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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| Malaria Research and Training Center, Bamako, Mali | OTHER |
| University of the Sciences, Techniques and Technologies of Bamako | OTHER |
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The purpose of this study is to evaluate the safety and tolerability of a one time SC administration of L9LS in healthy adults in Mali, as well as its protective efficacy against naturally occurring Plasmodium falciparum (Pf) infection over a 6-month malaria season. A secondary objective is to determine if SC administration of L9LS at 900 mg (compared to placebo) mediates protection against naturally occurring Pf infection in healthy Malian adult females stratified by weight during a single malaria season.
A phase 2 trial evaluating the safety and tolerability of a one time subcutaneous (SC) administration of L9LS, as well its protective efficacy against naturally occurring Pf infection over a 6-month malaria season. The primary study hypotheses is that L9LS will be safe and protective against malaria infection. As a secondary objective, the efficacy of L9LS within three body weight strata among female participants will each be compared to placebo. Before study agent administration, all subjects will be given artemether lumefantrine to clear any preexisting Pf blood stage infection.
The study is a randomized, double-blind, placebo-controlled, sex-stratified (2:1 female to male ratio) and weight-stratified trial (N=288 total) with 2 treatment arms: L9LS 900 mg SC (n=216) and placebo (n=72) to assess safety and protective efficacy of L9LS compared to placebo.
Subjects will receive the study agent and be followed at study visits 1, 3, 7, 14, 21, and 28 days later, and once every 2 weeks thereafter through 24 weeks. Primary study assessments include physical examination and blood collection for identification of Pf infection and other research laboratory evaluations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| L9LS 900 mg | Experimental | Adult participants receive a single dose of L9LS 900 mg subcutaneously. |
|
| Placebo | Placebo Comparator | Adult participants receive a single dose of Placebo subcutaneously. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L9LS (VRC-MALMAB0114-00-AB) | Biological | Administered one time via subcutaneous route. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Local Adverse Events (AEs) | Number of participants with local adverse events occurring within 7 days after administration of L9LS. Local reactogenicity included pain/tenderness, swelling, redness, bruising, and pruritus at the site of infusion. Adverse events were captured by Investigator examination and history from participants. | Within 7 days after administration of intervention |
| Number of Participants With Systemic Adverse Events (AEs) | Number of participants with local adverse events occurring within 7 days after administration of L9LS. Systemic reactogenicity events included fever, feeling unusually tired or unwell, muscle aches, headache, chills, nausea, and joint pain. Adverse events were captured by Investigator examination and history from participants. | Within 7 days after administration of intervention |
| Number of Participants With Local Adverse Events (AEs) (by Grade) | The severity of local AEs was graded using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Clinical Trials Grade 1: Pain = does not interfere with activity; Tenderness = mild discomfort to touch; Erythema/Redness = 2.5-5 cm; Induration/Swelling = 2.5-5 cm and does not interfere with activity. Grade 2: Pain = Repeated use of non-narcotic pain reliever > 24 hours or interferes with daily activity; Tenderness= Discomfort with movement; Erythema/Redness = 5.1-10 cm; Induration/Swelling = 5.1-10 cm and interferes with activity. Grade 3: Pain = Any use of narcotic pain reliever or prevents daily activity; Tenderness = Significant discomfort at rest; Erythema/Redness = > 10 cm; Induration/Swelling = > 10 cm or prevents daily activity. Grade 4: Pain = Emergency room (ER) visit or hospitalization; Tenderness = ER visit or hospitalization; Erythema/Redness = Necrosis or exfoliative dermatitis; induration/Swelling = Necrosis Grade 5: Death | Within 7 days after administration of intervention |
| Number of Participants With Systemic Adverse Events (AEs) (by Grade) |
| Measure | Description | Time Frame |
|---|---|---|
| Participants With Plasmodium Falciparum (Pf) Infection Detected by Real-Time Polymerase Chain Reaction (RT-PCR) | Number of participants with Plasmodium falciparum (Pf) blood stage infection defined as blood sample positive for Pf was assessed by real-time polymerase chain reaction (RT-PCR) of blood sample collected from participants from day 7 through week 24 (168 days) after administration of L9LS or placebo. Sample was collected every two weeks from day seven until week 24. Analysis was done as number of participants who had at least one positive blood sample. |
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Inclusion Criteria:
Females aged ≥18 and ≤49 years and weighing ≥ 45.0 and ≤ 90.0 kg.
