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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-005311-27 | EudraCT Number |
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To assess the long-term safety and efficacy of erenumab.
This was a multicenter, 52-week, open-label study designed to assess the long-term safety and efficacy of erenumab in adults with chronic migraine. Participants who completed the 12-week double-blind treatment of the parent Study 20120295 (NCT02066415) and met all Study 20130255 eligibility criteria were eligible for enrollment into this study. Enrollment occurred within 14 days after the parent study's week 12 visit.
The initial dose used in the study was erenumab 70 mg every month (QM). The protocol was subsequently amended to increase the dose to erenumab 140 mg QM (Protocol Amendment 2). Participants who had already completed the week 28 visit (ie, midpoint of the study) at the time of Protocol Amendment 2 continued to receive open-label erenumab 70 mg QM for the remainder of the study. Participants who enrolled but had not completed the week 28 visit at the time of Protocol Amendment 2 increased the open-label erenumab dose from 70 mg QM to 140 mg QM at the next visit. All participants who enrolled after Protocol Amendment 2 received open-label erenumab 140 mg QM throughout the study.
Participants may elect to participate in a separate clinical home use (CHU) substudy to assess subjects' ability to self-administer 140 mg of erenumab for in-home use using either two prefilled syringes (PFS) or two prefilled autoinjector/pens (AI/pens). Enrollment in the 12-week substudy occurred at either week 12 or week 40 of study 20130255. Participants were randomized to self-administer erenumab using either the PFS or AI/pen on CHU days 29 and 57 at home.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erenumab | Experimental | Participants received erenumab 70 mg once a month (QM) or 140 mg QM by subcutaneous injection for up to 52 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erenumab | Drug | Administered by subcutaneous injection once a month |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | Adverse events (AEs) were graded for severity using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, where Grade 1 = mild AE, asymptomatic or mild symptoms; Grade 2 = Moderate AE; Grade 3 = Severe or medically significant but not immediately life-threatening; Grade 4 = Life-threatening consequences; urgent intervention indicated; Grade 5 = Death related to AE. | From first dose of erenumab in extension study 20130255 to the end of the 12-week safety follow-up period (up to 64 weeks). |
| CHU Substudy: Number of Participants Able to Administer a Full Dose of Erenumab in Home-use | At the CHU substudy day 28 and day 56 visits, the site provided erenumab 140 mg to participants to self-administer at home on the following day. Study site staff then called the participants and asked if they administered a full, partial, or no dose of erenumab. A full dose was defined when the entire volume of both prefilled syringes or autoinjector/pens were injected. | Day 29 (week 4) and day 57 (week 8) of the substudy |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Study 20120295 Baseline in Monthly Migraine Days | A migraine day was any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined either as a migraine with or without aura. The change from baseline in monthly migraine days was calculated as the number of migraine days during the 4 weeks prior to each study visit - the number of migraine days during the 4-week baseline phase. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Newport Beach | California | 92663 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35272533 | Background | Zhou Y, Zhang F, Starcevic Manning M, Hu Z, Hsu CP, Chen PW, Peng C, Loop B, Mytych DT, Paiva da Silva Lima G. Immunogenicity of erenumab: A pooled analysis of six placebo-controlled trials with long-term extensions. Cephalalgia. 2022 Jul;42(8):749-760. doi: 10.1177/03331024221075621. Epub 2022 Mar 10. | |
| 31707815 | Background |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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Participants at sites in the United States, Sweden, and Germany had the option of enrolling in the Clinical Home Use (CHU) Substudy to assess their ability to self-administer 140 mg erenumab for in-home use. Participants in the substudy were randomized 1:1 to self-administer erenumab using either a prefilled syringe or autoinjector/pen.
