Chronic Migraine or Episodic Migraine
Conditions
Keywords
Migraine, Headache, Prevention, Prophylaxis
Brief summary
To evaluate the effect of AMG 301 compared to placebo on the change from the baseline period in monthly migraine days in subjects with migraine.
Detailed description
A Phase 2a, randomized, double-blind, placebo-controlled, 3-arm parallel group study to evaluate the efficacy and safety of AMG 301 in subjects with chronic migraine or episodic migraine.
Interventions
DRUGPlacebo
Placebo was presented in identical containers, stored/packaged the same as AMG 301. All injections were administered within 30 minutes on treatment days.
DRUGAMG 301
AMG 301 was packaged in 5 mL clear glass vials containing 1 mL of 70 mg/mL of AMG 301. All injections were administered within 30 minutes on treatment days.
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Adults ≥ 18 to ≤ 60 years of age at the time of signing the informed consent form. * History of migraine (with or without aura) for ≥ 12 months before screening according to the International Headache Society (IHS) Classification ICHD-III (Headache Classification Committee of the International Headache Society, 2013) * Migraine frequency: ≥ 4 migraine days per month on average across the 3 months before screening. * Failed at least 1 medication for prophylactic treatment of migraine due to tolerability or lack of efficacy
Exclusion criteria
* Older than 50 years of age at migraine onset. * History of cluster headache, hemiplegic migraine headache. * Unable to differentiate migraine from other headaches. * Migraine with continuous pain, in which the subject does not experience any pain-free periods (of any duration) during the 1 month before the screening period. * History or evidence of any other clinically significant disorder, condition or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Monthly Migraine Days to the Last 4 Weeks of the 12 Week Double-Blind Treatment Period | Baseline Day -28 to Day -1; Weeks 9-12 | A migraine day is any calendar day from the eDiary in which the participant experienced a migraine headache. A migraine headache is a headache with or without aura, lasting for \>= 4 hours, and meeting \>=1 of the criteria: 1. \>= 2 pain features (unilateral, throbbing, moderate to severe, exacerbated with exercise/physical activity) 2. \>= 1 symptoms (nausea and/or vomiting, photophobia and phonophobia) If the participant took a migraine-specific medication during aura or to treat headache, it was counted as a migraine day. Days without eDiary data in each monthly interval are handled by proration. Negative change from baseline values indicated improvement (i.e. fewer migraine days after treatment as compared to baseline). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Period in Monthly Acute Migraine-Specific Medication Days in the Last 4 Weeks of the 12-Week Double-Blind Treatment Period | Baseline Day -28 to Day -1; Weeks 9-12 | Number of days on which acute headache medications (triptans and ergotamine-derivatives, alone or in combination) are used as recorded in eDiary. Monthly acute headache medication treatment days at baseline are the number of acute headache medication treatment days in the baseline period. Days without eDiary data are handled by proration. Negative change from baseline values indicate improvement (i.e. fewer days requiring acute migraine-specific medications after treatment as compared to baseline). |
| Change From Baseline in Mean Physical Impairment Domain Scores as Measured by the Migraine Physical Function Impact Diary (MPFID) Over the Last 4 Weeks of the 12-Week Double-Blind Treatment Period | Baseline Day -28 to Day -1; Weeks 9-12 | Participants complete the MPFID every day during baseline (Days -28 to Day -1) and the 12-week Double Blind Treatment Period. The MPFID has 2 domains, Impact on Everyday Activities (7 items) and Physical Impairment (5 items), and 1 stand-alone global question that provides an assessment of the overall impact of migraine on participants' everyday activities. The recall period for each item is the past 24 hours. The Physical Impairment Domain Score is reported here. A participant's response to the difficulty of the 5 physical impairment items is measured using a 5-point scale, with difficulty measurements ranging from 1 to 5. The sum was rescaled to a 0 to 100 scale, with 0=no difficulty and 100=unable to do (maximum burden). Negative change from baseline values indicate improvement in migraine impact. |
| Change From Baseline in Mean Impact on Everyday Activity Domain Scores as Measured by the Migraine Physical Function Impact Diary (MPFID) Over the Last 4 Weeks of the 12-Week Double-Blind Treatment Period | Baseline Day -28 to Day -1; Weeks 9-12 | Participants complete the MPFID every day during baseline (Days -28 to Day -1) and the 12-week Double Blind Treatment Period. The MPFID has 2 domains, Impact on Everyday Activities (7 items) and Physical Impairment (5 items), and 1 stand-alone global question that provides an assessment of the overall impact of migraine on participants' everyday activities. The recall period for each item is the past 24 hours. The Impact on Everyday Activities Domain Score is reported here. A participant's response to the Impact on Everyday Activities 7 items is measured using a 5-point scale, with difficulty measurements ranging from 1 to 5. The sum was rescaled to a 0 to 100 scale, with 0=no difficulty and 100=unable to do (maximum burden). Negative change from baseline values indicate improvement in migraine impact. |
| Participants With Treatment-Emergent Adverse Events (TEAEs) | Day 1 up to Week 30 (12 weeks of double-blind treatment plus 18 weeks follow-up after last dose of investigational product) | Adverse events (AEs) were graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4, where: Grade 1 = Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; Grade 2 = Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL); Grade 3 = Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL; Grade 4 = Life-threatening consequences; urgent intervention indicated Grade 5 = Death related to AE. |
| Percentage of Participants Who Met Hy's Law Criteria at Baseline and On Study | Baseline: Day 1 On study: Weeks 4, 6, 12, 20, 28 | Hy's law predicts potential for drug-related hepatotoxicity. Hy's Law cases have three components: * The drug causes hepatocellular injury, generally defined as an elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) by 3-fold or greater above the upper limit of normal (ULN). * Among participants showing such aminotransferase elevations, they also have elevation of their serum total bilirubin of greater than 2 times the ULN, without findings of cholestasis (defined as serum alkaline phosphatase activity less than 2 times the upper limit of normal). * No other reason can be found to explain the combination of increased aminotransferase and serum total bilirubin, such as viral hepatitis, alcohol abuse, ischemia, preexisting liver disease, or another drug capable of causing the observed injury. |
| Percentage of Participants With Aminotransferase Test Abnormalities > 3 Times the Upper Limit of Normal (ULN) at Baseline and On Study | Baseline: Day 1 On study: Weeks 4, 6, 12, 20, 28 | Aminotransferase tests included alanine aminotransferase (ALT) and aspartate aminotransferase (AST). Percentage of participants with results that were greater than 3 \* ULN for either test are reported. |
| Percentage of Participants Who Responded, Defined as At Least a 50% Reduction From the Baseline Period in Monthly Migraine Days in the Last 4 Weeks of the 12-Week Double-Blind Treatment Period | Baseline Day -28 to Day -1; Weeks 9-12 | Responders are participants who had at least a 50% reduction from baseline in monthly migraine days during the last 4 weeks of treatment in the 12-week double blind period. |
| Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Day 1, Weeks 2, 4, 6, 8, 10, 12,16, 20, 24, 28 | Participant was expected to be in a supine position (or the most recumbent position possible) in a rested and calm state for at least 5 minutes before blood pressure assessments were conducted. Blood pressure units are millimeters of mercury (mmHg). |
| Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Day 1, Weeks 2, 4, 6, 8, 10, 12,16, 20, 24, 28 | Participant was expected to be in a supine position (or the most recumbent position possible) in a rested and calm state for at least 5 minutes before blood pressure assessments were conducted. Blood pressure units are millimeters of mercury (mmHg). |
| Percentage of Participants With Pulse Rate in Categories by Visit | Day 1, Weeks 2, 4, 6, 8, 10, 12,16, 20, 24, 28 | Participant was expected to be in a supine position (or the most recumbent position possible) in a rested and calm state for at least 5 minutes before pulse assessments were conducted. Pulse rate units are beats per minute (BPM) |
| Percentage of Participants With Temperature in Categories by Visit | Day 1, Weeks 2, 4, 6, 8, 10, 12,16, 20, 24, 28 | Participant was expected to be in a supine position (or the most recumbent position possible) in a rested and calm state for at least 5 minutes before vital sign assessments were conducted. Temperature units are reported in degrees Celsius (C). |
| Percentage of Participants With Respiratory Rates in Categories by Visit | Day 1, Weeks 2, 4, 6, 8, 10, 12,16, 20, 24, 28 | Participant was expected to be in a supine position (or the most recumbent position possible) in a rested and calm state for at least 5 minutes before vital sign assessments were conducted. Respiratory rate (RR) is reported in breaths/minute. |
| Percentage of Participants With Total Bilirubin Test Abnormalities > 2 Times the Upper Limit of Normal (ULN) at Baseline and On Study | Baseline: Day 1 On study: Weeks 4, 6, 12, 20, 28 | Percentage of participants with total bilirubin results that were greater than 2 \* ULN are reported. |
Countries
Austria, Canada, Czechia, Denmark, Finland, Germany, Sweden, United States
Participant flow
Recruitment details
A total of 510 subjects were screened.
