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The purpose of this study is to obtain initial information on the safety and tolerability (effects good or bad), pharmacokinetics (what the body does to the drug), and pharmacodynamics (what the drug does to the body) of a single dose of AMG 570.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMG 570 - 7 mg | Experimental | Participants will receive a single dose 7 mg dose of AMG 570 administered subcutaneously. |
|
| AMG 570 - 21 mg | Experimental | Participants will receive a single 21 mg dose of AMG 570 administered subcutaneously. |
|
| AMG 570 - 70 mg | Experimental | Participants will receive a single 70 mg dose of AMG 570 administered subcutaneously. |
|
| AMG 570 - 140 mg | Experimental | Participants will receive a single 140 mg dose of AMG 570 administered subcutaneously. |
|
| AMG 570 - 210 mg | Experimental | Participants will receive a single 210 mg dose of AMG 570 administered subcutaneously. |
|
| AMG 570 - 420 mg | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMG 570 | Biological | 7 dose levels of AMG 570 administered as single dose subcutaneous in healthy volunteers. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced One or More Treatment-emergent Adverse Events (TEAEs) | TEAEs were adverse events with an onset after the administration of study treatment. TEAEs were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limited age appropriate instrumental activities of daily life (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolonged hospitalization indicated; disabling; limited self care ADL. Grade 4 Life-threatening consequences; urgent interventions indicated. Serious adverse events (SAEs) were defined as meeting at least 1 of the following criteria:
| Day 1 to Day 105 |
| Number of Participants Who Experienced a Clinically Significant Change in Physical Examinations | Physical examinations were performed by the investigator, designated physician, or nurse practitioner. A complete physical examination included, at a minimum, assessment of cardiovascular, respiratory, gastrointestinal and neurological systems. A brief physical examination included assessment of the skin, lungs, cardiovascular system, and abdomen (liver and spleen). | Baseline to Day 105 |
| Number of Participants Who Experienced a Clinically Significant Change in Vital Signs | Any changes in blood pressure, body temperature, heart rate, and pulse rate that were deemed as clinically significant by the Investigator were reported. | Baseline to Day 105 |
| Number of Participants Who Experienced a Clinically Significant Change in Clinical Laboratory Safety Tests | Laboratory safety tests included chemistry, hematology, and urinalysis parameters. Clinically significant laboratory safety tests were any events assessed as CTCAE Grade ≥3 at any post-baseline visit. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolonged hospitalization indicated; disabling; limited self care ADL. Grade 4 Life-threatening consequences; urgent interventions indicated. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Concentration (Cmax) of AMG 570 | AMG 570 pharmacokinetic (PK) parameters were estimated using non-compartmental analysis. | Pre-dose and 12 hours post-dose on Day 1 and days 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 57, 71 and 105 |
| Time to Reach Maximum Observed Concentration (Tmax) of AMG 570 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Evansville | Indiana | 47710 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37150935 | Background | Abuqayyas L, Chen PW, Dos Santos MT, Parnes JR, Doshi S, Dutta S, Houk BE. Pharmacokinetics and Pharmacokinetic/Pharmacodynamic Properties of Rozibafusp Alfa, a Bispecific Inhibitor of BAFF and ICOSL: Analyses of Phase I Clinical Trials. Clin Pharmacol Ther. 2023 Aug;114(2):371-380. doi: 10.1002/cpt.2929. Epub 2023 May 24. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
Not provided
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 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. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. 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 URL below.
