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| ID | Type | Description | Link |
|---|---|---|---|
| B3411002 |
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This study will compare the analgesic efficacy of a single-dose of a novel ibuprofen formulation to placebo and acetaminophen in the treatment of post-surgical dental pain following "wisdom" tooth (third molar) removal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental |
| |
| Treatment B | Active Comparator |
| |
| Treatment C | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Novel Ibuprofen | Drug | Single-dose of novel ibuprofen (equal to 400 mg ibuprofen) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time-weighted Sum of Pain Relief Rating With Pain Intensity Difference From 0 to 6 Hours (SPRID 0-6) | SPRID: time-weighted sum of pain relief rating combined with pain intensity difference (PRID) over 6 hours. Score range: -6(worst) to 42(best) for SPRID 0-6. PRID: sum of pain intensity difference (PID) and pain relief rating (PRR) at each time point. Score range for PRID: -1(worst) to 7(best). PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). Total score range for PID: -1 (worst) to 3 (best). PRR: assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief). | 0 to 6 hours |
| Time to Onset of Meaningful Relief | Participants evaluated the time to meaningful relief by stopping a second stopwatch labeled 'meaningful relief' at the moment they first began to experience meaningful relief. Stopwatch was active up to 6 hours after dosing or until stopped by the participant, or rescue medication was administered. | 0 to 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Confirmed First Perceptible Relief | Participants evaluated the time to first perceptible relief by stopping a stopwatch labeled 'first perceptible relief' at the moment they first began to experience any relief. Stopwatch was active up to 6 hours after dosing or until stopped by the participant, or rescue medication was administered. The first perceptible relief was considered confirmed if the participant also stopped the second stopwatch indicating meaningful relief. |
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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 |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Salt Lake City | Utah | 84124 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25526232 | Derived | Jayawardena S, Leyva R, Kellstein D. Safety of a novel formulation of ibuprofen sodium compared with standard ibuprofen and placebo. Postgrad Med. 2015 Jan;127(1):33-7. doi: 10.1080/00325481.2015.993268. Epub 2014 Dec 15. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet. |
| FG001 | Ibuprofen Sodium | Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen. |
| FG002 | Acetaminophen | Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet. |
| BG001 | Ibuprofen Sodium | Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen. |
| 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 | Time-weighted Sum of Pain Relief Rating With Pain Intensity Difference From 0 to 6 Hours (SPRID 0-6) | SPRID: time-weighted sum of pain relief rating combined with pain intensity difference (PRID) over 6 hours. Score range: -6(worst) to 42(best) for SPRID 0-6. PRID: sum of pain intensity difference (PID) and pain relief rating (PRR) at each time point. Score range for PRID: -1(worst) to 7(best). PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). Total score range for PID: -1 (worst) to 3 (best). PRR: assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief). | Intent-to-treat (ITT) population included all randomized participants who received study medication and provided a baseline assessment. | Posted | Mean | Standard Deviation | units on a scale | 0 to 6 hours |
|
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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 | Placebo | Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
Not provided
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| Acetaminophen |
| Drug |
Single-dose of acetaminophen (1000mg) |
|
| Placebo | Drug | Single-dose of placebo |
|
| 0 to 6 hours |
| Pain Relief Rating (PRR) | PRR was evaluated at different time points during the study up to 6 hours after taking the study medication, and immediately before rescue medication was taken (if necessary). PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief. | 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours |
| Pain Intensity Difference (PID) | PID was derived by subtracting the pain severity score at a given post-dosing time point (pain severity score range 0 [none] to 3 [severe]) from the baseline score (Baseline pain severity score range 2 [moderate] to 3 [severe]). Total possible score range for PID: -1 (worst) to 3 (best). | 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours |
| Sum of Pain Relief Rating and Pain Intensity Difference (PRID) | PRID was sum of PID and PRR at each post-dosing time point. The overall possible score range, for PRID was -1 (worst) to 7 (best). PID was derived by subtracting the pain severity score at a given post-dosing time point (pain severity score range 0 [none] to 3 [severe]) from the baseline score (Baseline pain severity score range 2 [moderate] to 3 [severe]). Total possible score range for PID: -1 (worst) to 3 (best). PRR was assessed on 5-point categorical pain relief rating scale (0=No relief to 4=Complete relief). | 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours |
| Time-weighted Sum of Pain Intensity Difference (SPID) | SPID: time-weighted sum of PID over 2, 3 and 6 hours. Total score range: -2 (worst) to 6 (best) for SPID 0-2, -3 (worst) to 9 (best) for SPID 0-3, and -6 (worst) to 18 (best) for SPID 0-6. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). Total score range for PID: -1 (worst) to 3 (best). | 0 to 2, 0 to 3, 0 to 6 hours |
| Time-weighted Sum of Pain Relief Rating (TOTPAR) | TOTPAR: time-weighted sum of PRR over 2, 3, and 6 hours. Total score range: 0 (worst) to 8 (best) for TOTPAR 0-2, 0 (worst) to 12 (best) for TOTPAR 0-3, and 0 (worst) to 24 (best) for TOTPAR 0-6. PRR was evaluated at different time points during the study up to 6 hours, and immediately after taking rescue medication (if necessary). PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief. | 0 to 2, 0 to 3, 0 to 6 hours |
| Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID) | SPRID: time-weighted sum of PRID over 2 and 3 hours. Total score range: -2 (worst) to 14 (best) for SPRID 0-2, and -3 (worst) to 21 (best) for SPRID 0-3. PRID: sum of PID and PRR at each time point. Total score range for PRID: -1=worst to 7=best. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). Total score range for PID: -1 (worst) to 3 (best). PRR: assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief). | 0 to 2, 0 to 3 hours |
| Cumulative Percentage of Participants With Meaningful Relief | Percentage of participants with meaningful relief evaluated by stopping the stopwatch labeled 'meaningful relief' at the moment participant first began to experience meaningful relief. Stopwatch was active up to 6 hours after dosing or until stopped by the participant, or rescue medication was administered. | 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours |
| Cumulative Percentage of Participants With Confirmed First Perceptible Relief | Percentage of participants with first perceptible relief evaluated by stopping the stopwatch labeled 'first perceptible relief' at the moment participant first began to experience any relief. First perceptible relief was considered confirmed if the participant also stopped the second stopwatch indicating meaningful relief. Stopwatch was active up to 6 hours after dosing or until stopped by the participant, or rescue medication was administered. | 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours |
| Time to Treatment Failure | Median time of dropping out of the participants from the study due to lack of efficacy or use of rescue medication, whichever comes first. | 0 to 6 hours |
| Cumulative Percentage of Participants With Treatment Failure | Percentage of participants who withdrew from the study due to lack of efficacy or received rescue medication. | 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours |
| Cumulative Percentage of Participants With Complete Relief | Complete relief was defined as a PRR of 4. PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief. | 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours |
| Participant Global Evaluation of Study Medication | Participant global evaluation of study medication was performed at the 6-hour time point or immediately before taking the rescue medication. It was scored on a 6-point categorical scale where 0 = Very poor, 1 = Poor, 2 = Fair, 3 = Good, 4 = Very Good, and 5 = Excellent. | 6 hours |
| BG002 | Acetaminophen | Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Number of Participants with Pain Severity Score | Pain severity score was assessed on a 4-point categorical scale. Total possible pain severity score range was 0 to 3, where 0 = none, 1 = mild, 2 = moderate and 3 = severe. | Number | participants |
|
Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
| OG001 | Ibuprofen Sodium | Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen. |
| OG002 | Acetaminophen | Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen. |
|
|
|
| Primary | Time to Onset of Meaningful Relief | Participants evaluated the time to meaningful relief by stopping a second stopwatch labeled 'meaningful relief' at the moment they first began to experience meaningful relief. Stopwatch was active up to 6 hours after dosing or until stopped by the participant, or rescue medication was administered. | ITT population included all randomized participants who received study medication and provided a baseline assessment. | Posted | Median | 95% Confidence Interval | minutes | 0 to 6 hours |
|
|
|
|
| Secondary | Time to Confirmed First Perceptible Relief | Participants evaluated the time to first perceptible relief by stopping a stopwatch labeled 'first perceptible relief' at the moment they first began to experience any relief. Stopwatch was active up to 6 hours after dosing or until stopped by the participant, or rescue medication was administered. The first perceptible relief was considered confirmed if the participant also stopped the second stopwatch indicating meaningful relief. | ITT population included all randomized participants who received study medication and provided a baseline assessment. | Posted | Median | 95% Confidence Interval | minutes | 0 to 6 hours |
|
|
|
|
| Secondary | Pain Relief Rating (PRR) | PRR was evaluated at different time points during the study up to 6 hours after taking the study medication, and immediately before rescue medication was taken (if necessary). PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief. | ITT population included all randomized participants who received study medication and provided a baseline assessment. | Posted | Mean | Standard Deviation | units on a scale | 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours |
|
|
|
|
| Secondary | Pain Intensity Difference (PID) | PID was derived by subtracting the pain severity score at a given post-dosing time point (pain severity score range 0 [none] to 3 [severe]) from the baseline score (Baseline pain severity score range 2 [moderate] to 3 [severe]). Total possible score range for PID: -1 (worst) to 3 (best). | ITT population included all randomized participants who received study medication and provided a baseline assessment. | Posted | Mean | Standard Deviation | units on a scale | 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours |
|
|
|
|
| Secondary | Sum of Pain Relief Rating and Pain Intensity Difference (PRID) | PRID was sum of PID and PRR at each post-dosing time point. The overall possible score range, for PRID was -1 (worst) to 7 (best). PID was derived by subtracting the pain severity score at a given post-dosing time point (pain severity score range 0 [none] to 3 [severe]) from the baseline score (Baseline pain severity score range 2 [moderate] to 3 [severe]). Total possible score range for PID: -1 (worst) to 3 (best). PRR was assessed on 5-point categorical pain relief rating scale (0=No relief to 4=Complete relief). | ITT population included all randomized participants who received study medication and provided a baseline assessment. | Posted | Mean | Standard Deviation | units on a scale | 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours |
|
|
|
|
| Secondary | Time-weighted Sum of Pain Intensity Difference (SPID) | SPID: time-weighted sum of PID over 2, 3 and 6 hours. Total score range: -2 (worst) to 6 (best) for SPID 0-2, -3 (worst) to 9 (best) for SPID 0-3, and -6 (worst) to 18 (best) for SPID 0-6. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). Total score range for PID: -1 (worst) to 3 (best). | ITT population included all randomized participants who received study medication and provided a baseline assessment. | Posted | Mean | Standard Deviation | units on a scale | 0 to 2, 0 to 3, 0 to 6 hours |
|
|
|
|
| Secondary | Time-weighted Sum of Pain Relief Rating (TOTPAR) | TOTPAR: time-weighted sum of PRR over 2, 3, and 6 hours. Total score range: 0 (worst) to 8 (best) for TOTPAR 0-2, 0 (worst) to 12 (best) for TOTPAR 0-3, and 0 (worst) to 24 (best) for TOTPAR 0-6. PRR was evaluated at different time points during the study up to 6 hours, and immediately after taking rescue medication (if necessary). PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief. | ITT population included all randomized participants who received study medication and provided a baseline assessment. | Posted | Mean | Standard Deviation | units on a scale | 0 to 2, 0 to 3, 0 to 6 hours |
|
|
|
|
| Secondary | Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID) | SPRID: time-weighted sum of PRID over 2 and 3 hours. Total score range: -2 (worst) to 14 (best) for SPRID 0-2, and -3 (worst) to 21 (best) for SPRID 0-3. PRID: sum of PID and PRR at each time point. Total score range for PRID: -1=worst to 7=best. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). Total score range for PID: -1 (worst) to 3 (best). PRR: assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief). | ITT population included all randomized participants who received study medication and provided a baseline assessment. | Posted | Mean | Standard Deviation | units on a scale | 0 to 2, 0 to 3 hours |
|
|
|
|
| Secondary | Cumulative Percentage of Participants With Meaningful Relief | Percentage of participants with meaningful relief evaluated by stopping the stopwatch labeled 'meaningful relief' at the moment participant first began to experience meaningful relief. Stopwatch was active up to 6 hours after dosing or until stopped by the participant, or rescue medication was administered. | ITT population included all randomized participants who received study medication and provided a baseline assessment. | Posted | Number | percentage of participants | 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours |
|
|
|
|
| Secondary | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | Percentage of participants with first perceptible relief evaluated by stopping the stopwatch labeled 'first perceptible relief' at the moment participant first began to experience any relief. First perceptible relief was considered confirmed if the participant also stopped the second stopwatch indicating meaningful relief. Stopwatch was active up to 6 hours after dosing or until stopped by the participant, or rescue medication was administered. | ITT population included all randomized participants who received study medication and provided a baseline assessment. | Posted | Number | percentage of participants | 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours |
|
|
|
|
| Secondary | Time to Treatment Failure | Median time of dropping out of the participants from the study due to lack of efficacy or use of rescue medication, whichever comes first. | ITT population included all randomized participants who received study medication and provided a baseline assessment. | Posted | Median | 95% Confidence Interval | hours | 0 to 6 hours |
|
|
|
|
| Secondary | Cumulative Percentage of Participants With Treatment Failure | Percentage of participants who withdrew from the study due to lack of efficacy or received rescue medication. | ITT population included all randomized participants who received study medication and provided a baseline assessment. | Posted | Number | percentage of participants | 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours |
|
|
|
|
| Secondary | Cumulative Percentage of Participants With Complete Relief | Complete relief was defined as a PRR of 4. PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief. | ITT population included all randomized participants who received study medication and provided a baseline assessment. | Posted | Number | percentage of participants | 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours |
|
|
|
|
| Secondary | Participant Global Evaluation of Study Medication | Participant global evaluation of study medication was performed at the 6-hour time point or immediately before taking the rescue medication. It was scored on a 6-point categorical scale where 0 = Very poor, 1 = Poor, 2 = Fair, 3 = Good, 4 = Very Good, and 5 = Excellent. | ITT population included all randomized participants who received study medication and provided a baseline assessment. | Posted | Mean | Standard Deviation | units on a scale | 6 hours |
|
|
|
|
| 0 |
| 45 |
| 10 |
| 45 |
| EG001 | Ibuprofen Sodium | Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen. | 0 | 88 | 5 | 88 |
| EG002 | Acetaminophen | Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen. | 0 | 85 | 11 | 85 |
| Headache | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Hyperhidrosis | General disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Aniline Compounds |
| D000588 | Amines |
| HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model. Type I error controlled at 5% significance level(2-sided) by testing co-primary endpoints sequentially:IBU Na vs PBO, IBU Na vs APAP, APAP vs PBO for SPRID 0-6 then time to meaningful relief at each comparison.If comparison at preceding step was significant only then subsequent comparisons were significant. | Proportional hazards model | 0.468 | p-value was calculated using PH model with treatment, baseline PSR and gender terms. | Hazard Ratio (HR) | 1.14 | 2-Sided | 95 | 0.81 | 1.60 | No | Superiority or Other |
| HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model. Type I error controlled at 5% significance level(2-sided) by testing co-primary endpoints sequentially:IBU Na vs PBO, IBU Na vs APAP, APAP vs PBO for SPRID 0-6 then time to meaningful relief at each comparison.If comparison at preceding step was significant only then subsequent comparisons were significant. | Proportional hazards model | <0.001 | p-value was calculated using PH model with treatment, baseline PSR and gender terms. | Hazard Ratio (HR) | 10.43 | 2-Sided | 95 | 4.50 | 24.17 | No | Superiority or Other |
HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model. |
| Proportional hazards model |
| 0.323 |
p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). |
| Hazard Ratio (HR) |
| 1.19 |
| 2-Sided |
| 95 |
| 0.84 |
| 1.68 |
| No |
| Superiority or Other |
| HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model. | Proportional hazards model | <0.001 | p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Hazard Ratio (HR) | 11.81 | 2-Sided | 95 | 5.06 | 27.59 | No | Superiority or Other |
|
| 1 hour |
|
| 1.5 hours |
|
| 2 hours |
|
| 3 hours |
|
| 4 hours |
|
| 5 hours |
|
| 6 hours |
|
|
0.25 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model. |
| ANOVA |
| 0.101 |
p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). |
| LS mean difference |
| 0.20 |
| 2-Sided |
| 95 |
| -0.04 |
| 0.44 |
| No |
| Superiority or Other |
| 0.25 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.029 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 0.33 | 2-Sided | 95 | 0.03 | 0.62 | No | Superiority or Other |
| 0.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 1.44 | 2-Sided | 95 | 1.01 | 1.87 | No | Superiority or Other |
| 0.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.178 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 0.24 | 2-Sided | 95 | -0.11 | 0.59 | No | Superiority or Other |
| 0.5 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 1.20 | 2-Sided | 95 | 0.77 | 1.63 | No | Superiority or Other |
| 1 hour: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 2.07 | 2-Sided | 95 | 1.64 | 2.49 | No | Superiority or Other |
| 1 hour: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.014 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 0.44 | 2-Sided | 95 | 0.09 | 0.78 | No | Superiority or Other |
| 1 hour: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 1.63 | 2-Sided | 95 | 1.21 | 2.06 | No | Superiority or Other |
| 1.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 2.25 | 2-Sided | 95 | 1.79 | 2.70 | No | Superiority or Other |
| 1.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.055 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 0.37 | 2-Sided | 95 | -0.01 | 0.74 | No | Superiority or Other |
| 1.5 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 1.88 | 2-Sided | 95 | 1.43 | 2.34 | No | Superiority or Other |
| 2 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 2.31 | 2-Sided | 95 | 1.80 | 2.83 | No | Superiority or Other |
| 2 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.019 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 0.51 | 2-Sided | 95 | 0.08 | 0.93 | No | Superiority or Other |
| 2 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 1.81 | 2-Sided | 95 | 1.29 | 2.32 | No | Superiority or Other |
| 3 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 2.10 | 2-Sided | 95 | 1.53 | 2.66 | No | Superiority or Other |
| 3 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.013 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 0.59 | 2-Sided | 95 | 0.13 | 1.05 | No | Superiority or Other |
| 3 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 1.51 | 2-Sided | 95 | 0.95 | 2.07 | No | Superiority or Other |
| 4 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 1.97 | 2-Sided | 95 | 1.39 | 2.56 | No | Superiority or Other |
| 4 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.010 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 0.63 | 2-Sided | 95 | 0.15 | 1.10 | No | Superiority or Other |
| 4 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 1.35 | 2-Sided | 95 | 0.77 | 1.93 | No | Superiority or Other |
| 5 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 1.54 | 2-Sided | 95 | 0.95 | 2.14 | No | Superiority or Other |
| 5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.088 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 0.42 | 2-Sided | 95 | -0.06 | 0.91 | No | Superiority or Other |
| 5 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 1.12 | 2-Sided | 95 | 0.52 | 1.71 | No | Superiority or Other |
| 6 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 1.46 | 2-Sided | 95 | 0.85 | 2.07 | No | Superiority or Other |
| 6 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.061 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 0.47 | 2-Sided | 95 | -0.02 | 0.97 | No | Superiority or Other |
| 6 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.002 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 0.98 | 2-Sided | 95 | 0.38 | 1.59 | No | Superiority or Other |
|
| 1 hour |
|
| 1.5 hours |
|
| 2 hours |
|
| 3 hours |
|
| 4 hours |
|
| 5 hours |
|
| 6 hours |
|
|
0.25 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model. |
| ANOVA |
| 0.387 |
p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). |
| LS mean difference |
| 0.06 |
| 2-Sided |
| 95 |
| -0.08 |
| 0.21 |
| No |
| Superiority or Other |
| 0.25 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.007 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 0.25 | 2-Sided | 95 | 0.07 | 0.42 | No | Superiority or Other |
| 0.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 0.89 | 2-Sided | 95 | 0.64 | 1.15 | No | Superiority or Other |
| 0.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.019 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 0.25 | 2-Sided | 95 | 0.04 | 0.46 | No | Superiority or Other |
| 0.5 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 0.64 | 2-Sided | 95 | 0.38 | 0.90 | No | Superiority or Other |
| 1 hour: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 1.30 | 2-Sided | 95 | 1.01 | 1.59 | No | Superiority or Other |
| 1 hour: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.006 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 0.33 | 2-Sided | 95 | 0.09 | 0.57 | No | Superiority or Other |
| 1 hour: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 0.97 | 2-Sided | 95 | 0.68 | 1.26 | No | Superiority or Other |