Pre-assignment details
Participants were randomized 4:3:3 to placebo, AMG 301 210 mg Q4W, or AMG 301 420 mg Q2W, respectively. The randomization was stratified by * chronic migraine versus episodic migraine and * North America versus Rest of World.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants randomized to Placebo were administered 6 subcutaneous (SC) injections on day 1 and weeks 2, 4, 6, 8 and 10 during the 12 week double-blind treatment period. | 137 |
| AMG 301 210 mg Q4W Participants randomized to AMG 301 210 mg every fourth week (Q4W) received a total of 3 AMG 301 subcutaneous (SC) injections (70 mg/mL in each injection) plus 3 matching placebo injections on day 1 and weeks 4 and 8. Participants also received 6 SC placebo injections on weeks 2, 6, and 10 during the 12 week double-blind treatment period. | 104 |
| AMG 301 420 mg Q2W Participants randomized to AMG 301 420 mg every second week (Q2W) received a total of 6 AMG 301 subcutaneous (SC) injections (70 mg/mL in each injection) on day 1 and weeks 2, 4, 6, 8, and 10 during the 12 week double-blind treatment period. | 102 |
| Total | 343 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 | 2 |
| Overall Study | Decision by sponsor | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 2 | 1 | 2 |
| Overall Study | Withdrawal by Subject | 23 | 14 | 16 |
Baseline characteristics
| Characteristic | Placebo | Total | AMG 301 420 mg Q2W | AMG 301 210 mg Q4W |
|---|---|---|---|---|
| Age, Continuous | 41.8 years STANDARD_DEVIATION 9.9 | 42.2 years STANDARD_DEVIATION 9.7 | 42.5 years STANDARD_DEVIATION 9.4 | 42.3 years STANDARD_DEVIATION 9.7 |
| Baseline Migraine Type Chronic migraine | 44 Participants | 119 Participants | 36 Participants | 39 Participants |
| Baseline Migraine Type Episodic migraine | 93 Participants | 224 Participants | 66 Participants | 65 Participants |
| Body Mass Index | 25.29 kg/m^2 STANDARD_DEVIATION 4.66 | 25.72 kg/m^2 STANDARD_DEVIATION 4.95 | 25.64 kg/m^2 STANDARD_DEVIATION 4.78 | 26.37 kg/m^2 STANDARD_DEVIATION 5.45 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 15 Participants | 3 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 131 Participants | 328 Participants | 99 Participants | 98 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Height | 168.27 cm STANDARD_DEVIATION 7.82 | 167.69 cm STANDARD_DEVIATION 8.01 | 167.55 cm STANDARD_DEVIATION 7.72 | 167.05 cm STANDARD_DEVIATION 8.56 |
| Monthly Headache Days | 13.45 days STANDARD_DEVIATION 5.27 | 13.46 days STANDARD_DEVIATION 5.15 | 13.09 days STANDARD_DEVIATION 5.24 | 13.85 days STANDARD_DEVIATION 4.9 |
| Monthly Migraine Days | 12.18 monthly migraine days STANDARD_DEVIATION 5.14 | 12.26 monthly migraine days STANDARD_DEVIATION 5.08 | 12.14 monthly migraine days STANDARD_DEVIATION 5.32 | 12.47 monthly migraine days STANDARD_DEVIATION 4.78 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 12 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 129 Participants | 325 Participants | 96 Participants | 100 Participants |
| Reported Reasons for Prior Migraine Prophylactic Medication Failure Intolerance | 62 participants reporting the reason | 161 participants reporting the reason | 52 participants reporting the reason | 47 participants reporting the reason |
| Reported Reasons for Prior Migraine Prophylactic Medication Failure Lack of efficacy | 110 participants reporting the reason | 275 participants reporting the reason | 77 participants reporting the reason | 88 participants reporting the reason |
| Sex: Female, Male Female | 117 Participants | 301 Participants | 90 Participants | 94 Participants |
| Sex: Female, Male Male | 20 Participants | 42 Participants | 12 Participants | 10 Participants |
| Targeted Neurological Disease Diagnosis Anxiety | 21 participants with diagnosis | 52 participants with diagnosis | 16 participants with diagnosis | 15 participants with diagnosis |
| Targeted Neurological Disease Diagnosis Depression | 24 participants with diagnosis | 67 participants with diagnosis | 18 participants with diagnosis | 25 participants with diagnosis |
| Targeted Neurological Disease Diagnosis Migraine with aura | 40 participants with diagnosis | 115 participants with diagnosis | 43 participants with diagnosis | 32 participants with diagnosis |
| Targeted Neurological Disease Diagnosis Migraine without aura | 120 participants with diagnosis | 299 participants with diagnosis | 87 participants with diagnosis | 92 participants with diagnosis |
| Weight | 71.8 kg STANDARD_DEVIATION 15 | 72.5 kg STANDARD_DEVIATION 15.7 | 72.1 kg STANDARD_DEVIATION 14.9 | 73.8 kg STANDARD_DEVIATION 17.2 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 137 | 0 / 104 | 0 / 102 |
| other Total, other adverse events | 32 / 137 | 27 / 104 | 31 / 102 |
| serious Total, serious adverse events | 3 / 137 | 1 / 104 | 2 / 102 |
Outcome results
Primary
Change From Baseline in Monthly Migraine Days to the Last 4 Weeks of the 12 Week Double-Blind Treatment Period
A migraine day is any calendar day from the eDiary in which the participant experienced a migraine headache. A migraine headache is a headache with or without aura, lasting for \>= 4 hours, and meeting \>=1 of the criteria: 1. \>= 2 pain features (unilateral, throbbing, moderate to severe, exacerbated with exercise/physical activity) 2. \>= 1 symptoms (nausea and/or vomiting, photophobia and phonophobia) If the participant took a migraine-specific medication during aura or to treat headache, it was counted as a migraine day. Days without eDiary data in each monthly interval are handled by proration. Negative change from baseline values indicated improvement (i.e. fewer migraine days after treatment as compared to baseline).
Time frame: Baseline Day -28 to Day -1; Weeks 9-12
Population: Efficacy Analysis set consisting of participants who were randomized, received \>=1 dose of investigational product, and have \>=1 postbaseline monthly eDiary measurement. Participants were analyzed according to their randomized treatment group, regardless of treatment received.~Participants with both baseline and week 9-12 values are included.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Monthly Migraine Days to the Last 4 Weeks of the 12 Week Double-Blind Treatment Period | -2.45 days | Standard Error 0.4 |
| AMG 301 210 mg Q4W | Change From Baseline in Monthly Migraine Days to the Last 4 Weeks of the 12 Week Double-Blind Treatment Period | -2.20 days | Standard Error 0.45 |
| AMG 301 420 mg Q2W | Change From Baseline in Monthly Migraine Days to the Last 4 Weeks of the 12 Week Double-Blind Treatment Period | -2.19 days | Standard Error 0.46 |
Comparison: An adjusted analysis is presented that utilized a generalized linear mixed model which included treatment, visit, treatment-by-visit interaction, stratification factors of region and baseline migraine frequency (chronic migraine vs episodic migraine), and baseline value as covariates and assuming a first-order autoregressive covariance structure. The p-values for pairwise comparisons versus placebo are nominal p-values without multiplicity adjustment.p-value: 0.6695% CI: [-0.88, 1.4]Mixed Models Analysis
Comparison: An adjusted analysis is presented that utilized a generalized linear mixed model which included treatment, visit, treatment-by-visit interaction, stratification factors of region and baseline migraine frequency (chronic migraine vs episodic migraine), and baseline value as covariates and assuming a first-order autoregressive covariance structure. The p-values for pairwise comparisons versus placebo are nominal p-values without multiplicity adjustment.p-value: 0.6595% CI: [-0.89, 1.43]Mixed Models Analysis
Secondary
Change From Baseline in Mean Impact on Everyday Activity Domain Scores as Measured by the Migraine Physical Function Impact Diary (MPFID) Over the Last 4 Weeks of the 12-Week Double-Blind Treatment Period
Participants complete the MPFID every day during baseline (Days -28 to Day -1) and the 12-week Double Blind Treatment Period. The MPFID has 2 domains, Impact on Everyday Activities (7 items) and Physical Impairment (5 items), and 1 stand-alone global question that provides an assessment of the overall impact of migraine on participants' everyday activities. The recall period for each item is the past 24 hours. The Impact on Everyday Activities Domain Score is reported here. A participant's response to the Impact on Everyday Activities 7 items is measured using a 5-point scale, with difficulty measurements ranging from 1 to 5. The sum was rescaled to a 0 to 100 scale, with 0=no difficulty and 100=unable to do (maximum burden). Negative change from baseline values indicate improvement in migraine impact.
