Not provided
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Company decision to discontinue trial
Not provided
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Normal healthy volunteer (NHV) participants will enroll sequentially into a total of 6 escalating dose levels (6 subjects per dose level), randomized to receive a single dose of ARC-521 Injection or placebo. The maximum study duration for NHVs is approximately 21 weeks.
Hepatitis B e Antigen (HBeAg)-negative participants with (CHB) will enroll sequentially into 3 dose levels (8 patients per dose level) to receive multiple doses of open label ARC-521 Injection. For each CHB participant the maximum study duration is approximately 37 weeks.
Phase 1a/1b multicenter dose-escalation study of ARC-521 Injection in normal healthy volunteers and patients with CHB. Eligible participants who have signed an Ethics Committee (EC)/Institutional Review Board (IRB) approved informed consent form and have met all of the protocol eligibility criteria.
Patients will undergo the following evaluations at regular intervals during the study: medical history, physical examinations, vital sign measurements (blood pressure, heart rate, respiratory rate, and temperature), weight, adverse events assessment (AEs), concomitant medications/therapies assessment, electrocardiograms (ECGs), telemetry [NHVs only], measures of hepatic fibrosis [CHBs only], blood sample collection for hematology, coagulation, chemistry, Pharmacokinetics (PK) [NHVs only], metabolic analysis [NHVs only], exploratory Pharmacodynamic (PD) measures, urinalysis, hepatitis B virus (HBV) serology, immunogenicity, Follicle Stimulating Hormone (FSH) testing (post-menopausal females) and pregnancy testing for females of childbearing potential. Clinically significant changes including AEs will be followed until resolution, until the condition stabilizes, until the event is otherwise explained, or until the patient is lost to follow-up. Prior to enrollment there is a 60 day screening period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NHV Participants: Cohort 1 | Experimental | NHV participants administered a single dose of ARC-521 Injection at a dose of 0.6 mg/kg. |
|
| NHV Participants: Cohort 2 | Experimental | NHV participants administered a single dose of ARC-521 Injection at a dose of 1 mg/kg. |
|
| NHV Participants: Cohort 3 | Experimental | NHV participants administered a single dose of ARC-521 Injection at a dose of 2 mg/kg. |
|
| NHV Participants: Cohort 4 | Experimental | NHV participants administered a single dose of ARC-521 Injection at a dose of 4 mg/kg. |
|
| NHV Participants: Cohort 5 | Experimental | NHV participants administered a single dose of ARC-521 Injection at a dose of 5 mg/kg. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARC-521 Injection | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs): Healthy Volunteers | An adverse event (AE) is any untoward medical occurrence which does not necessarily have a causal relationship with this treatment. A serious AE is any AE that: results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is a medically important event or reaction.Events were categorized as mild, moderate or severe. TEAEs were defined as all AEs starting or worsening after commencement of treatment with investigational product. A treatment-related TEAE was one whose relationship to treatment was noted as unlikely, possibly, or probably related. | From first dose of study drug through Day 29 (± 1 day) |
| Number of Participants With TEAEs: CHB Participants | An AE is any untoward medical occurrence which does not necessarily have a causal relationship with this treatment. A serious AE is any AE that: results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is a medically important event or reaction.Events were categorized as mild, moderate or severe. TEAEs were defined as all AEs starting or worsening after commencement of treatment with investigational product. A treatment-related TEAE was one whose relationship to treatment was noted as unlikely, possibly, or probably related. | From first dose of study drug through Day 142 (± 3 days) |
| Pharmacokinetics of ARC-521 Injection: Area Under the Plasma-Concentration-Time Curve From Time 0-24 Hours (AUC0-24), Healthy Volunteers | Through 48 hours post-dose on Day 1 | |
| Pharmacokinetics of ARC-521 Injection: Area Under the Plasma-Concentration-Time Curve From Time 0 to the Last Quantifiable Plasma Concentration (AUClast), Healthy Volunteers | Through 48 hours post-dose on Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Change Over Time in Cytokine Levels After Single and Multiple Doses of ARC-521 Injection | Through 24 hours post-dose (Day 1 for NHVs, and Days 1, 29 & 57 for CHB participants) | |
