Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2011-005600-15 | EudraCT Number |
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The primary purpose of this study is to determine whether erenumab is safe and well tolerated in healthy adults and migraine patients. As part of the secondary objectives, this study will be conducted to characterize the pharmacokinetic (PK) profile of erenumab after single subcutaneous (SC) or intravenous (IV) doses in healthy participants and migraine patients as well as to characterize the effect of erenumab on the capsaicin-induced increase in dermal blood flow after single SC or IV doses in healthy participants and migraine patients.
This study was a single-dose, double-blind, placebo-controlled, sequential dose escalation study in which participants were to be enrolled into 8 cohorts.
In Part 1 healthy participants were randomized in a 3:1 ratio (erenumab:placebo) into 6 cohorts: 5 cohorts received the investigational product (IP) as an SC administration and 1 cohort received it as an IV administration. In Part 2 a total of 12 migraine patients were randomized in a 1:1 ratio (erenumab:placebo) in cohort 7. An additional 8 migraine patients could have been enrolled and randomized in a 3:1 ratio in the optional cohort 8, however this cohort was not enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erenumab | Experimental | Participants received a single dose of erenumab by subcutaneous injection at doses of 1 mg, 7 mg, 21 mg, 70 mg, 140 mg, and 210 mg or by IV injection at a dose of 140 mg. |
|
| Placebo | Placebo Comparator | Participants received a single dose of matching placebo administered by SC or IV injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erenumab | Drug | Administered by subcutaneous injection or intravenous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant. The event does not necessarily have a causal relationship with study treatment. The definition of adverse events includes worsening of a pre-existing medical condition. Laboratory value changes that require treatment or adjustment in current therapy are considered adverse events. Teatment-related adverse events (TRAEs) are those assessed by the investigator as being possibly related to study drug. A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria:
| From the initial dose of study drug up to 155 days. |
| Number of Participants Who Developed Anti-erenumab Antibodies | Participants who had a negative or no result at baseline and were antibody positive postbaseline. Blood samples were first tested for anti-erenumab binding antibodies, samples testing positive for binding antibodies were also tested for neutralizing antibodies. | Baseline and up to 155 days postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Concentration (Cmax) of Erenumab | Predose to 155 days postdose | |
| Time to Maximum Observed Concentration (Tmax) of Erenumab | Predose to 155 days postdose | |
Not provided
Inclusion Criteria:
- Healthy male and female subjects between 18 and 45 years of age, or male or female subjects with migraines between 18 and 55 years of age, inclusive, with no history or evidence of clinically relevant medical disorders as determined by the investigator in consultation with the Amgen physician;
Exclusion Criteria:
- History or evidence of clinically significant disorder (including psychiatric), condition or disease that, in the opinion of the Investigator or Amgen physician would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion;
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Leuven | 3000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28593473 | Background | Vu T, Ma P, Chen JS, de Hoon J, Van Hecken A, Yan L, Wu LS, Hamilton L, Vargas G. Pharmacokinetic-Pharmacodynamic Relationship of Erenumab (AMG 334) and Capsaicin-Induced Dermal Blood Flow in Healthy and Migraine Subjects. Pharm Res. 2017 Sep;34(9):1784-1795. doi: 10.1007/s11095-017-2183-6. Epub 2017 Jun 7. | |
| 28736918 | Background |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
Not provided
Healthy participants were randomized in a 3:1 ratio to erenumab or placebo within each dose cohort. Migraine participants were randomized in a 1:1 ratio to erenumab or placebo.
This study was conducted at a single center in Belgium from March 2012 to March 2013.
The study enrolled healthy participants (Part 1) and participants who had migraines for at least 6 months and at least 3 migraine attacks per month in the last 3 months (Part 2).
