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| Name | Class |
|---|---|
| IQVIA Pty Ltd | INDUSTRY |
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The study aims to investigate the safety, tolerability, efficacy, pharmacodynamics (PD), pharmacokinetics (PK), and immunogenicity of efgartigimod compared to placebo in participants with post-COVID-19 postural orthostatic tachycardia syndrome (POTS) (post-COVID-19 POTS).
The study aims to investigate the safety, tolerability, efficacy, pharmacodynamics (PD), pharmacokinetics (PK), and immunogenicity of efgartigimod compared to placebo in participants with post-COVID-19 postural orthostatic tachycardia syndrome (POTS) (post-COVID-19 POTS). Efgartigimod may be a viable treatment option for individuals diagnosed with post-COVID-19 POTS because it has been shown to reduce IgG levels, including IgG autoantibodies, which may underlie some of the autonomic disease manifestations in these patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Efgartigimod | Experimental | Receive efgartigimod IV 10mg/kg during weekly infusions during a treatment period of 24 weeks |
|
| Placebo | Placebo Comparator | Receive a matching placebo during weekly infusions during a treatment period of 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Efgartigimod | Drug | Efgartigimod IV 10 mg/kg infusion qw for 24 weeks. Participants will be randomized to receive efgartigimod IV 10 mg/kg or matching placebo in a 2:1 ratio, respectively |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 24 in the COMPASS 31 (2-week Recall Version) | Composite Autonomic Symptom Score (COMPASS) 31 modified version (2-week recall) is a self-rated questionnaire to evaluate the severity and distribution of autonomic symptoms in various autonomic nerve disorders. It consists of 31 questions in 6 weighted domains (orthostatic intolerance, vasomotor, secretomotor, gastrointestinal {GI}-mixed upper and diarrhea, bladder, and pupillomotor). A weighted total score of 0 (mild) to 100 (severe) was determined by adding a maximum raw score for each domain. Higher scores indicated a more severe degree of autonomic symptoms. | Baseline (Day 1) and Week 24 |
| Change From Baseline to Week 24 in the MaPS | The Malmö POTS Symptom Score (MaPS) score is a dedicated POTS symptom scoring questionnaire. The score consists of 12 questions that assess symptom burden related (tachycardia, palpitations, dizziness, presyncope) and unrelated to orthostatic intolerance (GI symptoms, insomnia, concentration difficulties). Participants graded their symptoms for the past 7 days using a visual analog scale ranging from 0 (no symptoms) to 10 (worst possible). The total score was calculated by summing up the items/individual items and range was 0 to 120 points, with higher scores indicating more severe symptoms. | Baseline (Day 1) and Week 24 |
| Number of Participants With TEAEs and TESAEs | An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. A serious adverse event (SAE) was any untoward medical occurrence that at any dose resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or any other medically important event. Treatment-emergent adverse events (TEAEs) were defined as AEs with onset on or after the first administration of study drug up to and including 60 days after the last study drug administration. | From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 236 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Improved PGI-S at Week 24 | The Patient Global Impression-Severity (PGI-S) is a participant-rated, single-item scale to assess the severity of a health condition. The scale was used to assess the severity of symptoms over the past week (1-week recall) and overall experience of symptoms over the past 2 weeks (2-week recall). Both were rated on a 4-point type Likert scale, with scores ranging from 1 (none), 2 (mild), 3 (moderate), and 4 (severe). Higher scores indicate greater symptom severity. An "improved PGI-S" was defined by a change from baseline of -3, -2 and -1. |
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Inclusion Criteria:
Reached the age of consent when signing the informed consent form
Capable of providing signed informed consent and complying with protocol requirements
Diagnosed with new-onset POTS post-COVID-19 established by the following:
i. Vasomotor symptoms: fatigue, orthostatic intolerance, brain fog, exertional dyspnea, difficulty with concentration, venous pooling, and exercise intolerance ii. Sympathetic over-compensation symptoms: palpitation, heat intolerance, nausea with or without vomiting, insomnia, anxiety, lack of appetite, chest pain, and diaphoresis
COMPASS 31 ≥35 at screening
Agree to use contraceptives consistent with local regulations regarding the methods of contraception for those participating in clinical studies and the following:
Male participants: No male contraception is required Female participants of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline before receiving IMP. Contraceptive requirements.