| Change Over Time in Complement Levels After Single and Multiple Doses of ARC-521 Injection |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site 1 | Grafton | Auckland | 1011 | New Zealand |
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| ID | Title | Description |
|---|---|---|
| FG000 | NHV Participants: Cohort 1 | Normal healthy volunteer (NHV) participants administered a single dose of ARC-521 Injection at a dose of 0.6 mg/kg. |
| FG001 | NHV Participants: Cohort 2 | NHV participants administered a single dose of ARC-521 Injection at a dose of 1 mg/kg. |
| FG002 | NHV Participants: Cohort 3 | NHV participants administered a single dose of ARC-521 Injection at a dose of 2 mg/kg. |
| FG003 | NHV Participants: Cohort 4 | NHV participants administered a single dose of ARC-521 Injection at a dose of 4 mg/kg. |
| FG004 | NHV Participants: Cohort 5 | NHV participants administered a single dose of ARC-521 Injection at a dose of 5 mg/kg. |
| FG005 | NHV Participants: Cohort 6 | NHV participants administered a single dose of ARC-521 Injection at a dose of 6 mg/kg. |
| FG006 | NHV Participants: Placebo | NHV participants administered 0.9% normal saline to match ARC-521 Injection at doses of 0.6, 1, 2, 4, 5 and 6 mg/kg. |
| FG007 | CHB Participants: Cohort 3b | Treatment-naive participants with chronic hepatitis B (CHB) administered 3 doses of ARC-521 Injection at 2 mg/kg once every 4 weeks. Participants are treatment-naive if they have not been on continual nucleoside analog (NUC) therapy (any NUC) for at least 6 months prior to screening (or have never been on NUCs). |
| FG008 | CHB Participants: Cohort 4b | Treatment-naive participants with CHB administered 3 doses of ARC-521 Injection at 4 mg/kg once every 4 weeks. Participants are treatment-naive if they have not been on continual NUC therapy (any NUC) for at least 6 months prior to screening (or have never been on NUCs). |
| FG009 | CHB Participants: Cohort 3c | Participants with CHB currently on NUCs (entecavir or tenofovir for at least 6 months) administered 3 doses of ARC-521 Injection at 2 mg/kg once every 4 weeks. |
| FG010 | CHB Participants: Cohort 4c | Participants with CHB currently on NUCs (entecavir or tenofovir for at least 6 months) administered 3 doses of ARC-521 Injection at 4 mg/kg once every 4 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | NHV Participants: Cohort 1 | NHV participants administered a single dose of ARC-521 Injection at a dose of 0.6 mg/kg. |
| BG001 | NHV Participants: Cohort 2 | NHV participants administered a single dose of ARC-521 Injection at a dose of 1 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 | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs): Healthy Volunteers | An adverse event (AE) is any untoward medical occurrence which does not necessarily have a causal relationship with this treatment. A serious AE is any AE that: results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is a medically important event or reaction.Events were categorized as mild, moderate or severe. TEAEs were defined as all AEs starting or worsening after commencement of treatment with investigational product. A treatment-related TEAE was one whose relationship to treatment was noted as unlikely, possibly, or probably related. | Posted | Count of Participants | Participants | From first dose of study drug through Day 29 (± 1 day) |
|
NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
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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 | NHV Participants: Cohort 1 | NHV participants administered a single dose of ARC-521 Injection at a dose of 0.6 mg/kg. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Transaminases increased | Investigations | MedDRA 19.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
The ARC-521 Injection development program was terminated early for regulatory and business reasons secondary to findings occurring in a non-clinical toxicology study. Program termination was not due to safety findings in humans.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Operating Officer | Arrowhead Pharmaceuticals, Inc. | 626-304-3400 |
Not provided
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D006633 | Histamine Antagonists |
| D000082 | Acetaminophen |
| C413685 | entecavir |
| D000068698 | Tenofovir |
| ID | Term |
|---|---|
| D018494 | Histamine Agents |
| D018377 | Neurotransmitter Agents |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
Not provided
Not provided
Not provided
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| NHV Participants: Cohort 6 | Experimental | NHV participants administered a single dose of ARC-521 Injection at a dose of 6 mg/kg. |
|
| NHV Participants: Placebo | Placebo Comparator | NHV participants administered 0.9% normal saline to match ARC-521 Injection at doses of 0.6, 1, 2, 4, 5 and 6 mg/kg. |
