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We are proposing a study in which we utilize and augment the sore throat pain model to assess the analgesic effectiveness of celecoxib compared to placebo in patients with painful pharyngitis under randomized, double-blind, placebo-controlled conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| celecoxib 50 mg/50 mg | Experimental |
| |
| celecoxib 100 mg/placebo | Experimental |
| |
| celecoxib 100 mg/50 mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celecoxib | Drug | dose 1 celecoxib 50 mg followed 6-12 hours later by dose 2 celecoxib 50 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sum of Sore Throat Pain Intensity Difference (SPID2) on Swallowing at 2 Hours Post-First Dose | Based on the Pain Intensity scores measured on a Visual Analogue Scale (PI-VAS: 0mm=no pain,100mm=worst possible pain), assessed by the subjects, the SPID2 is the area under the curve (AUC) over the 2-hour period post-first dose of the Pain Intensity Difference (PID) scores using the trapezoidal rule. | 2 hours Post-First Dose |
| Measure | Description | Time Frame |
|---|---|---|
| Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose | Pain intensity (PI) on Swallowing as Measured by PI-VAS scale: 0mm=no pain, 100mm=worst possible pain. Sore throat PID score was obtained by subtracting the PI at each time point from the Baseline PI score. Increase in scores indicated a lessening of subjects' pain compared to baseline scores; higher scores indicated a greater reduction in pain. |
| Measure | Description | Time Frame |
|---|---|---|
| Throat Soreness Scale (TSS) Difference Within 6 Hours Post-First Dose | The Pain Intensity Difference (PID) based on TSS (scale: 0=not sore to 10=very sore) was calculated as the difference between the pain intensity at the time and at baseline. | Within first 6 hours post-first dose |
| Throat Soreness Scale (TSS) Difference From 7 to 24 Hours Post-First Dose |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Connecticut Student Health Services | Storrs | Connecticut | 06269-2011 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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1 center in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Celecoxib 50mg/50mg | Dose 1 celecoxib 50 mg followed 6-12 hours later by dose 2 celecoxib 50 mg |
| FG001 | Celecoxib 100mg/Placebo | Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 placebo |
| FG002 | Celecoxib 100mg/50mg | Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 celecoxib 50 mg |
| FG003 | Placebo | Dose 1 placebo followed 6-12 hours later by dose 2 placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Celecoxib 50mg/50mg | Dose 1 celecoxib 50 mg followed 6-12 hours later by dose 2 celecoxib 50 mg |
| BG001 | Celecoxib 100mg/Placebo | Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 placebo |
| 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 | Sum of Sore Throat Pain Intensity Difference (SPID2) on Swallowing at 2 Hours Post-First Dose | Based on the Pain Intensity scores measured on a Visual Analogue Scale (PI-VAS: 0mm=no pain,100mm=worst possible pain), assessed by the subjects, the SPID2 is the area under the curve (AUC) over the 2-hour period post-first dose of the Pain Intensity Difference (PID) scores using the trapezoidal rule. | Modified intent-to-treat (MITT) population, defined as all subjects randomized to treatment who received at least 1 dose of study drug and had at least 1 post-treatment efficacy assessment. The celecoxib 100mg (pooled) treatment group and placebo were compared for the primary endpoint. Celecoxib 50mg/50mg group was not in this analysis. | Posted | Least Squares Mean | Standard Error | units on a scale * hours | 2 hours Post-First Dose |
|
Baseline (Day 1) up to 28 days after last dose of study drug ( up to a maximum of 30 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
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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 | Celecoxib 50mg/50mg | Dose 1 celecoxib 50 mg followed 6-12 hours later by dose 2 celecoxib 50 mg |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis | Eye disorders | MedDRA v10.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.govCallCenter@pfizer.com |
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| ID | Term |
|---|---|
| D010612 | Pharyngitis |
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Celecoxib | Drug | dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 placebo |
|
| celecoxib | Drug | dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 celecoxib 50 mg |
|
| placebo | Drug | dose 1 placebo followed 6-12 hours later by dose 2 placebo |
|
| Within First 6 hours Post-First Dose |
| Sore Throat Pain Intensity Difference (PID) From 7 to 24 Hours Post-First Dose | Pain intensity (PI) on Swallowing as Measured by PI-VAS scale: 0mm=no pain, 100mm=worst possible pain. PID score was obtained by subtracting the PI at each time point from the Baseline PI score. An increase in scores indicated a lessening of subjects' pain as compared to Baseline scores, thus, higher scores indicated a greater reduction in pain. | 7 to 24 hours |
| Sum of Sore Throat Pain Intensity Difference (SPID) Within 6 Hours Post-First Dose | The sum of pain intensity differences (SPID) was calculated as the AUC of the Pain Intensity Difference (PID) scores. The PID [based on PI-VAS scale: 0mm=no pain, 100mm=worst possible pain] was calculated as the difference between the pain intensity at the time and at baseline. | up to 6 hours |
| Sum of Sore Throat Pain Intensity Difference (SPID) From 7 to 24 Hours Post-First Dose | The sum of pain intensity differences (SPID) was calculated as the AUC of the Pain Intensity Difference (PID) scores. The PID [based on PI-VAS scale: 0mm=no pain, 100mm=worst possible pain] was calculated as the difference between the pain intensity at the time and at baseline. | 7 to 24 hours |
| Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose | STRRS score (scale: 0 no relief to 6 complete relief); a higher pain score indicated a greater reduction in pain. | within the first 6 hours |
| Sore Throat Relief Rating Scale (STRRS) From 7 to 24 Hours Post-First Dose | STRRS score (scale: 0 no relief to 6 complete relief); a higher score indicated a greater reduction in pain. | 7 to 24 hours |
| Sore Throat Relief Rating Scale (STRRS) - 'Moderate Relief' at 6 Hours Post-First Dose | Subjects Achieving at Least 'Moderate Relief' as Measured by STRRS (range: 0=no relief to 6=complete relief); Moderate relief is defined as STRRS = 3). | at 6 hours |
| Sore Throat Relief Rating Scale (STRRS) - 'Moderate Relief' at 12 Hours Post-First Dose | Subjects Achieving at Least 'Moderate Relief' as Measured by STRRS (range: 0=no relief to 6=complete relief); Moderate relief is defined as STRRS = 3). | 12 hours |
| Time to Perceptible Pain Relief | Defined as time (measured by stopwatch) when subject began to feel any pain relieving effect from the drug | Within 2 Hours Post-First Dose |
| Time to Meaningful Pain Relief | The time (measured by stopwatch) when the subject felt their pain relief was meaningful to them was not estimable thus the number of subjects experiencing meaningful pain relief within 2 hours of first dose is reported | Within 2 Hours Post-First Dose |
| Time to Onset of Analgesia | Equal to time of perceptible pain relief when both perceptible pain relief and meaningful pain relief were experienced- the median time was not estimable thus the number of subjects with onset of analgesia within 2 hours of first dose is reported | Within 2 Hours Post-First Dose |
| Patient's Global Evaluation of Study Medication at 6 Hours Post-First Dose | Subject assessment of overall impression of study drug on 4 point scale from 1 (poor) to 4 (excellent) | 6 Hours Post-First Dose |
| Patient's Global Evaluation of Study Medication at 12 and 24 Hours Post-First Dose | Subject assessment of overall impression of study drug on 4 point scale from 1 (poor) to 4 (excellent) | 12 and 24 hours Post-First Dose |
The Pain Intensity Difference (PID) based on TSS (scale: 0=not sore to 10=very sore) was calculated as the difference between the pain intensity at the time and at baseline. |
| 7 to 24 hours post-first dose |
| Sore Throat Pain Intensity Difference (SPID2) as Measured by Throat Soreness Scale (TSS) at 2 Hours Post-First Dose | SPID2 was calculated as the AUC of the Pain Intensity Difference (PID) scores. The Sore Throat PID was calculated as the difference between the pain intensity (TSS scale: 0=not sore to 10=very sore) at 2 hours post dose and at baseline. | 2 hour period Post-First Dose |
| Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) Within 6 Hours Post-First Dose | The sum of sore throat pain intensity differences (SPID) was calculated as the AUC of the Pain Intensity Difference (PID) scores. The Sore Throat PID was calculated as the difference between the pain intensity (TSS range: 0=not sore to 10=very sore) at the time and at baseline. | Within 6 hours Post-First Dose |
| Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) From 7 to 24 Hours Post-First Dose | The sum of sore throat pain intensity differences (SPID) was calculated as the AUC of the Pain Intensity Difference (PID) scores. The Sore Throat PID was calculated as the difference between the pain intensity (TSS range: 0=not sore to 10=very sore) at the time and at baseline. | 7 to 24 hours Post-First Dose |
| Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose | The Difficulty Swallowing Pain Intensity Difference (PID) was calculated as the difference between the pain intensity (DSS range: 0mm=not difficult, 100mm=very difficult) at the time and at baseline. | Within 6 hours Post-First Dose |
| Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose | The Difficulty Swallowing Pain Intensity Difference (PID) was calculated as the difference between the pain intensity (DSS range: 0mm=not difficult, 100mm=very difficult) at the time and at baseline. | 7 to 24 hours Post-First Dose |
| Sum of Sore Throat Pain Intensity Difference (SPID2) as Measured by Difficulty Swallowing Scale (DSS) at 2 Hours Post-First Dose | SPID2 was calculated as the AUC of the Pain Intensity Difference (PID) scores. The Difficulty Swallowing PID was calculated as the difference between the pain intensity (DSS scale: 0mm=not difficult, 100mm=very difficult) at 2 hours post dose and at baseline. | Over 2 hour Period Post-First Dose |
| Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose | The sum of pain intensity differences (SPID) was calculated as the AUC of the Pain Intensity Difference (PID) scores. The Difficulty Swallowing PID was calculated as the difference between the pain intensity (DSS range: 0mm=not difficult, 100mm=very difficult) at the time and at baseline. | Within 6 hours Post-First Dose |
| Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose | The sum of pain intensity differences (SPID) was calculated as the AUC of the Pain Intensity Difference (PID) scores. The Difficulty Swallowing PID was calculated as the difference between the pain intensity (DSS range: 0mm=not difficult, 100mm=very difficult) at the time and at baseline. | 7 to 24 hours Post-First Dose |
