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The primary objective of this trial is to evaluate analgesic efficacy of Fentanyl Sublingual Spray compared with placebo in participants with postoperative pain after a bunionectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lower Dose Fentanyl | Experimental | Lower dose Fentanyl delivered via sublingual spray every 4 hours. |
|
| Higher Dose Fentanyl Sublingual Spray | Experimental | Higher dose Fentanyl delivered via sublingual spray every 4 hours. |
|
| Placebo | Placebo Comparator | Placebo (matching Fentanyl) delivered via sublingual spray every 4 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fentanyl | Drug | Fentanyl delivered via sublingual spray |
|
| Measure | Description | Time Frame |
|---|---|---|
| Numeric Rating Scale (NRS) Summed Pain Intensity Difference (SPID) Over 0 to 48 Hours (NRS SPID-48) After Time 0 | Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug) and at multiple time points up to 48 hours after Time 0 (administration of first dose of study drug). Pain intensity difference is calculated by subtracting the pain intensity at each time point from the pain intensity at Time 0. The SPID scores are the sum of the differences at each time point multiplied by the duration in hours since the previous time point. Positive numbers indicate a reduction in pain [maximum(max)=10 at each time point], and negative numbers indicate an increase in pain [minimum(min)=-10 at each time point]. The overall min and max are -10 and 10 times the number of hours specified; SPID-48 range is -480 to 480. The NRS SPID-48 was analyzed using an analysis of covariance (ANCOVA) model, which included treatment and site as main effects and Baseline pain intensity as the covariate. | Over 0 to 48 hours after Time 0 |
| Measure | Description | Time Frame |
|---|---|---|
| NRS Pain Intensity Difference (NRS PID) at Each Categorical Time Point After Time 0 | Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug administration) and at multiple time points after Time 0 (time of administration of the first dose of study drug). NRS PID is defined as the difference in pain at each scheduled time point relative to Baseline (PID=pain intensity at baseline - pain intensity at time point). A higher value of NRS PID score indicates a higher decrease in pain from Baseline. NRS PID is reported as the least squares mean difference. |
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Inclusion Criteria:
Exclusion Criteria:
History or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
Signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
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| Name | Affiliation | Role |
|---|---|---|
| Giovanni DeCastro | INSYS Therapeutics Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Research Center | Phoenix | Arizona | 85023 | United States | ||
| Anaheim Clinical Trials |
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| ID | Title | Description |
|---|---|---|
| FG000 | Higher Dose Fentanyl Sublingual Spray | Higher dose Fentanyl delivered via sublingual spray every 4 hours. Fentanyl: Fentanyl delivered via sublingual spray |
| FG001 | Lower Dose Fentanyl | Lower dose Fentanyl delivered via sublingual spray every 4 hours. Fentanyl: Fentanyl delivered via sublingual spray |
| FG002 | Placebo | Placebo (matching Fentany) delivered via sublingual spray every 4 hours. Placebo: Matching placebo delivered via sublingual spray |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Higher Dose Fentanyl Sublingual Spray | Higher dose Fentanyl delivered via sublingual spray every 4 hours. Fentanyl: Fentanyl delivered via sublingual spray |
| BG001 | Lower Dose Fentanyl Sublingual Spray |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Numeric Rating Scale (NRS) Summed Pain Intensity Difference (SPID) Over 0 to 48 Hours (NRS SPID-48) After Time 0 | Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug) and at multiple time points up to 48 hours after Time 0 (administration of first dose of study drug). Pain intensity difference is calculated by subtracting the pain intensity at each time point from the pain intensity at Time 0. The SPID scores are the sum of the differences at each time point multiplied by the duration in hours since the previous time point. Positive numbers indicate a reduction in pain [maximum(max)=10 at each time point], and negative numbers indicate an increase in pain [minimum(min)=-10 at each time point]. The overall min and max are -10 and 10 times the number of hours specified; SPID-48 range is -480 to 480. The NRS SPID-48 was analyzed using an analysis of covariance (ANCOVA) model, which included treatment and site as main effects and Baseline pain intensity as the covariate. | All randomized participants from the Intent-to-Treat (ITT) population. | Posted | Mean | Standard Deviation | units on a scale | Over 0 to 48 hours after Time 0 |
