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AMG 334 20160172 Pediatric Migraine PK Study.
An Open-label, Randomized, Multiple-dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of AMG 334 in Children and Adolescents With Migraine
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Other | Subjects with a body weight at Day 1 of less than weight threshold. |
|
| Cohort 2 | Other | Subjects with a body weight at Day 1 of weight threshold or more. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMG 334 Dose 1 | Drug | Subjects weighing less than weight threshold at Day 1 will be randomized to either Dose 1 or Dose 3. Subjects weighing weight threshold or more at Day 1 will be randomized to either Dose 1 or Dose 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Maximum Concentration (Tmax) of Erenumab | Blood samples for pharmacokinetic (PK) testing were collected for the measurement of PK concentrations. Serum erenumab concentrations were determined using a validated assay. Noncompartmental analysis (NCA) was performed for erenumab PK parameter estimation. | First dose: Days 1 (pre-dose), 8, 15, and 29 (pre-dose); third dose: Days 57 (pre-dose), 64, 71, and 85 |
| Maximum Observed Concentration (Cmax) of Erenumab | Blood samples for PK testing were collected for the measurement of PK concentrations. Serum erenumab concentrations were determined using a validated assay. NCA was performed for erenumab PK parameter estimation. | First dose: Days 1 (pre-dose), 8, 15, and 29 (pre-dose); third dose: Days 57 (pre-dose), 64, 71, and 85 |
| Trough Concentration (Ctrough) of Erenumab | Blood samples for PK testing were collected for the measurement of PK concentrations. Serum erenumab concentrations were determined using a validated assay. NCA was performed for erenumab PK parameter estimation. | First dose: Days 1 (pre-dose), 8, 15, and 29 (pre-dose); third dose: Days 57 (pre-dose), 64, 71, and 85 |
| Area Under the Concentration Time Curve From 0 to 28 Days (AUC0-28day) of Erenumab | Blood samples for PK testing were collected for the measurement of PK concentrations. Serum erenumab concentrations were determined using a validated assay. NCA was performed for erenumab PK parameter estimation. | First dose: Days 1 (pre-dose), 8, 15, and 29 (pre-dose); third dose: Days 57 (pre-dose), 64, 71, and 85 |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant. A TEAE was defined as an AE starting on or after first dose of investigational product. The event did not necessarily have a causal relationship with study treatment. |
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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 |
|---|---|---|---|---|---|---|
| Arkansas Childrens Hospital | Little Rock | Arkansas | 72202 | United States | ||
| CarePoint |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38476099 | Background | Hershey AD, Paiva da Silva Lima G, Pannacciulli N, Mackowski M, Koukakis R, McVige JW. Pharmacokinetics and safety of erenumab in pediatric patients with migraine: A phase I, randomized, open-label, multiple-dose study. Clin Transl Sci. 2024 Mar;17(3):e13755. doi: 10.1111/cts.13755. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
Participants weighing < 40 kg (Cohort 1) received a dose of either 35 mg or 70 mg erenumab. Participants weighing ≥ 40 kg (Cohort 2) received a dose of either 70 mg or 140 mg erenumab. All participants participated in the initial treatment phase for a total of 12 weeks of treatment. Adolescents 12 to < 18 years of age at time of consent had the option of continuing treatment with the same dose they received in the initial treatment phase in a 40-week extension phase.