| Difficulty Swallowing Scale (DSS) Difference at Least 50% Gone at 6 Hours Post-First Dose | Number of Subjects with >= 50% Pain Intensity Difference (PID) on the DSS. The Difficulty Swallowing PID was calculated as the difference between the pain intensity (DSS scale: 0mm=not difficult, 100mm=very difficult) at 6 hours and at baseline. | At 6 hours |
| Difficulty Swallowing Scale (DSS) Difference at Least 50% Gone at 12 Hours Post-First Dose | Number of Subjects with >= 50% Pain Intensity Difference (PID) on the DSS. The Difficulty Swallowing PID was calculated as the difference between the pain intensity (DSS scale: 0mm=not difficult, 100mm=very difficult) at 12 hours and at baseline. | At 12 Hours |
| Total Pain Relief (TOTPAR) at 2 and 6 Hours Post-First Dose | TOTPAR is time-interval-weighted sum of accumulated Sore Throat Relief Rating Scale (STRRS) scores (scale: 0 no relief to 6 complete relief). | 2 and 6 hours Post-First Dose |
| Total Pain Relief (TOTPAR) at 12 and 24 Hours Post-First Dose | TOTPAR is time-interval-weighted sum of accumulated Sore Throat Relief Rating Scale (STRRS) scores (scale: 0 no relief to 6 complete relief). | 12 and 24 hours Post-First Dose |
| Subjects With >= 50% Total Pain Relief (TOTPAR) at 6 Hours Post-First Dose | TOTPAR is time-interval-weighted sum of accumulated Sore Throat Relief Rating Scale (STRRS) scores (scale: 0 no relief to 6 complete relief). Maximum TOTPAR over 6 hours is 36. If the subject calculated TOTPAR is greater than or equal to 50% of the maximum TOTPAR then the subject is said to have achieved >=50% TOTPAR. | 6 hours Post-First Dose |
| Subjects With >= 50% Total Pain Relief (TOTPAR) at 12 Hours Post-First Dose | TOTPAR is time-interval-weighted sum of accumulated Sore Throat Relief Rating Scale (STRRS) scores (scale: 0 no relief to 6 complete relief). Maximum TOTPAR over 12 hours is 72. If the subject calculated TOTPAR is greater than or equal to 50% of the maximum TOTPAR then the subject is said to have achieved >=50% TOTPAR. | 12 hours Post-First Dose |
| Number Needed to Treat (NNT) to Achieve at Least 50% of Maximum Total Pain Relief (TOTPAR) at 6 Hours Post-First Dose | NNT is number of subjects needed to treat to have one extra subject report a 50% or better pain relief over 6 hours based on maximum possible pain relief on Sore Throat Relief Rating Scale. Maximum TOTPAR over 6 hours is 36. If the subject TOTPAR is greater than or equal to 50% of the maximum TOTPAR then the subject has achieved >=50% TOTPAR. | 6 hours Post-First Dose |
| Number Needed to Treat (NNT) to Achieve at Least 50% of Maximum Total Pain Relief (TOTPAR) at 12 Hours Post-First Dose | NNT is number of subjects needed to treat to have one subject report a 50% or better pain relief over 12 hours based on maximum possible pain relief on Sore Throat Relief Rating Scale. Maximum TOTPAR over 12 hours is 72. If the subject TOTPAR is greater than or equal to 50% of the maximum TOTPAR then the subject has achieved >=50% TOTPAR. | 12 hours Post-First Dose |
| Subjects With Sore Throat Pain at Least 35% Gone and at Least 50% Gone at 2 and 6 Hours Post-First Dose | >= 35% and 50% Pain Intensity Difference (PID) on the Pain Intensity-Visual Analog Scale (PI-VAS) (scale: 0mm=no pain, 100mm=worst possible pain). The PID was calculated as the difference between the pain intensity at the time and at baseline. | 2 and 6 hours Post-First Dose |
| Subjects With Sore Throat Pain at Least 35% Gone and at Least 50% Gone at 12 Hours Post-First Dose | >= 35% and 50% Pain Intensity Difference (PID) on the Pain Intensity-Visual Analog Scale (PI-VAS) (scale: 0mm=no pain, 100mm=worst possible pain). The PID was calculated as the difference between the pain intensity at 12 hours and at baseline. | 12 hours Post-First Dose |
| Subjects Who Achieved Their Own Level of 'Meaningful Relief' and 'Much Improvement' at 2 and 6 Hours Post-First Dose | Symptom relief measured as self-directed endpoints defined by each individual at end of study using Sore Throat Relief Rating Scale (STRRS); STRRS score ranges from 0=no relief to 6=complete relief. If subject scored same or greater in their STRRS during the study then they achieved their 'Meaningful Relief' or 'Much Improvement'. | 2 and 6 hours Post-First Dose |
| Subjects Who Achieved Their Own Level of 'Meaningful Relief' and 'Much Improvement' at 12 Hours Post-First Dose | Symptom relief measured as self-directed endpoints defined by each individual at end of study using Sore Throat Relief Rating Scale (STRRS); STRRS score ranges from 0=no relief to 6=complete relief. If subject scored same or greater in their STRRS during the study then they achieved their 'Meaningful Relief' or 'Much Improvement'. | 12 hours Post-First Dose |
| Subjects Who Achieved Their Own Level of 'Meaningful Relief' Within 6 Hours Who Had Perceptible Relief Onset Time Within 1 Hour | At end of study subjects defined meaningful pain relief by completing Meaningful Relief Scale. Meaningful relief was achieved if Sore Throat Relief Rating Scale (STRRS) score (range: 0=no relief to 6=complete relief) at end of the study was the same or higher than individually defined relief score during the study. Perceptible relief is STRRS >0. | Within 6 hours Post-First Dose |
| Subjects Who Achieved Their Own Level of 'Meaningful Relief' Within 6 Hours Who Still Had Perceptible Relief at 12 and 24 Hours Post-First Dose | At end of study subjects defined meaningful pain relief by completing the Meaningful Relief Scale. Meaningful relief was achieved if Sore Throat Relief Rating Scale (STRRS)(range: 0=no relief to 6=complete relief) score at end of the study was the same or higher than individually defined relief score during the study. Perceptible relief is STRRS >0 | 12 and 24 hours Post-First Dose |
| Median Onset Time of First Perceptible Relief in Subjects Who Achieved Their Own Level of 'Meaningful Relief' Within 6 Hours Post-First Dose | Perceptible Relief is score >0 on STRRS. Individual level of meaningful relief had to be reached within 6 hours. Meaningful Relief was achieved if Sore Throat Relief Rating Scale (STRRS)(range: 0=no relief to 6=complete relief)score at the end of the study was the same or higher than individually defined meaningful relief score during the study. | 24 Hours |
| Median Offset Time of No Perceptible Relief in Subjects Who Achieved Their Own Level of 'Meaningful Relief' Within 6 Hours Post-First Dose | Offset time is time of first no perceptible relief (STRRS score=0) with meaningful relief (score>0) at earlier time. STRRS score ranges from 0=no relief to 6=complete relief. | 24 Hours |
| Treatment Failures on STRRS Questionnaire | Subjects were considered treatment failures if all of the STRRS scores were less than each individual's 'meaningful relief' scores. STRRS score ranges from 0=no relief to 6=complete relief. | 24 hours Post-First Dose |
| Subjects Taking Rescue Medication | Subjects were allowed to use rescue medication at any time during the trial, but were discouraged from taking rescue medication within 2 hours of administration of the first dose of study drug. | Within 24 hours Post-First Dose |
| Treatment Satisfaction Questionnaire for Medication (TSQM vII) | 11 questions scored on factors: effectiveness, side effects, convenience, overall satisfaction. TSQM vII scores range 0 to 100, with higher scores indicating a higher level of global satisfaction with treatment. | 24 hours or immediately prior to taking rescue medication |
| First Perceptible Relief | Subjects having First Perceptible Relief at each time point. Perceptible relief is score >0 on Sore Throat Relief Rating Scale(STRRS)(range: 0=no relief to 6=complete relief). | up to 24 hours |
| No Perceptible Relief | Subjects having No Perceptible Relief at each time point. No Perceptible relief is score = 0 on Sore Throat Relief Rating Scale (STRRS)(range: 0=no relief to 6=complete relief). | up to 24 hours |
| BG002 | Celecoxib 100mg/50mg | Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 celecoxib 50 mg |
| BG003 | Placebo | Dose 1 placebo followed 6-12 hours later by dose 2 placebo |
| BG004 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Placebo | Dose 1 placebo followed 6-12 hours later by dose 2 placebo |
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| Secondary | Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose | Pain intensity (PI) on Swallowing as Measured by PI-VAS scale: 0mm=no pain, 100mm=worst possible pain. Sore throat PID score was obtained by subtracting the PI at each time point from the Baseline PI score. Increase in scores indicated a lessening of subjects' pain compared to baseline scores; higher scores indicated a greater reduction in pain. | Subjects evaluated at each timepoint varied from: 90-85 for 50mg/50mg; 90-87 for 100mg (pooled); 89-85 for Placebo. MITT population | Posted | Least Squares Mean | Standard Error | units on a scale | Within First 6 hours Post-First Dose |
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| Secondary | Sore Throat Pain Intensity Difference (PID) From 7 to 24 Hours Post-First Dose | Pain intensity (PI) on Swallowing as Measured by PI-VAS scale: 0mm=no pain, 100mm=worst possible pain. PID score was obtained by subtracting the PI at each time point from the Baseline PI score. An increase in scores indicated a lessening of subjects' pain as compared to Baseline scores, thus, higher scores indicated a greater reduction in pain. | Subjects evaluated at each timepoint varied from: 85-80 for 50mg/50mg; 43-39 for 100mg/Placebo; 44-43 for 100mg/50mg; 82-73 for Placebo. MITT population | Posted | Least Squares Mean | Standard Error | units on a scale | 7 to 24 hours |
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| Secondary | Sum of Sore Throat Pain Intensity Difference (SPID) Within 6 Hours Post-First Dose | The sum of pain intensity differences (SPID) was calculated as the AUC of the Pain Intensity Difference (PID) scores. The PID [based on PI-VAS scale: 0mm=no pain, 100mm=worst possible pain] was calculated as the difference between the pain intensity at the time and at baseline. | Subjects evaluated at each timepoint varied from: 90-85 for 50mg/50mg; 90-87 for 100mg (pooled); 89-85 for Placebo. MITT population | Posted | Least Squares Mean | Standard Error | units on a scale * hours | up to 6 hours |
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| Secondary | Sum of Sore Throat Pain Intensity Difference (SPID) From 7 to 24 Hours Post-First Dose | The sum of pain intensity differences (SPID) was calculated as the AUC of the Pain Intensity Difference (PID) scores. The PID [based on PI-VAS scale: 0mm=no pain, 100mm=worst possible pain] was calculated as the difference between the pain intensity at the time and at baseline. | Subjects evaluated at each timepoint varied from: 85-80 for 50mg/50mg; 43-39 for 100mg/Placebo; 44-43 for 100mg/50mg; 82-73 for Placebo. MITT population | Posted | Least Squares Mean | Standard Error | units on a scale * hours | 7 to 24 hours |
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| Secondary | Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose | STRRS score (scale: 0 no relief to 6 complete relief); a higher pain score indicated a greater reduction in pain. | Subjects evaluated at each timepoint varied from: 90-85 for 50mg/50mg; 90-87 for 100mg (pooled); 89-85 for Placebo. MITT population | Posted | Least Squares Mean | Standard Error | scores on a scale | within the first 6 hours |