Males aged ≥18 and ≤55 years and weighing ≥ 50.0 and ≤ 100.0 kg.
Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
In good general health and without clinically significant medical history.
Able to provide informed consent.
Willing to have blood samples and data stored for future research.
Resides in or near Kalifabougou, Faladje, or Torodo, Mali, and available for the duration of the study.
Females of childbearing potential must be willing to use reliable contraception from 21 days prior to study day 0 through the final study visit as described below.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kassoum Kayentao, MD, MPH, PhD | Faculté de Médecine Pharmacie d'Odontostomatologie (FMPOS) | Principal Investigator |
| Peter Crompton, MD, MPH | National Institutes of Health (NIH) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faladje MRTC Clinic | Faladiè | Koulikoro | Mali | |||
| Kalifabougou MRTC Clinic |
Human data generated in this study for future research will be shared as follows:
Data will be shared at the time of publication or shortly thereafter.
Data from this study may be requested from other researchers indefinitely after the completion of the primary endpoint by contacting Laboratory of Immunogenetics at NIH
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490 participants were consented:
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| ID | Title | Description |
|---|---|---|
| FG000 | L9LS 900 mg | Adult participants receive a single dose of L9LS 900 mg subcutaneously. |
| FG001 | Placebo | Adult participants receive a single dose of Placebo subcutaneously. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | L9LS 900 mg | Adult participants receive a single dose of L9LS 900 mg subcutaneously. |
| BG001 | Placebo | Adult participants receive a single dose of Placebo subcutaneously. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of 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 | Number of Participants With Local Adverse Events (AEs) | Number of participants with local adverse events occurring within 7 days after administration of L9LS. Local reactogenicity included pain/tenderness, swelling, redness, bruising, and pruritus at the site of infusion. Adverse events were captured by Investigator examination and history from participants. | All participants who received study intervention. | Posted | Count of Participants | Participants | Within 7 days after administration of intervention |
|
Up to 24 weeks from administration of intervention
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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 | L9LS 900 mg | Adult participants receive a single dose of L9LS 900 mg subcutaneously. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | MedDRA version 26 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA version 26 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Peter D Crompton | National Institute of Allergy and Infectious Diseases (NIAID) | 301-761-5042 | pcrompton@niaid.nih.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 14, 2024 | Jan 13, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008288 | Malaria |
| D016778 | Malaria, Falciparum |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
Not provided
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| University of Washington |
| OTHER |
| Harvard School of Public Health (HSPH) | OTHER |
| Indiana University | OTHER |
Not provided
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| Placebo |
| Other |
Normal saline administered one time via subcutaneous route. |
|
The severity of systemic adverse events occurring after the administration of L9LS was assessed using the grading scale below:
Grade 1: Fever = 37.5^oC-37.9^oC; Fatigue, Headache, Myalgia = No interference with activity; Nausea = no interference with activity or 1-2 episodes/hour
Grade 2: Fever = 38^oC-38.4^oC; Fatigue, Myalgia = Some interference with activity; Headache = Repeated use of non-narcotic pain reliever > 24 hours or some interference with activity; Nausea = Some interference with activity or > 2 episodes/24 hours
Grade 3: Fever = 38.5^oC-39.5^oC; Fatigue = Prevents daily activity; Headache =Significant; any use of narcotic pain reliever or prevents daily activity; Myalgia =Significant; prevents daily activity; Nausea = Prevents daily activity, requires outpatient intravenous hydration
Grade 4: Fever = > 39.5^oC; Fatigue, Headache, Myalgia = Emergency room (ER) visit or hospitalization; Nausea = ER visit or hospitalization for hypotensive shock
Grade 5: Death
| Within 7 days after administration of intervention |
| Participants With Plasmodium Falciparum (Pf) Infection Detected by Microscopic Examination for Thick Blood Smear | Number of participants with Plasmodium falciparum (Pf) blood stage infection defined as blood smear-positive for Pf was assessed by microscopic examination of thick blood smear collected from participants from day 7 through week 24 (168 days) after administration of L9LS or placebo. Sample was collected every two weeks from day seven until week 24. Analysis was done as number of participants who had at least one positive blood smear. | Day 7 through week 24 |