Participants were enrolled at 64 centers across North America and Europe from 30 June 2014 to 4 March 2016. Participants who completed the 12-week double-blind treatment of the parent Study 20120295 (NCT02066415) and met all Study 20130255 eligibility criteria were eligible for enrollment into this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Erenumab | Participants received erenumab 70 mg once a month (QM) and/or 140 mg QM by subcutaneous injection for up to 52 weeks. Participants who enrolled prior to amendment 2 received erenumab 70 mg once a month (QM). Participants who had not completed the week 28 visit at the time of amendment 2 had their dose increased to 140 mg QM at their next visit whereas participants who had already completed the week 28 visit remained on erenumab 70 mg QM. Participants who enrolled after amendment 2 received erenumab 140 mg QM for the duration of the study. |
| 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 | Mar 31, 2016 | May 24, 2018 |
Not provided
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| 4-week baseline phase of Study 20120295 and the 4 weeks prior to the week 4, 8, 12, 24, 40, and 52 visits of Study 20130255 |
| Percentage of Participants With at Least a 50% Reduction in Monthly Migraine Days From Study 20120295 Baseline | A migraine day was any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined either as a migraine without aura or a migraine with aura. Monthly migraine days were calculated as the number of migraine days in the 4-week baseline phase and during the 4 weeks prior to each study visit. At least a 50% reduction from baseline (of study 20120295) in monthly migraine days was determined if the change in monthly migraine days from the 4-week baseline phase to the 4 weeks prior to each study visit * 100 / baseline monthly migraine days was less than or equal to -50%. | 4-week baseline phase of Study 20120295 and the 4 weeks prior to the week 4, 8, 12, 24, 40 and 52 visits of Study 20130255 |
| Change From Study 20120295 Baseline in Monthly Acute Migraine-Specific Medication Treatment Days | Monthly acute migraine-specific medication treatment days is the number of days on which migraine specific medications were used between monthly doses of study drug. Migraine-specific medications includes two categories of medications: triptan-based migraine medications and ergotamine-based migraine medications. | 4-week baseline phase of Study 20120295 and the 4 weeks prior to the week 4, 8, 12, 24, 40 and 52 visits of Study 20130255 |
| Change From Study 20120295 Baseline in Cumulative Monthly Headache Hours | The cumulative duration of any qualified headache between monthly doses of study drug regardless of acute treatment use. A qualified headache was defined as follows:
| 4-week baseline phase of Study 20120295 and the 4 weeks prior to the week 4, 8, 12, 24, 40, and 52 visits of Study 20130255 |
| CHU Substudy: Number of Participants With Adverse Events | Adverse events were graded for severity using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Injection site reactions were derived from a Medical Dictionary for Regulatory Activities (MedDRA) query using a list of pre-specified preferred terms. An adverse device effect (ADE) is any adverse event related to the use of a medical device. | From first dose of erenumab in the CHU substudy to 28 days after last dose of erenumab in the CHU substudy; up to 12 weeks. |
| Palo Alto |
| California |
| 94304 |
| United States |
| Research Site | Santa Monica | California | 90404 | United States |
| Research Site | Sherman Oaks | California | 91403 | United States |
| Research Site | Stamford | Connecticut | 06905 | United States |
| Research Site | Jacksonville | Florida | 32256 | United States |
| Research Site | Orlando | Florida | 32801 | United States |
| Research Site | Palm Beach Gardens | Florida | 33410 | United States |
| Research Site | West Palm Beach | Florida | 33407 | United States |
| Research Site | Atlanta | Georgia | 30342 | United States |
| Research Site | Decatur | Georgia | 30033 | United States |
| Research Site | Indianapolis | Indiana | 46256 | United States |
| Research Site | Pikesville | Maryland | 21208 | United States |
| Research Site | Watertown | Massachusetts | 02472 | United States |
| Research Site | Worcester | Massachusetts | 01605 | United States |
| Research Site | Ann Arbor | Michigan | 48104 | United States |