Body mass index (BMI) <35 kg/m2
Exclusion Criteria:
Diagnosis of or receiving treatment for the following conditions before COVID-19: peripheral neuropathy, POTS, myalgic encephalomyelitis encephalitis/chronic fatigue syndrome, Ehlers Danlos syndrome confirmed by genetic testing, autonomic neuropathy, multiple sclerosis, stroke, spinal cord injury, or any known lesions in the central nervous system by imaging or neurological exam
History of or currently being treated for clinically significant ongoing cardiac arrythmia, heart failure, myocarditis, pulmonary embolism requiring anticoagulation, pulmonary fibrosis, or critical illness-related polyneuropathy or myopathy
Known autoimmune disease that, in the investigator's judgment, would interfere with an accurate assessment of clinical symptoms of post-COVID-19 POTS or puts the participant at undue risk
Known HIV disease or common variable immunodeficiency
History of malignancy unless considered cured by adequate treatment with no evidence of recurrence for ≥3 years before the first administration of IMP. Adequately-treated participants with the following cancers may be included at any time:
Clinically significant uncontrolled active or chronic bacterial, viral, or fungal infection or positive SARS-CoV-2 PCR test at screening
Positive serum test at screening for an active infection with any of the following:
A medical condition that could confound the results of the study or put the participant at undue risk in the investigator's judgment
Clinically significant disease, recent major surgery (within 3 months of screening), or intends to have surgery during the study; or any other condition that in the opinion of the investigator could confound the results of the study or put the participant at undue risk
Total IgG <4 g/L at screening
Received within 12 weeks or 5 half-lives (whichever is longer) before screening an investigational product
Received within 12 weeks before screening either intravenous immunoglobulin (Ig) IV or SC or plasmapheresis/plasma exchange (PLEX)
Received a live or live-attenuated vaccine less than 4 weeks before screening
Known hypersensitivity to IMP or 1 of its excipients
Previously participated in an efgartigimod clinical study and received at least 1 dose of IMP
Currently participating in another interventional clinical study
History (within 12 months of screening) of or current alcohol, drug, or medication abuse
Pregnant or lactating or intends to become pregnant during the study
Unwilling to remain on a stable regimen of medications during the study
Unwilling to avoid initiation of new physical rehabilitation or other physician-prescribed exercise programs during the 24-week treatment period
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego Sulpizio Cardiovascular Center | La Jolla | California | 92037 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39413203 | Derived | Dani M, Fedorowski A. Tackling POTS Needs More Than Just a Sympathetic Approach. Hypertension. 2024 Nov;81(11):2248-2250. doi: 10.1161/HYPERTENSIONAHA.124.23716. Epub 2024 Oct 16. No abstract available. |
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The study consisted of a screening period (approximately 4 weeks), a treatment period (24 weeks) and a follow-up period (approximately 8 weeks for participants who did not roll over to the open label extension study ARGX-113-2105 [NCT05918978). A total of 53 participants were randomized in a 2:1 ratio to receive either efgartigimod or matching placebo, respectively.](streamdown:incomplete-link)
This phase 2, randomized, double-blind study was conducted at 11 sites in the United States from 23-Sep-22 to 18-Apr-24 in participants with post-coronavirus disease 2019 (COVID-19) postural orthostatic tachycardia syndrome (POTS).