Baseline up to 37 days approximately.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Higher Dose Fentanyl Sublingual Spray | Higher dose Fentanyl delivered via sublingual spray every 4 hours. Fentanyl: Fentanyl delivered via sublingual spray |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Development | Insys Therapeutics, Inc. | 480-500-3105 | gdecastro@insysrx.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 21, 2016 | Jan 19, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 19, 2016 | Jan 19, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | Matching placebo delivered via sublingual spray |
|
| Baseline, 1, 16, and 24 hours |
| NRS Pain Intensity Score at Each Scheduled Time Point After Time 0 | Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug administration) and at multiple time points after Time 0 (time of administration of the first dose of study drug). A lower value indicates improvement in pain. | Baseline, 1, 16, and 24 hours |
| NRS SPID After Time 0 | Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug) and at multiple time points after Time 0 (administration of first dose of study drug). Pain intensity difference is calculated by subtracting the pain intensity at each time point from the pain intensity at Time 0. The SPID scores are the sum of the differences at each time point multiplied by the duration in hours since the previous time point. Positive numbers indicate a reduction in pain [maximum(max)=10 at each timepoint], and negative numbers indicate an increase in pain [minimum(min)=-10 at each timepoint]. The overall min and max are -10 and 10 times the number of hours specified: SPID-4=(-40 to 40), SPID-8=(-80 to 80) and SPID-24=(-240 to 240). The NRS SPID-4, 8 and 24 were analyzed using an ANCOVA model which included treatment and site as main effects and Baseline pain intensity as the covariate. | Over 0 to 4 hours (NRS SPID-4), over 0 to 8 hours (NRS SPID-8), and over 0 to 24 hours (NRS SPID-24) |
| Total Pain Relief (TOTPAR) After Time 0 | TOTPAR was assessed by the participant using a 5-point NRS (0=no relief, 1=a little, 2=some, 3=a lot, 4=complete relief). TOTPAR scores were collected at Baseline (prior to study drug) and at multiple time points up to 48 hours after Time 0 (first dose of study drug). The TOTPAR scores are the sum of the pain relief at each time point multiplied by the duration in hours since the previous time point. Larger positive numbers indicate more pain relief (maximum=4 at each time point) and smaller positive numbers indicate less pain relief (minimum=0 at each time point). The overall minimum is 0 for each variable and the overall maximum is 4 times the number of hours specified for the variable: TOTPAR-4=(0 to 16), TOTPAR-8=(0 to 32), TOTPAR-24=(0 to 96) and TOTPAR-48=(0 to 192). TOTPAR-4, TOTPAR-8, TOTPAR-24 and TOTPAR-48 were analyzed using an ANCOVA model with factors for treatment, site and baseline pain intensity. | Over 0 to 4 hours (TOTPAR-4), over 0 to 8 hours (TOTPAR-8), over 0 to 24 hours (TOTPAR-24), and over 0 to 48 hours (TOTPAR-48) |
| Time to Onset of Analgesia | Measured as time to perceptible pain relief confirmed by meaningful pain relief using the 2-stopwatch method (2 stopwatches will be started as soon as the first dose of study drug is administered. Each participant will be instructed to stop the first stopwatch when he or she experiences any perceptible pain relief and the second stopwatch when he or she experiences pain relief that is meaningful to them.) | Within 48 hours |
| Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication) | Pain relief is determined on a 5-point categorical scale where 0=none, 1=a little, 2=some, 3=a lot, 4=complete. | 2.5, 5, 15, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 32, 40, and 48 hours, as well as immediately before each use of rescue analgesia |