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| Secondary | Sore Throat Relief Rating Scale (STRRS) From 7 to 24 Hours Post-First Dose | STRRS score (scale: 0 no relief to 6 complete relief); a higher score indicated a greater reduction in pain. | Subjects evaluated at each timepoint varied from: 85-80 for 50mg/50mg; 43-39 for 100mg/Placebo; 44-43 for 100mg/50mg; 82-73 for Placebo. MITT population | Posted | Least Squares Mean | Standard Error | scores on a scale | 7 to 24 hours |
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| Secondary | Sore Throat Relief Rating Scale (STRRS) - 'Moderate Relief' at 6 Hours Post-First Dose | Subjects Achieving at Least 'Moderate Relief' as Measured by STRRS (range: 0=no relief to 6=complete relief); Moderate relief is defined as STRRS = 3). | MITT population | Posted | Number | subjects | at 6 hours |
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| Secondary | Sore Throat Relief Rating Scale (STRRS) - 'Moderate Relief' at 12 Hours Post-First Dose | Subjects Achieving at Least 'Moderate Relief' as Measured by STRRS (range: 0=no relief to 6=complete relief); Moderate relief is defined as STRRS = 3). | MITT population | Posted | Number | subjects | 12 hours |
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| Secondary | Time to Perceptible Pain Relief | Defined as time (measured by stopwatch) when subject began to feel any pain relieving effect from the drug | MITT population. Number of Subjects achieving perceptible pain relief: 77 for celecoxib 50mg/50mg; 67 for celecoxib 100mg (pooled); 46 for placebo Upper 95% CI for placebo group was >120 | Posted | Median | 95% Confidence Interval | minutes | Within 2 Hours Post-First Dose |
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| Secondary | Time to Meaningful Pain Relief | The time (measured by stopwatch) when the subject felt their pain relief was meaningful to them was not estimable thus the number of subjects experiencing meaningful pain relief within 2 hours of first dose is reported | MITT population. The median time to meaningful pain relief, including all subjects, was >2 hours in each group (time was censored at 2 hours) Median time and CI were not estimable | Posted | Number | subjects | Within 2 Hours Post-First Dose |
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| Secondary | Time to Onset of Analgesia | Equal to time of perceptible pain relief when both perceptible pain relief and meaningful pain relief were experienced- the median time was not estimable thus the number of subjects with onset of analgesia within 2 hours of first dose is reported | MITT population. The median time to onset of analgesia, including all subjects, was >2 hours in each group (time was censored at 2 hours). Median time and CI were not estimable. | Posted | Number | subjects | Within 2 Hours Post-First Dose |
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| Secondary | Patient's Global Evaluation of Study Medication at 6 Hours Post-First Dose | Subject assessment of overall impression of study drug on 4 point scale from 1 (poor) to 4 (excellent) | MITT population | Posted | Number | subjects | 6 Hours Post-First Dose |
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| Secondary | Patient's Global Evaluation of Study Medication at 12 and 24 Hours Post-First Dose | Subject assessment of overall impression of study drug on 4 point scale from 1 (poor) to 4 (excellent) | Subjects analyzed at 24 hours were different for 2 groups: Celecoxib 100mg/Placebo=45 and Placebo=87. MITT population | Posted | Number | subjects | 12 and 24 hours Post-First Dose |
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| Other Pre-specified | Throat Soreness Scale (TSS) Difference Within 6 Hours Post-First Dose | The Pain Intensity Difference (PID) based on TSS (scale: 0=not sore to 10=very sore) was calculated as the difference between the pain intensity at the time and at baseline. | Subjects evaluated at each timepoint varied from: 90-85 for 50mg/50mg; 90-87 for 100mg (pooled); 89-85 for Placebo. MITT population | Posted | Least Squares Mean | Standard Error | scores on a scale | Within first 6 hours post-first dose |
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| Other Pre-specified | Throat Soreness Scale (TSS) Difference From 7 to 24 Hours Post-First Dose | The Pain Intensity Difference (PID) based on TSS (scale: 0=not sore to 10=very sore) was calculated as the difference between the pain intensity at the time and at baseline. | Subjects evaluated at each timepoint varied from: 85-80 for 50mg/50mg; 43-39 for 100mg/Placebo; 44-43 for 100mg/50mg; 82-73 for Placebo. MITT population | Posted | Least Squares Mean | Standard Error | scores on a scale | 7 to 24 hours post-first dose |
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| Other Pre-specified | Sore Throat Pain Intensity Difference (SPID2) as Measured by Throat Soreness Scale (TSS) at 2 Hours Post-First Dose | SPID2 was calculated as the AUC of the Pain Intensity Difference (PID) scores. The Sore Throat PID was calculated as the difference between the pain intensity (TSS scale: 0=not sore to 10=very sore) at 2 hours post dose and at baseline. | MITT population | Posted | Least Squares Mean | Standard Error | units on a scale * hours | 2 hour period Post-First Dose |
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| Other Pre-specified | Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) Within 6 Hours Post-First Dose | The sum of sore throat pain intensity differences (SPID) was calculated as the AUC of the Pain Intensity Difference (PID) scores. The Sore Throat PID was calculated as the difference between the pain intensity (TSS range: 0=not sore to 10=very sore) at the time and at baseline. | Subjects evaluated at each timepoint varied from: 90-85 for 50mg/50mg; 90-87 for 100mg (pooled); 89-85 for Placebo. MITT population At 15min the SE was <0.01 for all 3 groups | Posted | Least Squares Mean | Standard Error | units on a scale * hours | Within 6 hours Post-First Dose |
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| Other Pre-specified | Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) From 7 to 24 Hours Post-First Dose | The sum of sore throat pain intensity differences (SPID) was calculated as the AUC of the Pain Intensity Difference (PID) scores. The Sore Throat PID was calculated as the difference between the pain intensity (TSS range: 0=not sore to 10=very sore) at the time and at baseline. | Subjects evaluated at each timepoint varied from: 85-80 for 50mg/50mg; 43-39 for 100mg/Placebo; 44-43 for 100mg/50mg; 82-73 for Placebo. MITT population | Posted | Least Squares Mean | Standard Error | units on a scale * hours | 7 to 24 hours Post-First Dose |
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|
|
| Other Pre-specified | Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose | The Difficulty Swallowing Pain Intensity Difference (PID) was calculated as the difference between the pain intensity (DSS range: 0mm=not difficult, 100mm=very difficult) at the time and at baseline. | Subjects evaluated at each timepoint varied from: 90-85 for 50mg/50mg; 90-87 for 100mg (pooled); 89-85 for Placebo. MITT population | Posted | Least Squares Mean | Standard Error | units on a scale | Within 6 hours Post-First Dose |
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| Other Pre-specified | Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose | The Difficulty Swallowing Pain Intensity Difference (PID) was calculated as the difference between the pain intensity (DSS range: 0mm=not difficult, 100mm=very difficult) at the time and at baseline. | Subjects evaluated at each timepoint varied from: 85-80 for 50mg/50mg; 43-39 for 100mg/Placebo; 44-43 for 100mg/50mg; 82-73 for Placebo. MITT population | Posted | Least Squares Mean | Standard Error | units on a scale | 7 to 24 hours Post-First Dose |
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|
|
|
| Other Pre-specified | Sum of Sore Throat Pain Intensity Difference (SPID2) as Measured by Difficulty Swallowing Scale (DSS) at 2 Hours Post-First Dose | SPID2 was calculated as the AUC of the Pain Intensity Difference (PID) scores. The Difficulty Swallowing PID was calculated as the difference between the pain intensity (DSS scale: 0mm=not difficult, 100mm=very difficult) at 2 hours post dose and at baseline. | MITT population | Posted | Least Squares Mean | Standard Error | units on a scale * hours | Over 2 hour Period Post-First Dose |
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|
|
|
| Other Pre-specified | Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose | The sum of pain intensity differences (SPID) was calculated as the AUC of the Pain Intensity Difference (PID) scores. The Difficulty Swallowing PID was calculated as the difference between the pain intensity (DSS range: 0mm=not difficult, 100mm=very difficult) at the time and at baseline. | Subjects evaluated at each timepoint varied from: 90-85 for 50mg/50mg; 90-87 for 100mg (pooled); 89-85 for Placebo. MITT population | Posted | Least Squares Mean | Standard Error | units on a scale * hours | Within 6 hours Post-First Dose |
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|
|
|
| Other Pre-specified | Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose | The sum of pain intensity differences (SPID) was calculated as the AUC of the Pain Intensity Difference (PID) scores. The Difficulty Swallowing PID was calculated as the difference between the pain intensity (DSS range: 0mm=not difficult, 100mm=very difficult) at the time and at baseline. | Subjects evaluated at each timepoint varied from: 85-80 for 50mg/50mg; 43-39 for 100mg/Placebo; 44-43 for 100mg/50mg; 82-73 for Placebo. MITT population | Posted | Least Squares Mean | Standard Error | units on a scale * hours | 7 to 24 hours Post-First Dose |
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| Other Pre-specified | Difficulty Swallowing Scale (DSS) Difference at Least 50% Gone at 6 Hours Post-First Dose | Number of Subjects with >= 50% Pain Intensity Difference (PID) on the DSS. The Difficulty Swallowing PID was calculated as the difference between the pain intensity (DSS scale: 0mm=not difficult, 100mm=very difficult) at 6 hours and at baseline. | MITT population | Posted | Number | subjects | At 6 hours |
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| Other Pre-specified | Difficulty Swallowing Scale (DSS) Difference at Least 50% Gone at 12 Hours Post-First Dose | Number of Subjects with >= 50% Pain Intensity Difference (PID) on the DSS. The Difficulty Swallowing PID was calculated as the difference between the pain intensity (DSS scale: 0mm=not difficult, 100mm=very difficult) at 12 hours and at baseline. | MITT population | Posted | Number | subjects | At 12 Hours |
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| Other Pre-specified | Total Pain Relief (TOTPAR) at 2 and 6 Hours Post-First Dose | TOTPAR is time-interval-weighted sum of accumulated Sore Throat Relief Rating Scale (STRRS) scores (scale: 0 no relief to 6 complete relief). | Subjects evaluated at 6 hours: 85 for 50mg/50mg; 87 for 100mg (pooled); 85 for Placebo. MITT population | Posted | Least Squares Mean | Standard Error | scores on a scale | 2 and 6 hours Post-First Dose |