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A total of 56 healthy participants were enrolled at 3 research centers in the United States from 28 March 2016 to 06 September 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | AMG 570 - 7 mg | Participants received a single dose 7 mg dose of AMG 570 administered subcutaneously. |
| FG001 | AMG 570 - 21 mg | Participants received a single 21 mg dose of AMG 570 administered subcutaneously. |
| FG002 | AMG 570 - 70 mg | Participants received a single 70 mg dose of AMG 570 administered subcutaneously. |
| FG003 | AMG 570 - 140 mg | Participants received a single 140 mg dose of AMG 570 administered subcutaneously. |
| FG004 | AMG 570 - 210 mg | Participants received a single 210 mg dose of AMG 570 administered subcutaneously. |
| FG005 | AMG 570 - 420 mg | Participants received a single 420 mg dose of AMG 570 administered subcutaneously. |
| FG006 | AMG 570 - 700 mg | Participants received a single 700 mg dose of AMG 570 administered subcutaneously. |
| FG007 | Placebo | Participants received a single dose of the matching AMG 570 placebo administered subcutaneously. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The safety analysis set: all participants who received AMG 570 or the placebo.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | AMG 570 - 7 mg | Participants received a single dose 7 mg dose of AMG 570 administered subcutaneously. |
| BG001 | AMG 570 - 21 mg | Participants received a single 21 mg dose of AMG 570 administered subcutaneously. |
| 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 | Number of Participants Who Experienced One or More Treatment-emergent Adverse Events (TEAEs) | TEAEs were adverse events with an onset after the administration of study treatment. TEAEs were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limited age appropriate instrumental activities of daily life (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolonged hospitalization indicated; disabling; limited self care ADL. Grade 4 Life-threatening consequences; urgent interventions indicated. Serious adverse events (SAEs) were defined as meeting at least 1 of the following criteria:
| Safety analysis set: all participants who received AMG 570 or placebo. | Posted | Count of Participants | Participants | Day 1 to Day 105 |
Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
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 | AMG 570 - 7 mg | Participants received a single dose 7 mg dose of AMG 570 administered subcutaneously. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injury | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear pain | Ear and labyrinth disorders | MedDRA 21.0 | Systematic Assessment |
Not provided
| 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 | Jan 24, 2018 | Aug 5, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 26, 2018 | Aug 5, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000729492 | rozibafusp alfa |
| D004341 | Drug Evaluation |
| ID | Term |
|---|---|
| D000076722 | Drug Development |
| D008919 | Investigative Techniques |
| D005069 | Evaluation Studies as Topic |
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Participants will receive a single 420 mg dose of AMG 570 administered subcutaneously.
|
| AMG 570 - 700 mg | Experimental | Participants will receive a single 700 mg dose of AMG 570 administered subcutaneously. |
|
| Placebo | Placebo Comparator | Participants will receive a single dose of the matching AMG 570 placebo administered subcutaneously. |
|
|
| AMG 570 Matching Placebo | Biological | Placebo administered as single dose subcutaneous in healthy volunteers. |
|
|
| Baseline to Day 105 |
| Number of Participants Who Experienced a Clinically Significant Change in Electrocardiograms (ECGs) | Any changes in ECG parameters that were deemed clinically significant by the Investigator were reported. | Baseline to Day 105 |
AMG 570 PK parameters were estimated using non-compartmental analysis. |
| Pre-dose and 12 hours post-dose on Day 1 and days 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 57, 71 and 105 |
| Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUClast) of AMG 570 | AMG 570 PK parameters were estimated using non-compartmental analysis. | Pre-dose and 12 hours post-dose on Day 1 and days 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 57, 71 and 105 |
| Area Under the Concentration-time Curve Observed From Time Zero to Infinity (AUCinf) of AMG 570 | Pre-dose and 12 hours post-dose on Day 1 and days 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 57, 71 and 105 |
| Number of Participants With an Anti-AMG 570 Binding Antibody Positive Postbaseline Result | The presence of anti-AMG 570 binding antibodies was assessed using a validated assay. The number and percentage of participants who developed binding anti-AMG 570 antibodies at any postbaseline visit are presented. | Baseline to Day 105 |
| Mean Peripheral Blood B7-Related Protein-1 (B7RP-1) Receptor Occupancy on Total B Cells | Peripheral B7RP1 (also known as inducible costimulator ligand [ICOSL]) receptor occupancy was calculated from the free ICOSL and total ICOSL measurement from B cells in whole blood. | Day 8; Day 29; Day 57; and Day 105 |