Time frame: Baseline Day -28 to Day -1; Weeks 9-12
Population: Efficacy Analysis set consisting of participants who were randomized, received \>=1 dose of investigational product, and have \>=1 postbaseline monthly eDiary measurement. Participants were analyzed according to their randomized treatment group, regardless of treatment received.~Participants with both baseline and week 9-12 values are included.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Mean Impact on Everyday Activity Domain Scores as Measured by the Migraine Physical Function Impact Diary (MPFID) Over the Last 4 Weeks of the 12-Week Double-Blind Treatment Period | -3.42 units on a scale | Standard Error 0.79 |
| AMG 301 210 mg Q4W | Change From Baseline in Mean Impact on Everyday Activity Domain Scores as Measured by the Migraine Physical Function Impact Diary (MPFID) Over the Last 4 Weeks of the 12-Week Double-Blind Treatment Period | -4.28 units on a scale | Standard Error 0.89 |
| AMG 301 420 mg Q2W | Change From Baseline in Mean Impact on Everyday Activity Domain Scores as Measured by the Migraine Physical Function Impact Diary (MPFID) Over the Last 4 Weeks of the 12-Week Double-Blind Treatment Period | -2.86 units on a scale | Standard Error 0.92 |
Comparison: An adjusted analysis is presented that utilized a generalized linear mixed model which included treatment, visit, treatment-by-visit interaction, stratification factors of region and baseline migraine frequency (chronic migraine vs episodic migraine), and baseline value as covariates and assuming a first-order autoregressive covariance structure. The p-values for pairwise comparisons versus placebo are nominal p-values without multiplicity adjustment.p-value: 0.4695% CI: [-3.15, 1.44]Mixed Models Analysis
Comparison: An adjusted analysis is presented that utilized a generalized linear mixed model which included treatment, visit, treatment-by-visit interaction, stratification factors of region and baseline migraine frequency (chronic migraine vs episodic migraine), and baseline value as covariates and assuming a first-order autoregressive covariance structure. The p-values for pairwise comparisons versus placebo are nominal p-values without multiplicity adjustment.p-value: 0.6495% CI: [-1.77, 2.89]Mixed Models Analysis
Secondary
Change From Baseline in Mean Physical Impairment Domain Scores as Measured by the Migraine Physical Function Impact Diary (MPFID) Over the Last 4 Weeks of the 12-Week Double-Blind Treatment Period
Participants complete the MPFID every day during baseline (Days -28 to Day -1) and the 12-week Double Blind Treatment Period. The MPFID has 2 domains, Impact on Everyday Activities (7 items) and Physical Impairment (5 items), and 1 stand-alone global question that provides an assessment of the overall impact of migraine on participants' everyday activities. The recall period for each item is the past 24 hours. The Physical Impairment Domain Score is reported here. A participant's response to the difficulty of the 5 physical impairment items is measured using a 5-point scale, with difficulty measurements ranging from 1 to 5. The sum was rescaled to a 0 to 100 scale, with 0=no difficulty and 100=unable to do (maximum burden). Negative change from baseline values indicate improvement in migraine impact.
Time frame: Baseline Day -28 to Day -1; Weeks 9-12
Population: Efficacy Analysis set consisting of participants who were randomized, received \>=1 dose of investigational product, and have \>=1 postbaseline monthly eDiary measurement. Participants were analyzed according to their randomized treatment group, regardless of treatment received.~Participants with both baseline and week 9-12 values are included.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Mean Physical Impairment Domain Scores as Measured by the Migraine Physical Function Impact Diary (MPFID) Over the Last 4 Weeks of the 12-Week Double-Blind Treatment Period | -2.44 units on a scale | Standard Error 0.78 |
| AMG 301 210 mg Q4W | Change From Baseline in Mean Physical Impairment Domain Scores as Measured by the Migraine Physical Function Impact Diary (MPFID) Over the Last 4 Weeks of the 12-Week Double-Blind Treatment Period | -2.72 units on a scale | Standard Error 0.89 |
| AMG 301 420 mg Q2W | Change From Baseline in Mean Physical Impairment Domain Scores as Measured by the Migraine Physical Function Impact Diary (MPFID) Over the Last 4 Weeks of the 12-Week Double-Blind Treatment Period | -2.13 units on a scale | Standard Error 0.91 |
Comparison: An adjusted analysis is presented that utilized a generalized linear mixed model which included treatment, visit, treatment-by-visit interaction, stratification factors of region and baseline migraine frequency (chronic migraine vs episodic migraine), and baseline value as covariates and assuming a first-order autoregressive covariance structure. The p-values for pairwise comparisons versus placebo are nominal p-values without multiplicity adjustment.p-value: 0.8195% CI: [-2.56, 2.01]Mixed Models Analysis
Comparison: An adjusted analysis is presented that utilized a generalized linear mixed model which included treatment, visit, treatment-by-visit interaction, stratification factors of region and baseline migraine frequency (chronic migraine vs episodic migraine), and baseline value as covariates and assuming a first-order autoregressive covariance structure. The p-values for pairwise comparisons versus placebo are nominal p-values without multiplicity adjustment.p-value: 0.7995% CI: [-2.01, 2.63]Mixed Models Analysis
Secondary
Change From Baseline Period in Monthly Acute Migraine-Specific Medication Days in the Last 4 Weeks of the 12-Week Double-Blind Treatment Period
Number of days on which acute headache medications (triptans and ergotamine-derivatives, alone or in combination) are used as recorded in eDiary. Monthly acute headache medication treatment days at baseline are the number of acute headache medication treatment days in the baseline period. Days without eDiary data are handled by proration. Negative change from baseline values indicate improvement (i.e. fewer days requiring acute migraine-specific medications after treatment as compared to baseline).
Time frame: Baseline Day -28 to Day -1; Weeks 9-12
Population: Efficacy Analysis set consisting of participants who were randomized, received \>=1 dose of investigational product, and have \>=1 postbaseline monthly eDiary measurement. Participants were analyzed according to their randomized treatment group, regardless of treatment received.~Participants with both baseline and week 9-12 values are included.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline Period in Monthly Acute Migraine-Specific Medication Days in the Last 4 Weeks of the 12-Week Double-Blind Treatment Period | -1.25 days | Standard Error 0.29 |
| AMG 301 210 mg Q4W | Change From Baseline Period in Monthly Acute Migraine-Specific Medication Days in the Last 4 Weeks of the 12-Week Double-Blind Treatment Period | -1.28 days | Standard Error 0.33 |
| AMG 301 420 mg Q2W | Change From Baseline Period in Monthly Acute Migraine-Specific Medication Days in the Last 4 Weeks of the 12-Week Double-Blind Treatment Period | -1.34 days | Standard Error 0.34 |
Comparison: Adjusted analysis utilizes a generalized linear mixed model which includes treatment, visit, treatment-by-visit interaction, stratification factors of region and baseline migraine frequency (CM versus EM), and baseline value as covariates and assuming a first-order autoregressive covariance structure. The p-values for pairwise comparisons versus placebo are nominal p-values without multiplicity adjustment.p-value: 0.9495% CI: [-0.87, 0.81]Mixed Models Analysis
p-value: 0.8495% CI: [-0.94, 0.77]Mixed Models Analysis
Secondary
Participants With Treatment-Emergent Adverse Events (TEAEs)
Adverse events (AEs) were graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4, where: Grade 1 = Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; Grade 2 = Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL); Grade 3 = Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL; Grade 4 = Life-threatening consequences; urgent intervention indicated Grade 5 = Death related to AE.
