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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-002472-39 | EudraCT Number |
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| Name | Class |
|---|---|
| Syneos Health | OTHER |
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This is a Phase 1, randomized, double-blind, placebo-controlled single and multiple ascending dose study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of ALXN1820 administered subcutaneously (SC) (ALXN1820 SC) and intravenously (IV) (ALXN1820 IV).
This study will include up to 10 different dosing cohorts, with each cohort consisting of 2 groups (ALXN1820 group, placebo group). Participants will be randomly assigned in a 3:1 ratio to each of these 2 groups, respectively, within all 10 cohorts, to receive either a single or multiple doses of ALXN1820 SC, a single dose of ALXN1820 IV, or a single or multiple doses of placebo.
The study will be conducted in healthy adult participants and will also include a multiple SC dose cohort in healthy participants of Japanese descent.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALXN1820 | Experimental | Participants will receive ALXN1820 SC or ALXN1820 IV according to their assigned cohort. ALXN1820 SC will be evaluated in single and multiple ascending doses while ALXN1820 IV will be evaluated in a single dose cohort only. |
|
| Placebo | Placebo Comparator | Participants will receive Placebo SC or Placebo IV according to their assigned cohort. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALXN1820 SC | Drug | ALXN1820 SC will be administered as a manual SC push or SC infusion via a syringe pump. Doses will range from 12.5 milligrams (mg) to a maximum of 2250 mg. Multiple dosing duration will range from 3 to 5 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-related Adverse Events (TEAEs) For ALXN1820 SC And ALXN1820 IV | An adverse event (AE) was defined as any unfavorable and unintended sign (for example, including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or procedure, whether or not considered related to the medicinal product or procedure, which occurred during the course of the clinical study. TEAEs were defined as any AEs that commenced after the start of administration of study intervention. Serious AEs (SAEs) were defined as any untoward medical occurrence that met at least 1 of the following serious criteria: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, other medically important serious event. A summary of all SAEs and Other AEs (nonserious) regardless of causality is located in the 'Reported AEs' Section. | Cohorts 1 to 6: Baseline up to Day 127; Cohorts 8 to 9: Baseline up to Day 155 |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under The Concentration-time Curve (AUC) From Time 0 (Dosing) To Time Infinity (AUC0-inf) And AUC During The Dosing Interval (AUCtau) of Serum ALXN1820 For Single Dose Cohorts | Up to 126 days following the first day of dosing | |
| Area Under The Concentration-time Curve During The Dosing Interval (AUCtau) Of Serum ALXN1820 For Multiple Dose Cohorts |
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Inclusion Criteria:
Body weight 50 to 100 kilograms (kg); body mass index 17 to 32 kg/meter squared.
Cohort 9 only: Japanese participants (defined as those participants whose parents and grandparents are both Japanese and who have spent less than 5 years outside of Japan).
Satisfactory medical assessment.
Must follow protocol-specified contraception guidance while on treatment and for up to 6 months after last dose.
Vaccination requirement:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Herston | 4006 | Australia | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40134111 | Derived | Sandhu A, Shen T, Herrero PM, Yuan CX, Qureshi S, Jiang X, Sheng Y, Gasteyger C, Dai Y. Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of ALXN1820 (Tarperprumig) in Healthy Adults: Results of a Phase I Study. Clin Transl Sci. 2025 Apr;18(4):e70190. doi: 10.1111/cts.70190. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: ALXN1820 12.5 mg SC | Healthy participants received a single dose of ALXN1820 12.5 mg subcutaneous (SC) injection on Day 1. |
| FG001 | Cohort 2: ALXN1820 50 mg SC | Healthy participants received a single dose of ALXN1820 50 mg SC injection on Day 1. |
| FG002 | Cohort 3: ALXN1820 150 mg SC | Healthy participants received a single dose of ALXN1820 150 mg SC injection on Day 1. |
| FG003 | Cohort 4: ALXN1820 450 mg SC | Healthy participants received a single dose of ALXN1820 450 mg SC injection on Day 1. |
| FG004 | Cohort 5: ALXN1820 450 mg IV | Healthy participants received a single dose of ALXN1820 450 mg intravenous (IV) infusion on Day 1. |
| FG005 | Cohort 6: ALXN1820 1200 mg SC | Healthy participants received a single dose of ALXN1820 1200 mg SC injection on Day 1. |