| Percentage Change From Baseline for Cluster of Differentiation (CD)19+ Total B Cells Counts | Baseline to Day 8; Day 29; Day 57 and Day 105 |
| Percentage Change From Baseline for CD19+ Total B Cells Percentages (%) | Baseline to Day 8; Day 29; Day 57 and Day 105 |
| Overland Park |
| Kansas |
| 66212 |
| United States |
| Research Site | Madison | Wisconsin | 53704 | United States |
| Withdrawal by Subject |
|
| BG002 | AMG 570 - 70 mg | Participants received a single 70 mg dose of AMG 570 administered subcutaneously. |
| BG003 | AMG 570 - 140 mg | Participants received a single 140 mg dose of AMG 570 administered subcutaneously. |
| BG004 | AMG 570 - 210 mg | Participants received a single 210 mg dose of AMG 570 administered subcutaneously. |
| BG005 | AMG 570 - 420 mg | Participants received a single 420 mg dose of AMG 570 administered subcutaneously. |
| BG006 | AMG 570 - 700 mg | Participants received a single 700 mg dose of AMG 570 administered subcutaneously. |
| BG007 | Placebo | Participants received a single dose of the matching AMG 570 placebo administered subcutaneously. |
| BG008 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | AMG 570 - 7 mg | Participants received a single dose 7 mg dose of AMG 570 administered subcutaneously. |
| OG001 | AMG 570 - 21 mg | Participants received a single 21 mg dose of AMG 570 administered subcutaneously. |
| OG002 | AMG 570 - 70 mg | Participants received a single 70 mg dose of AMG 570 administered subcutaneously. |
| OG003 | AMG 570 - 140 mg | Participants received a single 140 mg dose of AMG 570 administered subcutaneously. |
| OG004 | AMG 570 - 210 mg | Participants received a single 210 mg dose of AMG 570 administered subcutaneously. |
| OG005 | AMG 570 - 420 mg | Participants received a single 420 mg dose of AMG 570 administered subcutaneously. |
| OG006 | AMG 570 - 700 mg | Participants received a single 700 mg dose of AMG 570 administered subcutaneously. |
| OG007 | Placebo | Participants received a single dose of the matching AMG 570 placebo administered subcutaneously. |
|
|
| Primary | Number of Participants Who Experienced a Clinically Significant Change in Physical Examinations | Physical examinations were performed by the investigator, designated physician, or nurse practitioner. A complete physical examination included, at a minimum, assessment of cardiovascular, respiratory, gastrointestinal and neurological systems. A brief physical examination included assessment of the skin, lungs, cardiovascular system, and abdomen (liver and spleen). | Safety analysis set: all participants who received AMG 570 or placebo. | Posted | Count of Participants | Participants | Baseline to Day 105 |
|
|
|
| Primary | Number of Participants Who Experienced a Clinically Significant Change in Vital Signs | Any changes in blood pressure, body temperature, heart rate, and pulse rate that were deemed as clinically significant by the Investigator were reported. | Safety analysis set: all participants who received AMG 570 or placebo. | Posted | Count of Participants | Participants | Baseline to Day 105 |
|
|
|
| Primary | Number of Participants Who Experienced a Clinically Significant Change in Clinical Laboratory Safety Tests | Laboratory safety tests included chemistry, hematology, and urinalysis parameters. Clinically significant laboratory safety tests were any events assessed as CTCAE Grade ≥3 at any post-baseline visit. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolonged hospitalization indicated; disabling; limited self care ADL. Grade 4 Life-threatening consequences; urgent interventions indicated. | Safety analysis set: all participants who received AMG 570 or placebo. | Posted | Count of Participants | Participants | Baseline to Day 105 |
|
|
|
| Primary | Number of Participants Who Experienced a Clinically Significant Change in Electrocardiograms (ECGs) | Any changes in ECG parameters that were deemed clinically significant by the Investigator were reported. | Safety analysis set: all participants who received AMG 570 or placebo. | Posted | Count of Participants | Participants | Baseline to Day 105 |
|
|
|
| Secondary | Maximum Observed Concentration (Cmax) of AMG 570 | AMG 570 pharmacokinetic (PK) parameters were estimated using non-compartmental analysis. | The PK concentration analysis set: all participants who received AMG 570 and had at least one quantifiable PK sample collected. | Posted | Mean | Standard Deviation | µg/mL | Pre-dose and 12 hours post-dose on Day 1 and days 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 57, 71 and 105 |
|
|
|
| Secondary | Time to Reach Maximum Observed Concentration (Tmax) of AMG 570 | AMG 570 PK parameters were estimated using non-compartmental analysis. | The PK concentration analysis set: all participants who received AMG 570 and had at least one quantifiable PK sample collected. | Posted | Median | Full Range | days | Pre-dose and 12 hours post-dose on Day 1 and days 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 57, 71 and 105 |
|
|
|