Time frame: Day 1 up to Week 30 (12 weeks of double-blind treatment plus 18 weeks follow-up after last dose of investigational product)
Population: The Safety Analysis Set (SAS) consists of all enrolled participants who received \>= 1 dose of investigational product (IP). If a participant received the incorrect dose during the entire double-blind treatment period (DBTP), the participant was analyzed according to treatment received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Participants With Treatment-Emergent Adverse Events (TEAEs) | Severity grade >= 4 | 0 Participants |
| Placebo | Participants With Treatment-Emergent Adverse Events (TEAEs) | TEAE leading to discontinuation of IP | 3 Participants |
| Placebo | Participants With Treatment-Emergent Adverse Events (TEAEs) | Fatal TEAE | 0 Participants |
| Placebo | Participants With Treatment-Emergent Adverse Events (TEAEs) | >= 1 TEAE | 90 Participants |
| Placebo | Participants With Treatment-Emergent Adverse Events (TEAEs) | Serious TEAE | 3 Participants |
| Placebo | Participants With Treatment-Emergent Adverse Events (TEAEs) | Severity grade >= 2 | 41 Participants |
| Placebo | Participants With Treatment-Emergent Adverse Events (TEAEs) | Severity grade >= 3 | 9 Participants |
| AMG 301 210 mg Q4W | Participants With Treatment-Emergent Adverse Events (TEAEs) | >= 1 TEAE | 71 Participants |
| AMG 301 210 mg Q4W | Participants With Treatment-Emergent Adverse Events (TEAEs) | Severity grade >= 4 | 1 Participants |
| AMG 301 210 mg Q4W | Participants With Treatment-Emergent Adverse Events (TEAEs) | TEAE leading to discontinuation of IP | 2 Participants |
| AMG 301 210 mg Q4W | Participants With Treatment-Emergent Adverse Events (TEAEs) | Severity grade >= 3 | 5 Participants |
| AMG 301 210 mg Q4W | Participants With Treatment-Emergent Adverse Events (TEAEs) | Severity grade >= 2 | 43 Participants |
| AMG 301 210 mg Q4W | Participants With Treatment-Emergent Adverse Events (TEAEs) | Fatal TEAE | 0 Participants |
| AMG 301 210 mg Q4W | Participants With Treatment-Emergent Adverse Events (TEAEs) | Serious TEAE | 1 Participants |
| AMG 301 420 mg Q2W | Participants With Treatment-Emergent Adverse Events (TEAEs) | Fatal TEAE | 0 Participants |
| AMG 301 420 mg Q2W | Participants With Treatment-Emergent Adverse Events (TEAEs) | Severity grade >= 4 | 0 Participants |
| AMG 301 420 mg Q2W | Participants With Treatment-Emergent Adverse Events (TEAEs) | Serious TEAE | 2 Participants |
| AMG 301 420 mg Q2W | Participants With Treatment-Emergent Adverse Events (TEAEs) | >= 1 TEAE | 65 Participants |
| AMG 301 420 mg Q2W | Participants With Treatment-Emergent Adverse Events (TEAEs) | Severity grade >= 2 | 39 Participants |
| AMG 301 420 mg Q2W | Participants With Treatment-Emergent Adverse Events (TEAEs) | Severity grade >= 3 | 8 Participants |
| AMG 301 420 mg Q2W | Participants With Treatment-Emergent Adverse Events (TEAEs) | TEAE leading to discontinuation of IP | 5 Participants |
Secondary
Percentage of Participants Who Met Hy's Law Criteria at Baseline and On Study
Hy's law predicts potential for drug-related hepatotoxicity. Hy's Law cases have three components: * The drug causes hepatocellular injury, generally defined as an elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) by 3-fold or greater above the upper limit of normal (ULN). * Among participants showing such aminotransferase elevations, they also have elevation of their serum total bilirubin of greater than 2 times the ULN, without findings of cholestasis (defined as serum alkaline phosphatase activity less than 2 times the upper limit of normal). * No other reason can be found to explain the combination of increased aminotransferase and serum total bilirubin, such as viral hepatitis, alcohol abuse, ischemia, preexisting liver disease, or another drug capable of causing the observed injury.
Time frame: Baseline: Day 1 On study: Weeks 4, 6, 12, 20, 28
Population: Safety analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Who Met Hy's Law Criteria at Baseline and On Study | Baseline | 0 percentage of participants |
| Placebo | Percentage of Participants Who Met Hy's Law Criteria at Baseline and On Study | On study | 0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants Who Met Hy's Law Criteria at Baseline and On Study | Baseline | 0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants Who Met Hy's Law Criteria at Baseline and On Study | On study | 0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants Who Met Hy's Law Criteria at Baseline and On Study | Baseline | 0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants Who Met Hy's Law Criteria at Baseline and On Study | On study | 0 percentage of participants |
Secondary
Percentage of Participants Who Responded, Defined as At Least a 50% Reduction From the Baseline Period in Monthly Migraine Days in the Last 4 Weeks of the 12-Week Double-Blind Treatment Period
Responders are participants who had at least a 50% reduction from baseline in monthly migraine days during the last 4 weeks of treatment in the 12-week double blind period.
Time frame: Baseline Day -28 to Day -1; Weeks 9-12
Population: Efficacy Analysis set consisting of participants who were randomized, received \>=1 dose of investigational product, and have \>=1 postbaseline monthly eDiary measurement. Participants were analyzed according to their randomized treatment group, regardless of treatment received.~Participants with both baseline and week 9-12 values are included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Who Responded, Defined as At Least a 50% Reduction From the Baseline Period in Monthly Migraine Days in the Last 4 Weeks of the 12-Week Double-Blind Treatment Period | 22.7 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants Who Responded, Defined as At Least a 50% Reduction From the Baseline Period in Monthly Migraine Days in the Last 4 Weeks of the 12-Week Double-Blind Treatment Period | 19.4 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants Who Responded, Defined as At Least a 50% Reduction From the Baseline Period in Monthly Migraine Days in the Last 4 Weeks of the 12-Week Double-Blind Treatment Period | 18.8 percentage of participants |
Comparison: The common odds ratios and p-values are obtained from a Cochran-Mantel-Haenszel test, stratified by stratification factors of region and baseline migraine frequency (chronic migraine vs episodic migraine).p-value: 0.5795% CI: [0.41, 1.62]Cochran-Mantel-Haenszel
Comparison: The common odds ratios and p-values are obtained from a Cochran-Mantel-Haenszel test, stratified by stratification factors of region and baseline migraine frequency (chronic migraine vs episodic migraine).p-value: 0.4595% CI: [0.37, 1.54]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Aminotransferase Test Abnormalities > 3 Times the Upper Limit of Normal (ULN) at Baseline and On Study
Aminotransferase tests included alanine aminotransferase (ALT) and aspartate aminotransferase (AST). Percentage of participants with results that were greater than 3 \* ULN for either test are reported.
Time frame: Baseline: Day 1 On study: Weeks 4, 6, 12, 20, 28
Population: Safety analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Aminotransferase Test Abnormalities > 3 Times the Upper Limit of Normal (ULN) at Baseline and On Study | Baseline | 0 percentage of participants |
| Placebo | Percentage of Participants With Aminotransferase Test Abnormalities > 3 Times the Upper Limit of Normal (ULN) at Baseline and On Study | On study | 0.7 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Aminotransferase Test Abnormalities > 3 Times the Upper Limit of Normal (ULN) at Baseline and On Study | Baseline | 1.9 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Aminotransferase Test Abnormalities > 3 Times the Upper Limit of Normal (ULN) at Baseline and On Study | On study | 1.9 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Aminotransferase Test Abnormalities > 3 Times the Upper Limit of Normal (ULN) at Baseline and On Study | Baseline | 0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Aminotransferase Test Abnormalities > 3 Times the Upper Limit of Normal (ULN) at Baseline and On Study | On study | 0 percentage of participants |
Secondary
Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit
Participant was expected to be in a supine position (or the most recumbent position possible) in a rested and calm state for at least 5 minutes before blood pressure assessments were conducted. Blood pressure units are millimeters of mercury (mmHg).