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| Other Pre-specified | Total Pain Relief (TOTPAR) at 12 and 24 Hours Post-First Dose | TOTPAR is time-interval-weighted sum of accumulated Sore Throat Relief Rating Scale (STRRS) scores (scale: 0 no relief to 6 complete relief). | Subjects evaluated at 24 hours: 84 for 50mg/50mg; 43 for 100mg/Placebo; 44 for 100mg/50mg; 81 for Placebo. MITT population | Posted | Least Squares Mean | Standard Error | scores on a scale | 12 and 24 hours Post-First Dose |
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| Other Pre-specified | Subjects With >= 50% Total Pain Relief (TOTPAR) at 6 Hours Post-First Dose | TOTPAR is time-interval-weighted sum of accumulated Sore Throat Relief Rating Scale (STRRS) scores (scale: 0 no relief to 6 complete relief). Maximum TOTPAR over 6 hours is 36. If the subject calculated TOTPAR is greater than or equal to 50% of the maximum TOTPAR then the subject is said to have achieved >=50% TOTPAR. | MITT population | Posted | Number | subjects | 6 hours Post-First Dose |
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| Other Pre-specified | Subjects With >= 50% Total Pain Relief (TOTPAR) at 12 Hours Post-First Dose | TOTPAR is time-interval-weighted sum of accumulated Sore Throat Relief Rating Scale (STRRS) scores (scale: 0 no relief to 6 complete relief). Maximum TOTPAR over 12 hours is 72. If the subject calculated TOTPAR is greater than or equal to 50% of the maximum TOTPAR then the subject is said to have achieved >=50% TOTPAR. | MITT population | Posted | Number | subjects | 12 hours Post-First Dose |
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| Other Pre-specified | Number Needed to Treat (NNT) to Achieve at Least 50% of Maximum Total Pain Relief (TOTPAR) at 6 Hours Post-First Dose | NNT is number of subjects needed to treat to have one extra subject report a 50% or better pain relief over 6 hours based on maximum possible pain relief on Sore Throat Relief Rating Scale. Maximum TOTPAR over 6 hours is 36. If the subject TOTPAR is greater than or equal to 50% of the maximum TOTPAR then the subject has achieved >=50% TOTPAR. | MITT population | Posted | Number | subjects | 6 hours Post-First Dose |
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| Other Pre-specified | Number Needed to Treat (NNT) to Achieve at Least 50% of Maximum Total Pain Relief (TOTPAR) at 12 Hours Post-First Dose | NNT is number of subjects needed to treat to have one subject report a 50% or better pain relief over 12 hours based on maximum possible pain relief on Sore Throat Relief Rating Scale. Maximum TOTPAR over 12 hours is 72. If the subject TOTPAR is greater than or equal to 50% of the maximum TOTPAR then the subject has achieved >=50% TOTPAR. | MITT population Comparison Celecoxib 100mg/50mg - Placebo: the NNT value was non-estimable | Posted | Number | subjects | 12 hours Post-First Dose |
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| Other Pre-specified | Subjects With Sore Throat Pain at Least 35% Gone and at Least 50% Gone at 2 and 6 Hours Post-First Dose | >= 35% and 50% Pain Intensity Difference (PID) on the Pain Intensity-Visual Analog Scale (PI-VAS) (scale: 0mm=no pain, 100mm=worst possible pain). The PID was calculated as the difference between the pain intensity at the time and at baseline. | MITT population | Posted | Number | subjects | 2 and 6 hours Post-First Dose |
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| Other Pre-specified | Subjects With Sore Throat Pain at Least 35% Gone and at Least 50% Gone at 12 Hours Post-First Dose | >= 35% and 50% Pain Intensity Difference (PID) on the Pain Intensity-Visual Analog Scale (PI-VAS) (scale: 0mm=no pain, 100mm=worst possible pain). The PID was calculated as the difference between the pain intensity at 12 hours and at baseline. | MITT population | Posted | Number | subjects | 12 hours Post-First Dose |
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| Other Pre-specified | Subjects Who Achieved Their Own Level of 'Meaningful Relief' and 'Much Improvement' at 2 and 6 Hours Post-First Dose | Symptom relief measured as self-directed endpoints defined by each individual at end of study using Sore Throat Relief Rating Scale (STRRS); STRRS score ranges from 0=no relief to 6=complete relief. If subject scored same or greater in their STRRS during the study then they achieved their 'Meaningful Relief' or 'Much Improvement'. | MITT population | Posted | Number | subjects | 2 and 6 hours Post-First Dose |
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| Other Pre-specified | Subjects Who Achieved Their Own Level of 'Meaningful Relief' and 'Much Improvement' at 12 Hours Post-First Dose | Symptom relief measured as self-directed endpoints defined by each individual at end of study using Sore Throat Relief Rating Scale (STRRS); STRRS score ranges from 0=no relief to 6=complete relief. If subject scored same or greater in their STRRS during the study then they achieved their 'Meaningful Relief' or 'Much Improvement'. | MITT population | Posted | Number | subjects | 12 hours Post-First Dose |
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| Other Pre-specified | Subjects Who Achieved Their Own Level of 'Meaningful Relief' Within 6 Hours Who Had Perceptible Relief Onset Time Within 1 Hour | At end of study subjects defined meaningful pain relief by completing Meaningful Relief Scale. Meaningful relief was achieved if Sore Throat Relief Rating Scale (STRRS) score (range: 0=no relief to 6=complete relief) at end of the study was the same or higher than individually defined relief score during the study. Perceptible relief is STRRS >0. | MITT population | Posted | Number | subjects | Within 6 hours Post-First Dose |
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| Other Pre-specified | Subjects Who Achieved Their Own Level of 'Meaningful Relief' Within 6 Hours Who Still Had Perceptible Relief at 12 and 24 Hours Post-First Dose | At end of study subjects defined meaningful pain relief by completing the Meaningful Relief Scale. Meaningful relief was achieved if Sore Throat Relief Rating Scale (STRRS)(range: 0=no relief to 6=complete relief) score at end of the study was the same or higher than individually defined relief score during the study. Perceptible relief is STRRS >0 | MITT population | Posted | Number | subjects | 12 and 24 hours Post-First Dose |
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| Other Pre-specified | Median Onset Time of First Perceptible Relief in Subjects Who Achieved Their Own Level of 'Meaningful Relief' Within 6 Hours Post-First Dose | Perceptible Relief is score >0 on STRRS. Individual level of meaningful relief had to be reached within 6 hours. Meaningful Relief was achieved if Sore Throat Relief Rating Scale (STRRS)(range: 0=no relief to 6=complete relief)score at the end of the study was the same or higher than individually defined meaningful relief score during the study. | Number of subjects who achieved meaningful relief within 6 hours | Posted | Median | Full Range | hours | 24 Hours |
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| Other Pre-specified | Median Offset Time of No Perceptible Relief in Subjects Who Achieved Their Own Level of 'Meaningful Relief' Within 6 Hours Post-First Dose | Offset time is time of first no perceptible relief (STRRS score=0) with meaningful relief (score>0) at earlier time. STRRS score ranges from 0=no relief to 6=complete relief. | Number of subjects who achieved Meaningful Relief within 6 hours | Posted | Median | Full Range | hours | 24 Hours |
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| Other Pre-specified | Treatment Failures on STRRS Questionnaire | Subjects were considered treatment failures if all of the STRRS scores were less than each individual's 'meaningful relief' scores. STRRS score ranges from 0=no relief to 6=complete relief. | MITT population | Posted | Number | subjects | 24 hours Post-First Dose |
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| Other Pre-specified | Subjects Taking Rescue Medication | Subjects were allowed to use rescue medication at any time during the trial, but were discouraged from taking rescue medication within 2 hours of administration of the first dose of study drug. | MITT population | Posted | Number | subjects | Within 24 hours Post-First Dose |
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| Other Pre-specified | Treatment Satisfaction Questionnaire for Medication (TSQM vII) | 11 questions scored on factors: effectiveness, side effects, convenience, overall satisfaction. TSQM vII scores range 0 to 100, with higher scores indicating a higher level of global satisfaction with treatment. | MITT population | Posted | Mean | Standard Deviation | scores on a scale | 24 hours or immediately prior to taking rescue medication |
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| Other Pre-specified | First Perceptible Relief | Subjects having First Perceptible Relief at each time point. Perceptible relief is score >0 on Sore Throat Relief Rating Scale(STRRS)(range: 0=no relief to 6=complete relief). | MITT population Number of subjects assessed at each hour is: N = Celecoxib 50mg/50mg, Celecoxib 100mg/Placebo, Celecoxib 100mg/50mg, Placebo | Posted | Number | subjects | up to 24 hours |
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| Other Pre-specified | No Perceptible Relief | Subjects having No Perceptible Relief at each time point. No Perceptible relief is score = 0 on Sore Throat Relief Rating Scale (STRRS)(range: 0=no relief to 6=complete relief). | MITT population Number of subjects at each time point (in hour) is: N = Celecoxib 50mg/50mg, Celecoxib 100mg/Placebo, Celecoxib 100mg/50mg, Placebo | Posted | Number | subjects | up to 24 hours |
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|
|
|
| 0 |
| 90 |
| 0 |
| 90 |
| 8 |
| 90 |
| EG001 | Celecoxib 100mg/Placebo | Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 placebo | 0 | 45 | 0 | 45 | 5 | 45 |
| EG002 | Celecoxib 100mg/50mg | Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 celecoxib 50 mg | 0 | 45 | 0 | 45 | 5 | 45 |
| EG003 | Placebo | Dose 1 placebo followed 6-12 hours later by dose 2 placebo | 0 | 89 | 0 | 89 | 6 | 89 |
| Dyspepsia | Gastrointestinal disorders | MedDRA v10.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA v10.1 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA v10.1 | Non-systematic Assessment |
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| Otitis media | Infections and infestations | MedDRA v10.1 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA v10.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA v10.1 | Non-systematic Assessment |
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| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA v10.1 | Non-systematic Assessment |
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| Rash generalized | Skin and subcutaneous tissue disorders | MedDRA v10.1 | Non-systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA v10.1 | Non-systematic Assessment |
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| Feeling abnormal | General disorders | MedDRA v10.1 | Non-systematic Assessment |
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| Viral rash | Infections and infestations | MedDRA v10.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of <60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), <12 mo from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.
