any subjects with a documented history of fever at inclusion, but who did not subsequently have a documented temperature reading >37.5°C during the 24 hours after initial dosing, were not included in this end point analysis. | Subjects meeting the following: completed a full course of study medication and had known efficacy endpoints; no missed dose due to vomiting (except at D0); no concom. medication, except acetaminophen; no concom. disease that could have interfered with treatment outcome; no major protocol violation with respect to entry eligibility criteria. | Posted | Mean | Standard Deviation | hours | Every 8 hours for at least 72 hours after the first dose |
|
|
|
| Secondary | Parasite Clearance | Parasite clearance is defined as zero presence of parasites for 2 consecutive negative readings 8 hours apart, with confirmed negative reading at 24 hours after the first negative slide. The proportion of subjects with parasite clearance was summarized at Days 1, 2, and 3. | Subjects meeting the following: completed a full course of study medication and had known efficacy endpoints; no missed dose due to vomiting (except at D0); no concom. medication, except acetaminophen; no concom. disease that could have interfered with treatment outcome; no major protocol violation with respect to entry eligibility criteria. | Posted | Number | 95% Confidence Interval | percentage of subjects | Days 1, 2, and 3 |
|
|
|
| Secondary | Fever Clearance | Fever clearance was defined as a subject without fever for 2 consecutive assessments, plus confirmed normal temperature at 24 hours. The proportion of subjects with fever clearance was summarized at Days 1, 2, and 3. | Subjects meeting the following: completed a full course of study medication and had known efficacy endpoints; no missed dose due to vomiting (except at D0); no concom. medication, except acetaminophen; no concom. disease that could have interfered with treatment outcome; no major protocol violation with respect to entry eligibility criteria. | Posted | Number | 95% Confidence Interval | percentage of subjects | Days 1, 2 and 3 |
|
|
|
| Secondary | Adverse Events (AEs) | An AE was defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study | The safety population includes all subjects who were randomized and received any study medication, regardless of the amount. | Posted | Count of Participants | Participants | Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier |
|
|
|
| 0 |
| 160 |
| 3 |
| 160 |
| 106 |
| 160 |
| EG001 | Group B: Pyronaridine/Artesunate (9:3 mg/kg) | Pyronaridine tetraphosphate 9 mg/kg and artesunate 3 mg/kg Pyronaridine/artesunate: Tablets of fixed dose combination of pyronaridine and artesunate at a ratio of 3:1 | 0 | 157 | 0 | 157 | 90 | 157 |
| EG002 | Group C: Pyronaridine/Artesunate (12:4 mg/kg) | Pyronaridine tetraphsophate 12 mg/kg and artesunate 4 mg/kg Pyronaridine/artesunate: Tablets of fixed dose combination of pyronaridine and artesunate at a ratio of 3:1 | 0 | 159 | 1 | 159 | 91 | 159 |
| Abscess Limb | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Malaria | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA 9.0 | Systematic Assessment |
|
| Abortion incomplete | Pregnancy, puerperium and perinatal conditions | MedDRA 9.0 | Systematic Assessment |
|
| Eosinophilia | Blood and lymphatic system disorders | MedDRA 9.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 9.0 | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA 9.0 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 9.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 9.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Fatigue | Congenital, familial and genetic disorders | MedDRA 9.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Malaria | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Otitis media acute | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Parasitic infection intestinal | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Plasmodium falciparum infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 9.0 | Systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 9.0 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 9.0 | Systematic Assessment |
|
| Eosinophil count increased | Investigations | MedDRA 9.0 | Systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA 9.0 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 9.0 | Systematic Assessment |
|
| Pelvic pain | Reproductive system and breast disorders | MedDRA 9.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Rash | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
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| D000079426 |
| Vector Borne Diseases |
| Male |
|
| Black |
|
| Asian/Oriental |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Clearance rate (%) at Day 2 (48h after first dose) |
|
| Clearance rate (%) at Day 3 (72h after first dose) |
|
| Clearance rate (%) at Day 2 (48h after first dose) |
|
| Clearance rate (%) at Day 3 (72h after first dose) |
|
|
| Nr subj. with ≥1 SAE |
|
| Nr subj. with ≥1 treatment-related SAE |
|
| Nr subj. with ≥1 AE leading to death |
|
| Nr subj. with ≥1 AE leading to study withdrawal |
|