|
| CHB Participants: Cohort 3b | Experimental | Treatment-naive participants with CHB administered 3 doses of ARC-521 Injection at 2 mg/kg once every 4 weeks. Participants are treatment-naive if they have not been on continual nucleoside analog (NUC) therapy (any NUC) for at least 6 months prior to screening (or have never been on NUCs). |
|
| CHB Participants: Cohort 4b | Experimental | Treatment-naive participants with CHB administered 3 doses of ARC-521 Injection at 4 mg/kg once every 4 weeks. Participants are treatment-naive if they have not been on continual NUC therapy (any NUC) for at least 6 months prior to screening (or have never been on NUCs). |
|
| CHB Participants: Cohort 3c | Experimental | Participants with CHB currently on NUCs (entecavir or tenofovir for at least 6 months) administered 3 doses of ARC-521 Injection at 2 mg/kg once every 4 weeks. |
|
| CHB Participants: Cohort 4c | Experimental | Participants with CHB currently on NUCs (entecavir or tenofovir for at least 6 months) administered 3 doses of ARC-521 Injection at 4 mg/kg once every 4 weeks. |
|
| Placebo | Other | 0.9% normal saline |
|
| antihistamine | Drug | Approximately two hours prior to ARC-521 or placebo administration, participants will be pre-treated with an oral antihistamine, selected by the investigator from the list of approved antihistamines that is available in that country. Approved antihistamines are: diphenhydramine 50 mg by mouth (PO), chlorpheniramine 8 mg PO, or hydroxyzine 50 mg PO. |
|
| acetaminophen | Drug | Approximately two hours prior to ARC-521 or placebo administration, participants will be pre-treated with acetaminophen (500 - 1000 mg PO, per local strength availability). |
|
| entecavir | Drug | Participants take entecavir OR tenofovir daily throughout the study. |
|
| tenofovir | Drug | Participants take entecavir OR tenofovir daily throughout the study. |
|
| Pharmacokinetics of ARC-521 Injection: Area Under the Plasma-Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUCinf), Healthy Volunteers | Through 48 hours post-dose on Day 1 |
| Pharmacokinetics of ARC-521 Injection: Maximum Observed Plasma Concentration (Cmax), Healthy Volunteers | Through 48 hours post-dose on Day 1 |
| Pharmacokinetics of ARC-521 Injection: Clearance (CL), Healthy Volunteers | Through 48 hrs post-dose on Day 1 |
| Pharmacokinetics of ARC-521 Injection: Apparent Volume of Distribution (V), Healthy Volunteers | Through 48 hours post-dose on Day 1 |
| Pharmacokinetics of ARC-521 Injection: Terminal Elimination Rate Constant (Kel), Healthy Volunteers | Through 48 hours post-dose on Day 1 |
| Pharmacokinetics of ARC-521 Injection: Terminal Elimination Half-Life (t1/2), Healthy Volunteers | Through 48 hours post-dose on Day 1 |
| Change Over Time in Viral Antigens and DNA in CHB Participants as a Measure of Activity of ARC-521 Injection | Baseline to Day 142 |
| Through 24 hours post-dose (Day 1 for NHVs, and Days 1, 29 & 57 for CHB participants) |
| BG002 | NHV Participants: Cohort 3 | NHV participants administered a single dose of ARC-521 Injection at a dose of 2 mg/kg. |
| BG003 | NHV Participants: Cohort 4 | NHV participants administered a single dose of ARC-521 Injection at a dose of 4 mg/kg. |
| BG004 | NHV Participants: Cohort 5 | NHV participants administered a single dose of ARC-521 Injection at a dose of 5 mg/kg. |
| BG005 | NHV Participants: Cohort 6 | NHV participants administered a single dose of ARC-521 Injection at a dose of 6 mg/kg. |
| BG006 | NHV Participants: Placebo | NHV participants administered 0.9% normal saline to match ARC-521 Injection at doses of 0.6, 1, 2, 4, 5 and 6 mg/kg. |
| BG007 | CHB Participants: Cohort 3b | Treatment-naive participants with CHB administered 3 doses of ARC-521 Injection at 2 mg/kg once every 4 weeks. Participants are treatment-naive if they have not been on continual NUC therapy (any NUC) for at least 6 months prior to screening (or have never been on NUCs). |
| BG008 | CHB Participants: Cohort 4b | Treatment-naive participants with CHB administered 3 doses of ARC-521Injection at 4 mg/kg once every 4 weeks. Participants are treatment-naive if they have not been on continual NUC therapy (any NUC) for at least 6 months prior to screening (or have never been on NUCs). |
| BG009 | CHB Participants: Cohort 3c | Participants with CHB currently on NUCs (entecavir or tenofovir for at least 6 months) administered 3 doses of ARC-521 Injection at 2 mg/kg once every 4 weeks. |
| BG010 | CHB Participants: Cohort 4c | Participants with CHB currently on NUCs (entecavir or tenofovir for at least 6 months) administered 3 doses of ARC-521 Injection at 4 mg/kg once every 4 weeks. |
| BG011 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
NHV participants administered a single dose of ARC-521 Injection at a dose of 0.6 mg/kg.