| D012140 |
| Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
|
| 45 min |
|
| 60 min |
|
| 75 min |
|
| 90 min |
|
| 1.75 hours |
|
| 2 hours |
|
| 3 hours |
|
| 4 hours |
|
| 5 hours |
|
| 6 hours |
|
| Generalized linear model |
Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate |
| 0.056 |
Analysis at 30 min Overall P-value |
| 95 |
| Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.005 | Analysis at 45 min Overall P-value | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.002 | Analysis at 60 min Overall P-value | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 75 min Overall P-value | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 90 min Overall P-value | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 1.75 hours Overall P-value | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 2 hours Overall P-value | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 3 hours Overall P-value | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 4 hours Overall P-value | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 5 hours Overall P-value | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 6 hours Overall P-value | 95 | Superiority or Other (legacy) |
| 8 hours |
|
| 9 hours |
|
| 10 hours |
|
| 11 hours |
|
| 12 hours |
|
| 24 hours |
|
| Generalized linear model |
Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate |
| <0.001 |
Analysis at 8 hours Overall P-value |
| 95 |
| Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.006 | Analysis at 9 hours Overall P-value | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.007 | Analysis at 10 hours Overall P-value | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.014 | Analysis at 11 hours Overall P-value | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.012 | Analysis at 12 hours Overall P-value | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.365 | Analysis at 24 hours Overall P-value | 95 | Superiority or Other (legacy) |
|
| 45 min |
|
| 60 min |
|
| 75 min |
|
| 90 min |
|
| 1.75 hours |
|
| 2 hours |
|
| 3 hours |
|
| 4 hours |
|
| 5 hours |
|
| 6 hours |
|
| Generalized linear model |
Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate |
| 0.069 |
Analysis at 30 min Pairwise comparison. No adjustment made for multiplicity. |
| 95 |
| Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.010 | Analysis at 45 min Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.002 | Analysis at 60 min Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 75 min Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 90 min Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 1.75 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 2 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 3 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 4 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 5 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 6 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.096 | Analysis at 15 min Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.034 | Analysis at 30 min Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.022 | Analysis at 45 min Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.010 | Analysis at 60 min Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.005 | Analysis at 75 min Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.002 | Analysis at 90 min Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.001 | Analysis at 1.75 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 2 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 3 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 4 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 5 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 6 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.741 | Analysis at 15 min Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.759 | Analysis at 30 min Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.775 | Analysis at 45 min Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.561 | Analysis at 60 min Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.419 | Analysis at 75 min Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.237 | Analysis at 90 min Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.146 | Analysis at 1.75 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.113 | Analysis at 2 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.086 | Analyaia at 3 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.111 | Analysis at 4 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.183 | Analysis at 5 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.259 | Analysis at 6 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| 8 hours |
|
| 9 hours |
|
| 10 hours |
|
| 11 hours |
|
| 12 hours |
|
| 24 hours |
|
| Generalized linear model |
Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate |
| <0.001 |
Analysis at 8 hours Pairwise comparison. No adjustment made for multiplicity. |
| 95 |
| Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 9 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 10 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 11 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 12 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 24 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 7 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 8 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 9 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 10 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 12 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.017 | Analysis at 24 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.011 | Analysis at 7 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.009 | Analysis at 8 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.008 | Analysis at 9 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.008 | Analysis at 10 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.008 | Analysis at 11 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.008 | Analysis at 12 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.012 | Analysis at 24 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.904 | Analysis at 7 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.891 | Analysis at 8 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.929 | Analysis at 9 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.994 | Analysis at 10 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.933 | Analysis at 11 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.876 | Analysis at 12 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.622 | Analysis at 24 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.081 | Analysis at 7 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.117 | Analysis at 8 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.152 | Analysis at 9 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.171 | Analysis at 10 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.197 | Analysis at 11 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.244 | Analysis at 12 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.708 | Analysis at 24 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.106 | Analysis at 7 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.140 | Analysis at 8 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.188 | Analysis at 9 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.239 | Analysis at 10 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.297 | Analysis at 11 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.383 | Analysis at 12 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.919 | Analysis at 24 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 11 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
|
| 45 min |
|
| 60 min |
|
| 75 min |
|
| 90 min |
|
| 1.75 hours |
|
| 2 hours |
|
| 3 hours |
|
| 4 hours |
|
| 5 hours |
|
| 6 hours |
|
| Generalized linear model |
Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate |
| 0.697 |
Analysis at 30 min Overall P-value |
| 95 |
| Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.203 | Analysis at 45 min Overall P-value | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.003 | Analysis at 60 min Overall P-value | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 75 min Overall P-value | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 90 min Overall P-value | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 1.75 hours Overall P-value | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 2 hours Overall P-value | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 3 hours Overall P-value | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 4 hours Overall P-value | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 5 hours Overall P-value | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 6 hours Overall P-value | 95 | Superiority or Other (legacy) |
| 8 hours |
|
| 9 hours |
|
| 10 hours |
|
| 11 hours |
|
| 12 hours |
|
| 24 hours |
|
| Generalized linear model |
Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate |
| 0.005 |
Analysis at 8 hours Overall P-value |
| 95 |
| Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.046 | Analysis at 9 hours Overall P-value | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.046 | Analysis at 10 hours Overall P-value | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.111 | Analysis at 11 hours Overall P-value | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.226 | Analysis at 12 hours Overall P-value | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.537 | Analysis at 24 hours Overall P-value | 95 | Superiority or Other (legacy) |
| 0.003 |
Treatment as a factor |
| Odds Ratio (OR) |
| 3.07 |
| 95 |
| 1.5 |
| 6.4 |
| Superiority or Other (legacy) |
| Regression, Logistic | 0.634 | Treatment as a factor | Odds Ratio (OR) | 1.16 | 95 | 0.6 | 2.2 | Superiority or Other (legacy) |
| 0.077 |
Treatment as a factor |
| Odds Ratio (OR) |
| 2.18 |
| 95 |
| 0.9 |
| 5.1 |
| Superiority or Other (legacy) |
| Regression, Logistic | 0.134 | Treatment as a factor | Odds Ratio (OR) | 1.95 | 95 | 0.8 | 4.7 | Superiority or Other (legacy) |
| Regression, Logistic | 0.671 | Treatment as a factor | Odds Ratio (OR) | 0.84 | 95 | 0.4 | 1.9 | Superiority or Other (legacy) |
| Regression, Logistic | 0.484 | Treatment as a factor | Odds Ratio (OR) | 0.75 | 95 | 0.3 | 1.7 | Superiority or Other (legacy) |
| Regression, Logistic | 0.814 | Treatment as a factor | Odds Ratio (OR) | 1.12 | 95 | 0.4 | 2.8 | Superiority or Other (legacy) |
For subjects who did not experience perceptible pain relief within 2 hours post-first dose, the time to perceptible pain relief was censored at 2 hours
| Log Rank |
| <0.05 |
p-value for distribution of time to perceptible pain relief |
| 95 |
| Superiority or Other (legacy) |
| For subjects who did not experience perceptible pain relief within 2 hours post-first dose, the time to perceptible pain relief was censored at 2 hours | Log Rank | <0.05 | p-value for distribution of time to perceptible pain relief | 95 | Superiority or Other (legacy) |
For subjects who did not experience meaningful pain relief within 2 hours post-first dose, the time to meaningful pain relief was censored at 2 hours
| Log Rank |
| <0.05 |
p-value for distribution of time to meaningful pain relief |
| 95 |
| Superiority or Other (legacy) |
For subjects who did not experience onset of analgesia within 2 hours post-first dose, the time to onset of analgesia was censored at 2 hours
| Log Rank |
| <0.05 |
p-value for distribution of time to onset of analgesia |
| 95 |
| Superiority or Other (legacy) |
| Title | Measurements |
|---|---|
|
| Fair (2) |
|
| Poor (1) |
|
| Mantel Haenszel |
Test of row mean score differences based on modified ridits (standardizing the mid-rank) |
| <0.001 |
Overall test of Celecoxib 100mg (pooled) versus Placebo that takes into account the ordered data (categories: excellent, good, fair, poor). |
| 95 |
| Superiority or Other (legacy) |
| Mantel Haenszel | Test of row mean score differences based on modified ridits (standardizing the mid-rank) | 0.889 | Overall test of Celecoxib 50mg/50mg versus Celecoxib 100mg (pooled) that takes into account the ordered data (categories: excellent, good, fair, poor). | 95 | Superiority or Other (legacy) |
| Good (3) - 12 hours |
|
| Fair (2) - 12 hours |
|
| Poor (1) - 12 hours |
|
| Excellent (4) - 24 hours |
|
| Good (3) - 24 hours |
|
| Fair (2) - 24 hours |
|
| Poor (1) - 24 hours |
|
| Mantel Haenszel |
Test of row mean score differences based on modified ridits (standardizing the mid-rank) |
| 0.002 |
Analysis at 12 hours Overall test of Celecoxib 100mg/Placebo versus Placebo that takes into account the ordered data (categories: excellent, good, fair, poor). |
| 95 |
| Superiority or Other (legacy) |
| Mantel Haenszel | Test of row mean score differences based on modified ridits (standardizing the mid-rank) | 0.015 | Analysis at 12 hours Overall test of Celecoxib 100mg/50mg versus Placebo that takes into account the ordered data (categories: excellent, good, fair, poor). | 95 | Superiority or Other (legacy) |
| Mantel Haenszel | Test of row mean score differences based on modified ridits (standardizing the mid-rank) | 0.411 | Analysis at 12 hours Overall test of Celecoxib 50mg/50mg versus Celecoxib 100mg/50mg that takes into account the ordered data (categories: excellent, good, fair, poor). | 95 | Superiority or Other (legacy) |