Time frame: Day 1, Weeks 2, 4, 6, 8, 10, 12,16, 20, 24, 28
Population: Safety analysis population of participants with data at that visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 6 DBP > 100 mmHg | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 2 DBP <50 mmHg | 0.7 percentage of participants |
| Placebo | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 16 DBP <50 mmHg | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 8 DBP <50 mmHg | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 4 DBP > 100 mmHg | 0.7 percentage of participants |
| Placebo | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 12 DBP > 100 mmHg | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 8 DBP > 90 mmHg | 4.6 percentage of participants |
| Placebo | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 24 DBP > 90 mmHg | 4.7 percentage of participants |
| Placebo | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 12 DBP > 90 mmHg | 7.2 percentage of participants |
| Placebo | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 8 DBP > 100 mmHg | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 2 DBP > 90 mmHg | 3.7 percentage of participants |
| Placebo | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 12 DBP <50 mmHg | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 10 DBP <50 mmHg | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 28 DBP > 90 mmHg | 4.6 percentage of participants |
| Placebo | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 10 DBP > 100 mmHg | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 10 DBP > 90 mmHg | 6.6 percentage of participants |
| Placebo | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 2 DBP > 100 mmHg | 0.7 percentage of participants |
| Placebo | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Day 1 DBP > 90 mmHg | 4.5 percentage of participants |
| Placebo | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 24 DBP <50 mmHg | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 4 DBP <50 mmHg | 0.7 percentage of participants |
| Placebo | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Day 1 DBP <50 mmHg | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 20 DBP > 100 mmHg | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 4 DBP > 90 mmHg | 5.2 percentage of participants |
| Placebo | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 28 DBP <50 mmHg | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 20 DBP > 90 mmHg | 8.0 percentage of participants |
| Placebo | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Day 1 DBP > 100 mmHg | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 20 DBP <50 mmHg | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 6 DBP <50 mmHg | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 28 DBP > 100 mmHg | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 16 DBP > 100 mmHg | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 6 DBP > 90 mmHg | 9.2 percentage of participants |
| Placebo | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 24 DBP > 100 mmHg | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 16 DBP > 90 mmHg | 5.3 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 2 DBP <50 mmHg | 0.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Day 1 DBP <50 mmHg | 0.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Day 1 DBP > 90 mmHg | 6.7 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Day 1 DBP > 100 mmHg | 1.1 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 2 DBP > 90 mmHg | 4.9 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 2 DBP > 100 mmHg | 1.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 4 DBP <50 mmHg | 0.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 4 DBP > 90 mmHg | 7.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 4 DBP > 100 mmHg | 2.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 6 DBP <50 mmHg | 0.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 6 DBP > 90 mmHg | 3.1 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 6 DBP > 100 mmHg | 0.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 8 DBP <50 mmHg | 0.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 8 DBP > 90 mmHg | 6.5 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 8 DBP > 100 mmHg | 1.1 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 10 DBP <50 mmHg | 0.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 10 DBP > 90 mmHg | 4.3 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 10 DBP > 100 mmHg | 0.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 12 DBP <50 mmHg | 0.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 12 DBP > 90 mmHg | 3.3 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 12 DBP > 100 mmHg | 0.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 16 DBP <50 mmHg | 0.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 16 DBP > 90 mmHg | 5.6 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 16 DBP > 100 mmHg | 0.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 20 DBP <50 mmHg | 0.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 20 DBP > 90 mmHg | 8.1 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 20 DBP > 100 mmHg | 1.2 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 24 DBP <50 mmHg | 0.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 24 DBP > 90 mmHg | 7.3 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 24 DBP > 100 mmHg | 2.4 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 28 DBP <50 mmHg | 0.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 28 DBP > 90 mmHg | 10.6 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 28 DBP > 100 mmHg | 1.2 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 6 DBP > 90 mmHg | 7.4 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 28 DBP > 90 mmHg | 10.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 16 DBP > 90 mmHg | 12.5 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 6 DBP <50 mmHg | 0.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 24 DBP > 100 mmHg | 1.3 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 16 DBP > 100 mmHg | 2.3 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 4 DBP > 100 mmHg | 1.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Day 1 DBP > 90 mmHg | 7.4 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 20 DBP <50 mmHg | 0.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 4 DBP > 90 mmHg | 9.3 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 2 DBP > 90 mmHg | 11.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 20 DBP > 90 mmHg | 7.3 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 4 DBP <50 mmHg | 0.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 28 DBP <50 mmHg | 0.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 20 DBP > 100 mmHg | 1.2 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 2 DBP > 100 mmHg | 0.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Day 1 DBP <50 mmHg | 0.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 10 DBP > 90 mmHg | 9.9 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 10 DBP <50 mmHg | 0.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 24 DBP <50 mmHg | 0.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 10 DBP > 100 mmHg | 1.1 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 8 DBP > 100 mmHg | 0.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 2 DBP <50 mmHg | 0.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 12 DBP <50 mmHg | 0.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 8 DBP > 90 mmHg | 9.6 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 28 DBP > 100 mmHg | 1.3 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 12 DBP > 90 mmHg | 8.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 8 DBP <50 mmHg | 0.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 24 DBP > 90 mmHg | 11.4 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 12 DBP > 100 mmHg | 1.1 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 6 DBP > 100 mmHg | 1.1 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Day 1 DBP > 100 mmHg | 0.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit | Week 16 DBP <50 mmHg | 0.0 percentage of participants |
Secondary
Percentage of Participants With Pulse Rate in Categories by Visit
Participant was expected to be in a supine position (or the most recumbent position possible) in a rested and calm state for at least 5 minutes before pulse assessments were conducted. Pulse rate units are beats per minute (BPM)
Time frame: Day 1, Weeks 2, 4, 6, 8, 10, 12,16, 20, 24, 28
Population: Safety analysis population of participants with data at that visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Pulse Rate in Categories by Visit | Week 24 Pulse rate >100 bpm | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Pulse Rate in Categories by Visit | Week 16 Pulse rate >100 bpm | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Pulse Rate in Categories by Visit | Week 8 Pulse rate <60 bpm | 9.2 percentage of participants |
| Placebo | Percentage of Participants With Pulse Rate in Categories by Visit | Week 2 Pulse rate >100 bpm | 0.7 percentage of participants |
| Placebo | Percentage of Participants With Pulse Rate in Categories by Visit | Week 16 Pulse rate <60 bpm | 10.6 percentage of participants |
| Placebo | Percentage of Participants With Pulse Rate in Categories by Visit | Week 8 Pulse rate >100 bpm | 1.5 percentage of participants |
| Placebo | Percentage of Participants With Pulse Rate in Categories by Visit | Week 28 Pulse rate >100 bpm | 0.9 percentage of participants |
| Placebo | Percentage of Participants With Pulse Rate in Categories by Visit | Week 12 Pulse rate >100 bpm | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Pulse Rate in Categories by Visit | Week 10 Pulse rate <60 bpm | 11.5 percentage of participants |
| Placebo | Percentage of Participants With Pulse Rate in Categories by Visit | Week 24 Pulse rate <60 bpm | 10.4 percentage of participants |
| Placebo | Percentage of Participants With Pulse Rate in Categories by Visit | Week 12 Pulse rate <60 bpm | 13.6 percentage of participants |
| Placebo | Percentage of Participants With Pulse Rate in Categories by Visit | Week 10 Pulse rate >100 bpm | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Pulse Rate in Categories by Visit | Week 4 Pulse rate <60 bpm | 10.4 percentage of participants |
| Placebo | Percentage of Participants With Pulse Rate in Categories by Visit | Week 28 Pulse rate <60 bpm | 8.3 percentage of participants |
| Placebo | Percentage of Participants With Pulse Rate in Categories by Visit | Week 20 Pulse rate >100 bpm | 0.9 percentage of participants |
| Placebo | Percentage of Participants With Pulse Rate in Categories by Visit | Week 4 Pulse rate >100 bpm | 0.7 percentage of participants |
| Placebo | Percentage of Participants With Pulse Rate in Categories by Visit | Week 2 Pulse rate <60 bpm | 11.2 percentage of participants |
| Placebo | Percentage of Participants With Pulse Rate in Categories by Visit | Day 1 Pulse rate <60 bpm | 15.5 percentage of participants |
| Placebo | Percentage of Participants With Pulse Rate in Categories by Visit | Week 6 Pulse rate <60 bpm | 6.9 percentage of participants |
| Placebo | Percentage of Participants With Pulse Rate in Categories by Visit | Day 1 Pulse rate >100 bpm | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Pulse Rate in Categories by Visit | Week 20 Pulse rate <60 bpm | 10.6 percentage of participants |