| OG001 | NHV Participants: Cohort 2 | NHV participants administered a single dose of ARC-521 Injection at a dose of 1 mg/kg. |
| OG002 | NHV Participants: Cohort 3 | NHV participants administered a single dose of ARC-521 Injection at a dose of 2 mg/kg. |
| OG003 | NHV Participants: Cohort 4 | NHV participants administered a single dose of ARC-521 Injection at a dose of 4 mg/kg. |
| OG004 | NHV Participants: Cohort 5 | NHV participants administered a single dose of ARC-521 Injection at a dose of 5 mg/kg. |
| OG005 | NHV Participants: Cohort 6 | NHV participants administered a single dose of ARC-521 Injection at a dose of 6 mg/kg. |
| OG006 | NHV Participants: Placebo | NHV participants administered 0.9% normal saline to match ARC-521 Injection at doses of 0.6, 1, 2, 4, 5 and 6 mg/kg. |
|
|
| Primary | Number of Participants With TEAEs: CHB Participants | An AE is any untoward medical occurrence which does not necessarily have a causal relationship with this treatment. A serious AE is any AE that: results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is a medically important event or reaction.Events were categorized as mild, moderate or severe. TEAEs were defined as all AEs starting or worsening after commencement of treatment with investigational product. A treatment-related TEAE was one whose relationship to treatment was noted as unlikely, possibly, or probably related. | Posted | Count of Participants | Participants | From first dose of study drug through Day 142 (± 3 days) |
|
|
|
| Primary | Pharmacokinetics of ARC-521 Injection: Area Under the Plasma-Concentration-Time Curve From Time 0-24 Hours (AUC0-24), Healthy Volunteers | Analysis was not planned or conducted per statistical analysis plan (SAP) due to study termination. | Posted | Through 48 hours post-dose on Day 1 |
|
|
| Primary | Pharmacokinetics of ARC-521 Injection: Area Under the Plasma-Concentration-Time Curve From Time 0 to the Last Quantifiable Plasma Concentration (AUClast), Healthy Volunteers | Analysis was not planned or conducted per SAP due to study termination. | Posted | Through 48 hours post-dose on Day 1 |
|
|
| Primary | Pharmacokinetics of ARC-521 Injection: Area Under the Plasma-Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUCinf), Healthy Volunteers | Analysis was not planned or conducted per SAP due to study termination. | Posted | Through 48 hours post-dose on Day 1 |
|
|
| Primary | Pharmacokinetics of ARC-521 Injection: Maximum Observed Plasma Concentration (Cmax), Healthy Volunteers | Analysis was not planned or conducted per SAP due to study termination. | Posted | Through 48 hours post-dose on Day 1 |
|
|
| Primary | Pharmacokinetics of ARC-521 Injection: Clearance (CL), Healthy Volunteers | Analysis was not planned or conducted per SAP due to study termination. | Posted | Through 48 hrs post-dose on Day 1 |
|
|
| Primary | Pharmacokinetics of ARC-521 Injection: Apparent Volume of Distribution (V), Healthy Volunteers | Analysis was not planned or conducted per SAP due to study termination. | Posted | Through 48 hours post-dose on Day 1 |
|
|
| Primary | Pharmacokinetics of ARC-521 Injection: Terminal Elimination Rate Constant (Kel), Healthy Volunteers | Analysis was not planned or conducted per SAP due to study termination. | Posted | Through 48 hours post-dose on Day 1 |
|
|
| Primary | Pharmacokinetics of ARC-521 Injection: Terminal Elimination Half-Life (t1/2), Healthy Volunteers | Analysis was not planned or conducted per SAP due to study termination. | Posted | Through 48 hours post-dose on Day 1 |
|
|