| Day 7 through week 24 |
| Maximum Total Plasma Concentration (Cmax) for L9LS | Maximum total plasma concentration (Cmax) following a 900 mg dose of L9LS. Serum collected on days 0, 1, 7, 14, 28, 56, 84, 112, 140, & 168 after the administration of L9LS. Cmax for L9LS was obtained directly by visual inspection of the plasma concentration versus time profiles postdose. Analysis was done to determine each participant's observed maximum concentration based on all available timepoints and cumulative output was calculated as the central tendency and dispersion metric based on the observed maximum concentrations. | Measure through week 24 |
| Time to Maximum Plasma Concentration (TMax) for L9LS - Hours | Time to maximum total plasma concentration (Cmax) following a 900 mg dose of L9LS on day 7 post administration of drug. Tmax for L9LS was obtained directly by visual inspection of the plasma concentration versus time profiles. Analysis was done to determine the time (in hours) at which the maximum observed concentration was achieved for each participant and cumulative output was calculated as the central tendency and dispersion metric based on the observed time of maximum concentration. | Day 7 post administration of drug |
| Time to Maximum Plasma Concentration (TMax) for L9LS - Days | Time to maximum total plasma concentration (Cmax) following a 900 mg dose of L9LS. Serum collected on days 0, 1, 7, 14, 28, 56, 84, 112, 140, & 168 after the administration of L9LS. Tmax for L9LS was obtained directly by visual inspection of the plasma concentration versus time profiles. Analysis was done to determine the time (in days) at which the maximum observed concentration was achieved for each participant and cumulative output was calculated as the central tendency and dispersion metric based on the observed time of maximum concentration. | Measure through week 24 |
| Kalifabougou |
| Koulikoro |
| Mali |
| Torodo MRTC Clinic | Torodo | Koulikoro | Mali |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Number of Participants With Systemic Adverse Events (AEs) | Number of participants with local adverse events occurring within 7 days after administration of L9LS. Systemic reactogenicity events included fever, feeling unusually tired or unwell, muscle aches, headache, chills, nausea, and joint pain. Adverse events were captured by Investigator examination and history from participants. | All participants who received study intervention. | Posted | Count of Participants | Participants | Within 7 days after administration of intervention |
|
|
|
| Primary | Number of Participants With Local Adverse Events (AEs) (by Grade) | The severity of local AEs was graded using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Clinical Trials Grade 1: Pain = does not interfere with activity; Tenderness = mild discomfort to touch; Erythema/Redness = 2.5-5 cm; Induration/Swelling = 2.5-5 cm and does not interfere with activity. Grade 2: Pain = Repeated use of non-narcotic pain reliever > 24 hours or interferes with daily activity; Tenderness= Discomfort with movement; Erythema/Redness = 5.1-10 cm; Induration/Swelling = 5.1-10 cm and interferes with activity. Grade 3: Pain = Any use of narcotic pain reliever or prevents daily activity; Tenderness = Significant discomfort at rest; Erythema/Redness = > 10 cm; Induration/Swelling = > 10 cm or prevents daily activity. Grade 4: Pain = Emergency room (ER) visit or hospitalization; Tenderness = ER visit or hospitalization; Erythema/Redness = Necrosis or exfoliative dermatitis; induration/Swelling = Necrosis Grade 5: Death | All participants who received study intervention. | Posted | Count of Participants | Participants | Within 7 days after administration of intervention |
|
|
|
| Primary | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | The severity of systemic adverse events occurring after the administration of L9LS was assessed using the grading scale below: Grade 1: Fever = 37.5^oC-37.9^oC; Fatigue, Headache, Myalgia = No interference with activity; Nausea = no interference with activity or 1-2 episodes/hour Grade 2: Fever = 38^oC-38.4^oC; Fatigue, Myalgia = Some interference with activity; Headache = Repeated use of non-narcotic pain reliever > 24 hours or some interference with activity; Nausea = Some interference with activity or > 2 episodes/24 hours Grade 3: Fever = 38.5^oC-39.5^oC; Fatigue = Prevents daily activity; Headache =Significant; any use of narcotic pain reliever or prevents daily activity; Myalgia =Significant; prevents daily activity; Nausea = Prevents daily activity, requires outpatient intravenous hydration Grade 4: Fever = > 39.5^oC; Fatigue, Headache, Myalgia = Emergency room (ER) visit or hospitalization; Nausea = ER visit or hospitalization for hypotensive shock Grade 5: Death | All participants who received study intervention. | Posted | Count of Participants | Participants | Within 7 days after administration of intervention |