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy: Placebo | Healthy participants received a single dose of matching placebo administered by subcutaneous (SC) or intravenous (IV) injection. |
| FG001 | Healthy: Erenumab 1 mg SC | Healthy participants received a single dose of erenumab 1 mg administered by subcutaneous injection. |
| FG002 | Healthy: Erenumab 7 mg SC | Healthy participants received a single dose of erenumab 7 mg administered by subcutaneous injection. |
| FG003 | Healthy: Erenumab 21 mg SC | Healthy participants received a single dose of erenumab 21 mg administered by subcutaneous injection. |
| FG004 | Healthy: Erenumab 70 mg SC | Healthy participants received a single dose of erenumab 70 mg administered by subcutaneous injection. |
| FG005 | Healthy: Erenumab 140 mg SC | Healthy participants received a single dose of erenumab 140 mg administered by subcutaneous injection. |
| FG006 | Healthy: Erenumab 140 mg IV | Healthy participants received a single dose of erenumab 140 mg administered by intravenous injection. |
| FG007 | Healthy: Erenumab 210 mg SC | Healthy participants received a single dose of erenumab 210 mg administered by subcutaneous injection. |
| FG008 | Migraine: Placebo | Participants with migraine received a single dose of placebo administered by subcutaneous injection. |
| FG009 | Migraine: Erenumab 140 mg SC | Participants with migraine received a single dose of erenumab 140 mg administered by subcutaneous injection. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants who received study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Healthy: Placebo | Healthy participants received a single dose of matching placebo administered by subcutaneous (SC) or intravenous (IV) injection. |
| BG001 | Healthy: Erenumab 1 mg SC |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Data are reported separately for each part of the study. |
| 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 | An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant. The event does not necessarily have a causal relationship with study treatment. The definition of adverse events includes worsening of a pre-existing medical condition. Laboratory value changes that require treatment or adjustment in current therapy are considered adverse events. Teatment-related adverse events (TRAEs) are those assessed by the investigator as being possibly related to study drug. A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria:
| All participants who received study drug. | Posted | Count of Participants | Participants | From the initial dose of study drug up to 155 days. |
|
From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
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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 | Healthy: Placebo | Healthy participants received a single dose of matching placebo administered by subcutaneous (SC) or intravenous (IV) injection. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eosinophilia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 |
Not provided
| 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 |
Not provided
Not provided
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| Placebo | Drug | Administered by subcutaneous injection or intravenous injection |
|
| Area Under the Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of Erenumab |
| Predose to 155 days postdose |
| Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) of Erenumab | Predose to 155 days postdose |
| Ratio of Post-capsaicin Dermal Blood Flow to Pre-capsaicin Dermal Blood Flow | Inhibition of capsaicin-induced dermal blood flow (DBF) by erenumab was used to measure calcitonin gene-related peptide (CGRP) receptor antagonism. Capsaicin was applied at 2 sites on the volar surface of the participants' left or right forearms and a control mixture was applied to 1 site on the volar surface of either the participants' left or right forearm. Dermal blood flow was assessed by laser Doppler perfusion imaging and was done immediately before ('baseline') and 0.5 hours post-capsaicin on the surface of these 3 sites. Data reported are the least square geometric mean ratios for the post-capsaicin dermal blood flow to pre-capsaicin dermal blood flow. According to the protocol, not all cohorts had dermal blood flow measurements at all time points. | Days 4, 15, 29, 43, 64, 85, 99, 127, and end of study (defined as day 43 for the 1 mg, 7 mg and 21 mg erenumab cohorts, day 99 for the 70 mg erenumab cohort, day 127 for the 140 mg erenumab cohorts and day 155 for the 210 mg erenumab cohort). |
| de Hoon J, Van Hecken A, Vandermeulen C, Yan L, Smith B, Chen JS, Bautista E, Hamilton L, Waksman J, Vu T, Vargas G. Phase I, Randomized, Double-blind, Placebo-controlled, Single-dose, and Multiple-dose Studies of Erenumab in Healthy Subjects and Patients With Migraine. Clin Pharmacol Ther. 2018 May;103(5):815-825. doi: 10.1002/cpt.799. Epub 2017 Oct 24. |
Healthy participants received a single dose of erenumab 1 mg administered by subcutaneous injection.