| Primary | Change Over Time in Viral Antigens and DNA in CHB Participants as a Measure of Activity of ARC-521 Injection | Analysis was not planned or conducted per SAP due to study termination. | Posted | Baseline to Day 142 |
|
|
| Secondary | Change Over Time in Cytokine Levels After Single and Multiple Doses of ARC-521 Injection | Analysis was not planned or conducted per SAP due to study termination. | Posted | Through 24 hours post-dose (Day 1 for NHVs, and Days 1, 29 & 57 for CHB participants) |
|
|
| Secondary | Change Over Time in Complement Levels After Single and Multiple Doses of ARC-521 Injection | Analysis was not planned or conducted per SAP due to study termination. | Posted | Through 24 hours post-dose (Day 1 for NHVs, and Days 1, 29 & 57 for CHB participants) |
|
|
| 0 |
| 4 |
| 1 |
| 4 |
| EG001 | NHV Participants: Cohort 2 | NHV participants administered a single dose of ARC-521 Injection at a dose of 1 mg/kg. | 0 | 4 | 2 | 4 |
| EG002 | NHV Participants: Cohort 3 | NHV participants administered a single dose of ARC-521 Injection at a dose of 2 mg/kg. | 0 | 4 | 3 | 4 |
| EG003 | NHV Participants: Cohort 4 | NHV participants administered a single dose of ARC-521 Injection at a dose of 4 mg/kg. | 0 | 4 | 4 | 4 |
| EG004 | NHV Participants: Cohort 5 | NHV participants administered a single dose of ARC-521 Injection at a dose of 5 mg/kg. | 0 | 4 | 3 | 4 |
| EG005 | NHV Participants: Cohort 6 | NHV participants administered a single dose of ARC-521 Injection at a dose of 6 mg/kg. | 0 | 4 | 2 | 4 |
| EG006 | NHV Participants: Placebo | NHV participants administered 0.9% normal saline to match ARC-521 Injection at doses of 0.6, 1, 2, 4, 5 and 6 mg/kg. | 0 | 12 | 10 | 12 |
| EG007 | CHB Participants: Cohort 3b | Treatment-naive participants with CHB administered 3 doses of ARC-521 Injection at 2 mg/kg once every 4 weeks. Participants are treatment-naive if they have not been on continual NUC therapy (any NUC) for at least 6 months prior to screening (or have never been on NUCs). | 0 | 4 | 2 | 4 |
| EG008 | CHB Participants: Cohort 4b | Treatment-naive participants with CHB administered 3 doses of ARC-521Injection at 4 mg/kg once every 4 weeks. Participants are treatment-naive if they have not been on continual NUC therapy (any NUC) for at least 6 months prior to screening (or have never been on NUCs). | 1 | 2 | 0 | 2 |
| EG009 | CHB Participants: Cohort 3c | Participants with CHB currently on NUCs (entecavir or tenofovir for at least 6 months) administered 3 doses of ARC-521 Injection at 2 mg/kg once every 4 weeks. | 0 | 4 | 4 | 4 |
| EG010 | CHB Participants: Cohort 4c | Participants with CHB currently on NUCs (entecavir or tenofovir for at least 6 months) administered 3 doses of ARC-521 Injection at 4 mg/kg once every 4 weeks. | 0 | 1 | 1 | 1 |
| Ear deformity acquired | Ear and labyrinth disorders | MedDRA 19.1 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Sensitivity of teeth | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Catheter site bruise | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Catheter site pain | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Catheter site swelling | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Paronychia | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Renal colic | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
Not provided
Not provided
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D020164 | Chemical Actions and Uses |
| D045505 | Physiological Effects of Drugs |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| >/= 1 Serious TEAE |
|
| >/= 1 Related TEAE |
|
| >/= 1 Related Serious TEAE |
|