| Placebo | Percentage of Participants With Pulse Rate in Categories by Visit | Week 6 Pulse rate >100 bpm | 0.8 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Pulse Rate in Categories by Visit | Week 20 Pulse rate <60 bpm | 9.3 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Pulse Rate in Categories by Visit | Day 1 Pulse rate <60 bpm | 13.5 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Pulse Rate in Categories by Visit | Day 1 Pulse rate >100 bpm | 0.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Pulse Rate in Categories by Visit | Week 2 Pulse rate <60 bpm | 4.9 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Pulse Rate in Categories by Visit | Week 2 Pulse rate >100 bpm | 1.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Pulse Rate in Categories by Visit | Week 4 Pulse rate <60 bpm | 8.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Pulse Rate in Categories by Visit | Week 4 Pulse rate >100 bpm | 0.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Pulse Rate in Categories by Visit | Week 6 Pulse rate <60 bpm | 8.2 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Pulse Rate in Categories by Visit | Week 6 Pulse rate >100 bpm | 0.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Pulse Rate in Categories by Visit | Week 8 Pulse rate <60 bpm | 7.6 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Pulse Rate in Categories by Visit | Week 8 Pulse rate >100 bpm | 0.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Pulse Rate in Categories by Visit | Week 10 Pulse rate <60 bpm | 8.6 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Pulse Rate in Categories by Visit | Week 10 Pulse rate >100 bpm | 0.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Pulse Rate in Categories by Visit | Week 12 Pulse rate <60 bpm | 13.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Pulse Rate in Categories by Visit | Week 12 Pulse rate >100 bpm | 1.1 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Pulse Rate in Categories by Visit | Week 16 Pulse rate <60 bpm | 8.9 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Pulse Rate in Categories by Visit | Week 16 Pulse rate >100 bpm | 0.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Pulse Rate in Categories by Visit | Week 20 Pulse rate >100 bpm | 1.2 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Pulse Rate in Categories by Visit | Week 24 Pulse rate <60 bpm | 8.5 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Pulse Rate in Categories by Visit | Week 24 Pulse rate >100 bpm | 1.2 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Pulse Rate in Categories by Visit | Week 28 Pulse rate <60 bpm | 11.8 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Pulse Rate in Categories by Visit | Week 28 Pulse rate >100 bpm | 1.2 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Pulse Rate in Categories by Visit | Week 16 Pulse rate <60 bpm | 8.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Pulse Rate in Categories by Visit | Week 6 Pulse rate >100 bpm | 1.1 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Pulse Rate in Categories by Visit | Day 1 Pulse rate >100 bpm | 0.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Pulse Rate in Categories by Visit | Week 16 Pulse rate >100 bpm | 0.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Pulse Rate in Categories by Visit | Week 6 Pulse rate <60 bpm | 9.6 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Pulse Rate in Categories by Visit | Week 4 Pulse rate >100 bpm | 0.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Pulse Rate in Categories by Visit | Week 20 Pulse rate <60 bpm | 9.8 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Pulse Rate in Categories by Visit | Week 4 Pulse rate <60 bpm | 6.2 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Pulse Rate in Categories by Visit | Week 28 Pulse rate >100 bpm | 0.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Pulse Rate in Categories by Visit | Week 20 Pulse rate >100 bpm | 1.2 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Pulse Rate in Categories by Visit | Week 2 Pulse rate >100 bpm | 0.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Pulse Rate in Categories by Visit | Week 28 Pulse rate <60 bpm | 10.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Pulse Rate in Categories by Visit | Week 24 Pulse rate <60 bpm | 7.6 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Pulse Rate in Categories by Visit | Week 10 Pulse rate >100 bpm | 0.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Pulse Rate in Categories by Visit | Week 10 Pulse rate <60 bpm | 6.6 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Pulse Rate in Categories by Visit | Week 2 Pulse rate <60 bpm | 6.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Pulse Rate in Categories by Visit | Week 12 Pulse rate <60 bpm | 8.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Pulse Rate in Categories by Visit | Week 8 Pulse rate >100 bpm | 0.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Pulse Rate in Categories by Visit | Day 1 Pulse rate <60 bpm | 6.2 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Pulse Rate in Categories by Visit | Week 12 Pulse rate >100 bpm | 1.1 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Pulse Rate in Categories by Visit | Week 8 Pulse rate <60 bpm | 12.8 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Pulse Rate in Categories by Visit | Week 24 Pulse rate >100 bpm | 1.3 percentage of participants |
Secondary
Percentage of Participants With Respiratory Rates in Categories by Visit
Participant was expected to be in a supine position (or the most recumbent position possible) in a rested and calm state for at least 5 minutes before vital sign assessments were conducted. Respiratory rate (RR) is reported in breaths/minute.
Time frame: Day 1, Weeks 2, 4, 6, 8, 10, 12,16, 20, 24, 28
Population: Safety analysis population of participants with data at that visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Respiratory Rates in Categories by Visit | Week 24 RR > 20 breaths/min | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Respiratory Rates in Categories by Visit | Week 16 RR > 20 breaths/min | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Respiratory Rates in Categories by Visit | Week 8 RR < 12 breaths/min | 3.1 percentage of participants |
| Placebo | Percentage of Participants With Respiratory Rates in Categories by Visit | Week 2 RR > 20 breaths/min | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Respiratory Rates in Categories by Visit | Week 16 RR < 12 breaths/min | 4.4 percentage of participants |
| Placebo | Percentage of Participants With Respiratory Rates in Categories by Visit | Week 8 RR > 20 breaths/min | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Respiratory Rates in Categories by Visit | Week 28 RR > 20 breaths/min | 0.9 percentage of participants |
| Placebo | Percentage of Participants With Respiratory Rates in Categories by Visit | Week 12 RR > 20 breaths/min | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Respiratory Rates in Categories by Visit | Week 10 RR < 12 breaths/min | 5.7 percentage of participants |
| Placebo | Percentage of Participants With Respiratory Rates in Categories by Visit | Week 24 RR < 12 breaths/min | 1.9 percentage of participants |
| Placebo | Percentage of Participants With Respiratory Rates in Categories by Visit | Week 12 RR < 12 breaths/min | 4.0 percentage of participants |
| Placebo | Percentage of Participants With Respiratory Rates in Categories by Visit | Week 10 RR > 20 breaths/min | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Respiratory Rates in Categories by Visit | Week 4 RR < 12 breaths/min | 2.2 percentage of participants |
| Placebo | Percentage of Participants With Respiratory Rates in Categories by Visit | Week 28 RR < 12 breaths/min | 3.7 percentage of participants |
| Placebo | Percentage of Participants With Respiratory Rates in Categories by Visit | Week 20 RR > 20 breaths/min | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Respiratory Rates in Categories by Visit | Week 4 RR > 20 breaths/min | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Respiratory Rates in Categories by Visit | Week 2 RR < 12 breaths/min | 5.2 percentage of participants |
| Placebo | Percentage of Participants With Respiratory Rates in Categories by Visit | Day 1 RR < 12 breaths/min | 4.6 percentage of participants |
| Placebo | Percentage of Participants With Respiratory Rates in Categories by Visit | Week 6 RR < 12 breaths/min | 6.1 percentage of participants |
| Placebo | Percentage of Participants With Respiratory Rates in Categories by Visit | Day 1 RR > 20 breaths/min | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Respiratory Rates in Categories by Visit | Week 20 RR < 12 breaths/min | 5.3 percentage of participants |
| Placebo | Percentage of Participants With Respiratory Rates in Categories by Visit | Week 6 RR > 20 breaths/min | 0.8 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Respiratory Rates in Categories by Visit | Week 20 RR < 12 breaths/min | 0.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Respiratory Rates in Categories by Visit | Day 1 RR < 12 breaths/min | 2.2 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Respiratory Rates in Categories by Visit | Day 1 RR > 20 breaths/min | 2.2 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Respiratory Rates in Categories by Visit | Week 2 RR < 12 breaths/min | 2.9 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Respiratory Rates in Categories by Visit | Week 2 RR > 20 breaths/min | 0.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Respiratory Rates in Categories by Visit | Week 4 RR < 12 breaths/min | 3.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Respiratory Rates in Categories by Visit | Week 4 RR > 20 breaths/min | 0.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Respiratory Rates in Categories by Visit | Week 6 RR < 12 breaths/min | 1.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Respiratory Rates in Categories by Visit | Week 6 RR > 20 breaths/min | 0.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Respiratory Rates in Categories by Visit | Week 8 RR < 12 breaths/min | 2.2 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Respiratory Rates in Categories by Visit | Week 8 RR > 20 breaths/min | 2.2 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Respiratory Rates in Categories by Visit | Week 10 RR < 12 breaths/min | 1.1 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Respiratory Rates in Categories by Visit | Week 10 RR > 20 breaths/min | 2.2 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Respiratory Rates in Categories by Visit | Week 12 RR < 12 breaths/min | 1.1 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Respiratory Rates in Categories by Visit | Week 12 RR > 20 breaths/min | 0.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Respiratory Rates in Categories by Visit | Week 16 RR < 12 breaths/min | 2.2 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Respiratory Rates in Categories by Visit | Week 16 RR > 20 breaths/min | 1.1 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Respiratory Rates in Categories by Visit | Week 20 RR > 20 breaths/min | 1.2 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Respiratory Rates in Categories by Visit | Week 24 RR < 12 breaths/min | 0.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Respiratory Rates in Categories by Visit | Week 24 RR > 20 breaths/min | 4.9 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Respiratory Rates in Categories by Visit | Week 28 RR < 12 breaths/min | 1.2 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Respiratory Rates in Categories by Visit | Week 28 RR > 20 breaths/min | 2.4 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Respiratory Rates in Categories by Visit | Week 16 RR < 12 breaths/min | 4.5 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Respiratory Rates in Categories by Visit | Week 6 RR > 20 breaths/min | 0.