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| ID | Title | Description |
|---|---|---|
| FG000 | Efgartigimod | Participants received efgartigimod 10 milligram/kilogram (mg/kg) via intravenous (IV) infusion once weekly from Day 1 up to 24 weeks. |
| FG001 | Placebo | Participants received placebo matched to efgartigimod via IV infusion once weekly from Day 1 up to 24 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 25, 2023 | Apr 18, 2025 |
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| Placebo | Drug | Receive a matching placebo during weekly infusions during a treatment period of 24 weeks. Participants will be randomized to receive efgartigimod IV 10 mg/kg or matching placebo in a 2:1 ratio, respectively |
|
| Baseline (Day 1) and Week 24 |
| Percentage of Participants With Improved in PGI-C at Week 24 | The Patient Global Impression-Change (PGIC) is a single-item scale to capture the participant's perception of a change in their overall symptom severity. Overall change in symptoms was rated on a 7-point Likert scale, with scores ranging from 1 (much better), 2 (somewhat better), 3 (a little better), 4 (no change), 5 (a little worse), 6 (somewhat worse), and 7 (much worse). Higher PGI-C scores signify worse outcome. An "improved PGI-C" was defined by a change from baseline of 1, 2 and 3. | Baseline (Day 1) and Week 24 |
| Change From Baseline to Week 24 in the PROMIS Fatigue Short Form 8a | The Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 8a assesses the impact and perceived fatigue during the last 7 days. This validated 8-question scale has 5 response options, with scores ranging from 1 (not at all) to 5 (very much). Total scores ranged from 8 to 40; higher scores indicated higher fatigue levels and were converted to a T-score with a mean of 50 and standard deviation of 10. A decrease in T-score (negative change from baseline) indicated improvement in fatigue. | Baseline (Day 1) and Week 24 |
| Change From Baseline to Week 24 in the PROMIS Cognitive Function Short Form 6a | PROMIS Cognitive Function Short Form 6a assesses the frequency of cognitive difficulties experienced in the past 7 days. The questionnaire comprises 6 questions on subjective cognitive difficulties regarding a participant's concentration, memory, language, mental acuity, and perceived changes in cognitive functioning. The participant marks their response on a 5-point Likert scale (1: never and 5: very often). Scores ranged from 6 to 30; higher scores indicated worse perceived cognitive functioning and were converted to a T-score with a mean of 50 and standard deviation of 10. An increase in T-score (positive change from baseline) indicated better cognitive function. | Baseline (Day 1) and Week 24 |
| Percent Change From Baseline in Total IgG Levels at Week 24 | Blood samples for immunoglobulin G (IgG) analysis were collected at specified time points. Total IgG concentrations were quantified using validated methods at a central laboratory. | Baseline (Day 1) and Week 24 |
| Serum Concentration of Efgartigimod | Serum samples were collected at specified timepoints to determine the concentration of efgartigimod. | Pre-dose and post-dose at Baseline (Day 1), Weeks 1, 4, 12 and at Week 24 |
| Number of Participants With ADAs Against Efgartigimod | Blood samples were collected at specified timepoints to assess anti-drug antibodies (ADAs) against efgartigimod. ADA incidence reported here was defined as total number of participants with treatment-induced and treatment-boosted ADA. Treatment-induced ADA was defined as a baseline negative sample and at least 1 positive post-baseline sample. Treatment-boosted ADA was defined as a baseline positive sample and the titer value increased 4-fold or more compared to baseline. | Up to Week 24 |
| Stanford Movement Disorder Center |
| Palo Alto |
| California |
| 94304 |
| United States |
| Northshore University Health System | Glenview | Illinois | 60026 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21224 | United States |
| Harvard Medical School, Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Case Western Reserve University | Cleveland | Ohio | 44106 | United States |
| Vandetbilt University Medical Center / Clinical Research Center | Nashville | Tennessee | 37232 | United States |
| Apex Trials Croup, LLC | Fort Worth | Texas | 76132 | United States |
| Texas Institute of Cardiology | McKinney | Texas | 75071 | United States |
| Pioneer Clinical Research | Rosharon | Texas | 77583 | United States |
| Metrodora Institute | West Valley City | Utah | 84119 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Analysis was performed on full analysis set (FAS) which included all randomized participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Efgartigimod | Participants received efgartigimod 10 mg/kg via IV infusion once weekly from Day 1 up to 24 weeks. |