| Mantel Haenszel | Test of row mean score differences based on modified ridits (standardizing the mid-rank) | 0.930 | Analysis at 12 hours Overall test of Celecoxib 50mg/50mg versus Celecoxib 100mg/Placebo that takes into account the ordered data (categories: excellent, good, fair, poor). | 95 | Superiority or Other (legacy) |
| Mantel Haenszel | Test of row mean score differences based on modified ridits (standardizing the mid-rank) | 0.438 | Analysis at 12 hours Overall test of Celecoxib 100mg/Placebo versus Celecoxib 100mg/50mg that takes into account the ordered data (categories: excellent, good, fair, poor). | 95 | Superiority or Other (legacy) |
| Mantel Haenszel | Test of row mean score differences based on modified ridits (standardizing the mid-rank) | 0.002 | Analysis at 24 hours Overall test of Celecoxib 50mg/50mg versus Placebo that takes into account the ordered data (categories: excellent, good, fair, poor). | 95 | Superiority or Other (legacy) |
| Mantel Haenszel | Test of row mean score differences based on modified ridits (standardizing the mid-rank) | 0.013 | Analysis at 24 hours Overall test of Celecoxib 100mg/Placebo versus Placebo that takes into account the ordered data (categories: excellent, good, fair, poor). | 95 | Superiority or Other (legacy) |
| Mantel Haenszel | Test of row mean score differences based on modified ridits (standardizing the mid-rank) | 0.015 | Analysis at 24 hours Overall test of Celecoxib 100mg/50mg versus Placebo that takes into account the ordered data (categories: excellent, good, fair, poor). | 95 | Superiority or Other (legacy) |
| Mantel Haenszel | Test of row mean score differences based on modified ridits (standardizing the mid-rank) | 0.748 | Analysis at 24 hours Overall test of Celecoxib 50mg/50mg versus Celecoxib 100mg/50mg that takes into account the ordered data (categories: excellent, good, fair, poor). | 95 | Superiority or Other (legacy) |
| Mantel Haenszel | Test of row mean score differences based on modified ridits (standardizing the mid-rank) | 0.958 | Analysis at 24 hours Overall test of Celecoxib 50mg/50mg versus Celecoxib 100mg/Placebo that takes into account the ordered data (categories: excellent, good, fair, poor). | 95 | Superiority or Other (legacy) |
| Mantel Haenszel | Test of row mean score differences based on modified ridits (standardizing the mid-rank) | 0.747 | Analysis at 24 hours Overall test of Celecoxib 100mg/Placebo versus Celecoxib 100mg/50mg that takes into account the ordered data (categories: excellent, good, fair, poor). | 95 | Superiority or Other (legacy) |
|
| 45 min |
|
| 60 min |
|
| 75 min |
|
| 90 min |
|
| 1.75 hours |
|
| 2 hours |
|
| 3 hours |
|
| 4 hours |
|
| 5 hours |
|
| 6 hours |
|
| Generalized linear model |
Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate |
| 0.609 |
Analysis at 30 min Overall P-value |
| 95 |
| Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.076 | Analysis at 45 min Overall P-value | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.008 | Analysis at 60 min Overall P-value | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 75 min Overall P-value | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 90 min Overall P-value | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 1.75 hours Overall P-value | 95 | Superiority or Other (legacy) |
| Generalized linear model | Continuous data were analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 2 hours Overall P-value | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 3 hours Overall P-value | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 4 hours Overall P-value | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 5 hours Overall P-value | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.001 | Analysis at 6 hours Overall P-value | 95 | Superiority or Other (legacy) |
| 8 hours |
|
| 9 hours |
|
| 10 hours |
|
| 11 hours |
|
| 12 hours |
|
| 24 hours |
|
| Generalized linear model |
Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate |
| 0.009 |
Analysis at 8 hours Overall P-value |
| 95 |
| Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.043 | Analysis at 9 hours Overall P-value | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.032 | Analysis at 10 hours Overall P-value | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.029 | Analysis at 11 hours Overall P-value | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.066 | Analysis at 12 hours Overall P-value | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.482 | Analysis at 24 hours Overall P-value | 95 | Superiority or Other (legacy) |
| Generalized linear model |
Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate |
| 0.002 |
Pairwise comparison. No adjustment made for multiplicity. |
| Mean Difference (Final Values) |
| 0.9 |
| 95 |
| 0.4 |
| 1.5 |
| Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.186 | Pairwise comparison. No adjustment made for multiplicity. | Mean Difference (Final Values) | -0.4 | 95 | -1.0 | 0.2 | Superiority or Other (legacy) |
|
| 45 min |
|
| 60 min |
|
| 75 min |
|
| 90 min |
|
| 1.75 hours |
|
| 2 hours |
|
| 3 hours |
|
| 4 hours |
|
| 5 hours |
|
| 6 hours |
|
| Generalized linear model |
Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate |
| 0.985 |
Analysis at 15 min Pairwise comparison. No adjustment made for multiplicity. |
| 95 |
| Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.975 | Analysis at 15 min Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.532 | Analysis at 30 min Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.690 | Analysis at 30 min Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.820 | Analysis at 30 min Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.180 | Analysis at 45 min Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.344 | Analysis at 45 min Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.693 | Analysis at 45 min Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.039 | Analysis at 60 min Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.154 | Analysis at 60 min Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.521 | Analysis at 60 min Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.006 | Analysis at 75 min Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.070 | Analysis at 75 min Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.344 | Analysis at 75 min Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.001 | Analysis at 90 min Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.022 | Analysis at 90 min Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.249 | Analysis at 90 min Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 1.75 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.006 | Analysis at 1.75 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.205 | Analysis at 1.75 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 2 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.002 | Analysis at 2 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.186 | Analysis at 2 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 3 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 3 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.179 | Analysis at 3 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 4 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 4 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.259 | Analysis at 4 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 5 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 5 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.393 | Analysis at 5 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 6 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 6 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.512 | Analysis at 6 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| 8 hours |
|
| 9 hours |
|
| 10 hours |
|
| 11 hours |
|
| 12 hours |
|
| 24 hours |
|
| Generalized linear model |
Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate |
| <0.001 |
Analysis at 7 hours Pairwise comparison. No adjustment made for multiplicity. |
| 95 |
| Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.026 | Analysis at 7 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.463 | Analysis at 7 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.131 | Analysis at 7 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.053 | Analysis at 7 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 8 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 8 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.020 | Analysis at 8 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.484 | Analysis at 8 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.197 | Analysis at 8 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.086 | Analysis at 8 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 9 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 9 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.018 | Analysis at 9 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.561 | Analysis at 9 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.252 | Analysis at 9 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.136 | Analysis at 9 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 10 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 10 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.018 | Analysis at 10 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.653 | Analysis at 10 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.287 | Analysis at 10 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.191 | Analysis at 10 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 11 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 11 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.018 | Analysis at 11 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.741 | Analysis at 11 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.326 | Analysis at 11 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.256 | Analysis at 11 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 12 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.001 | Analysis at 12 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.016 | Analysis at 12 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.808 | Analysis at 12 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.394 | Analysis at 12 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.343 | Analysis at 12 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.005 | Analysis at 24 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.029 | Analysis at 24 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.023 | Analysis at 24 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.892 | Analysis at 24 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.952 | Analysis at 24 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.948 | Analysis at 24 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
|
| 45 min |
|
| 60 min |
|
| 75 min |
|
| 90 min |
|
| 1.75 hours |
|
| 2 hours |
|
| 3 hours |
|
| 4 hours |
|
| 5 hours |
|
| 6 hours |
|
| Generalized linear model |
Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate |
| 0.094 |
Analysis at 30 min Overall P-value |
| 95 |
| Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.114 | Analysis at 45 min Overall P-value | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.005 | Analysis at 60 min Overall P-value | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 75 min Overall P-value | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 90 min Overall P-value | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 1.75 hours Overall P-value | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 2 hours Overall P-value | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 3 hours Overall P-value | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 4 hours Overall P-value | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 5 hours Overall P-value | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.001 | Analysis at 6 hours Overall P-value | 95 | Superiority or Other (legacy) |
| 8 hours |
|
| 9 hours |
|
| 10 hours |
|
| 11 hours |
|
| 12 hours |
|
| 24 hours |
|
| Generalized linear model |
Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate |
| 0.002 |
Analysis at 8 hours Overall P-value |
| 95 |
| Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.007 | Analysis at 9 hours Overall P-value | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.015 | Analysis at 10 hours Overall P-value | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.033 | Analysis at 11 hours Overall P-value | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.036 | Analysis at 12 hours Overall P-value | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.500 | Analysis at 24 hours Overall P-value | 95 | Superiority or Other (legacy) |
| Generalized linear model |
Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate |
| 0.009 |
Analysis at 2 hours Pairwise comparison. No adjustment made for multiplicity. |
| Mean Difference (Final Values) |
| 10.2 |
| 95 |
| 2.6 |
| 17.9 |
| Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.127 | Analysis at 2 hours Pairwise comparison. No adjustment made for multiplicity. | Mean Difference (Final Values) | -5.9 | 95 | -13.5 | 1.7 | Superiority or Other (legacy) |