| BG002 | Healthy: Erenumab 7 mg SC | Healthy participants received a single dose of erenumab 7 mg administered by subcutaneous injection. |
| BG003 | Healthy: Erenumab 21 mg SC | Healthy participants received a single dose of erenumab 21 mg administered by subcutaneous injection. |
| BG004 | Healthy: Erenumab 70 mg SC | Healthy participants received a single dose of erenumab 70 mg administered by subcutaneous injection. |
| BG005 | Healthy: Erenumab 140 mg SC | Healthy participants received a single dose of erenumab 140 mg administered by subcutaneous injection. |
| BG006 | Healthy: Erenumab 140 mg IV | Healthy participants received a single dose of erenumab 140 mg administered by intravenous injection. |
| BG007 | Healthy: Erenumab 210 mg SC | Healthy participants received a single dose of erenumab 210 mg administered by subcutaneous injection. |
| BG008 | Migraine: Placebo | Participants with migraine received a single dose of placebo administered by subcutaneous injection. |
| BG009 | Migraine: Erenumab 140 mg SC | Participants with migraine received a single dose of erenumab 140 mg administered by subcutaneous injection. |
| BG010 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG000 | Healthy: Placebo | Healthy participants received a single dose of matching placebo administered by subcutaneous (SC) or intravenous (IV) injection. |
| OG001 | Healthy: Erenumab 1 mg SC | Healthy participants received a single dose of erenumab 1 mg administered by subcutaneous injection. |
| OG002 | Healthy: Erenumab 7 mg SC | Healthy participants received a single dose of erenumab 7 mg administered by subcutaneous injection. |
| OG003 | Healthy: Erenumab 21 mg SC | Healthy participants received a single dose of erenumab 21 mg administered by subcutaneous injection. |
| OG004 | Healthy: Erenumab 70 mg SC | Healthy participants received a single dose of erenumab 70 mg administered by subcutaneous injection. |
| OG005 | Healthy: Erenumab 140 mg SC | Healthy participants received a single dose of erenumab 140 mg administered by subcutaneous injection. |
| OG006 | Healthy: Erenumab 140 mg IV | Healthy participants received a single dose of erenumab 140 mg administered by intravenous injection. |
| OG007 | Healthy: Erenumab 210 mg SC | Healthy participants received a single dose of erenumab 210 mg administered by subcutaneous injection. |
| OG008 | Migraine: Placebo | Participants with migraine received a single dose of placebo administered by subcutaneous injection. |
| OG009 | Migraine: Erenumab 140 mg SC | Participants with migraine received a single dose of erenumab 140 mg administered by subcutaneous injection. |
|
|
| Primary | Number of Participants Who Developed Anti-erenumab Antibodies | Participants who had a negative or no result at baseline and were antibody positive postbaseline. Blood samples were first tested for anti-erenumab binding antibodies, samples testing positive for binding antibodies were also tested for neutralizing antibodies. | All participants who received study drug | Posted | Count of Participants | Participants | Baseline and up to 155 days postdose |
|
|
|
| Secondary | Maximum Observed Concentration (Cmax) of Erenumab | All participants who received erenumab | Posted | Mean | Standard Deviation | µg/mL | Predose to 155 days postdose |
|
|
|
|
| Secondary | Time to Maximum Observed Concentration (Tmax) of Erenumab | All participants who received erenumab | Posted | Median | Full Range | days | Predose to 155 days postdose |
|
|
|
| Secondary | Area Under the Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of Erenumab | All participants who received erenumab | Posted | Mean | Standard Deviation | days*µg/mL | Predose to 155 days postdose |
|
|
|
|
| Secondary | Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) of Erenumab | All participants who received erenumab | Posted | Mean | Standard Deviation | days*µg/mL | Predose to 155 days postdose |
|
|
|
|