| Research Site | Springfield | Missouri | 65807 | United States |
| Research Site | St Louis | Missouri | 63141 | United States |
| Research Site | Reno | Nevada | 89502 | United States |
| Research Site | Amherst | New York | 14226 | United States |
| Research Site | Greensboro | North Carolina | 27405 | United States |
| Research Site | Cleveland | Ohio | 44195 | United States |
| Research Site | Philadelphia | Pennsylvania | 19107 | United States |
| Research Site | Nashville | Tennessee | 37203 | United States |
| Research Site | Austin | Texas | 78731 | United States |
| Research Site | Dallas | Texas | 75214 | United States |
| Research Site | Dallas | Texas | 75231 | United States |
| Research Site | Virginia Beach | Virginia | 23454 | United States |
| Research Site | Seattle | Washington | 98195 | United States |
| Research Site | Calgary | Alberta | T3M 1M4 | Canada |
| Research Site | Montreal | Quebec | H2L 4M1 | Canada |
| Research Site | Brno | 611 00 | Czechia |
| Research Site | Brno | 656 91 | Czechia |
| Research Site | Prague | 120 00 | Czechia |
| Research Site | Prague | 140 59 | Czechia |
| Research Site | Glostrup Municipality | 2600 | Denmark |
| Research Site | Helsinki | 00100 | Finland |
| Research Site | Oulu | 90101 | Finland |
| Research Site | Tampere | 33100 | Finland |
| Research Site | Turku | 20100 | Finland |
| Research Site | Berlin | 10117 | Germany |
| Research Site | Berlin | 10435 | Germany |
| Research Site | Bochum | 44787 | Germany |
| Research Site | Essen | 45147 | Germany |
| Research Site | Hamburg | 20251 | Germany |
| Research Site | Kiel | 24149 | Germany |
| Research Site | Ålesund | 6003 | Norway |
| Research Site | Lillehammer | 2629 | Norway |
| Research Site | Sandvika | 1337 | Norway |
| Research Site | Stavanger | 4005 | Norway |
| Research Site | Krakow | 31-209 | Poland |
| Research Site | Lodz | 90-338 | Poland |
| Research Site | Lublin | 20-016 | Poland |
| Research Site | Poznan | 60-355 | Poland |
| Research Site | Świdnik | 21-040 | Poland |
| Research Site | Warsaw | 00-669 | Poland |
| Research Site | Falköping | 521 37 | Sweden |
| Research Site | Stockholm | 112 45 | Sweden |
| Research Site | Stockholm | 114 33 | Sweden |
| Research Site | Stockholm | 141 86 | Sweden |
| Research Site | Vällingby | 162 68 | Sweden |
| Research Site | Glasgow | G51 4TF | United Kingdom |
| Research Site | Hull | HU3 2JZ | United Kingdom |
| Research Site | London | SE5 9RS | United Kingdom |
| Research Site | Stoke-on-Trent | ST4 6QG | United Kingdom |
| Ashina M, Kudrow D, Reuter U, Dolezil D, Silberstein S, Tepper SJ, Xue F, Picard H, Zhang F, Wang A, Zhou Y, Hong F, Klatt J, Mikol DD. Long-term tolerability and nonvascular safety of erenumab, a novel calcitonin gene-related peptide receptor antagonist for prevention of migraine: A pooled analysis of four placebo-controlled trials with long-term extensions. Cephalalgia. 2019 Dec;39(14):1798-1808. doi: 10.1177/0333102419888222. Epub 2019 Nov 10. |
| 34928306 | Derived | Ashina M, Goadsby PJ, Dodick DW, Tepper SJ, Xue F, Zhang F, Brennan F, Paiva da Silva Lima G. Assessment of Erenumab Safety and Efficacy in Patients With Migraine With and Without Aura: A Secondary Analysis of Randomized Clinical Trials. JAMA Neurol. 2022 Feb 1;79(2):159-168. doi: 10.1001/jamaneurol.2021.4678. |
| 34301173 | Derived | Tepper SJ, Ashina M, Reuter U, Hallstrom Y, Broessner G, Bonner JH, Picard H, Cheng S, Chou DE, Zhang F, Klatt J, Mikol DD. Reduction in acute migraine-specific and non-specific medication use in patients treated with erenumab: post-hoc analyses of episodic and chronic migraine clinical trials. J Headache Pain. 2021 Jul 23;22(1):81. doi: 10.1186/s10194-021-01292-w. |
| 32216456 | Derived | Tepper SJ, Ashina M, Reuter U, Brandes JL, Dolezil D, Silberstein SD, Winner P, Zhang F, Cheng S, Mikol DD. Long-term safety and efficacy of erenumab in patients with chronic migraine: Results from a 52-week, open-label extension study. Cephalalgia. 2020 May;40(6):543-553. doi: 10.1177/0333102420912726. Epub 2020 Mar 26. |
| 31852816 | Derived | Kudrow D, Pascual J, Winner PK, Dodick DW, Tepper SJ, Reuter U, Hong F, Klatt J, Zhang F, Cheng S, Picard H, Eisele O, Wang J, Latham JN, Mikol DD. Vascular safety of erenumab for migraine prevention. Neurology. 2020 Feb 4;94(5):e497-e510. doi: 10.1212/WNL.0000000000008743. Epub 2019 Dec 18. |