| Secondary | Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUClast) of AMG 570 | AMG 570 PK parameters were estimated using non-compartmental analysis. | The PK concentration analysis set: all participants who received AMG 570 and had at least one quantifiable PK sample collected. | Posted | Mean | Standard Deviation | day*µg/mL | Pre-dose and 12 hours post-dose on Day 1 and days 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 57, 71 and 105 |
|
|
|
| Secondary | Area Under the Concentration-time Curve Observed From Time Zero to Infinity (AUCinf) of AMG 570 | The PK concentration analysis set: all participants who received AMG 570 and had at least one quantifiable PK sample collected. | Posted | Mean | Standard Deviation | day*µg/mL | Pre-dose and 12 hours post-dose on Day 1 and days 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 57, 71 and 105 |
|
|
|
| Secondary | Number of Participants With an Anti-AMG 570 Binding Antibody Positive Postbaseline Result | The presence of anti-AMG 570 binding antibodies was assessed using a validated assay. The number and percentage of participants who developed binding anti-AMG 570 antibodies at any postbaseline visit are presented. | All participants who received AMG 570 and had a negative or no result for binding antibodies at baseline. | Posted | Count of Participants | Participants | Baseline to Day 105 |
|
|
|
| Secondary | Mean Peripheral Blood B7-Related Protein-1 (B7RP-1) Receptor Occupancy on Total B Cells | Peripheral B7RP1 (also known as inducible costimulator ligand [ICOSL]) receptor occupancy was calculated from the free ICOSL and total ICOSL measurement from B cells in whole blood. | The pharmacodynamic (PD) analysis set: all participants who had received AMG 570 or placebo and for whom at least one PD parameter had quantifiable baseline sample and a quantifiable PD sample collected at each specified visit. | Posted | Mean | Standard Deviation | Percentage B7RP-1 receptor occupancy | Day 8; Day 29; Day 57; and Day 105 |
|
|
|
| Secondary | Percentage Change From Baseline for Cluster of Differentiation (CD)19+ Total B Cells Counts | The pharmacodynamic (PD) analysis set: all participants who had received AMG 570 or placebo and for whom at least one PD parameter had quantifiable baseline sample and a quantifiable PD sample collected at each specified visit. | Posted | Mean | Standard Deviation | Percentage of change | Baseline to Day 8; Day 29; Day 57 and Day 105 |
|
|
|
| Secondary | Percentage Change From Baseline for CD19+ Total B Cells Percentages (%) | The PD analysis set: all participants who had received AMG 570 or placebo and for whom at least one PD parameters had quantifiable baseline sample and at quantifiable PD sample collected at each specified visit. | Posted | Mean | Standard Deviation | Percentage of change | Baseline to Day 8; Day 29; Day 57 and Day 105 |
|
|
|
| 0 |
| 6 |
| 1 |
| 6 |
| 6 |
| 6 |
| EG001 | AMG 570 - 21 mg | Participants received a single 21 mg dose of AMG 570 administered subcutaneously. | 0 | 6 | 0 | 6 | 5 | 6 |
| EG002 | AMG 570 - 70 mg | Participants received a single 70 mg dose of AMG 570 administered subcutaneously. | 0 | 6 | 0 | 6 | 4 | 6 |
| EG003 | AMG 570 - 140 mg | Participants received a single 140 mg dose of AMG 570 administered subcutaneously. | 0 | 6 | 0 | 6 | 4 | 6 |
| EG004 | AMG 570 - 210 mg | Participants received a single 210 mg dose of AMG 570 administered subcutaneously. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG005 | AMG 570 - 420 mg | Participants received a single 420 mg dose of AMG 570 administered subcutaneously. | 0 | 6 | 0 | 6 | 3 | 6 |
| EG006 | AMG 570 - 700 mg | Participants received 700 mg dose of AMG 570 administered as single dose subcutaneous in healthy volunteers. | 0 | 6 | 0 | 6 | 4 | 6 |
| EG007 | Placebo | Participants received a single dose of the matching AMG 570 placebo administered subcutaneously. | 0 | 14 | 0 | 14 | 9 | 14 |
| Conjunctivitis allergic | Eye disorders | MedDRA 21.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Food poisoning | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Application site erythema | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Injection site haemorrhage | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Injection site warmth | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Vessel puncture site bruise | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Vessel puncture site haemorrhage | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Vaginal infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Exposure to toxic agent | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Blood pressure systolic increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hyperaesthesia | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Papule | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Skin hypopigmentation | Skin and subcutaneous tissue disorders | MedDRA 21.0 | 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.
|
| Day 29 |
|
|
| Day 57 |
|
|
| Day 105 |
|
|
|
| Percentage change from Baseline at Day 29 |
|
|
| Percentage change from Baseline at Day 57 |
|
|
| Percentage change from Baseline at Day 105 |
|
|
|
| Percentage change from Baseline at Day 29 |
|
|
| Percentage change from Baseline at Day 57 |
|
|
| Percentage change from Baseline at Day 105 |
|
|