Of the 63 participants screened, 53 participants were enrolled at 9 centers in the United States between 04 May 2018 and 23 November 2021. Enrollment was staggered by age category with adolescents 12 to < 18 years of age starting enrollment first, followed by children 6 to < 12 years of age.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: Erenumab 35 mg | Participants weighing < 40 kg received a dose of 35 mg erenumab Q4W via SC injection in the initial 12-week treatment phase. Adolescents 12 to < 18 years of age at time of consent had the option of continuing treatment with the same dose they received in the initial treatment phase in a 40-week extension phase, for a total of 52 weeks of treatment. |
| FG001 | Cohort 1: Erenumab 70 mg | Participants weighing < 40 kg received a dose of 70 mg erenumab Q4W via SC injection in the initial 12-week treatment phase. Adolescents 12 to < 18 years of age at time of consent had the option of continuing treatment with the same dose they received in the initial treatment phase in a 40-week extension phase, for a total of 52 weeks of treatment. |
| FG002 | Cohort 2: Erenumab 70 mg | Participants weighing ≥ 40 kg received a dose of 70 mg erenumab Q4W via SC injection in the initial 12-week treatment phase. Adolescents 12 to < 18 years of age at time of consent had the option of continuing treatment with the same dose they received in the initial treatment phase in a 40-week extension phase, for a total of 52 weeks of treatment. |
| FG003 | Cohort 2: Erenumab 140 mg | Participants weighing ≥ 40 kg received a dose of 140 mg erenumab Q4W via SC injection in the initial 12-week treatment phase. Adolescents 12 to < 18 years of age at time of consent had the option of continuing treatment with the same dose they received in the initial treatment phase in a 40-week extension phase, for a total of 52 weeks of treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Initial Treatment Phase |
|
| ||||||||||||||||||
| Optional Extension Phase |
|
The full analysis set included all randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: Erenumab 35 mg | Participants weighing < 40 kg received a dose of 35 mg erenumab Q4W via SC injection in the initial 12-week treatment phase. Adolescents 12 to < 18 years of age at time of consent had the option of continuing treatment with the same dose they received in the initial treatment phase in a 40-week extension phase, for a total of 52 weeks of treatment. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Maximum Concentration (Tmax) of Erenumab | Blood samples for pharmacokinetic (PK) testing were collected for the measurement of PK concentrations. Serum erenumab concentrations were determined using a validated assay. Noncompartmental analysis (NCA) was performed for erenumab PK parameter estimation. | The PK analysis set contained all randomized participants who received at least 1 dose of erenumab and had at least 1 PK concentration result. Data were excluded from the NCA if:
| Posted | Median | Full Range | days | First dose: Days 1 (pre-dose), 8, 15, and 29 (pre-dose); third dose: Days 57 (pre-dose), 64, 71, and 85 |
|
Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up
The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.
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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 | Initial Treatment Phase Cohort 1: Erenumab 35 mg | Participants weighing < 40 kg received a dose of 35 mg erenumab Q4W via SC injection in the initial 12-week treatment phase. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastritis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 | medinfo@amgen.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 3, 2021 | Nov 4, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 17, 2022 | Nov 4, 2022 | SAP_001.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 |
|---|---|
| D053523 | Amelogenin |
| ID | Term |
|---|---|
| D003746 | Dental Enamel Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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| AMG 334 Dose 2 | Drug | Subjects weighing weight threshold or more at Day 1 will be randomized to either Dose 1 or Dose 2. |
|
| AMG 334 Dose 3 | Drug | Subjects weighing less than weight threshold at Day 1 will be randomized to either Dose 1 or Dose 3. |
|
| Up to Week 52 + 16-week safety follow-up |
| Number of Participants With Clinically Significant Changes in Vital Signs Measurements | The following measurements were performed: systolic/diastolic blood pressure, heart rate, and temperature. | Up to Week 52 + 16-week safety follow-up |
| Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Measurements | Clinically significant changes in ECG was defined as incidence of abnormal ECG diagnosis based on 12-lead ECG including heart rate, QRS, QTc and PR intervals. | Up to Week 52 |
| Number of Participants With Clinically Significant Changes in Clinical Laboratory Safety Tests | The clinical laboratory safety tests included: chemistry, hematology, and urinalysis. | Up to Week 52 + 16-week safety follow-up |
| Number of Participants With Clinically Significant Changes in Neurological Assessments | The neurological examinations were completed as per standard of care. | Up to Week 52 + 16-week safety follow-up |