| Enrolled in CHU Substudy |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Erenumab | Participants received erenumab 70 mg once a month (QM) and/or 140 mg QM by subcutaneous injection for up to 52 weeks. Participants who enrolled prior to amendment 2 received erenumab 70 mg once a month (QM). Participants who had not completed the week 28 visit at the time of amendment 2 had their dose increased to 140 mg QM at their next visit whereas participants who had already completed the week 28 visit remained on erenumab 70 mg QM. Participants who enrolled after amendment 2 received erenumab 140 mg QM for the duration of the study. |
| 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 |
| |||||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | 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 Adverse Events | Adverse events (AEs) were graded for severity using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, where Grade 1 = mild AE, asymptomatic or mild symptoms; Grade 2 = Moderate AE; Grade 3 = Severe or medically significant but not immediately life-threatening; Grade 4 = Life-threatening consequences; urgent intervention indicated; Grade 5 = Death related to AE. | All enrolled participants who received at least 1 dose of erenumab | Posted | Count of Participants | Participants | From first dose of erenumab in extension study 20130255 to the end of the 12-week safety follow-up period (up to 64 weeks). |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | CHU Substudy: Number of Participants Able to Administer a Full Dose of Erenumab in Home-use | At the CHU substudy day 28 and day 56 visits, the site provided erenumab 140 mg to participants to self-administer at home on the following day. Study site staff then called the participants and asked if they administered a full, partial, or no dose of erenumab. A full dose was defined when the entire volume of both prefilled syringes or autoinjector/pens were injected. | All randomized participants who received at least 1 dose of erenumab in the CHU substudy. | Posted | Count of Participants | Participants | Day 29 (week 4) and day 57 (week 8) of the substudy |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Study 20120295 Baseline in Monthly Migraine Days | A migraine day was any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined either as a migraine with or without aura. The change from baseline in monthly migraine days was calculated as the number of migraine days during the 4 weeks prior to each study visit - the number of migraine days during the 4-week baseline phase. | Enrolled participants who received at least one dose of erenumab and had at least one change from baseline measurement in monthly migraine day in study 20130255. The number of participants analyzed includes participants with available data at each time point. | Posted | Mean | Standard Deviation | migraine days / month | 4-week baseline phase of Study 20120295 and the 4 weeks prior to the week 4, 8, 12, 24, 40, and 52 visits of Study 20130255 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With at Least a 50% Reduction in Monthly Migraine Days From Study 20120295 Baseline | A migraine day was any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined either as a migraine without aura or a migraine with aura. Monthly migraine days were calculated as the number of migraine days in the 4-week baseline phase and during the 4 weeks prior to each study visit. At least a 50% reduction from baseline (of study 20120295) in monthly migraine days was determined if the change in monthly migraine days from the 4-week baseline phase to the 4 weeks prior to each study visit * 100 / baseline monthly migraine days was less than or equal to -50%. | Enrolled participants who received at least one dose of erenumab and had at least one change from baseline measurement in monthly migraine day in study 20130255. The analysis includes participants with available data at each time point. | Posted | Number | 95% Confidence Interval | percentage of participants | 4-week baseline phase of Study 20120295 and the 4 weeks prior to the week 4, 8, 12, 24, 40 and 52 visits of Study 20130255 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Study 20120295 Baseline in Monthly Acute Migraine-Specific Medication Treatment Days | Monthly acute migraine-specific medication treatment days is the number