| BG001 | Placebo | Participants received placebo matched to efgartigimod via IV infusion once weekly from Day 1 up to 24 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| 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 | Change From Baseline to Week 24 in the COMPASS 31 (2-week Recall Version) | Composite Autonomic Symptom Score (COMPASS) 31 modified version (2-week recall) is a self-rated questionnaire to evaluate the severity and distribution of autonomic symptoms in various autonomic nerve disorders. It consists of 31 questions in 6 weighted domains (orthostatic intolerance, vasomotor, secretomotor, gastrointestinal {GI}-mixed upper and diarrhea, bladder, and pupillomotor). A weighted total score of 0 (mild) to 100 (severe) was determined by adding a maximum raw score for each domain. Higher scores indicated a more severe degree of autonomic symptoms. | The FAS included all randomized participants who received at least 1 dose of study drug. Only those participants with data collected at Baseline and Week 24 are reported. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day 1) and Week 24 |
|
|
| ||||||||||||||||||||||||||||
| Primary | Change From Baseline to Week 24 in the MaPS | The Malmö POTS Symptom Score (MaPS) score is a dedicated POTS symptom scoring questionnaire. The score consists of 12 questions that assess symptom burden related (tachycardia, palpitations, dizziness, presyncope) and unrelated to orthostatic intolerance (GI symptoms, insomnia, concentration difficulties). Participants graded their symptoms for the past 7 days using a visual analog scale ranging from 0 (no symptoms) to 10 (worst possible). The total score was calculated by summing up the items/individual items and range was 0 to 120 points, with higher scores indicating more severe symptoms. | The FAS included all randomized participants who received at least 1 dose of study drug. Only those participants with data collected at Baseline and Week 24 are reported. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day 1) and Week 24 |
|
| |||||||||||||||||||||||||||||
| Primary | Number of Participants With TEAEs and TESAEs | An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. A serious adverse event (SAE) was any untoward medical occurrence that at any dose resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or any other medically important event. Treatment-emergent adverse events (TEAEs) were defined as AEs with onset on or after the first administration of study drug up to and including 60 days after the last study drug administration. | The safety analysis set (SAF) included all randomized participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | No | From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 236 days |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Improved PGI-S at Week 24 | The Patient Global Impression-Severity (PGI-S) is a participant-rated, single-item scale to assess the severity of a health condition. The scale was used to assess the severity of symptoms over the past week (1-week recall) and overall experience of symptoms over the past 2 weeks (2-week recall). Both were rated on a 4-point type Likert scale, with scores ranging from 1 (none), 2 (mild), 3 (moderate), and 4 (severe). Higher scores indicate greater symptom severity. An "improved PGI-S" was defined by a change from baseline of -3, -2 and -1. | The FAS included all randomized participants who received at least 1 dose of study drug. Only participants with available data at week 24 are included. | Posted | Number | percentage of participants | Baseline (Day 1) and Week 24 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Improved in PGI-C at Week 24 | The Patient Global Impression-Change (PGIC) is a single-item scale to capture the participant's perception of a change in their overall symptom severity. Overall change in symptoms was rated on a 7-point Likert scale, with scores ranging from 1 (much better), 2 (somewhat better), 3 (a little better), 4 (no change), 5 (a little worse), 6 (somewhat worse), and 7 (much worse). Higher PGI-C scores signify worse outcome. An "improved PGI-C" was defined by a change from baseline of 1, 2 and 3. | The FAS included all randomized participants who received at least 1 dose of study drug. Only participants with data available for week 24 are included. | Posted | Number | percentage of participants | Baseline (Day 1) and Week 24 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 24 in the PROMIS Fatigue Short Form 8a | The Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 8a assesses the impact and perceived fatigue during the last 7 days. This validated 8-question scale has 5 response options, with scores ranging from 1 (not at all) to 5 (very much). Total scores ranged from 8 to 40; higher scores indicated higher fatigue levels and were converted to a T-score with a mean of 50 and standard deviation of 10. A decrease in T-score (negative change from baseline) indicated improvement in fatigue. | The FAS included all randomized participants who received at least 1 dose of study drug. Only those participants with data collected at Baseline and Week 24 are reported. | Posted | Mean | Standard Deviation | T-score | Baseline (Day 1) and Week 24 |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 24 in the PROMIS Cognitive Function Short Form 6a | PROMIS Cognitive