| 1.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 1.43 | 2-Sided | 95 | 1.12 | 1.74 | No | Superiority or Other |
| 1.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.014 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 0.32 | 2-Sided | 95 | 0.07 | 0.58 | No | Superiority or Other |
| 1.5 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 1.11 | 2-Sided | 95 | 0.80 | 1.42 | No | Superiority or Other |
| 2 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 1.43 | 2-Sided | 95 | 1.09 | 1.78 | No | Superiority or Other |
| 2 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.030 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 0.31 | 2-Sided | 95 | 0.03 | 0.59 | No | Superiority or Other |
| 2 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 1.12 | 2-Sided | 95 | 0.78 | 1.46 | No | Superiority or Other |
| 3 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 1.29 | 2-Sided | 95 | 0.91 | 1.66 | No | Superiority or Other |
| 3 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.007 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 0.42 | 2-Sided | 95 | 0.12 | 0.73 | No | Superiority or Other |
| 3 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 0.87 | 2-Sided | 95 | 0.49 | 1.24 | No | Superiority or Other |
| 4 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 1.27 | 2-Sided | 95 | 0.89 | 1.65 | No | Superiority or Other |
| 4 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.004 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 0.45 | 2-Sided | 95 | 0.15 | 0.76 | No | Superiority or Other |
| 4 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 0.82 | 2-Sided | 95 | 0.44 | 1.19 | No | Superiority or Other |
| 5 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 0.92 | 2-Sided | 95 | 0.54 | 1.31 | No | Superiority or Other |
| 5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.084 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 0.28 | 2-Sided | 95 | -0.04 | 0.59 | No | Superiority or Other |
| 5 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 0.65 | 2-Sided | 95 | 0.27 | 1.03 | No | Superiority or Other |
| 6 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 0.93 | 2-Sided | 95 | 0.54 | 1.32 | No | Superiority or Other |
| 6 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.020 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 0.38 | 2-Sided | 95 | 0.06 | 0.69 | No | Superiority or Other |
| 6 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.005 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 0.56 | 2-Sided | 95 | 0.17 | 0.94 | No | Superiority or Other |
|
| 1 hour |
|
| 1.5 hours |
|
| 2 hours |
|
| 3 hours |
|
| 4 hours |
|
| 5 hours |
|
| 6 hours |
|
|
0.25 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model. |
| ANOVA |
| 0.148 |
p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). |
| LS mean difference |
| 0.27 |
| 2-Sided |
| 95 |
| -0.10 |
| 0.63 |
| No |
| Superiority or Other |
| 0.25 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.011 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 0.57 | 2-Sided | 95 | 0.13 | 1.02 | No | Superiority or Other |
| 0.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 2.34 | 2-Sided | 95 | 1.68 | 2.99 | No | Superiority or Other |
| 0.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.071 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 0.49 | 2-Sided | 95 | -0.04 | 1.03 | No | Superiority or Other |
| 0.5 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 1.84 | 2-Sided | 95 | 1.19 | 2.50 | No | Superiority or Other |
| 1 hour: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 3.37 | 2-Sided | 95 | 2.67 | 4.06 | No | Superiority or Other |
| 1 hour: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.008 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 0.77 | 2-Sided | 95 | 0.20 | 1.33 | No | Superiority or Other |
| 1 hour: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 2.60 | 2-Sided | 95 | 1.91 | 3.30 | No | Superiority or Other |
| 1.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 3.68 | 2-Sided | 95 | 2.92 | 4.43 | No | Superiority or Other |
| 1.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.028 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 0.69 | 2-Sided | 95 | 0.07 | 1.30 | No | Superiority or Other |
| 1.5 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 2.99 | 2-Sided | 95 | 2.24 | 3.74 | No | Superiority or Other |
| 2 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 3.75 | 2-Sided | 95 | 2.90 | 4.59 | No | Superiority or Other |
| 2 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.020 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 0.82 | 2-Sided | 95 | 0.13 | 1.51 | No | Superiority or Other |
| 2 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 2.93 | 2-Sided | 95 | 2.09 | 3.77 | No | Superiority or Other |
| 3 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 3.38 | 2-Sided | 95 | 2.46 | 4.30 | No | Superiority or Other |
| 3 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.009 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 1.01 | 2-Sided | 95 | 0.26 | 1.76 | No | Superiority or Other |
| 3 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 2.38 | 2-Sided | 95 | 1.46 | 3.30 | No | Superiority or Other |
| 4 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 3.24 | 2-Sided | 95 | 2.30 | 4.19 | No | Superiority or Other |
| 4 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.006 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 1.08 | 2-Sided | 95 | 0.31 | 1.85 | No | Superiority or Other |
| 4 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 2.16 | 2-Sided | 95 | 1.22 | 3.10 | No | Superiority or Other |
| 5 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 2.47 | 2-Sided | 95 | 1.51 | 3.43 | No | Superiority or Other |
| 5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.080 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 0.70 | 2-Sided | 95 | -0.09 | 1.49 | No | Superiority or Other |
| 5 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 1.77 | 2-Sided | 95 | 0.81 | 2.73 | No | Superiority or Other |
| 6 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 2.39 | 2-Sided | 95 | 1.41 | 3.37 | No | Superiority or Other |
| 6 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.037 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 0.85 | 2-Sided | 95 | 0.05 | 1.65 | No | Superiority or Other |