| FG006 | Cohort 8: ALXN1820 150 mg SC (QW*5) | Healthy participants received multiple doses of ALXN1820 150 mg SC injection once weekly (QW) for 5 weeks. |
| FG007 | Cohort 9: ALXN1820 150 mg SC (QW*5) | Healthy Japanese participants received multiple doses of ALXN1820 150 mg SC injection once weekly for 5 weeks. |
| FG008 | All Placebo | Healthy participants received placebo matched to ALXN1820 SC injection or IV infusion. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The Safety Set included all participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: ALXN1820 12.5 mg SC | Healthy participants received a single dose of ALXN1820 12.5 mg SC injection on Day 1. |
| BG001 | Cohort 2: ALXN1820 50 mg SC | Healthy participants received a single dose of ALXN1820 50 mg SC injection on Day 1. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 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 Treatment-related Adverse Events (TEAEs) For ALXN1820 SC And ALXN1820 IV | An adverse event (AE) was defined as any unfavorable and unintended sign (for example, including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or procedure, whether or not considered related to the medicinal product or procedure, which occurred during the course of the clinical study. TEAEs were defined as any AEs that commenced after the start of administration of study intervention. Serious AEs (SAEs) were defined as any untoward medical occurrence that met at least 1 of the following serious criteria: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, other medically important serious event. A summary of all SAEs and Other AEs (nonserious) regardless of causality is located in the 'Reported AEs' Section. | The Safety Set included all participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Cohorts 1 to 6: Baseline up to Day 127; Cohorts 8 to 9: Baseline up to Day 155 |
Baseline up to Day 155
The Safety Set included all participants who received at least 1 dose of study drug.
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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 | Cohort 1: ALXN1820 12.5 mg SC | Healthy participants received a single dose of ALXN1820 12.5 mg SC injection on Day 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alexion Pharmaceuticals, Inc. | Alexion Pharmaceuticals, Inc. | +1-855-752-2356 | clinicaltrials@alexion.com |
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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 | Jul 6, 2021 | Aug 28, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 28, 2022 | Aug 28, 2023 | SAP_001.pdf |
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| ALXN1820 IV | Drug | ALXN1820 IV (450 mg) will be administered as an IV infusion. |
|
| Placebo SC | Drug | Placebo SC will be administered as a manual SC push or SC infusion via a syringe pump. |
|
| Placebo IV | Drug | Placebo IV will be administered as an IV infusion. |
|
| Up to 154 days following the first day of dosing |
| Maximum Observed Serum Concentration (Cmax) Of Serum ALXN1820 For Single Dose Cohorts | Up to 126 days following the first day of dosing |
| Maximum Observed Serum Concentration (Cmax) Of Serum ALXN1820 For Multiple Dose Cohorts | Up to 154 days following the first day of dosing |
| Change From Baseline in Serum Concentrations Of Total Properdin For ALXN1820 SC And ALXN1820 IV-Single Dose Cohorts | Baseline, Day 127 |
| Change From Baseline in Serum Concentrations Of Free Properdin For ALXN1820 SC And ALXN1820 IV-Single Dose Cohorts | Baseline, Day 127 |
| Change From Baseline In Serum Concentrations of Total Properdin For ALXN1820 SC- Multiple Dose Cohorts | Baseline, Day 155 |
| Change From Baseline In Serum Concentrations of Free Properdin For ALXN1820 SC- Multiple Dose Cohorts | Baseline, Day 155 |
| Change From Baseline In Complement Alternative Pathway (CAP) Activity Using The Wieslab Alternative Pathway (AP) Assay For ALXN1820 SC And ALXN1820 IV-Single Dose Cohorts | Baseline, Day 127 |
| Change From Baseline In Complement Alternative Pathway Activity Using The Wieslab Alternative Pathway Assay For ALXN1820 SC- Multiple Dose Cohorts | Baseline, Day 155 |
| Number Of Participants With Positive Antidrug Antibodies (ADAs) To ALXN1820 SC And ALXN1820 IV | Baseline up to Day 155 |
| Absolute Bioavailability Of ALXN1820 SC | The absolute bioavailability was expressed as ratio and was calculated as the geometric mean for the AUC[0-inf] for SC divided by the geometric mean for the AUC[0-inf] for IV. Least square means were calculated with cohort, treatment, and sequence as the fixed effects, and participant-participant (sequence) as a random effect. | Baseline up to Day 127 |
| London |
| SE1 1YR |
| United Kingdom |
| Research Site | London | SE5 9RS | United Kingdom |
| Other |
|
| Lost to Follow-up |