|
|
|
| Primary | Participants With Plasmodium Falciparum (Pf) Infection Detected by Microscopic Examination for Thick Blood Smear | Number of participants with Plasmodium falciparum (Pf) blood stage infection defined as blood smear-positive for Pf was assessed by microscopic examination of thick blood smear collected from participants from day 7 through week 24 (168 days) after administration of L9LS or placebo. Sample was collected every two weeks from day seven until week 24. Analysis was done as number of participants who had at least one positive blood smear. | All participants who received study intervention. | Posted | Count of Participants | Participants | Day 7 through week 24 |
|
|
|
| Secondary | Participants With Plasmodium Falciparum (Pf) Infection Detected by Real-Time Polymerase Chain Reaction (RT-PCR) | Number of participants with Plasmodium falciparum (Pf) blood stage infection defined as blood sample positive for Pf was assessed by real-time polymerase chain reaction (RT-PCR) of blood sample collected from participants from day 7 through week 24 (168 days) after administration of L9LS or placebo. Sample was collected every two weeks from day seven until week 24. Analysis was done as number of participants who had at least one positive blood sample. | All participants who received study intervention. | Posted | Count of Participants | Participants | Day 7 through week 24 |
|
|
|
| Secondary | Maximum Total Plasma Concentration (Cmax) for L9LS | Maximum total plasma concentration (Cmax) following a 900 mg dose of L9LS. Serum collected on days 0, 1, 7, 14, 28, 56, 84, 112, 140, & 168 after the administration of L9LS. Cmax for L9LS was obtained directly by visual inspection of the plasma concentration versus time profiles postdose. Analysis was done to determine each participant's observed maximum concentration based on all available timepoints and cumulative output was calculated as the central tendency and dispersion metric based on the observed maximum concentrations. | Per protocol document, measure apply to participants who received L9LS | Posted | Mean | Standard Deviation | ug/mL | Measure through week 24 |
|
|
|
| Secondary | Time to Maximum Plasma Concentration (TMax) for L9LS - Hours | Time to maximum total plasma concentration (Cmax) following a 900 mg dose of L9LS on day 7 post administration of drug. Tmax for L9LS was obtained directly by visual inspection of the plasma concentration versus time profiles. Analysis was done to determine the time (in hours) at which the maximum observed concentration was achieved for each participant and cumulative output was calculated as the central tendency and dispersion metric based on the observed time of maximum concentration. | Per protocol document, measure apply to participants who received L9LS. | Posted | Mean | Standard Deviation | Hours | Day 7 post administration of drug |
|
|
|
| Secondary | Time to Maximum Plasma Concentration (TMax) for L9LS - Days | Time to maximum total plasma concentration (Cmax) following a 900 mg dose of L9LS. Serum collected on days 0, 1, 7, 14, 28, 56, 84, 112, 140, & 168 after the administration of L9LS. Tmax for L9LS was obtained directly by visual inspection of the plasma concentration versus time profiles. Analysis was done to determine the time (in days) at which the maximum observed concentration was achieved for each participant and cumulative output was calculated as the central tendency and dispersion metric based on the observed time of maximum concentration. | Per protocol document, measure apply to participants who received L9LS. | Posted | Mean | Standard Deviation | Days | Measure through week 24 |
|
|
|
| 0 |
| 217 |
| 0 |
| 217 |
| 192 |
| 217 |
| EG001 | Placebo | Adult participants receive a single dose of Placebo subcutaneously. | 0 | 71 | 1 | 71 | 57 | 71 |
| Leukopenia | Blood and lymphatic system disorders | MedDRA version 26 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA version 26 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA version 26 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA version 26 | Systematic Assessment |
|
| Ear Pain | Ear and labyrinth disorders | MedDRA version 26 | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA version 26 | Systematic Assessment |
|
| Dental Caries | Gastrointestinal disorders | MedDRA version 26 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA version 26 | Systematic Assessment |
|
| Food Poisoning | Gastrointestinal disorders | MedDRA version 26 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA version 26 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA version 26 | Systematic Assessment |
|