Function Short Form 6a assesses the frequency of cognitive difficulties experienced in the past 7 days. The questionnaire comprises 6 questions on subjective cognitive difficulties regarding a participant's concentration, memory, language, mental acuity, and perceived changes in cognitive functioning. The participant marks their response on a 5-point Likert scale (1: never and 5: very often). Scores ranged from 6 to 30; higher scores indicated worse perceived cognitive functioning and were converted to a T-score with a mean of 50 and standard deviation of 10. An increase in T-score (positive change from baseline) indicated better cognitive function. | The FAS included all randomized participants who received at least 1 dose of study drug. Only those participants with data collected at Baseline and Week 24 are reported. | Posted | Mean | Standard Deviation | T-score | Baseline (Day 1) and Week 24 |
| ||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Total IgG Levels at Week 24 | Blood samples for immunoglobulin G (IgG) analysis were collected at specified time points. Total IgG concentrations were quantified using validated methods at a central laboratory. | The SAF included all randomized participants who received at least 1 dose of study drug. Only those participants with data collected at Baseline and Week 24 are reported. | Posted | Mean | Standard Deviation | percent change | Baseline (Day 1) and Week 24 |
|
| |||||||||||||||||||||||||||||
| Secondary | Serum Concentration of Efgartigimod | Serum samples were collected at specified timepoints to determine the concentration of efgartigimod. | The pharmacokinetic (PK) analysis set included all randomized participants who received at least 1 dose of efgartigimod and had at least 1 measured concentration of efgartigimod at a scheduled PK time point after start of dosing without protocol violations or events with potential to affect the PK concentration. Only those participants with data collected at specified timepoints are reported. | Posted | Mean | Standard Deviation | nanogram (ng)/mL | Pre-dose and post-dose at Baseline (Day 1), Weeks 1, 4, 12 and at Week 24 |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With ADAs Against Efgartigimod | Blood samples were collected at specified timepoints to assess anti-drug antibodies (ADAs) against efgartigimod. ADA incidence reported here was defined as total number of participants with treatment-induced and treatment-boosted ADA. Treatment-induced ADA was defined as a baseline negative sample and at least 1 positive post-baseline sample. Treatment-boosted ADA was defined as a baseline positive sample and the titer value increased 4-fold or more compared to baseline. | The SAF included all randomized participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | No | Up to Week 24 |
|
|
From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 236 days.
Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.
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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 | Efgartigimod | Participants received efgartigimod 10 mg/kg via IV infusion once weekly from Day 1 up to 24 weeks. | 0 | 36 | 0 | 36 | 31 | 36 |
| EG001 | Placebo | Participants received placebo matched to efgartigimod via IV infusion once weekly from Day 1 up to 24 weeks. | 0 | 17 | 0 | 17 | 14 | 17 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Ear discomfort | Ear and labyrinth disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Mydriasis | Eye disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Infusion site bruising | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Infusion site pain | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Injection site oedema | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Injection site rash | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Overgrowth bacterial | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Post-acute COVID-19 syndrome | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Vaccination complication | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Heart rate increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypervolaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Fibromyalgia | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Myoclonus | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Panic attack | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Regulatory Manager | argenx BV | +32 93103400 | regulatory@argenx.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 2, 2024 | Apr 18, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D054972 | Postural Orthostatic Tachycardia Syndrome |
| D000094024 | Post-Acute COVID-19 Syndrome |
| ID | Term |
|---|---|
| D054971 | Orthostatic Intolerance |
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000718373 | efgartigimod alfa |
Not provided
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
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| Participants |
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| Participants |
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