|
| Adverse Event |
|
| BG002 | Cohort 3: ALXN1820 150 mg SC | Healthy participants received a single dose of ALXN1820 150 mg SC injection on Day 1. |
| BG003 | Cohort 4: ALXN1820 450 mg SC | Healthy participants received a single dose of ALXN1820 450 mg SC injection on Day 1. |
| BG004 | Cohort 5: ALXN1820 450 mg IV | Healthy participants received a single dose of ALXN1820 450 mg IV infusion on Day 1. |
| BG005 | Cohort 6: ALXN1820 1200 mg SC | Healthy participants received a single dose of ALXN1820 1200 mg SC injection on Day 1. |
| BG006 | Cohort 8: ALXN1820 150 mg SC (QW*5) | Healthy participants received multiple doses of ALXN1820 150 mg SC injection once weekly for 5 weeks. |
| BG007 | Cohort 9: ALXN1820 150 mg SC (QW*5) | Healthy Japanese participants received multiple doses of ALXN1820 150 mg SC injection once weekly for 5 weeks. |
| BG008 | All Placebo | Healthy participants received placebo matched to ALXN1820 SC injection or IV infusion. |
| BG009 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Cohort 1: ALXN1820 12.5 mg SC | Healthy participants received a single dose of ALXN1820 12.5 mg SC injection on Day 1. |
| OG001 | Cohort 2: ALXN1820 50 mg SC | Healthy participants received a single dose of ALXN1820 50 mg SC injection on Day 1. |
| OG002 | Cohort 3: ALXN1820 150 mg SC | Healthy participants received a single dose of ALXN1820 150 mg SC injection on Day 1. |
| OG003 | Cohort 4: ALXN1820 450 mg SC | Healthy participants received a single dose of ALXN1820 450 mg SC injection on Day 1. |
| OG004 | Cohort 5: ALXN1820 450 mg IV | Healthy participants received a single dose of ALXN1820 450 mg IV infusion on Day 1. |
| OG005 | Cohort 6: ALXN1820 1200 mg SC | Healthy participants received a single dose of ALXN1820 1200 mg SC injection on Day 1. |
| OG006 | Cohort 8: ALXN1820 150 mg SC (QW*5) | Healthy participants received multiple doses of ALXN1820 150 mg SC injection once weekly for 5 weeks. |
| OG007 | Cohort 9: ALXN1820 150 mg SC (QW*5) | Healthy Japanese participants received multiple doses of ALXN1820 150 mg SC injection once weekly for 5 weeks. |
| OG008 | All Placebo | Healthy participants received placebo matched to ALXN1820 SC injection or IV infusion. |
|
|
| Secondary | Area Under The Concentration-time Curve (AUC) From Time 0 (Dosing) To Time Infinity (AUC0-inf) And AUC During The Dosing Interval (AUCtau) of Serum ALXN1820 For Single Dose Cohorts | The Pharmacokinetic (PK) Set included all participants who received at least 1 dose of study drug and had at least 1 post-dose PK concentration measured. As per pre-specified analysis, only data for Cohorts 1-6 were collected for this Outcome Measure. Here, number analyzed (n) signifies those participants who were evaluable at specified categories. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours*micrograms/milliliters | Up to 126 days following the first day of dosing |
|
|
|
| Secondary | Area Under The Concentration-time Curve During The Dosing Interval (AUCtau) Of Serum ALXN1820 For Multiple Dose Cohorts | The Pharmacokinetic Set included all participants who received at least 1 dose of study drug and had at least 1 post-dose PK concentration measured. Here, Number of participants analyzed signifies those who were evaluable for this outcome measure. As per pre-specified analysis, only data for Cohorts 8 and 9 were collected for this Outcome Measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours*micrograms/milliliters | Up to 154 days following the first day of dosing |
|
|
|
| Secondary | Maximum Observed Serum Concentration (Cmax) Of Serum ALXN1820 For Single Dose Cohorts | The Pharmacokinetic Set included all participants who received at least 1 dose of study drug and had at least 1 post-dose PK concentration measured. As per pre-specified analysis, only data for Cohorts 1-6 were collected for this Outcome Measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms/milliliters | Up to 126 days following the first day of dosing |
|
|
|
| Secondary | Maximum Observed Serum Concentration (Cmax) Of Serum ALXN1820 For Multiple Dose Cohorts | The Pharmacokinetic Set included all participants who received at least 1 dose of study drug and had at least 1 post-dose PK concentration measured. Here, Number of participants analyzed signifies those who were evaluable for this outcome measure. As per pre-specified analysis, only data for Cohorts 8 and 9 were collected for this Outcome Measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms/milliliters | Up to 154 days following the first day of dosing |
|
|
|