of days on which migraine specific medications were used between monthly doses of study drug. Migraine-specific medications includes two categories of medications: triptan-based migraine medications and ergotamine-based migraine medications. | Enrolled participants who received at least one dose of erenumab and had at least one change from baseline measurement in monthly migraine day in study 20130255. The analysis includes participants with available data at each time point. | Posted | Mean | Standard Deviation | acute migraine treatment days / month | 4-week baseline phase of Study 20120295 and the 4 weeks prior to the week 4, 8, 12, 24, 40 and 52 visits of Study 20130255 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Study 20120295 Baseline in Cumulative Monthly Headache Hours | The cumulative duration of any qualified headache between monthly doses of study drug regardless of acute treatment use. A qualified headache was defined as follows:
| Enrolled participants who received at least one dose of erenumab and had at least one change from baseline measurement in monthly migraine day in study 20130255. The analysis includes participants with available data at each time point. | Posted | Mean | Standard Deviation | hours / month | 4-week baseline phase of Study 20120295 and the 4 weeks prior to the week 4, 8, 12, 24, 40, and 52 visits of Study 20130255 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | CHU Substudy: Number of Participants With Adverse Events | Adverse events were graded for severity using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Injection site reactions were derived from a Medical Dictionary for Regulatory Activities (MedDRA) query using a list of pre-specified preferred terms. An adverse device effect (ADE) is any adverse event related to the use of a medical device. | All randomized participants who received at least one dose of erenumab in the CHU substudy. | Posted | Count of Participants | Participants | From first dose of erenumab in the CHU substudy to 28 days after last dose of erenumab in the CHU substudy; up to 12 weeks. |
|
|
From first dose of erenumab in extension study 20130255 to the end of the 12-week safety follow-up period (up to 64 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Erenumab | Participants received erenumab 70 mg once a month (QM) and/or 140 mg QM by subcutaneous injection for up to 52 weeks. Participants who enrolled prior to amendment 2 received erenumab 70 mg once a month (QM). Participants who had not completed the week 28 visit at the time of amendment 2 had their dose increased to 140 mg QM at their next visit whereas participants who had already completed the week 28 visit remained on erenumab 70 mg QM. Participants who enrolled after amendment 2 received erenumab 140 mg QM for the duration of the study. | 0 | 609 | 24 | 609 | 162 | 609 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial bridging | Congenital, familial and genetic disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Volvulus | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Alcoholic liver disease | Hepatobiliary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Post procedural oedema | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Medication overuse headache | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Radicular syndrome | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Vestibular migraine | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Alcoholism | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinusitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 | medinfo@amgen.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 7, 2016 | May 24, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| C000605816 | erenumab |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
|
| Black or African American |
|
| Native Hawaiian or Other Pacific Islander |
|
| White |
|
| Other |
|
| Title | Measurements |
|---|---|
|
| Adverse event grade ≥ 4 |
|
| Treatment-related adverse events |
|
| Serious adverse events |
|
| AE leading to discontinuation of erenumab |
|
| Fatal adverse events |
|
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| Units | Counts |
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| Participants |
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| Participants |
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