| Englewood |
| Colorado |
| 80112 |
| United States |
| New England Institute for Clinical Research | Stamford | Connecticut | 06905 | United States |
| Synergy Health | Bradenton | Florida | 34208 | United States |
| Premiere Research Institute | West Palm Beach | Florida | 33407 | United States |
| PANDA Neurology and Atlanta Headache Specialists | Atlanta | Georgia | 30328 | United States |
| Riley Hosptial | Indianapolis | Indiana | 46202 | United States |
| Clinical Research Institute Inc | Plymouth | Minnesota | 55441 | United States |
| Childrens Mercy Hospital | Kansas City | Missouri | 64108 | United States |
| Meridian Clinical Research | Hastings | Nebraska | 68901 | United States |
| Dent Neurosciences Research Center | Amherst | New York | 14226 | United States |
| State University of New York Upstate Medical University | Syracuse | New York | 13210 | United States |
| Cincinnati Childrens Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| Nationwide Childrens Hospital | Columbus | Ohio | 43205 | United States |
| Withdrawal by Subject |
|
| Decision by Sponsor |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG001 | Cohort 1: Erenumab 70 mg | Participants weighing < 40 kg received a dose of 70 mg erenumab Q4W via SC injection in the initial 12-week treatment phase. Adolescents 12 to < 18 years of age at time of consent had the option of continuing treatment with the same dose they received in the initial treatment phase in a 40-week extension phase, for a total of 52 weeks of treatment. |
| BG002 | Cohort 2: Erenumab 70 mg | Participants weighing ≥ 40 kg received a dose of 70 mg erenumab Q4W via SC injection in the initial 12-week treatment phase. Adolescents 12 to < 18 years of age at time of consent had the option of continuing treatment with the same dose they received in the initial treatment phase in a 40-week extension phase, for a total of 52 weeks of treatment. |
| BG003 | Cohort 2: Erenumab 140 mg | Participants weighing ≥ 40 kg received a dose of 140 mg erenumab Q4W via SC injection in the initial 12-week treatment phase. Adolescents 12 to < 18 years of age at time of consent had the option of continuing treatment with the same dose they received in the initial treatment phase in a 40-week extension phase, for a total of 52 weeks of treatment. |
| BG004 | Total | Total of all reporting groups |
| 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 |
|
Participants weighing < 40 kg received a dose of 35 mg erenumab Q4W via SC injection in the initial 12-week treatment phase. Adolescents 12 to < 18 years of age at time of consent had the option of continuing treatment with the same dose they received in the initial treatment phase in a 40-week extension phase, for a total of 52 weeks of treatment. |
| OG001 | Cohort 1: Erenumab 70 mg | Participants weighing < 40 kg received a dose of 70 mg erenumab Q4W via SC injection in the initial 12-week treatment phase. Adolescents 12 to < 18 years of age at time of consent had the option of continuing treatment with the same dose they received in the initial treatment phase in a 40-week extension phase, for a total of 52 weeks of treatment. |
| OG002 | Cohort 2: Erenumab 70 mg | Participants weighing ≥ 40 kg received a dose of 70 mg erenumab Q4W via SC injection in the initial 12-week treatment phase. Adolescents 12 to < 18 years of age at time of consent had the option of continuing treatment with the same dose they received in the initial treatment phase in a 40-week extension phase, for a total of 52 weeks of treatment. |
| OG003 | Cohort 2: Erenumab 140 mg | Participants weighing ≥ 40 kg received a dose of 140 mg erenumab Q4W via SC injection in the initial 12-week treatment phase. Adolescents 12 to < 18 years of age at time of consent had the option of continuing treatment with the same dose they received in the initial treatment phase in a 40-week extension phase, for a total of 52 weeks of treatment. |
|
|
| Primary | Maximum Observed Concentration (Cmax) of Erenumab | Blood samples for PK testing were collected for the measurement of PK concentrations. Serum erenumab concentrations were determined using a validated assay. NCA was performed for erenumab PK parameter estimation. | The PK analysis set contained all randomized participants who received at least 1 dose of erenumab and had at least 1 PK concentration result. Data were excluded from the NCA if:
| Posted | Mean | Standard Deviation | μg/mL | First dose: Days 1 (pre-dose), 8, 15, and 29 (pre-dose); third dose: Days 57 (pre-dose), 64, 71, and 85 |
|
|
|
| Primary | Trough Concentration (Ctrough) of Erenumab | Blood samples for PK testing were collected for the measurement of PK concentrations. Serum erenumab concentrations were determined using a validated assay. NCA was performed for erenumab PK parameter estimation. | The PK analysis set contained all randomized participants who received at least 1 dose of erenumab and had at least 1 PK concentration result. Data were excluded from the NCA if:
| Posted | Mean | Standard Deviation | μg/mL | First dose: Days 1 (pre-dose), 8, 15, and 29 (pre-dose); third dose: Days 57 (pre-dose), 64, 71, and 85 |
|
|
|
