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Researchers are trying to determine if there is a difference between brain images of subjects that do respond to treatment with erenumab and subjects who do not respond to treatment with erenumab using Magnetic Resonance Imaging (MRI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erenumab | Other | All participants receive erenumab 140mg by subcutaneous injection at baseline and again 4 weeks later. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erenumab | Drug | Erenumab will be used per label instructions. |
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| Measure | Description | Time Frame |
|---|---|---|
| Resting State Functional Connectivity | Brain MRI resting state functional connectivity measured as global efficiency percentage. An increase in global efficiency suggests an improvement in the ability of the brain regions to functionally communicate on a global scale. Efficiency relates to the network. In this case, the investigators defined the network to be the pain matrix. Increased efficiency would mean the connectivity within the matrix is increased and more efficient. This has not been attributed to a clinical outcome but is rather a characteristic of the network. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Erenumab Responders | The number of participants who responded to erenumab treatment. Treatment response was defined as at least a 50% reduction in the frequency of migraine days during weeks 5-8 compared to the 4 week pre-treatment run-in phases as recorded in the headache diary. | 8 weeks |
| Iron Accumulation in Periaqueductal Gray Brain Region |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Todd J Schwedt | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36517767 | Derived | Schwedt TJ, Nikolova S, Dumkrieger G, Li J, Wu T, Chong CD. Longitudinal changes in functional connectivity and pain-induced brain activations in patients with migraine: a functional MRI study pre- and post- treatment with Erenumab. J Headache Pain. 2022 Dec 14;23(1):159. doi: 10.1186/s10194-022-01526-5. |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Erenumab | All participants receive erenumab 140mg by subcutaneous injection at baseline and again 4 weeks later. Erenumab: Erenumab will be used per label instructions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Erenumab | All participants receive erenumab 140mg by subcutaneous injection at baseline and again 4 weeks later. Erenumab: Erenumab will be used per label instructions. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Resting State Functional Connectivity | Brain MRI resting state functional connectivity measured as global efficiency percentage. An increase in global efficiency suggests an improvement in the ability of the brain regions to functionally communicate on a global scale. Efficiency relates to the network. In this case, the investigators defined the network to be the pain matrix. Increased efficiency would mean the connectivity within the matrix is increased and more efficient. This has not been attributed to a clinical outcome but is rather a characteristic of the network. | Of the 32 participants to complete a functional MRI (fMRI) of the brain, 18 participants were identified as erenumab responders and 14 were erenumab non-responders. | Posted | Mean | Standard Error | global efficiency percentage | 8 weeks |
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Adverse events were collected on each participant from the time of the first erenumab treatment through the end of the safety follow up visit (8 weeks after the last dose of the investigational product) for a total of approximately 12 weeks.
Out of 50 participants, 36 received the first dose of erenumab but 4 withdrew from the study prior to completing a function MRI (fMRI) of the brain.
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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 | Erenumab | All participants receive erenumab 140mg by subcutaneous injection at baseline and again 4 weeks later. Erenumab: Erenumab will be used per label instructions. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Todd Schwedt | Mayo Clinic | 480-342-2695 | schwedt.todd@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 18, 2020 | May 24, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C000605816 | erenumab |
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Iron accumulation in the periaqueductal gray as measured by magnetic resonance imaging (MRI) transverse relaxation rates (T2*). |
| 8 weeks |
| Iron Accumulation in Anterior Cingulate Cortex Brain Region | Iron accumulation in the anterior cingulate cortex as measured by magnetic resonance imaging (MRI) transverse relaxation rates (T2*). | 8 weeks |
| Change in the Migraine Disability Assessment Questionnaire (MIDAS) | The MIDAS questionnaire consists of 5 questions that assess the degree of headache related disability. Each question asks the patient to record the number of days in the past 3 months where a headache has impacted various daily life activities. The individual responses to each of the five questions are then added to obtain a total score and level of disability. A total score of 0-5 days reflects little or no disability (Grade I); 6-10 days is mild disability (Grade II); 11-20 days is moderate disability (Grade III) and over 21 days is severe disability (Grade IV). A lower score indicates less disability while a higher score reflects more disability. | Baseline, 8 weeks |