| Inguinal Hernia | Gastrointestinal disorders | MedDRA version 26 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA version 26 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA version 26 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA version 26 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA version 26 | Systematic Assessment |
|
| Chest Pain | General disorders | MedDRA version 26 | Systematic Assessment |
|
| Chills | General disorders | MedDRA version 26 | Systematic Assessment |
|
| Injection Site Swelling | General disorders | MedDRA version 26 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA version 26 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA version 26 | Systematic Assessment |
|
| Dysentery | Infections and infestations | MedDRA version 26 | Systematic Assessment |
|
| Furuncle | Infections and infestations | MedDRA version 26 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA version 26 | Systematic Assessment |
|
| Genital Infection | Infections and infestations | MedDRA version 26 | Systematic Assessment |
|
| Genitourinary Tract Infection | Infections and infestations | MedDRA version 26 | Systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA version 26 | Systematic Assessment |
|
| Malaria | Infections and infestations | MedDRA version 26 | Systematic Assessment |
|
| Mastitis | Infections and infestations | MedDRA version 26 | Systematic Assessment |
|
| Paronychia | Infections and infestations | MedDRA version 26 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA version 26 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA version 26 | Systematic Assessment |
|
| Salmonellosis | Infections and infestations | MedDRA version 26 | Systematic Assessment |
|
| Tinea Infection | Infections and infestations | MedDRA version 26 | Systematic Assessment |
|
| Tinea Pedis | Infections and infestations | MedDRA version 26 | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA version 26 | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA version 26 | Systematic Assessment |
|
| Joint Dislocation | Injury, poisoning and procedural complications | MedDRA version 26 | Systematic Assessment |
|
| Limb Injury | Injury, poisoning and procedural complications | MedDRA version 26 | Systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA version 26 | Systematic Assessment |
|
| Alanine Aminotransferase Increased | Investigations | MedDRA version 26 | Systematic Assessment |
|
| Blood Creatinine Increased | Investigations | MedDRA version 26 | Systematic Assessment |
|
| Blood Pressure Diastolic Decreased | Investigations | MedDRA version 26 | Systematic Assessment |
|
| Blood Pressure Diastolic Increased | Investigations | MedDRA version 26 | Systematic Assessment |
|
| Blood Pressure Increased | Investigations | MedDRA version 26 | Systematic Assessment |
|
| Blood Pressure Systolic Increased | Investigations | MedDRA version 26 | Systematic Assessment |
|
| Haemoglobin Decreased | Investigations | MedDRA version 26 | Systematic Assessment |
|
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA version 26 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 26 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA version 26 | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA version 26 | Systematic Assessment |
|
| Joint Swelling | Musculoskeletal and connective tissue disorders | MedDRA version 26 | Systematic Assessment |
|
| Torticollis | Musculoskeletal and connective tissue disorders | MedDRA version 26 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA version 26 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA version 26 | Systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA version 26 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA version 26 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA version 26 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA version 26 | Systematic Assessment |
|
| Menorrhagia | Reproductive system and breast disorders | MedDRA version 26 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 26 | Systematic Assessment |
|
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA version 26 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 26 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA version 26 | Systematic Assessment |
|
| Dermatitis Contact | Skin and subcutaneous tissue disorders | MedDRA version 26 | Systematic Assessment |
|
| Dermatosis | Skin and subcutaneous tissue disorders | MedDRA version 26 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 26 | Systematic Assessment |
|
| Tooth Extraction | Surgical and medical procedures | MedDRA version 26 | Systematic Assessment |
|
Not provided
Not provided
| D000079426 |
| Vector Borne Diseases |
| Muscle aches |
|
| Headache |
|
| Chills |
|
| Nausea |
|
| Joint pain |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 5 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 5 |
|