| Primary | Area Under the Concentration Time Curve From 0 to 28 Days (AUC0-28day) of Erenumab | Blood samples for PK testing were collected for the measurement of PK concentrations. Serum erenumab concentrations were determined using a validated assay. NCA was performed for erenumab PK parameter estimation. | The PK analysis set contained all randomized participants who received at least 1 dose of erenumab and had at least 1 PK concentration result. Data were excluded from the NCA if:
| Posted | Median | Full Range | day*μg/mL | First dose: Days 1 (pre-dose), 8, 15, and 29 (pre-dose); third dose: Days 57 (pre-dose), 64, 71, and 85 |
|
|
|
| Primary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant. A TEAE was defined as an AE starting on or after first dose of investigational product. The event did not necessarily have a causal relationship with study treatment. | The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase. | Posted | Count of Participants | Participants | Up to Week 52 + 16-week safety follow-up |
|
|
|
| Primary | Number of Participants With Clinically Significant Changes in Vital Signs Measurements | The following measurements were performed: systolic/diastolic blood pressure, heart rate, and temperature. | The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase. | Posted | Count of Participants | Participants | Up to Week 52 + 16-week safety follow-up |
|
|
|
| Primary | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Measurements | Clinically significant changes in ECG was defined as incidence of abnormal ECG diagnosis based on 12-lead ECG including heart rate, QRS, QTc and PR intervals. | The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase. | Posted | Count of Participants | Participants | Up to Week 52 |
|
|
|
| Primary | Number of Participants With Clinically Significant Changes in Clinical Laboratory Safety Tests | The clinical laboratory safety tests included: chemistry, hematology, and urinalysis. | The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase. | Posted | Count of Participants | Participants | Up to Week 52 + 16-week safety follow-up |
|
|
|
| Primary | Number of Participants With Clinically Significant Changes in Neurological Assessments | The neurological examinations were completed as per standard of care. | The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase. | Posted | Count of Participants | Participants | Up to Week 52 + 16-week safety follow-up |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 2 |
| 4 |
| EG001 | Initial Treatment Phase Cohort 1: Erenumab 70 mg | Participants weighing < 40 kg received a dose of 70 mg erenumab Q4W via SC injection in the initial 12-week treatment phase. | 0 | 9 | 0 | 9 | 6 | 9 |
| EG002 | Initial Treatment Phase Cohort 2: Erenumab 70 mg | Participants weighing ≥ 40 kg received a dose of 70 mg erenumab Q4W via SC injection in the initial 12-week treatment phase. | 0 | 8 | 1 | 8 | 6 | 8 |
| EG003 | Initial Treatment Phase Cohort 2: Erenumab 140 mg | Participants weighing ≥ 40 kg received a dose of 140 mg erenumab Q4W via SC injection in the initial 12-week treatment phase. | 0 | 32 | 1 | 32 | 19 | 32 |
| EG004 | Optional Extension Phase Cohort 1: Erenumab 35 mg | Adolescents 12 to < 18 years of age at time of consent weighing < 40 kg continued to receive a dose of 35 mg erenumab Q4W via SC injection in the 40-week extension phase. | 0 | 1 | 0 | 1 | 0 | 1 |
| EG005 | Optional Extension Phase Cohort 1: Erenumab 70 mg | Adolescents 12 to < 18 years of age at time of consent weighing < 40 kg continued to receive a dose of 70 mg erenumab Q4W via SC injection in the 40-week extension phase. | 0 | 3 | 1 | 3 | 2 | 3 |
| EG006 | Optional Extension Phase Cohort 2: Erenumab 70 mg | Adolescents 12 to < 18 years of age at time of consent weighing ≥ 40 kg continued to receive a dose of 70 mg erenumab Q4W via SC injection in the 40-week extension phase. | 0 | 5 | 0 | 5 | 4 | 5 |
| EG007 | Optional Extension Phase Cohort 2: Erenumab 140 mg | Adolescents 12 to < 18 years of age at time of consent weighing ≥ 40 kg continued to receive a dose of 140 mg erenumab Q4W via SC injection in the 40-week extension phase. | 0 | 27 | 1 | 27 | 19 | 27 |
| Appendicitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
|
| Suicide attempt | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 24.0 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Injection site induration | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Injection site warmth | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| QRS axis abnormal | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Mobility decreased | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Posture abnormal | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Temporomandibular joint syndrome | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Balance disorder | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Adjustment disorder with mixed anxiety and depressed mood | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
|
| Panic attack | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA 24.0 | 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.
| D009422 | Nervous System Diseases |
| Title | Measurements |
|---|---|
|
|
| Third Dose |
|
|
|
| Third Dose |
|
|
|
| Third Dose |
|
|