| Peak Pain Relief From Time 0 (First Dose of Study Medication) | The highest level of pain relief achieved on a 5-point categorical scale where 0=none, 1=a little, 2=some, 3=a lot, 4=complete. | Within 48 hours after Time 0 |
| Time (Minutes) to Peak Pain Relief From Time 0 (First Dose of Study Medication) | Within 48 hours after Time 0 |
| Time (Minutes) to First Perceptible Pain Relief From Time 0 (First Dose of Study Medication) | Time to perceptible and meaningful pain relief will be evaluated using the 2-stopwatch method (after the first dose only) (2 stopwatches will be started as soon as the first dose of study drug is administered. Each participant will be instructed to stop the first stopwatch when he or she experiences any perceptible pain relief and the second stopwatch when he or she experiences pain relief that is meaningful to them.) | Within 48 hours after Time 0 |
| Time (Minutes) to Meaningful Pain Relief From Time 0 (First Dose of Study Medication) | Time to perceptible and meaningful pain relief will be evaluated using the 2-stopwatch method (after the first dose only) (2 stopwatches will be started as soon as the first dose of study drug is administered. Each participant will be instructed to stop the first stopwatch when he or she experiences any perceptible pain relief and the second stopwatch when he or she experiences pain relief that is meaningful to them.) | Within 48 hours after Time 0 |
| Number of Participants Using Rescue Medication | Within 48 hours |
| Time (Minutes) to First Use of Rescue Medication (Duration of Analgesia) Following Each Dose of the Investigational Product (IP) | Within 48 hours |
| Number of Participants Using Rescue Analgesia Over 0 to 24 Hours and Over 0 to 48 Hours | Over 0 to 24 hours; Over 0 to 48 hours |
| Participant Global Evaluation of Study Drug | Participants provide a global evaluation of study drug on a 5-point categorical scale where 0=poor, 1=fair, 2=good, 3=very good, and 4=excellent. | Within 48 hours |
| Anaheim |
| California |
| 92801 |
| United States |
Lower dose Fentanyl delivered via sublingual spray every 4 hours.
Fentanyl: Fentanyl delivered via sublingual spray
| BG002 | Placebo | Placebo (matching Fentany) delivered via sublingual spray every 4 hours. Placebo: Matching placebo delivered via sublingual spray |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Higher Dose Fentanyl Sublingual Spray | Higher dose Fentanyl delivered via sublingual spray every 4 hours. Fentanyl: Fentanyl delivered via sublingual spray |
| OG001 | Lower Dose Fentanyl Sublingual Spray | Lower dose Fentanyl delivered via sublingual spray every 4 hours. Fentanyl: Fentanyl delivered via sublingual spray |
| OG002 | Placebo | Placebo (matching Fentany) delivered via sublingual spray every 4 hours. Placebo: Matching placebo delivered via sublingual spray |
|
|
| Secondary | NRS Pain Intensity Difference (NRS PID) at Each Categorical Time Point After Time 0 | Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug administration) and at multiple time points after Time 0 (time of administration of the first dose of study drug). NRS PID is defined as the difference in pain at each scheduled time point relative to Baseline (PID=pain intensity at baseline - pain intensity at time point). A higher value of NRS PID score indicates a higher decrease in pain from Baseline. NRS PID is reported as the least squares mean difference. | All randomized participants from the Intent-to-Treat (ITT) population. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 1, 16, and 24 hours |
|
|
|
|
| Secondary | NRS Pain Intensity Score at Each Scheduled Time Point After Time 0 | Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug administration) and at multiple time points after Time 0 (time of administration of the first dose of study drug). A lower value indicates improvement in pain. | All randomized participants from the Intent-to-Treat (ITT) population. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 1, 16, and 24 hours |
|
|
|