| ROI-ROI Functional Connectivity of Middle Temporal Left With Supramarginal Gyrus Right Regions of the Brain | Temporal correlations in blood oxygen level dependent (BOLD) signal fluctuations between selected regions of interest (ROIs). The correlation coefficient ( r ) is measured between seed regions. This measurement is bound by the range [ -1 to 1]. In order to perform statistical tests (such as T-tests) we Fisher transform the correlation coefficient from [-1 1] to a real number [ -infinity infinity] Mathematically it is: z=atanh( r ). The Z-score themselves are functional connectivity between the regions and do not serve as clinical biomarkers. The difference, and longitudinal changes are of greater interest as they indicate alterations to normal pain processing. A more efficient pain processing network would suggest that more of these regions are being enlisted and with greater connectivity. | 8 weeks |
| ROI-ROI Functional Connectivity of Temporal Pole Right With Middle Occipital Right | Temporal correlations in blood oxygen level dependent (BOLD) signal fluctuations between selected regions of interest (ROIs). The correlation coefficient ( r ) is measured between seed regions. This measurement is bound by the range [ -1 to 1]. In order to perform statistical tests (such as T-tests) we Fisher transform the correlation coefficient from [-1 1] to a real number [ -infinity infinity] Mathematically it is: z=atanh( r ). The Z-score themselves are functional connectivity between the regions and do not serve as clinical biomarkers. The difference, and longitudinal changes are of greater interest as they indicate alterations to normal pain processing. A more efficient pain processing network would suggest that more of these regions are being enlisted and with greater connectivity. | 8 weeks |
| ROI-ROI Functional Connectivity of Inferior Lateral Parietal Right With Middle Frontal Left | Temporal correlations in blood oxygen level dependent (BOLD) signal fluctuations between selected regions of interest (ROIs). The correlation coefficient ( r ) is measured between seed regions. This measurement is bound by the range [ -1 to 1]. In order to perform statistical tests (such as T-tests) we Fisher transform the correlation coefficient from [-1 1] to a real number [ -infinity infinity] Mathematically it is: z=atanh( r ). The Z-score themselves are functional connectivity between the regions and do not serve as clinical biomarkers. The difference, and longitudinal changes are of greater interest as they indicate alterations to normal pain processing. A more efficient pain processing network would suggest that more of these regions are being enlisted and with greater connectivity. | 8 weeks |
| ROI-ROI Functional Connectivity of Dorsolateral Prefrontal Cortex Left With Hypothalamus Right | Temporal correlations in blood oxygen level dependent (BOLD) signal fluctuations between selected regions of interest (ROIs). The correlation coefficient ( r ) is measured between seed regions. This measurement is bound by the range [ -1 to 1]. In order to perform statistical tests (such as T-tests) we Fisher transform the correlation coefficient from [-1 1] to a real number [ -infinity infinity] Mathematically it is: z=atanh( r ). The Z-score themselves are functional connectivity between the regions and do not serve as clinical biomarkers. The difference, and longitudinal changes are of greater interest as they indicate alterations to normal pain processing. A more efficient pain processing network would suggest that more of these regions are being enlisted and with greater connectivity. | 8 weeks |
| ROI-ROI Functional Connectivity of Inferior Lateral Parietal Right With Supramarginal Gyrus Right | Temporal correlations in blood oxygen level dependent (BOLD) signal fluctuations between selected regions of interest (ROIs). The correlation coefficient ( r ) is measured between seed regions. This measurement is bound by the range [ -1 to 1]. In order to perform statistical tests (such as T-tests) we Fisher transform the correlation coefficient from [-1 1] to a real number [ -infinity infinity] Mathematically it is: z=atanh( r ). The Z-score themselves are functional connectivity between the regions and do not serve as clinical biomarkers. The difference, and longitudinal changes are of greater interest as they indicate alterations to normal pain processing. A more efficient pain processing network would suggest that more of these regions are being enlisted and with greater connectivity. | 8 weeks |
| ROI-ROI Functional Connectivity of Ventromedial Prefrontal Cortex Left With Pulvinar Right | Temporal correlations in blood oxygen level dependent (BOLD) signal fluctuations between selected regions of interest (ROIs). The correlation coefficient ( r ) is measured between seed regions. This measurement is bound by the range [ -1 to 1]. In order to perform statistical tests (such as T-tests) we Fisher transform the correlation coefficient from [-1 1] to a real number [ -infinity infinity] Mathematically it is: z=atanh( r ). The Z-score themselves are functional connectivity between the regions and do not serve as clinical biomarkers. The difference, and longitudinal changes are of greater interest as they indicate alterations to normal pain processing. A more efficient pain processing network would suggest that more of these regions are being enlisted and with greater connectivity. | 8 weeks |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Erenumab Responders | The number of participants who responded to erenumab treatment. Treatment response was defined as at least a 50% reduction in the frequency of migraine days during weeks 5-8 compared to the 4 week pre-treatment run-in phases as recorded in the headache diary. | Of the 50 participants enrolled, 32 received erenumab treatment and completed a functional MRI (fMRI) of the brain. | Posted | Count of Participants | Participants | 8 weeks |