| 6 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.002 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 1.54 | 2-Sided | 95 | 0.57 | 2.52 | No | Superiority or Other |
|
| SPID 0-6 |
|
|
SPID 0-2: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model. |
| ANOVA |
| 0.007 |
p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). |
| LS mean difference |
| 0.56 |
| 2-Sided |
| 95 |
| 0.15 |
| 0.97 |
| No |
| Superiority or Other |
| SPID 0-2: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 1.82 | 2-Sided | 95 | 1.32 | 2.32 | No | Superiority or Other |
| SPID 0-3: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 3.67 | 2-Sided | 95 | 2.85 | 4.49 | No | Superiority or Other |
| SPID 0-3: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.004 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 0.98 | 2-Sided | 95 | 0.31 | 1.66 | No | Superiority or Other |
| SPID 0-3: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 2.69 | 2-Sided | 95 | 1.87 | 3.51 | No | Superiority or Other |
| SPID 0-6: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 6.80 | 2-Sided | 95 | 4.96 | 8.64 | No | Superiority or Other |
| SPID 0-6: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.007 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 2.09 | 2-Sided | 95 | 0.59 | 3.59 | No | Superiority or Other |
| SPID 0-6: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 4.71 | 2-Sided | 95 | 2.87 | 6.54 | No | Superiority or Other |
|
| TOTPAR 0-6 |
|
|
TOTPAR 0-2: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model. |
| ANOVA |
| 0.016 |
p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). |
| LS mean difference |
| 0.76 |
| 2-Sided |
| 95 |
| 0.14 |
| 1.38 |
| No |
| Superiority or Other |
| TOTPAR 0-2: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 3.04 | 2-Sided | 95 | 2.29 | 3.80 | No | Superiority or Other |
| TOTPAR 0-3: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 5.90 | 2-Sided | 95 | 4.66 | 7.15 | No | Superiority or Other |
| TOTPAR 0-3: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.010 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 1.35 | 2-Sided | 95 | 0.33 | 2.37 | No | Superiority or Other |
| TOTPAR 0-3: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 4.56 | 2-Sided | 95 | 3.31 | 5.80 | No | Superiority or Other |
| TOTPAR 0-6: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 10.88 | 2-Sided | 95 | 8.05 | 13.70 | No | Superiority or Other |
| TOTPAR 0-6: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.015 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 2.87 | 2-Sided | 95 | 0.57 | 5.18 | No | Superiority or Other |
| TOTPAR 0-6: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 8.00 | 2-Sided | 95 | 5.18 | 10.83 | No | Superiority or Other |
|
|
SPRID 0-2: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model. |
| ANOVA |
| 0.010 |
p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). |
| LS mean difference |
| 1.33 |
| 2-Sided |
| 95 |
| 0.32 |
| 2.33 |
| No |
| Superiority or Other |
| SPRID 0-2: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 4.87 | 2-Sided | 95 | 3.63 | 6.10 | No | Superiority or Other |
| SPRID 0-3: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 9.58 | 2-Sided | 95 | 7.54 | 11.61 | No | Superiority or Other |
| SPRID 0-3: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.006 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 2.33 | 2-Sided | 95 | 0.67 | 4.00 | No | Superiority or Other |
| SPRID 0-3: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 7.24 | 2-Sided | 95 | 5.21 | 9.28 | No | Superiority or Other |
| Title | Measurements |
|---|---|
|
| 1 hour |
|
| 1.5 hours |
|
| 2 hours |
|
| 3 hours |
|
| 4 hours |
|
| 5 hours |
|
| 6 hours |
|
| 0.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.799 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 1.58 | 2-Sided | 95 | -10.54 | 13.70 | No | Superiority or Other |
| 0.5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.001 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 20.09 | 2-Sided | 95 | 11.45 | 28.72 | No | Superiority or Other |
| 1 hour: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 53.22 | 2-Sided | 95 | 42.92 | 63.53 | No | Superiority or Other |
| 1 hour: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.695 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | -2.98 | 2-Sided | 95 | -17.67 | 11.70 | No | Superiority or Other |
| 1 hour: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 57.06 | 2-Sided | 95 | 46.53 | 67.60 | No | Superiority or Other |
| 1.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 70.58 | 2-Sided | 95 | 60.28 | 80.88 | No | Superiority or Other |
| 1.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.261 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 7.99 | 2-Sided | 95 | -5.85 | 21.84 | No | Superiority or Other |
| 1.5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 62.88 | 2-Sided | 95 | 51.78 | 73.99 | No | Superiority or Other |
| 2 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 66.24 | 2-Sided | 95 | 53.77 | 78.71 | No | Superiority or Other |
| 2 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.522 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 4.38 | 2-Sided | 95 | -8.89 | 17.64 | No | Superiority or Other |
| 2 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 61.93 | 2-Sided | 95 | 49.06 | 74.80 | No | Superiority or Other |
| 3 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 66.35 | 2-Sided | 95 | 53.61 | 79.09 | No | Superiority or Other |
| 3 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.415 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 5.46 | 2-Sided | 95 | -7.53 | 18.44 | No | Superiority or Other |
| 3 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 60.92 | 2-Sided | 95 | 47.65 | 74.19 | No | Superiority or Other |
| 4 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 65.32 | 2-Sided | 95 | 52.18 | 78.46 | No | Superiority or Other |
| 4 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.519 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 4.21 | 2-Sided | 95 | -8.39 | 16.81 | No | Superiority or Other |
| 4 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 61.14 | 2-Sided | 95 | 47.60 | 74.68 | No | Superiority or Other |