| Secondary | NRS SPID After Time 0 | Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug) and at multiple time points after Time 0 (administration of first dose of study drug). Pain intensity difference is calculated by subtracting the pain intensity at each time point from the pain intensity at Time 0. The SPID scores are the sum of the differences at each time point multiplied by the duration in hours since the previous time point. Positive numbers indicate a reduction in pain [maximum(max)=10 at each timepoint], and negative numbers indicate an increase in pain [minimum(min)=-10 at each timepoint]. The overall min and max are -10 and 10 times the number of hours specified: SPID-4=(-40 to 40), SPID-8=(-80 to 80) and SPID-24=(-240 to 240). The NRS SPID-4, 8 and 24 were analyzed using an ANCOVA model which included treatment and site as main effects and Baseline pain intensity as the covariate. | All randomized participants from the Intent-to-Treat (ITT) population. | Posted | Mean | Standard Deviation | units on a scale | Over 0 to 4 hours (NRS SPID-4), over 0 to 8 hours (NRS SPID-8), and over 0 to 24 hours (NRS SPID-24) |
|
|
|
| Secondary | Total Pain Relief (TOTPAR) After Time 0 | TOTPAR was assessed by the participant using a 5-point NRS (0=no relief, 1=a little, 2=some, 3=a lot, 4=complete relief). TOTPAR scores were collected at Baseline (prior to study drug) and at multiple time points up to 48 hours after Time 0 (first dose of study drug). The TOTPAR scores are the sum of the pain relief at each time point multiplied by the duration in hours since the previous time point. Larger positive numbers indicate more pain relief (maximum=4 at each time point) and smaller positive numbers indicate less pain relief (minimum=0 at each time point). The overall minimum is 0 for each variable and the overall maximum is 4 times the number of hours specified for the variable: TOTPAR-4=(0 to 16), TOTPAR-8=(0 to 32), TOTPAR-24=(0 to 96) and TOTPAR-48=(0 to 192). TOTPAR-4, TOTPAR-8, TOTPAR-24 and TOTPAR-48 were analyzed using an ANCOVA model with factors for treatment, site and baseline pain intensity. | All randomized participants from the Intent-to-Treat (ITT) population. | Posted | Mean | Standard Deviation | units on a scale | Over 0 to 4 hours (TOTPAR-4), over 0 to 8 hours (TOTPAR-8), over 0 to 24 hours (TOTPAR-24), and over 0 to 48 hours (TOTPAR-48) |
|
|
|
| Secondary | Time to Onset of Analgesia | Measured as time to perceptible pain relief confirmed by meaningful pain relief using the 2-stopwatch method (2 stopwatches will be started as soon as the first dose of study drug is administered. Each participant will be instructed to stop the first stopwatch when he or she experiences any perceptible pain relief and the second stopwatch when he or she experiences pain relief that is meaningful to them.) | All randomized participants from the Intent-to-Treat (ITT) population. | Posted | Mean | 95% Confidence Interval | minutes | Within 48 hours |
|
|
|
| Secondary | Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication) | Pain relief is determined on a 5-point categorical scale where 0=none, 1=a little, 2=some, 3=a lot, 4=complete. | All randomized participants from the Intent-to-Treat (ITT) population. The number analyzed differs in the later time points for the Fentanyl groups because some participants withdrew over the course of the study. | Posted | Count of Participants | Participants | 2.5, 5, 15, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 32, 40, and 48 hours, as well as immediately before each use of rescue analgesia |
|
|
|
| Secondary | Peak Pain Relief From Time 0 (First Dose of Study Medication) | The highest level of pain relief achieved on a 5-point categorical scale where 0=none, 1=a little, 2=some, 3=a lot, 4=complete. | All randomized participants from the Intent-to-Treat (ITT) population. | Posted | Count of Participants | Participants | Within 48 hours after Time 0 |
|
|
|
| Secondary | Time (Minutes) to Peak Pain Relief From Time 0 (First Dose of Study Medication) | All randomized participants from the Intent-to-Treat (ITT) population. | Posted | Mean | 95% Confidence Interval | minutes | Within 48 hours after Time 0 |
|
|
|
| Secondary | Time (Minutes) to First Perceptible Pain Relief From Time 0 (First Dose of Study Medication) | Time to perceptible and meaningful pain relief will be evaluated using the 2-stopwatch method (after the first dose only) (2 stopwatches will be started as soon as the first dose of study drug is administered. Each participant will be instructed to stop the first stopwatch when he or she experiences any perceptible pain relief and the second stopwatch when he or she experiences pain relief that is meaningful to them.) | All randomized participants from the Intent-to-Treat (ITT) population. | Posted | Mean | 95% Confidence Interval | minutes | Within 48 hours after Time 0 |
|
|
|