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| Secondary | Iron Accumulation in Periaqueductal Gray Brain Region | Iron accumulation in the periaqueductal gray as measured by magnetic resonance imaging (MRI) transverse relaxation rates (T2*). | Of the 28 participants with complete MRI T2* results, 15 participants were identified as erenumab responders and 13 were erenumab non-responders. | Posted | Mean | Standard Error | milliseconds (ms) | 8 weeks |
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| Secondary | Iron Accumulation in Anterior Cingulate Cortex Brain Region | Iron accumulation in the anterior cingulate cortex as measured by magnetic resonance imaging (MRI) transverse relaxation rates (T2*). | Of the 28 participants with complete MRI T2* results, 15 participants were identified as erenumab responders and 13 were erenumab non-responders. | Posted | Mean | Standard Error | milliseconds (ms) | 8 weeks |
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| Secondary | Change in the Migraine Disability Assessment Questionnaire (MIDAS) | The MIDAS questionnaire consists of 5 questions that assess the degree of headache related disability. Each question asks the patient to record the number of days in the past 3 months where a headache has impacted various daily life activities. The individual responses to each of the five questions are then added to obtain a total score and level of disability. A total score of 0-5 days reflects little or no disability (Grade I); 6-10 days is mild disability (Grade II); 11-20 days is moderate disability (Grade III) and over 21 days is severe disability (Grade IV). A lower score indicates less disability while a higher score reflects more disability. | Of the 28 participants that completed the MIDAS questionnaire, 15 participants were identified as erenumab responders and 13 were erenumab non-responders. | Posted | Mean | Standard Error | score on a scale | Baseline, 8 weeks |
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| Secondary | ROI-ROI Functional Connectivity of Middle Temporal Left With Supramarginal Gyrus Right Regions of the Brain | Temporal correlations in blood oxygen level dependent (BOLD) signal fluctuations between selected regions of interest (ROIs). The correlation coefficient ( r ) is measured between seed regions. This measurement is bound by the range [ -1 to 1]. In order to perform statistical tests (such as T-tests) we Fisher transform the correlation coefficient from [-1 1] to a real number [ -infinity infinity] Mathematically it is: z=atanh( r ). The Z-score themselves are functional connectivity between the regions and do not serve as clinical biomarkers. The difference, and longitudinal changes are of greater interest as they indicate alterations to normal pain processing. A more efficient pain processing network would suggest that more of these regions are being enlisted and with greater connectivity. | Of the 32 participants to complete a functional MRI (fMRI) of the brain, 18 participants were identified as erenumab responders and 14 were erenumab non-responders. | Posted | Number | correlation coefficient | 8 weeks |
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| Secondary | ROI-ROI Functional Connectivity of Temporal Pole Right With Middle Occipital Right | Temporal correlations in blood oxygen level dependent (BOLD) signal fluctuations between selected regions of interest (ROIs). The correlation coefficient ( r ) is measured between seed regions. This measurement is bound by the range [ -1 to 1]. In order to perform statistical tests (such as T-tests) we Fisher transform the correlation coefficient from [-1 1] to a real number [ -infinity infinity] Mathematically it is: z=atanh( r ). The Z-score themselves are functional connectivity between the regions and do not serve as clinical biomarkers. The difference, and longitudinal changes are of greater interest as they indicate alterations to normal pain processing. A more efficient pain processing network would suggest that more of these regions are being enlisted and with greater connectivity. | Of the 32 participants to complete a functional MRI (fMRI) of the brain, 18 participants were identified as erenumab responders and 14 were erenumab non-responders. | Posted | Number | correlation coefficient | 8 weeks |
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| Secondary | ROI-ROI Functional Connectivity of Inferior Lateral Parietal Right With Middle Frontal Left | Temporal correlations in blood oxygen level dependent (BOLD) signal fluctuations between selected regions of interest (ROIs). The correlation coefficient ( r ) is measured between seed regions. This measurement is bound by the range [ -1 to 1]. In order to perform statistical tests (such as T-tests) we Fisher transform the correlation coefficient from [-1 1] to a real number [ -infinity infinity] Mathematically it is: z=atanh( r ). The Z-score themselves are functional connectivity between the regions and do not serve as clinical biomarkers. The difference, and longitudinal changes are of greater interest as they indicate alterations to normal pain processing. A more efficient pain processing network would suggest that more of these regions are being enlisted and with greater connectivity. | Of the 32 participants to complete a functional MRI (fMRI) of the brain, 18 participants were identified as erenumab responders and 14 were erenumab non-responders. | Posted | Number | correlation coefficient | 8 weeks |