| Secondary | Change From Baseline in Serum Concentrations Of Total Properdin For ALXN1820 SC And ALXN1820 IV-Single Dose Cohorts | The Pharmacodynamic Set included all participants who received at least 1 dose of study drug and had evaluable properdin concentration, CAP or complement classical pathway activity data. Here, Number of participants analyzed signifies those who were evaluable for this outcome measure. As per pre-specified analysis, only data for Cohorts 1-6 and the placebo arm were collected for this Outcome Measure. | Posted | Mean | Standard Deviation | micrograms/milliliters | Baseline, Day 127 |
|
|
|
| Secondary | Change From Baseline in Serum Concentrations Of Free Properdin For ALXN1820 SC And ALXN1820 IV-Single Dose Cohorts | The Pharmacodynamic Set included all participants who received at least 1 dose of study drug and had evaluable properdin concentration, CAP or complement classical pathway activity data. Here, Number of participants analyzed signifies those who were evaluable for this outcome measure. As per pre-specified analysis, only data for Cohorts 1-6 and the placebo arm were collected for this Outcome Measure. | Posted | Mean | Standard Deviation | nanograms/milliliters | Baseline, Day 127 |
|
|
|
| Secondary | Change From Baseline In Serum Concentrations of Total Properdin For ALXN1820 SC- Multiple Dose Cohorts | The Pharmacodynamic Set included all participants who received at least 1 dose of study drug and had evaluable properdin concentration, CAP or complement classical pathway activity data. Here, Number of participants analyzed signifies those who were evaluable for this outcome measure. As per pre-specified analysis, only data for Cohorts 8 and 9 and the placebo arm were collected for this Outcome Measure. | Posted | Mean | Standard Deviation | micrograms/milliliters | Baseline, Day 155 |
|
|
|
| Secondary | Change From Baseline In Serum Concentrations of Free Properdin For ALXN1820 SC- Multiple Dose Cohorts | The Pharmacodynamic Set included all participants who received at least 1 dose of study drug and had evaluable properdin concentration, CAP or complement classical pathway activity data. Here, Number of participants analyzed signifies those who were evaluable for this outcome measure. As per pre-specified analysis, only data for Cohorts 8 and 9 and the placebo arm were collected for this Outcome Measure. | Posted | Mean | Standard Deviation | nanograms/milliliters | Baseline, Day 155 |
|
|
|
| Secondary | Change From Baseline In Complement Alternative Pathway (CAP) Activity Using The Wieslab Alternative Pathway (AP) Assay For ALXN1820 SC And ALXN1820 IV-Single Dose Cohorts | The Pharmacodynamic Set included all participants who received at least 1 dose of study drug and had evaluable properdin concentration, CAP or complement classical pathway activity data. Here, Number of Participants analyzed signifies those who were evaluable for this outcome measure. As per pre-specified analysis, only data for Cohorts 1-6 and the placebo arm were collected for this Outcome Measure. | Posted | Mean | Standard Deviation | percentage of activity | Baseline, Day 127 |
|
|
|
| Secondary | Change From Baseline In Complement Alternative Pathway Activity Using The Wieslab Alternative Pathway Assay For ALXN1820 SC- Multiple Dose Cohorts | The Pharmacodynamic Set included all participants who received at least 1 dose of study drug and had evaluable properdin concentration, CAP or complement classical pathway activity data. Here, Number of participants analyzed signifies those who were evaluable for this outcome measure. As per pre-specified analysis, only data for Cohorts 8 and 9 and the placebo arm were collected for this Outcome Measure. | Posted | Mean | Standard Deviation | percentage of activity | Baseline, Day 155 |
|
|
|
| Secondary | Number Of Participants With Positive Antidrug Antibodies (ADAs) To ALXN1820 SC And ALXN1820 IV | The Immunogenicity Set included all participants who had a predose and at least 1 postdose ADA sample collected. As per pre-specified analysis, only data for Cohorts 1-6, and Cohorts 8 and 9, and the placebo arm were collected for this Outcome Measure. | Posted | Count of Participants | Participants | Baseline up to Day 155 |
|
|
|
| Secondary | Absolute Bioavailability Of ALXN1820 SC | The absolute bioavailability was expressed as ratio and was calculated as the geometric mean for the AUC[0-inf] for SC divided by the geometric mean for the AUC[0-inf] for IV. Least square means were calculated with cohort, treatment, and sequence as the fixed effects, and participant-participant (sequence) as a random effect. | The Pharmacokinetic Set included all participants who received at least 1 dose of study drug and had at least 1 post-dose PK concentration measured. Data for the arms reported is from the data collected based on pre-specified analysis. | Posted | Geometric Least Squares Mean | 95% Confidence Interval | Ratio | Baseline up to Day 127 |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 4 |
| 5 |
| EG001 | Cohort 2: ALXN1820 50 mg SC | Healthy participants received a single dose of ALXN1820 50 mg SC injection on Day 1. | 0 | 6 | 0 | 6 | 6 | 6 |