| 5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 66.44 | 2-Sided | 95 | 53.38 | 79.51 | No | Superiority or Other |
| 5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.412 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 5.31 | 2-Sided | 95 | -7.22 | 17.83 | No | Superiority or Other |
| 5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 61.14 | 2-Sided | 95 | 47.60 | 74.68 | No | Superiority or Other |
| 6 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 66.44 | 2-Sided | 95 | 53.38 | 79.51 | No | Superiority or Other |
| 6 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.412 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 5.31 | 2-Sided | 95 | -7.22 | 17.83 | No | Superiority or Other |
| 6 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 61.14 | 2-Sided | 95 | 47.60 | 74.68 | No | Superiority or Other |
| Title | Measurements |
|---|---|
|
| 1 hour |
|
| 1.5 hours |
|
| 2 hours |
|
| 3 hours |
|
| 4 hours |
|
| 5 hours |
|
| 6 hours |
|
| 0.25 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.602 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 3.53 | 2-Sided | 95 | -9.85 | 16.91 | No | Superiority or Other |
| 0.25 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.001 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 22.72 | 2-Sided | 95 | 12.39 | 33.05 | No | Superiority or Other |
| 0.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 60.37 | 2-Sided | 95 | 48.61 | 72.12 | No | Superiority or Other |
| 0.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.761 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 2.25 | 2-Sided | 95 | -12.10 | 16.59 | No | Superiority or Other |
| 0.5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 58.32 | 2-Sided | 95 | 46.59 | 70.05 | No | Superiority or Other |
| 1 hour: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 67.52 | 2-Sided | 95 | 54.91 | 80.12 | No | Superiority or Other |
| 1 hour: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.410 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 5.42 | 2-Sided | 95 | -7.34 | 18.18 | No | Superiority or Other |
| 1 hour: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 62.13 | 2-Sided | 95 | 48.96 | 75.29 | No | Superiority or Other |
| 1.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 68.64 | 2-Sided | 95 | 56.11 | 81.16 | No | Superiority or Other |
| 1.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.412 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 5.31 | 2-Sided | 95 | -7.22 | 17.83 | No | Superiority or Other |
| 1.5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 63.34 | 2-Sided | 95 | 50.32 | 76.35 | No | Superiority or Other |
| 2 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 66.44 | 2-Sided | 95 | 53.38 | 79.51 | No | Superiority or Other |
| 2 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.412 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 5.31 | 2-Sided | 95 | -7.22 | 17.83 | No | Superiority or Other |
| 2 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 61.14 | 2-Sided | 95 | 47.60 | 74.68 | No | Superiority or Other |
| 3 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 66.44 | 2-Sided | 95 | 53.38 | 79.51 | No | Superiority or Other |
| 3 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.412 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 5.31 | 2-Sided | 95 | -7.22 | 17.83 | No | Superiority or Other |
| 3 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 61.14 | 2-Sided | 95 | 47.60 | 74.68 | No | Superiority or Other |
| 4 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 66.44 | 2-Sided | 95 | 53.38 | 79.51 | No | Superiority or Other |
| 4 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.412 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 5.31 | 2-Sided | 95 | -7.22 | 17.83 | No | Superiority or Other |
| 4 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 61.14 | 2-Sided | 95 | 47.60 | 74.68 | No | Superiority or Other |
| 5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 66.44 | 2-Sided | 95 | 53.38 | 79.51 | No | Superiority or Other |
| 5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.412 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 5.31 | 2-Sided | 95 | -7.22 | 17.83 | No | Superiority or Other |
| 5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 61.14 | 2-Sided | 95 | 47.60 | 74.68 | No | Superiority or Other |
| 6 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 66.44 | 2-Sided | 95 | 53.38 | 79.51 | No | Superiority or Other |
| 6 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.412 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 5.31 | 2-Sided | 95 | -7.22 | 17.83 | No | Superiority or Other |
| 6 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 61.14 | 2-Sided | 95 | 47.60 | 74.68 | No | Superiority or Other |
HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model. |
| Proportional hazards model |
| 0.303 |
p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). |
| Hazard Ratio (HR) |
| 0.76 |
| 2-Sided |
| 95 |
| 0.45 |
| 1.28 |
| No |
| Superiority or Other |
| HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model. | Proportional hazards model | <0.001 | p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Hazard Ratio (HR) | 0.17 | 2-Sided | 95 | 0.10 | 0.28 | No | Superiority or Other |
| Title | Measurements |
|---|---|
|
| 1 hour |
|
| 1.5 hours |
|
| 2 hours |
|
| 3 hours |
|
| 4 hours |
|
| 5 hours |
|
| 6 hours |
|
| 1.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.958 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | -0.12 | 2-Sided | 95 | -4.52 | 4.28 | No | Superiority or Other |
| 1.5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | -40.19 | 2-Sided | 95 | -55.51 | -24.87 | No | Superiority or Other |
| 2 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | -63.40 | 2-Sided | 95 | -77.81 | -48.99 | No | Superiority or Other |
| 2 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.108 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | -7.17 | 2-Sided | 95 | -15.91 | 1.57 | No | Superiority or Other |
| 2 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | -56.39 | 2-Sided | 95 | -71.68 | -41.09 | No | Superiority or Other |
| 3 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | -71.01 | 2-Sided | 95 | -84.09 | -57.93 | No | Superiority or Other |