| Secondary | Time (Minutes) to Meaningful Pain Relief From Time 0 (First Dose of Study Medication) | Time to perceptible and meaningful pain relief will be evaluated using the 2-stopwatch method (after the first dose only) (2 stopwatches will be started as soon as the first dose of study drug is administered. Each participant will be instructed to stop the first stopwatch when he or she experiences any perceptible pain relief and the second stopwatch when he or she experiences pain relief that is meaningful to them.) | All randomized participants from the Intent-to-Treat (ITT) population. | Posted | Mean | 95% Confidence Interval | minutes | Within 48 hours after Time 0 |
|
|
|
| Secondary | Number of Participants Using Rescue Medication | All randomized participants from the Intent-to-Treat (ITT) population. | Posted | Count of Participants | Participants | Within 48 hours |
|
|
|
| Secondary | Time (Minutes) to First Use of Rescue Medication (Duration of Analgesia) Following Each Dose of the Investigational Product (IP) | All randomized participants from the Intent-to-Treat (ITT) population. | Posted | Mean | 95% Confidence Interval | minutes | Within 48 hours |
|
|
|
| Secondary | Number of Participants Using Rescue Analgesia Over 0 to 24 Hours and Over 0 to 48 Hours | All randomized participants from the Intent-to-Treat (ITT) population. | Posted | Count of Participants | Participants | Over 0 to 24 hours; Over 0 to 48 hours |
|
|
|
| Secondary | Participant Global Evaluation of Study Drug | Participants provide a global evaluation of study drug on a 5-point categorical scale where 0=poor, 1=fair, 2=good, 3=very good, and 4=excellent. | All randomized participants from the Intent-to-Treat (ITT) population. | Posted | Count of Participants | Participants | Within 48 hours |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 12 |
| 15 |
| EG001 | Lower Dose Fentanyl Sublingual Spray | Lower dose Fentanyl delivered via sublingual spray every 4 hours. Fentanyl: Fentanyl delivered via sublingual spray | 0 | 15 | 0 | 15 | 8 | 15 |
| EG002 | Placebo | Placebo (matching Fentany) delivered via sublingual spray every 4 hours. Placebo: Matching placebo delivered via sublingual spray | 0 | 15 | 0 | 15 | 6 | 15 |
| Vomiting | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Application Site Pain | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| Burning Sensation | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Vulvovaginal Mycotic Infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Restless Leg Syndrome | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Oropharyngeal Swelling | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Hot Flush | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
|
Not provided
Not provided
|
| 16 Hours |
|
| 24 Hours |
|
| 0.2493 |
| LS Mean Difference |
| -1.06 |
| Standard Error of the Mean |
| 0.90 |
| 2-Sided |
| 95 |
| -2.89 |
| 0.77 |
| Other |
| NRS PID at 16 hours | ANCOVA | 0.0052 | LS Mean Difference | -2.94 | Standard Error of the Mean | 0.99 | 2-Sided | 95 | -4.95 | -0.94 | Other |
| NRS PID at 16 hours | ANCOVA | 0.0926 | LS Mean Difference | -1.67 | Standard Error of the Mean | 0.97 | 2-Sided | 95 | -3.62 | 0.29 | Other |
| NRS PID at 24 hours | ANCOVA | 0.0951 | LS Means Difference | -1.40 | Standard Error of the Mean | 0.82 | 2-Sided | 95 | -3.06 | 0.26 | Other |
| NRS PID at 24 hours | ANCOVA | 0.9866 | LS Mean Difference | 0.01 | Standard Error of the Mean | 0.80 | 2-Sided | 95 | -1.60 | 1.63 | Other |
|
| 16 Hours |
|
| 24 hours |
|
|
| Over 4 Hours |
|
|
| Over 8 Hours |
|
| Over 4 Hours |
|
| A Little Relief |
|
| Some Relief |
|
| A Lot of Relief |
|
| Complete Relief |
|
| 5 Minutes After Time 0 |
|
|
| 15 Minutes After Time 0 |
|
|
| 30 Minutes After Time 0 - No Relief |
|
|
| 45 Minutes After Time 0 |
|
|
| 1 Hour After Time 0 |
|
|
| 1.5 Hours After Time 0 |
|
|
| 2 Hours After Time 0 |
|
|
| 3 Hours After Time 0 |
|
|
| 4 Hours After Time 0 |
|
|
| 5 Hours After Time 0 |
|
|
| 6 Hours After Time 0 |
|
|
| 7 Hours After Time 0 |
|
|
| 8 Hours After Time 0 |
|
|
| 12 Hours After Time 0 |
|
|
| 16 Hours After Time 0 |
|
|
| 20 Hours After Time 0 |
|
|
| 24 Hours After Time 0 |
|
|
| 32 Hours After Time 0 |
|
|
| 40 Hours After Time 0 |
|
|
| 48 Hours After Time 0 |
|
|
| Title | Measurements |
|---|---|
|
| A Lot of Relief |
|
| Complete Relief |
|
| Title | Measurements |
|---|---|
|
| Good |
|
| Very Good |
|
| Excellent |
|