|
| 45 min |
|
| 60 min |
|
| 75 min |
|
| 90 min |
|
| 1.75 hours |
|
| 2 hours |
|
| 3 hours |
|
| 4 hours |
|
| 5 hours |
|
| 6 hours |
|
| Generalized linear model |
Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate |
| 0.780 |
Analysis at 15 min Pairwise comparison. No adjustment made for multiplicity. |
| 95 |
| Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.667 | Analysis at 15 min Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.153 | Analysis at 30 min Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.479 | Analysis at 30 min Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.469 | Analysis at 30 min Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.062 | Analysis at 45 min Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.284 | Analysis at 45 min Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.421 | Analysis at 45 min Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.022 | Analysis at 60 min Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.171 | Analysis at 60 min Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.354 | Analysis at 60 min Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.005 | Analysis at 75 min Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.090 | Analysis at 75 min Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.262 | Analysis at 75 min Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.001 | Analysis at 90 min Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.044 | Analysis at 90 min Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.194 | Analysis at 90 min Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 1.75 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.020 | Analysis at 1.75 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.148 | Analysis at 1.75 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 2 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.009 | Analysis at 2 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.127 | Analysis at 2 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 3 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.001 | Analysis at 3 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.122 | Analysis at 3 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 4 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 4 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.164 | Analysis at 4 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 5 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 5 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.244 | Analysis at 5 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 6 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 6 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.336 | Analysis at 6 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| 8 hours |
|
| 9 hours |
|
| 10 hours |
|
| 11 hours |
|
| 12 hours |
|
| 24 hours |
|
| Generalized linear model |
Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate |
| <0.001 |
Analysis at 7 hours Pairwise comparison. No adjustment made for multiplicity. |
| 95 |
| Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.090 | Analysis at 7 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.518 | Analysis at 7 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.038 | Analysis at 7 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.019 | Analysis at 7 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 8 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 8 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.081 | Analysis at 8 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.552 | Analysis at 8 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.050 | Analysis at 8 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.027 | Analysis at 8 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 9 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 9 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.071 | Analysis at 9 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.609 | Analysis at 9 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.065 | Analysis at 9 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.042 | Analysis at 9 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 10 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 10 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.070 | Analysis at 10 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.689 | Analysis at 10 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Continuous data were analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.075 | Analysis at 10 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.059 | Analysis at 10 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 11 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 11 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.069 | Analysis at 11 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.762 | Analysis at 11 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.089 | Analysis at 11 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.083 | Analysis at 11 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 12 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 12 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.064 | Analysis at 12 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.841 | Analysis at 12 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.110 | Analysis at 12 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.119 | Analysis at 12 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.001 | Analysis at 24 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.015 | Analysis at 24 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.087 | Analysis at 24 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.826 | Analysis at 24 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.345 | Analysis at 24 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.530 | Analysis at 24 hours Pairwise comparison. No adjustment made for multiplicity. | 95 | Superiority or Other (legacy) |
Treatment as a factor
| 0.076 |
| Odds Ratio (OR) |
| 1.95 |
| 95 |
| 0.9 |
| 4.1 |
| Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | 0.733 | Odds Ratio (OR) | 1.12 | 95 | 0.6 | 2.2 | Superiority or Other (legacy) |
Treatment as a factor
| 0.064 |
| Odds Ratio (OR) |
| 2.33 |
| 95 |
| 1.0 |
| 5.7 |
| Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | 0.201 | Odds Ratio (OR) | 1.83 | 95 | 0.7 | 4.6 | Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | 0.575 | Odds Ratio (OR) | 1.27 | 95 | 0.5 | 3.0 | Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | 1.000 | Odds Ratio (OR) | 1.00 | 95 | 0.4 | 2.2 | Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | 0.624 | Odds Ratio (OR) | 1.27 | 95 | 0.5 | 3.3 | Superiority or Other (legacy) |
|
| Generalized linear model |
Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate |
| 0.003 |
Analysis at 2 hours Pairwise comparison. No adjustment made for multiplicity. |
| Mean Difference (Final Values) |
| 0.88 |
| 95 |
| 0.3 |
| 1.5 |
| Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.177 | Analysis at 2 hours Pairwise comparison. No adjustment made for multiplicity. | Mean Difference (Final Values) | -0.40 | 95 | -1.0 | 0.2 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 6 hours Pairwise comparison. No adjustment made for multiplicity. | Mean Difference (Final Values) | 5.25 | 95 | 3.0 | 7.5 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | <0.001 | Analysis at 6 hours Pairwise comparison. No adjustment made for multiplicity. | Mean Difference (Final Values) | 4.54 | 95 | 2.3 | 6.8 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.531 | Analysis at 6 hours Pairwise comparison. No adjustment made for multiplicity. | Mean Difference (Final Values) | -0.72 | 95 | -3.0 | 1.5 | Superiority or Other (legacy) |
| 24 hours |
|
| Generalized linear model |
Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate |
| <0.001 |
Analysis at 12 hours Pairwise comparison. No adjustment made for multiplicity. |
| Mean Difference (Final Values) |
| 10.46 |
| 95 |
| 4.7 |
| 16.2 |
| Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.041 | Analysis at 12 hours Pairwise comparison. No adjustment made for multiplicity. | Mean Difference (Final Values) | 5.96 | 95 | 0.2 | 11.7 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.633 | Analysis at 12 hours Pairwise comparison. No adjustment made for multiplicity. | Mean Difference (Final Values) | -1.39 | 95 | -7.1 | 4.3 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.284 | Analysis at 12 hours Pairwise comparison. No adjustment made for multiplicity. | Mean Difference (Final Values) | 3.11 | 95 | -2.6 | 8.8 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.180 | Analysis at 12 hours Pairwise comparison. No adjustment made for multiplicity. | Mean Difference (Final Values) | 4.50 | 95 | -2.1 | 11.1 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.009 | Analysis at 24 hours Pairwise comparison. No adjustment made for multiplicity. | Mean Difference (Final Values) | 13.57 | 95 | 3.4 | 23.7 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.026 | Analysis at 24 hours Pairwise comparison. No adjustment made for multiplicity. | Mean Difference (Final Values) | 14.15 | 95 | 1.7 | 26.6 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.138 | Analysis at 24 hours Pairwise comparison. No adjustment made for multiplicity. | Mean Difference (Final Values) | 9.39 | 95 | -3.0 | 21.8 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.926 | Analysis at 24 hours Pairwise comparison. No adjustment made for multiplicity. | Mean Difference (Final Values) | -0.59 | 95 | -13.0 | 11.8 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.507 | Analysis at 24 hours Pairwise comparison. No adjustment made for multiplicity. | Mean Difference (Final Values) | 4.18 | 95 | -8.2 | 16.6 | Superiority or Other (legacy) |
| Generalized linear model | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | 0.513 | Analysis at 24 hours Pairwise comparison. No adjustment made for multiplicity. | Mean Difference (Final Values) | 4.77 | 95 | -9.6 | 19.1 | Superiority or Other (legacy) |
Treatment as a factor
| 0.015 |
| Odds Ratio (OR) |
| 3.13 |
| 95 |
| 1.2 |
| 7.9 |
| Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | 0.854 | Odds Ratio (OR) | 1.07 | 95 | 0.5 | 2.2 | Superiority or Other (legacy) |
Treatment as a factor
| 0.003 |
| Odds Ratio (OR) |
| 5.03 |
| 95 |
| 1.7 |
| 14.5 |
| Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | 0.057 | Odds Ratio (OR) | 2.99 | 95 | 1.0 | 9.2 | Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | 0.758 | Odds Ratio (OR) | 1.16 | 95 | 0.5 | 2.9 | Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | 0.381 | Odds Ratio (OR) | 0.69 | 95 | 0.3 | 1.6 | Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | 0.313 | Mean Difference (Final Values) | 1.68 | 95 | 0.6 | 4.6 | Superiority or Other (legacy) |
| NNT at 6 hours |
| 7.5 |
| 95 |
| 4.3 |
| 32.0 |
| Superiority or Other (legacy) |
| NNT at 12 hours |
| 5.0 |
| 95 |
| 3.0 |
| 16.7 |
| Superiority or Other (legacy) |
| Title | Measurements |
|---|---|
|
| 2 hours >=50% gone |
|
| 6 hours >=50% gone |
|
Treatment as a factor |
| 0.005 |
Analysis for 2 hours >=35% gone |
| Odds Ratio (OR) |
| 2.72 |
| 95 |
| 1.3 |
| 5.5 |
| Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | 0.286 | Analysis for 2 hours >=35% gone | Odds Ratio (OR) | 0.72 | 95 | 0.4 | 1.3 | Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | 0.001 | Analysis for 6 hours >=35% gone | Odds Ratio (OR) | 3.37 | 95 | 1.6 | 7.1 | Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | 0.004 | Analysis for 6 hours >=35% gone | Odds Ratio (OR) | 3.05 | 95 | 1.4 | 6.5 | Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | 0.752 | Analysis for 6 hours >=35% gone | Odds Ratio (OR) | 0.90 | 95 | 0.5 | 1.7 | Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | <0.001 | Analysis for 2 hours >=50% gone | Odds Ratio (OR) | 4.57 | 95 | 1.9 | 10.7 | Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | 0.003 | Analysis for 2 hours >=50% gone | Odds Ratio (OR) | 3.68 | 95 | 1.6 | 8.7 | Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | 0.511 | Analysis for 2 hours >=50% gone | Odds Ratio (OR) | 0.81 | 95 | 0.4 | 1.5 | Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | 0.009 | Analysis for 6 hours >=50% gone | Odds Ratio (OR) | 3.05 | 95 | 1.3 | 7.0 | Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | 0.014 | Analysis for 6 hours >=50% gone | Odds Ratio (OR) | 2.88 | 95 | 1.2 | 6.7 | Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | 0.863 | Analysis for 6 hours >=50% gone | Odds Ratio (OR) | 0.94 | 95 | 0.5 | 1.9 | Superiority or Other (legacy) |
| 12 hours >=50% gone |
|
Treatment as a factor |
| 0.052 |
12 hours >=35% gone |
| Odds Ratio (OR) |
| 2.37 |
| 95 |
| 1.0 |
| 5.7 |
| Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | 0.095 | 12 hours >=35% gone | Odds Ratio (OR) | 2.13 | 95 | 0.9 | 5.1 | Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | 0.431 | 12 hours >=35% gone | Odds Ratio (OR) | 1.38 | 95 | 0.6 | 3.0 | Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | 0.602 | 12 hours >=35% gone | Odds Ratio (OR) | 1.23 | 95 | 0.6 | 2.7 | Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | 0.814 | 12 hours >=35% gone | Odds Ratio (OR) | 1.12 | 95 | 0.4 | 2.8 | Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | 0.014 | 12 hours >=50% gone | Odds Ratio (OR) | 2.88 | 95 | 1.2 | 6.7 | Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | 0.016 | 12 hours >=50% gone | Odds Ratio (OR) | 3.23 | 95 | 1.2 | 8.4 | Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | 0.063 | 12 hours >=50% gone | Odds Ratio (OR) | 2.54 | 95 | 0.9 | 6.8 | Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | 0.775 | 12 hours >=50% gone | Odds Ratio (OR) | 1.13 | 95 | 0.5 | 2.7 | Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | 0.779 | 12 hours >=50% gone | Odds Ratio (OR) | 0.89 | 95 | 0.4 | 2.0 | Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | 0.624 | 12 hours >=50% gone | Odds Ratio (OR) | 1.27 | 95 | 0.5 | 3.3 | Superiority or Other (legacy) |
|
| meaningful relief - 6 hours- achieved |
|
| meaningful relief- 6 hours- not achieved |
|
| much improvement - 2 hours- achieved |
|
| much improvement - 2 hours- not achieved |
|
| much improvement - 6 hours- achieved |
|
| much improvement - 6 hours- not achieved |
|
Treatment as a factor |
| 0.012 |
Analysis for meaningful Relief at 2 hours |
| 95 |
| Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | 0.453 | Analysis for meaningful Relief at 2 hours | 95 | Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | <0.001 | Analysis for meaningful Relief at 6 hours | 95 | Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | 0.001 | Analysis for meaningful Relief at 6 hours | 95 | Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | 0.814 | Analysis for meaningful Relief at 6 hours | 95 | Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | 0.024 | Analysis for Much Improvement at 2 hours | 95 | Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | 0.022 | Analysis for Much Improvement at 2 hours | 95 | Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | 0.966 | Analysis for Much Improvement at 2 hours | 95 | Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | 0.001 | Analysis for Much Improvement at 6 hours | 95 | Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | 0.001 | Analysis for Much Improvement at 6 hours | 95 | Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | 0.798 | Analysis for Much Improvement at 6 hours | 95 | Superiority or Other (legacy) |
| Meaningful Relief - not achieved |
|
| Much Improvement - achieved |
|
| Much Improvement - not achieved |
|
Treatment as a factor |
| <0.001 |
Analysis for Meaningful Relief |
| 95 |
| Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | 0.008 | Analysis for Meaningful Relief | 95 | Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | 0.709 | Analysis for Meaningful Relief | 95 | Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | 0.331 | Analysis for Meaningful Relief | 95 | Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | 0.246 | Analysis for Meaningful Relief | 95 | Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | 0.001 | Analysis for Much Improvement | 95 | Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | <0.001 | Analysis for Much Improvement | 95 | Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | 0.219 | Analysis for Much Improvement | 95 | Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | 0.095 | Analysis for Much Improvement | 95 | Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | 0.463 | Analysis for Much Improvement | 95 | Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | 0.038 | Analysis for Much Improvement | 95 | Superiority or Other (legacy) |
| Title | Measurements |
|---|---|
|
| 0.008 |
| 95 |
| Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | 0.557 | 95 | Superiority or Other (legacy) |
| at 12 hours - Not Achieved |
|
| at 24 hours - Achieved |
|
| at 24 hours - Not Achieved |
|
Treatment as a factor
| 0.002 |
Analysis at 12 hours |
| 95 |
| Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | 0.036 | Analysis at 12 hours | 95 | Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | 0.339 | Analysis at 12 hours | 95 | Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | 1.000 | Analysis at 12 hours | 95 | Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | 0.401 | Analysis at 12 hours | 95 | Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | 0.003 | Analysis at 24 hours | 95 | Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | 0.002 | Analysis at 24 hours | 95 | Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | 0.223 | Analysis at 24 hours | 95 | Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | 0.198 | Analysis at 24 hours | 95 | Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | 0.604 | Analysis at 24 hours | 95 | Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | 0.117 | Analysis at 24 hours | 95 | Superiority or Other (legacy) |
| Treatment failures |
|
| <0.001 |
| 95 |
| Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | 0.025 | 95 | Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | 0.539 | 95 | Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | 0.329 | 95 | Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | 0.171 | 95 | Superiority or Other (legacy) |
| 0.244 |
| 95 |
| Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | 0.096 | 95 | Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | 0.579 | 95 | Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | 0.277 | 95 | Superiority or Other (legacy) |
| Regression, Logistic | Treatment as a factor | 0.649 | 95 | Superiority or Other (legacy) |
| Side Effects |
|
| Convenience |
|
| Global Satisfaction |
|
Treatment as a fixed effect |
| 0.003 |
Analysis of Effectiveness |
| Mean Difference (Final Values) |
| 14.4 |
| 95 |
| 4.9 |
| 24.0 |
| Superiority or Other (legacy) |
| Generalized linear model | Treatment as a fixed effect | 0.096 | Analysis of Effectiveness | Mean Difference (Final Values) | 8.2 | 95 | -1.5 | 17.8 | Superiority or Other (legacy) |
| Generalized linear model | Treatment as a fixed effect | 0.141 | Analysis of Effectiveness | Mean Difference (Final Values) | 7.2 | 95 | -2.4 | 16.8 | Superiority or Other (legacy) |
| Generalized linear model | Treatment as a fixed effect | 0.849 | Analysis of Effectiveness | Mean Difference (Final Values) | 0.9 | 95 | -8.6 | 10.5 | Superiority or Other (legacy) |
| Generalized linear model | Treatment as a fixed effect | 0.266 | Analysis of Effectiveness | Mean Difference (Final Values) | 6.3 | 95 | -4.8 | 17.4 | Superiority or Other (legacy) |
| Generalized linear model | Treatment as a fixed effect | 0.141 | Analysis of Side Effects | Mean Difference (Final Values) | -2.3 | 95 | -5.4 | 0.8 | Superiority or Other (legacy) |
| Generalized linear model | Treatment as a fixed effect | 0.312 | Analysis of Side Effects | Mean Difference (Final Values) | -1.9 | 95 | -5.7 | 1.8 | Superiority or Other (legacy) |
| Generalized linear model | Treatment as a fixed effect | 0.724 | Analysis of Side Effects | Mean Difference (Final Values) | -0.7 | 95 | -4.5 | 3.1 | Superiority or Other (legacy) |
| Generalized linear model | Treatment as a fixed effect | 0.398 | Analysis of Side Effects | Mean Difference (Final Values) | -1.6 | 95 | -5.4 | 2.1 | Superiority or Other (legacy) |
| Generalized linear model | Treatment as a fixed effect | 0.846 | Analysis of Side Effects | Mean Difference (Final Values) | -0.4 | 95 | -4.1 | 3.4 | Superiority or Other (legacy) |
| Generalized linear model | Treatment as a fixed effect | 0.572 | Analysis of Side Effects | Mean Difference (Final Values) | -1.3 | 95 | -5.6 | 3.1 | Superiority or Other (legacy) |
| Generalized linear model | Treatment as a fixed effect | 0.014 | Analysis of Convenience | Mean Difference (Final Values) | 5.8 | 95 | 1.2 | 10.4 | Superiority or Other (legacy) |
| Generalized linear model | Treatment as a fixed effect | 0.573 | Analysis of Convenience | Mean Difference (Final Values) | 1.6 | 95 | -4.0 | 7.2 | Superiority or Other (legacy) |
| Generalized linear model | Treatment as a fixed effect | 0.482 | Analysis of Convenience | Mean Difference (Final Values) | -2.0 | 95 | -7.7 | 3.6 | Superiority or Other (legacy) |
| Generalized linear model | Treatment as a fixed effect | 0.007 | Analysis of Convenience | Mean Difference (Final Values) | 7.8 | 95 | 2.2 | 13.5 | Superiority or Other (legacy) |
| Generalized linear model | Treatment as a fixed effect | 0.143 | Analysis of Convenience | Mean Difference (Final Values) | 4.2 | 95 | -1.4 | 9.8 | Superiority or Other (legacy) |
| Generalized linear model | Treatment as a fixed effect | 0.273 | Analysis of Convenience | Mean Difference (Final Values) | 3.6 | 95 | -2.9 | 10.2 | Superiority or Other (legacy) |
| Generalized linear model | Treatment as a fixed effect | 0.003 | Analysis of Global Satisfaction | Mean Difference (Final Values) | 13.0 | 95 | 4.4 | 21.6 | Superiority or Other (legacy) |
| Generalized linear model | Treatment as a fixed effect | 0.029 | Analysis of Global Satisfaction | Mean Difference (Final Values) | 11.7 | 95 | 1.2 | 22.2 | Superiority or Other (legacy) |
| Generalized linear model | Treatment as a fixed effect | 0.251 | Analysis of Global Satisfaction | Mean Difference (Final Values) | 6.2 | 95 | -4.4 | 16.8 | Superiority or Other (legacy) |
| Generalized linear model | Treatment as a fixed effect | 0.204 | Analysis of Global Satisfaction | Mean Difference (Final Values) | 6.8 | 95 | -3.7 | 17.4 | Superiority or Other (legacy) |
| Generalized linear model | Treatment as a fixed effect | 0.808 | Analysis of Global Satisfaction | Mean Difference (Final Values) | 1.3 | 95 | -9.2 | 11.8 | Superiority or Other (legacy) |
| Generalized linear model | Treatment as a fixed effect | 0.371 | Analysis of Global Satisfaction | Mean Difference (Final Values) | 5.5 | 95 | -6.6 | 17.7 | Superiority or Other (legacy) |
|
| 1 hour - No onset subjects in hour |
|
|
| 2 hour - Onset subjects in hour |
|
|
| 2 hour-No onset subjects in hour |
|
|
| 3 hour - Onset subjects in hour |
|
|
| 3 hour-No onset subjects in hour |
|
|
| 4 hour - Onset subjects in hour |
|
|
| 4 hour- No onset subjects in hour |
|
|
| 5 hour - Onset subjects in hour |
|
|
| 5 hour-No onset subjects in hour |
|
|
| 6 hour - Onset subjects in hour |
|
|
| 6 hour-No onset subjects in hour |
|
|
| 7 hour - Onset subjects in hour |
|
|
| 7 hour-No onset subjects in hour |
|
|
| 8 hour - Onset subjects in hour |
|
|
| 8 hour-No onset subjects in hour |
|
|
| 9 hour - Onset subjects in hour |
|
|
| 9 hour-No onset subjects in hour |
|
|
| 10 hour - Onset subjects in hour |
|
|
| 10 hour-No onset subjects in hour |
|
|
| 11 hour - Onset subjects in hour |
|
|
| 11 hour-No onset subjects in hour ( |
|
|
| 12 hour - Onset subjects in hour |
|
|
| 12 hour-No onset subjects in hour |
|
|
| 24 hour - Onset subjects in hour |
|
|
| 24 hour-No onset subjects in hour |
|
|
| 0.002 |
Based on life-table extension of Mantel-Haenszel method. p-value for general association |
| 95 |
| Superiority or Other (legacy) |
| Mantel Haenszel | 0.235 | Based on life-table extension of Mantel-Haenszel method. p-value for general association | 95 | Superiority or Other (legacy) |
| Mantel Haenszel | 0.012 | Based on life-table extension of Mantel-Haenszel method. p-value for general association | 95 | Superiority or Other (legacy) |
| Mantel Haenszel | 0.438 | Based on life-table extension of Mantel-Haenszel method. p-value for general association | 95 | Superiority or Other (legacy) |
| Mantel Haenszel | 0.067 | Based on life-table extension of Mantel-Haenszel method. p-value for general association | 95 | Superiority or Other (legacy) |
|
| 1 hour-No offset subjects in hour |
|
|
| 2 hour- Offset subjects in hour |
|
|
| 2 hour-No offset subjects in hr |
|
|
| 3 hour- Offset subjects in hour |
|
|
| 3 hour-No offset subjects in hr |
|
|
| 4 hour- Offset subjects in hour |
|
|
| 4 hour-No offset subjects in hr |
|
|
| 5 hour- Offset subjects in hour |
|
|
| 5 hour-No offset subjects in hr |
|
|
| 6 hour- Offset subjects in hour |
|
|
| 6 hour-No offset subjects in hr |
|
|
| 7 hour- Offset subjects in hour |
|
|
| 7 hour-No offset subjects in hr |
|
|
| 8 hour- Offset subjects in hour |
|
|
| 8 hour-No offset subjects in hr |
|
|
| 9 hour- Offset subjects in hour |
|
|
| 9 hour-No offset subjects in hr |
|
|
| 10 hour-Offset subjects in hour |
|
|
| 10 hour-No offset subjects in hr |
|
|
| 11 hour-Offset subjects in hour |
|
|
| 11 hour-No offset subjects in hr |
|
|
| 12 hour-Offset subjects in hour |
|
|
| 12 hour-No offset subjects in hr |
|
|
| 24 hour-Offset subjects in hour (N=78,37, 41, 81) |
|
|
| 24 hour-No offset subjects in hr (N=78,37,41, 81) |
|
|
| 0.123 |
Based on life-table extension of Mantel-Haenszel method. p-value for general association |
| 95 |
| Superiority or Other (legacy) |
| Mantel Haenszel | 0.266 | Based on life-table extension of Mantel-Haenszel method. p-value for general association | 95 | Superiority or Other (legacy) |
| Mantel Haenszel | 0.849 | Based on life-table extension of Mantel-Haenszel method. p-value for general association | 95 | Superiority or Other (legacy) |
| Mantel Haenszel | 0.828 | Based on life-table extension of Mantel-Haenszel method. p-value for general association | 95 | Superiority or Other (legacy) |
| Mantel Haenszel | 0.741 | Based on life-table extension of Mantel-Haenszel method. p-value for general association | 95 | Superiority or Other (legacy) |