| Secondary | Ratio of Post-capsaicin Dermal Blood Flow to Pre-capsaicin Dermal Blood Flow | Inhibition of capsaicin-induced dermal blood flow (DBF) by erenumab was used to measure calcitonin gene-related peptide (CGRP) receptor antagonism. Capsaicin was applied at 2 sites on the volar surface of the participants' left or right forearms and a control mixture was applied to 1 site on the volar surface of either the participants' left or right forearm. Dermal blood flow was assessed by laser Doppler perfusion imaging and was done immediately before ('baseline') and 0.5 hours post-capsaicin on the surface of these 3 sites. Data reported are the least square geometric mean ratios for the post-capsaicin dermal blood flow to pre-capsaicin dermal blood flow. According to the protocol, not all cohorts had dermal blood flow measurements at all time points. | All participants for whom at least one post-dose capsaicin response measure was recorded. | Posted | Geometric Least Squares Mean | Standard Error | ratio | Days 4, 15, 29, 43, 64, 85, 99, 127, and end of study (defined as day 43 for the 1 mg, 7 mg and 21 mg erenumab cohorts, day 99 for the 70 mg erenumab cohort, day 127 for the 140 mg erenumab cohorts and day 155 for the 210 mg erenumab cohort). |
|
|
|
| 0 |
| 12 |
| 10 |
| 12 |
| EG001 | Healthy: Erenumab 1 mg SC | Healthy participants received a single dose of erenumab 1 mg administered by subcutaneous injection. | 0 | 3 | 2 | 3 |
| EG002 | Healthy: Erenumab 7 mg SC | Healthy participants received a single dose of erenumab 7 mg administered by subcutaneous injection. | 0 | 3 | 1 | 3 |
| EG003 | Healthy: Erenumab 21 mg SC | Healthy participants received a single dose of erenumab 21 mg administered by subcutaneous injection. | 0 | 6 | 6 | 6 |
| EG004 | Healthy: Erenumab 70 mg SC | Healthy participants received a single dose of erenumab 70 mg administered by subcutaneous injection. | 0 | 6 | 5 | 6 |
| EG005 | Healthy: Erenumab 140 mg SC | Healthy participants received a single dose of erenumab 140 mg administered by subcutaneous injection. | 0 | 6 | 5 | 6 |
| EG006 | Healthy: Erenumab 140 mg IV | Healthy participants received a single dose of erenumab 140 mg administered by intravenous injection. | 0 | 6 | 5 | 6 |
| EG007 | Healthy: Erenumab 210 mg SC | Healthy participants received a single dose of erenumab 210 mg administered by subcutaneous injection. | 0 | 6 | 6 | 6 |
| EG008 | Migraine: Placebo | Participants with migraine received a single dose of placebo administered by subcutaneous injection. | 0 | 6 | 5 | 6 |
| EG009 | Migraine: Erenumab 140 mg SC | Participants with migraine received a single dose of erenumab 140 mg administered by subcutaneous injection. | 0 | 6 | 6 | 6 |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Ear haemorrhage | Ear and labyrinth disorders | MedDRA 15.0 | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA 15.0 | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA 15.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Injection site haemorrhage | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Genital infection fungal | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 15.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 15.0 | Systematic Assessment |
|
| Electrocardiogram PR prolongation | Investigations | MedDRA 15.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Dysaesthesia | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
|
| Leukocyturia | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
|
| Pyuria | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
|
| Breast cyst | Reproductive system and breast disorders | MedDRA 15.0 | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 15.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Pharyngeal erythema | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Pharyngeal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA 15.0 | 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 |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Black or African American |
|
| Mixed race |
|
| Native Hawaiian or Other Pacific Islander |
|
| White |
|
| Neutralizing antibody positive |
|
|
| Day 15 |
|
|
| Day 29 |
|
|
| Day 43 |
|
|
| Day 64 |
|
|
| Day 85 |
|
|
| Day 99 |
|
|
| Day 127 |
|
|
| End of study |
|
|