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| Secondary | ROI-ROI Functional Connectivity of Dorsolateral Prefrontal Cortex Left With Hypothalamus Right | Temporal correlations in blood oxygen level dependent (BOLD) signal fluctuations between selected regions of interest (ROIs). The correlation coefficient ( r ) is measured between seed regions. This measurement is bound by the range [ -1 to 1]. In order to perform statistical tests (such as T-tests) we Fisher transform the correlation coefficient from [-1 1] to a real number [ -infinity infinity] Mathematically it is: z=atanh( r ). The Z-score themselves are functional connectivity between the regions and do not serve as clinical biomarkers. The difference, and longitudinal changes are of greater interest as they indicate alterations to normal pain processing. A more efficient pain processing network would suggest that more of these regions are being enlisted and with greater connectivity. | Of the 32 participants to complete a functional MRI (fMRI) of the brain, 18 participants were identified as erenumab responders and 14 were erenumab non-responders. | Posted | Number | correlation coefficient | 8 weeks |
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| Secondary | ROI-ROI Functional Connectivity of Inferior Lateral Parietal Right With Supramarginal Gyrus Right | Temporal correlations in blood oxygen level dependent (BOLD) signal fluctuations between selected regions of interest (ROIs). The correlation coefficient ( r ) is measured between seed regions. This measurement is bound by the range [ -1 to 1]. In order to perform statistical tests (such as T-tests) we Fisher transform the correlation coefficient from [-1 1] to a real number [ -infinity infinity] Mathematically it is: z=atanh( r ). The Z-score themselves are functional connectivity between the regions and do not serve as clinical biomarkers. The difference, and longitudinal changes are of greater interest as they indicate alterations to normal pain processing. A more efficient pain processing network would suggest that more of these regions are being enlisted and with greater connectivity. | Of the 32 participants to complete a functional MRI (fMRI) of the brain, 18 participants were identified as erenumab responders and 14 were erenumab non-responders. | Posted | Number | correlation coefficient | 8 weeks |
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| Secondary | ROI-ROI Functional Connectivity of Ventromedial Prefrontal Cortex Left With Pulvinar Right | Temporal correlations in blood oxygen level dependent (BOLD) signal fluctuations between selected regions of interest (ROIs). The correlation coefficient ( r ) is measured between seed regions. This measurement is bound by the range [ -1 to 1]. In order to perform statistical tests (such as T-tests) we Fisher transform the correlation coefficient from [-1 1] to a real number [ -infinity infinity] Mathematically it is: z=atanh( r ). The Z-score themselves are functional connectivity between the regions and do not serve as clinical biomarkers. The difference, and longitudinal changes are of greater interest as they indicate alterations to normal pain processing. A more efficient pain processing network would suggest that more of these regions are being enlisted and with greater connectivity. | Of the 32 participants to complete a functional MRI (fMRI) of the brain, 18 participants were identified as erenumab responders and 14 were erenumab non-responders. | Posted | Number | correlation coefficient | 8 weeks |
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| 36 |
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| 36 |
| 25 |
| 36 |
| Flank pain | General disorders | Systematic Assessment |
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| Loss of balance | General disorders | Systematic Assessment |
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| Weight gain | General disorders | Systematic Assessment |
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| Arm twitching | General disorders | Systematic Assessment |
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| Ear infection | Infections and infestations | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | Systematic Assessment |
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| Agitation | General disorders | Systematic Assessment |
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| Communication issues | General disorders | Systematic Assessment |
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| Insomnia | General disorders | Systematic Assessment |
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| Covid-19 infection | Infections and infestations | Systematic Assessment |
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| Allergic reaction | General disorders | Systematic Assessment |
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| West Nile Virus | General disorders | Systematic Assessment |
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| Itching/skin sensitivity | General disorders | Systematic Assessment |
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| Tinnitus | General disorders | Systematic Assessment |
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| Worsening headache | General disorders | Systematic Assessment |
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| Constipation | General disorders | Systematic Assessment |
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| Abdominal pain | General disorders | Systematic Assessment |
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| Injection site erythema | General disorders | Systematic Assessment |
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| D009422 | Nervous System Diseases |
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