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Respiratory Rates in Categories by Visit | Day 1 RR > 20 breaths/min | 1.3 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Respiratory Rates in Categories by Visit | Week 16 RR > 20 breaths/min | 0.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Respiratory Rates in Categories by Visit | Week 6 RR < 12 breaths/min | 4.3 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Respiratory Rates in Categories by Visit | Week 4 RR > 20 breaths/min | 2.1 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Respiratory Rates in Categories by Visit | Week 20 RR < 12 breaths/min | 1.2 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Respiratory Rates in Categories by Visit | Week 4 RR < 12 breaths/min | 5.2 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Respiratory Rates in Categories by Visit | Week 28 RR > 20 breaths/min | 1.3 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Respiratory Rates in Categories by Visit | Week 20 RR > 20 breaths/min | 0.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Respiratory Rates in Categories by Visit | Week 2 RR > 20 breaths/min | 0.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Respiratory Rates in Categories by Visit | Week 28 RR < 12 breaths/min | 2.5 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Respiratory Rates in Categories by Visit | Week 24 RR < 12 breaths/min | 0.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Respiratory Rates in Categories by Visit | Week 10 RR > 20 breaths/min | 0.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Respiratory Rates in Categories by Visit | Week 10 RR < 12 breaths/min | 4.4 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Respiratory Rates in Categories by Visit | Week 2 RR < 12 breaths/min | 5.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Respiratory Rates in Categories by Visit | Week 12 RR < 12 breaths/min | 0.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Respiratory Rates in Categories by Visit | Week 8 RR > 20 breaths/min | 0.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Respiratory Rates in Categories by Visit | Day 1 RR < 12 breaths/min | 3.8 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Respiratory Rates in Categories by Visit | Week 12 RR > 20 breaths/min | 0.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Respiratory Rates in Categories by Visit | Week 8 RR < 12 breaths/min | 1.1 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Respiratory Rates in Categories by Visit | Week 24 RR > 20 breaths/min | 0.0 percentage of participants |
Secondary
Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit
Participant was expected to be in a supine position (or the most recumbent position possible) in a rested and calm state for at least 5 minutes before blood pressure assessments were conducted. Blood pressure units are millimeters of mercury (mmHg).
Time frame: Day 1, Weeks 2, 4, 6, 8, 10, 12,16, 20, 24, 28
Population: Safety analysis population of participants with data at that visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 2 SBP < 90 mmHg | 1.5 percentage of participants |
| Placebo | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 6 SBP > 160 mmHg | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 4 SBP > 160 mmHg | 0.7 percentage of participants |
| Placebo | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 24 SBP > 140 mmHg | 4.7 percentage of participants |
| Placebo | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 8 SBP < 90 mmHg | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 20 SBP > 140 mmHg | 4.4 percentage of participants |
| Placebo | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 2 SBP > 140 mmHg | 5.2 percentage of participants |
| Placebo | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 8 SBP > 140 mmHg | 2.3 percentage of participants |
| Placebo | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 4 SBP > 140 mmHg | 3.0 percentage of participants |
| Placebo | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 6 SBP < 90 mmHg | 0.8 percentage of participants |
| Placebo | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 8 SBP > 160 mmHg | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 24 SBP > 160 mmHg | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Day 1 SBP > 140 mmHg | 5.5 percentage of participants |
| Placebo | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 10 SBP < 90 mmHg | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 16 SBP > 140 mmHg | 4.4 percentage of participants |
| Placebo | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 2 SBP > 160 mmHg | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 10 SBP > 140 mmHg | 4.1 percentage of participants |
| Placebo | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Day 1 SBP > 160 mmHg | 0.9 percentage of participants |
| Placebo | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 28 SBP < 90 mmHg | 0.9 percentage of participants |
| Placebo | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 10 SBP > 160 mmHg | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 20 SBP > 160 mmHg | 0.9 percentage of participants |
| Placebo | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Day 1 SBP <90 mmHg | 0.9 percentage of participants |
| Placebo | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 12 SBP < 90 mmHg | 0.8 percentage of participants |
| Placebo | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 28 SBP > 140 mmHg | 8.3 percentage of participants |
| Placebo | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 4 SBP < 90 mmHg | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 12 SBP > 140 mmHg | 6.4 percentage of participants |
| Placebo | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 20 SBP < 90 mmHg | 0.9 percentage of participants |
| Placebo | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 6 SBP > 140 mmHg | 3.1 percentage of participants |
| Placebo | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 12 SBP > 160 mmHg | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 28 SBP > 160 mmHg | 0.9 percentage of participants |
| Placebo | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 24 SBP < 90 mmHg | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 16 SBP < 90 mmHg | 0.9 percentage of participants |
| Placebo | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 16 SBP > 160 mmHg | 0.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 8 SBP > 140 mmHg | 5.4 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 16 SBP > 140 mmHg | 4.4 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 4 SBP > 140 mmHg | 3.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 16 SBP > 160 mmHg | 0.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 20 SBP < 90 mmHg | 0.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 20 SBP > 140 mmHg | 8.1 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 4 SBP > 160 mmHg | 0.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 20 SBP > 160 mmHg | 0.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 24 SBP < 90 mmHg | 1.2 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Day 1 SBP > 160 mmHg | 0.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 24 SBP > 140 mmHg | 6.1 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 24 SBP > 160 mmHg | 0.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 6 SBP < 90 mmHg | 0.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 28 SBP < 90 mmHg | 1.2 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 28 SBP > 140 mmHg | 4.7 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 28 SBP > 160 mmHg | 1.2 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 6 SBP > 140 mmHg | 3.1 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 6 SBP > 160 mmHg | 0.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 2 SBP < 90 mmHg | 0.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 8 SBP < 90 mmHg | 0.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 2 SBP > 140 mmHg | 2.9 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 8 SBP > 160 mmHg | 0.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 10 SBP < 90 mmHg | 0.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 10 SBP > 140 mmHg | 1.1 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 2 SBP > 160 mmHg | 0.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 10 SBP > 160 mmHg | 0.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Day 1 SBP > 140 mmHg | 7.9 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 12 SBP < 90 mmHg | 0.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 12 SBP > 140 mmHg | 2.2 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 4 SBP < 90 mmHg | 0.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 12 SBP > 160 mmHg | 0.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Day 1 SBP <90 mmHg | 0.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 16 SBP < 90 mmHg | 0.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 28 SBP > 160 mmHg | 0.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 2 SBP < 90 mmHg | 0.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Day 1 SBP <90 mmHg | 0.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Day 1 SBP > 140 mmHg | 4.9 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Day 1 SBP > 160 mmHg | 0.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 2 SBP > 140 mmHg | 8.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 2 SBP > 160 mmHg | 1.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 4 SBP < 90 mmHg | 0.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 4 SBP > 140 mmHg | 6.2 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 4 SBP > 160 mmHg | 1.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 6 SBP < 90 mmHg | 0.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 6 SBP > 140 mmHg | 3.2 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 6 SBP > 160 mmHg | 0.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 8 SBP < 90 mmHg | 0.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 8 SBP > 140 mmHg | 8.5 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 8 SBP > 160 mmHg | 1.1 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 10 SBP < 90 mmHg | 0.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 10 SBP > 140 mmHg | 2.2 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 10 SBP > 160 mmHg | 2.2 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 12 SBP < 90 mmHg | 0.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 12 SBP > 140 mmHg | 5.7 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 12 SBP > 160 mmHg | 0.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 16 SBP < 90 mmHg | 0.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 16 SBP > 140 mmHg | 5.7 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 16 SBP > 160 mmHg | 3.4 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 20 SBP < 90 mmHg | 0.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 20 SBP > 140 mmHg | 7.3 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 24 SBP < 90 mmHg | 0.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 24 SBP > 140 mmHg | 8.9 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 24 SBP > 160 mmHg | 0.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 28 SBP < 90 mmHg | 0.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 28 SBP > 140 mmHg | 6.3 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit | Week 20 SBP > 160 mmHg | 0.0 percentage of participants |
Secondary
Percentage of Participants With Temperature in Categories by Visit
Participant was expected to be in a supine position (or the most recumbent position possible) in a rested and calm state for at least 5 minutes before vital sign assessments were conducted. Temperature units are reported in degrees Celsius (C).