| 3 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.083 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | -9.82 | 2-Sided | 95 | -20.18 | 1.16 | No | Superiority or Other |
| 3 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | -61.14 | 2-Sided | 95 | -75.40 | -46.87 | No | Superiority or Other |
| 4 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | -66.37 | 2-Sided | 95 | -80.08 | -52.66 | No | Superiority or Other |
| 4 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.079 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | -11.03 | 2-Sided | 95 | -23.37 | 1.21 | No | Superiority or Other |
| 4 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | -55.53 | 2-Sided | 95 | -70.12 | -40.85 | No | Superiority or Other |
| 5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | -57.33 | 2-Sided | 95 | -71.90 | -42.77 | No | Superiority or Other |
| 5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.263 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | -7.73 | 2-Sided | 95 | -21.08 | 5.63 | No | Superiority or Other |
| 5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | -49.93 | 2-Sided | 95 | -64.74 | -35.12 | No | Superiority or Other |
| 6 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | -52.75 | 2-Sided | 95 | -67.62 | -37.88 | No | Superiority or Other |
| 6 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.439 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | -5.51 | 2-Sided | 95 | -19.27 | 8.25 | No | Superiority or Other |
| 6 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | -47.72 | 2-Sided | 95 | -62.62 | -32.83 | No | Superiority or Other |
| Title | Measurements |
|---|---|
|
| 1 hours |
|
| 1.5 hours |
|
| 2 hours |
|
| 3 hours |
|
| 4 hours |
|
| 5 hours |
|
| 6 hours |
|
| 0.25 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.458 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 1.21 | 2-Sided | 95 | -1.16 | 3.58 | No | Superiority or Other |
| 0.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.073 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 6.81 | 2-Sided | 95 | 1.57 | 12.06 | No | Superiority or Other |
| 0.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.583 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 1.96 | 2-Sided | 95 | -4.94 | 8.85 | No | Superiority or Other |
| 0.5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.137 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 4.81 | 2-Sided | 95 | 0.14 | 9.49 | No | Superiority or Other |
| 1 hour: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 23.86 | 2-Sided | 95 | 14.81 | 32.91 | No | Superiority or Other |
| 1 hour: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.165 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 8.45 | 2-Sided | 95 | -3.43 | 20.33 | No | Superiority or Other |
| 1 hour: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.006 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 15.46 | 2-Sided | 95 | 7.66 | 23.26 | No | Superiority or Other |
| 1.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 29.41 | 2-Sided | 95 | 19.78 | 39.05 | No | Superiority or Other |
| 1.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.497 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 4.61 | 2-Sided | 95 | -8.78 | 17.99 | No | Superiority or Other |
| 1.5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 25.13 | 2-Sided | 95 | 15.81 | 34.46 | No | Superiority or Other |
| 2 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 31.78 | 2-Sided | 95 | 20.03 | 43.53 | No | Superiority or Other |
| 2 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.349 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 6.70 | 2-Sided | 95 | -7.38 | 20.79 | No | Superiority or Other |
| 2 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 25.34 | 2-Sided | 95 | 13.73 | 36.94 | No | Superiority or Other |
| 3 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 37.64 | 2-Sided | 95 | 25.47 | 49.81 | No | Superiority or Other |
| 3 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.233 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 8.85 | 2-Sided | 95 | -5.72 | 23.42 | No | Superiority or Other |
| 3 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 28.96 | 2-Sided | 95 | 17.17 | 40.75 | No | Superiority or Other |
| 4 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 38.73 | 2-Sided | 95 | 25.87 | 51.60 | No | Superiority or Other |
| 4 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.189 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 9.83 | 2-Sided | 95 | -4.80 | 24.45 | No | Superiority or Other |
| 4 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 29.19 | 2-Sided | 95 | 16.71 | 41.66 | No | Superiority or Other |
| 5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 36.55 | 2-Sided | 95 | 23.22 | 49.88 | No | Superiority or Other |
| 5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.189 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 9.83 | 2-Sided | 95 | -4.80 | 24.45 | No | Superiority or Other |
| 5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 26.97 | 2-Sided | 95 | 14.00 | 39.94 | No | Superiority or Other |
| 6 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 37.72 | 2-Sided | 95 | 24.36 | 51.07 | No | Superiority or Other |
| 6 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.144 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 10.97 | 2-Sided | 95 | -3.67 | 25.61 | No | Superiority or Other |
| 6 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 26.97 | 2-Sided | 95 | 14.00 | 39.94 | No | Superiority or Other |
|
Treatment difference (Ibuprofen sodium - Acetaminophen) and the associated CI were calculated based on the weighted Gamma statistic. |
| Cochran-Mantel-Haenszel |
| 0.020 |
P-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). |
| Mean Difference (Final Values) |
| 0.25 |
| 2-Sided |
| 95 |
| 0.05 |
| 0.45 |
| No |
| Superiority or Other |
| Treatment difference (Acetaminophen - Placebo) and the associated CI were calculated based on the weighted Gamma statistic. | Cochran-Mantel-Haenszel | <0.001 | P-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided). | Mean Difference (Final Values) | 0.77 | 2-Sided | 95 | 0.63 | 0.91 | No | Superiority or Other |