| EG002 | Cohort 3: ALXN1820 150 mg SC | Healthy participants received a single dose of ALXN1820 150 mg SC injection on Day 1. | 0 | 5 | 0 | 5 | 2 | 5 |
| EG003 | Cohort 4: ALXN1820 450 mg SC | Healthy participants received a single dose of ALXN1820 450 mg SC injection on Day 1. | 0 | 5 | 0 | 5 | 4 | 5 |
| EG004 | Cohort 5: ALXN1820 450 mg IV | Healthy participants received a single dose of ALXN1820 450 mg IV infusion on Day 1. | 0 | 5 | 0 | 5 | 4 | 5 |
| EG005 | Cohort 6: ALXN1820 1200 mg SC | Healthy participants received a single dose of ALXN1820 1200 mg SC injection on Day 1. | 0 | 6 | 0 | 6 | 6 | 6 |
| EG006 | Cohort 8: ALXN1820 150 mg SC (QW*5) | Healthy participants received multiple doses of ALXN1820 150 mg SC injection once weekly for 5 weeks. | 0 | 7 | 0 | 7 | 6 | 7 |
| EG007 | Cohort 9: ALXN1820 150 mg SC (QW*5) | Healthy Japanese participants received multiple doses of ALXN1820 150 mg SC injection once weekly for 5 weeks. | 0 | 6 | 0 | 6 | 5 | 6 |
| EG008 | All Placebo | Healthy participants received placebo matched to ALXN1820 SC injection or IV infusion. | 0 | 15 | 0 | 15 | 11 | 15 |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
|
| Vulvovaginal candidiasis | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
|
| Oral herpes | 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 |
|
| Candida infection | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
|
| Dermatophytosis | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
|
| Nausea | 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 |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Aphthous ulcer | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Epigastric discomfort | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Faeces discoloured | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal 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 |
|
| Dizziness | Nervous system disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Dizziness exertional | Nervous system disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Migraine with aura | Nervous system disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Tension headache | Nervous system disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Infusion site erythema | General disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Infusion site pain | General disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA v25.1 | Non-systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA v25.1 | Non-systematic Assessment |
|
| Heat exhaustion | Injury, poisoning and procedural complications | MedDRA v25.1 | Non-systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA v25.1 | Non-systematic Assessment |
|
| Post vaccination syndrome | Injury, poisoning and procedural complications | MedDRA v25.1 | Non-systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA v25.1 | Non-systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA v25.1 | Non-systematic Assessment |
|
| Skin injury | Injury, poisoning and procedural complications | MedDRA v25.1 | Non-systematic Assessment |
|
| Vaccination complication | Injury, poisoning and procedural complications | MedDRA v25.1 | Non-systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Vulvovaginal dryness | Reproductive system and breast disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Intermenstrual bleeding | Reproductive system and breast disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Photophobia | Eye disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Anogenital warts | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v25.1 | Non-systematic Assessment |
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| Benign breast neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v25.1 | Non-systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA v25.1 | Non-systematic Assessment |
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| Urine odour abnormal | Renal and urinary disorders | MedDRA v25.1 | Non-systematic Assessment |
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| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA v25.1 | Non-systematic Assessment |
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| Immunisation reaction | Immune system disorders | MedDRA v25.1 | Non-systematic Assessment |
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| Electrocardiogram QT prolonged | Investigations | MedDRA v25.1 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA v25.1 | Non-systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | Non-systematic Assessment |
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Not provided
Not provided
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| AUCtau |
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