Time frame: Day 1, Weeks 2, 4, 6, 8, 10, 12,16, 20, 24, 28
Population: Safety analysis population of participants with data at that visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Temperature in Categories by Visit | Week 28 Temperature < 36 C | 6.5 percentage of participants |
| Placebo | Percentage of Participants With Temperature in Categories by Visit | Week 16 Temperature > 38 C | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Temperature in Categories by Visit | Week 8 Temperature < 36 C | 7.7 percentage of participants |
| Placebo | Percentage of Participants With Temperature in Categories by Visit | Week 2 Temperature > 38 C | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Temperature in Categories by Visit | Week 16 Temperature < 36 C | 6.2 percentage of participants |
| Placebo | Percentage of Participants With Temperature in Categories by Visit | Week 8 Temperature > 38 C | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Temperature in Categories by Visit | Week 2 Temperature < 36 C | 11.2 percentage of participants |
| Placebo | Percentage of Participants With Temperature in Categories by Visit | Week 12 Temperature > 38 C | 0.8 percentage of participants |
| Placebo | Percentage of Participants With Temperature in Categories by Visit | Week 10 Temperature < 36 C | 9.0 percentage of participants |
| Placebo | Percentage of Participants With Temperature in Categories by Visit | Week 24 Temperature > 38 C | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Temperature in Categories by Visit | Week 12 Temperature < 36 C | 8.0 percentage of participants |
| Placebo | Percentage of Participants With Temperature in Categories by Visit | Week 10 Temperature > 38 C | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Temperature in Categories by Visit | Week 4 Temperature < 36 C | 8.9 percentage of participants |
| Placebo | Percentage of Participants With Temperature in Categories by Visit | Day 1 Temperature < 36 C | 5.5 percentage of participants |
| Placebo | Percentage of Participants With Temperature in Categories by Visit | Week 24 Temperature < 36 C | 5.7 percentage of participants |
| Placebo | Percentage of Participants With Temperature in Categories by Visit | Week 4 Temperature > 38 C | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Temperature in Categories by Visit | Day 1 Temperature > 38 C | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Temperature in Categories by Visit | Week 20 Temperature > 38 C | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Temperature in Categories by Visit | Week 6 Temperature < 36 C | 6.1 percentage of participants |
| Placebo | Percentage of Participants With Temperature in Categories by Visit | Week 28 Temperature > 38 C | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Temperature in Categories by Visit | Week 20 Temperature < 36 C | 10.6 percentage of participants |
| Placebo | Percentage of Participants With Temperature in Categories by Visit | Week 6 Temperature > 38 C | 0.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Temperature in Categories by Visit | Week 20 Temperature < 36 C | 7.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Temperature in Categories by Visit | Day 1 Temperature > 38 C | 0.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Temperature in Categories by Visit | Day 1 Temperature < 36 C | 10.1 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Temperature in Categories by Visit | Week 2 Temperature < 36 C | 9.8 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Temperature in Categories by Visit | Week 2 Temperature > 38 C | 0.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Temperature in Categories by Visit | Week 4 Temperature < 36 C | 12.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Temperature in Categories by Visit | Week 4 Temperature > 38 C | 0.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Temperature in Categories by Visit | Week 6 Temperature < 36 C | 12.4 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Temperature in Categories by Visit | Week 6 Temperature > 38 C | 0.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Temperature in Categories by Visit | Week 8 Temperature < 36 C | 7.6 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Temperature in Categories by Visit | Week 8 Temperature > 38 C | 0.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Temperature in Categories by Visit | Week 10 Temperature < 36 C | 14.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Temperature in Categories by Visit | Week 10 Temperature > 38 C | 0.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Temperature in Categories by Visit | Week 12 Temperature < 36 C | 13.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Temperature in Categories by Visit | Week 12 Temperature > 38 C | 0.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Temperature in Categories by Visit | Week 16 Temperature < 36 C | 7.8 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Temperature in Categories by Visit | Week 16 Temperature > 38 C | 0.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Temperature in Categories by Visit | Week 20 Temperature > 38 C | 0.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Temperature in Categories by Visit | Week 24 Temperature < 36 C | 8.5 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Temperature in Categories by Visit | Week 24 Temperature > 38 C | 0.0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Temperature in Categories by Visit | Week 28 Temperature < 36 C | 9.4 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Temperature in Categories by Visit | Week 28 Temperature > 38 C | 0.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Temperature in Categories by Visit | Week 16 Temperature < 36 C | 13.6 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Temperature in Categories by Visit | Week 6 Temperature > 38 C | 0.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Temperature in Categories by Visit | Week 2 Temperature < 36 C | 8.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Temperature in Categories by Visit | Week 16 Temperature > 38 C | 0.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Temperature in Categories by Visit | Week 6 Temperature < 36 C | 8.5 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Temperature in Categories by Visit | Day 1 Temperature < 36 C | 7.4 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Temperature in Categories by Visit | Week 20 Temperature < 36 C | 9.8 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Temperature in Categories by Visit | Week 4 Temperature > 38 C | 0.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Temperature in Categories by Visit | Week 28 Temperature > 38 C | 0.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Temperature in Categories by Visit | Week 20 Temperature > 38 C | 0.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Temperature in Categories by Visit | Week 4 Temperature < 36 C | 10.3 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Temperature in Categories by Visit | Week 28 Temperature < 36 C | 11.3 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Temperature in Categories by Visit | Week 24 Temperature < 36 C | 11.4 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Temperature in Categories by Visit | Week 10 Temperature > 38 C | 0.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Temperature in Categories by Visit | Week 10 Temperature < 36 C | 7.7 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Temperature in Categories by Visit | Week 2 Temperature > 38 C | 0.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Temperature in Categories by Visit | Week 12 Temperature < 36 C | 12.5 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Temperature in Categories by Visit | Week 8 Temperature > 38 C | 0.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Temperature in Categories by Visit | Day 1 Temperature > 38 C | 0.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Temperature in Categories by Visit | Week 12 Temperature > 38 C | 0.0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Temperature in Categories by Visit | Week 8 Temperature < 36 C | 8.5 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Temperature in Categories by Visit | Week 24 Temperature > 38 C | 0.0 percentage of participants |
Secondary
Percentage of Participants With Total Bilirubin Test Abnormalities > 2 Times the Upper Limit of Normal (ULN) at Baseline and On Study
Percentage of participants with total bilirubin results that were greater than 2 \* ULN are reported.
Time frame: Baseline: Day 1 On study: Weeks 4, 6, 12, 20, 28
Population: Safety analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Total Bilirubin Test Abnormalities > 2 Times the Upper Limit of Normal (ULN) at Baseline and On Study | Baseline | 0 percentage of participants |
| Placebo | Percentage of Participants With Total Bilirubin Test Abnormalities > 2 Times the Upper Limit of Normal (ULN) at Baseline and On Study | On study | 0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Total Bilirubin Test Abnormalities > 2 Times the Upper Limit of Normal (ULN) at Baseline and On Study | Baseline | 0 percentage of participants |
| AMG 301 210 mg Q4W | Percentage of Participants With Total Bilirubin Test Abnormalities > 2 Times the Upper Limit of Normal (ULN) at Baseline and On Study | On study | 0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Total Bilirubin Test Abnormalities > 2 Times the Upper Limit of Normal (ULN) at Baseline and On Study | Baseline | 0 percentage of participants |
| AMG 301 420 mg Q2W | Percentage of Participants With Total Bilirubin Test Abnormalities > 2 Times the Upper Limit of Normal (ULN) at Baseline and On Study | On study | 0 percentage of participants |