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This study will compare the pain relieving effect of a single-dose of a novel ibuprofen formulation to placebo and two formulations of standard ibuprofen 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 | Active Comparator |
| |
| Treatment D | 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 and Pain Intensity Difference From 0-8 Hours (SPRID 0-8) | SPRID: time-weighted sum of pain relief rating combined with pain intensity difference (PRID) over 8 hours. SPRID 0-8 score range: -8 (worst) to 56 (best). PRID: sum of Pain intensity differences (PID) and pain relief rating (PRR) at each time point. PRID score range: -1=worst to 7=best. PID: baseline pain severity score minus pain severity score at a given time point (pain severity score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). PID score range: -1(worst) to 3 (best). PRR: assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief). | 0 to 8 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 8 hours after dosing or until stopped by the participant, or rescue medication was administered. | 0 to 8 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 8 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 |
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| 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. | |
| 25119511 | Derived | Brain P, Leyva R, Doyle G, Kellstein D. Onset of analgesia and efficacy of ibuprofen sodium in postsurgical dental pain: a randomized, placebo-controlled study versus standard ibuprofen. Clin J Pain. 2015 May;31(5):444-50. doi: 10.1097/AJP.0000000000000142. |
| 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. |
| FG001 | Ibuprofen Sodium | Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen. |
| FG002 | Ibuprofen (Advil) | Single oral dose of 2 ibuprofen (Advil) 200 mg tablets (total dose of 400 mg ibuprofen). |
| FG003 | Ibuprofen (Motrin IB) | Single oral dose of 2 ibuprofen [Motrin ibuprofen (IB)] 200 mg tablets (total dose of 400 mg ibuprofen). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Single oral dose of 2 placebo tablets. |
| BG001 | Ibuprofen Sodium | Single oral dose of 2 ibuprofen sodium 256 milligram (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 and Pain Intensity Difference From 0-8 Hours (SPRID 0-8) | SPRID: time-weighted sum of pain relief rating combined with pain intensity difference (PRID) over 8 hours. SPRID 0-8 score range: -8 (worst) to 56 (best). PRID: sum of Pain intensity differences (PID) and pain relief rating (PRR) at each time point. PRID score range: -1=worst to 7=best. PID: baseline pain severity score minus pain severity score at a given time point (pain severity score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). PID score range: -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 8 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA v13.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Standard Ibuprofen |
| Drug |
Single-dose of standard ibuprofen (400mg) |
|
| Standard Ibuprofen | Drug | Single-dose of standard ibuprofen (400mg) |
|
| Placebo | Drug | Single-dose of placebo |
|
| 0 to 8 hours |
| Pain Relief Rating (PRR) | PRR was evaluated at different time points during the study up to 8 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, 7, 8 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, 7, 8 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, 7, 8 hours |
| Time-weighted Sum of Pain Intensity Difference (SPID) | SPID: time-weighted sum of PID over 2, 3, 6 and 8 hours. SPID scores range was -2 (worst) to 6 (best) for SPID 0-2, -3 (worst) to 9 (best) for SPID 0-3, -6 (worst) to 18 (best) for SPID 0-6, -8 (worst) to 24 (best) for SPID 0-8. PID: baseline pain severity score minus pain severity score at a given time point (pain severity 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). | 0-2, 0-3, 0-6, 0-8 hours |
| Time-weighted Sum of Pain Relief Rating (TOTPAR) | TOTPAR: time-weighted sum of PRR scores over 2, 3, 6 and 8 hours. TOTPAR score range was 0 (worst) to 8 (best) for TOTPAR 0-2, 0 (worst) to 12 (best) for TOTPAR 0-3, 0 (worst) to 24 (best) for TOTPAR 0-6, 0 (worst) to 32 (best) for TOTPAR 0-8. PRR was evaluated at different time points during the study up to 8 hours, and immediately after taking rescue medication (if necessary). PRR was assessed on a 5-point categorical pain relief rating scale wherein 0=No relief to 4=Complete relief. | 0-2, 0-3, 0-6, 0-8 hours |
| Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID) | SPRID: time-weighted sum of PRID over 2, 3, 6 and 8 hours. SPRID score range:-2 (worst) to 14(best) for SPRID 0-2, -3(worst) to 21(best) for SPRID 0-3, -6(worst) to 42(best) for SPRID 0-6, -8(worst) to 56(best) for SPRID 0-8. 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 given time(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: scored on 5-point pain relief rating scale(0=No relief to 4=Complete relief). | 0-2, 0-3, 0-6, 0-8 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 the participant first began to experience meaningful relief. Stopwatch was active up to 8 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, 7, 8 hours |
| Cumulative Percentage of Participants With Confirmed First Perceptible Relief | Percentage of participants with first perceptible relief was evaluated by stopping a stopwatch labeled 'first perceptible relief' at the moment the participant first began to experience any relief. Stopwatch was active up to 8 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. | 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours |
| Time to Treatment Failure | Median time of dropping out of the participants from the study due to lack of efficacy or rescue medication, whichever came first. | 0 to 8 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, 7, 8 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, 7, 8 hours |
| Participant Global Evaluation of Study Medication | Participant global evaluation of study medication was performed at the 8-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. | 8 hours |
| BG002 | Ibuprofen (Advil) | Single oral dose of 2 ibuprofen (Advil) 200 mg tablets (total dose of 400 mg ibuprofen). |
| BG003 | Ibuprofen (Motrin IB) | Single oral dose of 2 ibuprofen [Motrin ibuprofen (IB)] 200 mg tablets (total dose of 400 mg ibuprofen). |
| BG004 | 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.
| OG001 | Ibuprofen Sodium | Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen. |
|
|
|
| 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 8 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 8 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 8 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 8 hours |
|
|
|
|
| Secondary | Pain Relief Rating (PRR) | PRR was evaluated at different time points during the study up to 8 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, 7, 8 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, 7, 8 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, 7, 8 hours |
|
|
|
|
| Secondary | Time-weighted Sum of Pain Intensity Difference (SPID) | SPID: time-weighted sum of PID over 2, 3, 6 and 8 hours. SPID scores range was -2 (worst) to 6 (best) for SPID 0-2, -3 (worst) to 9 (best) for SPID 0-3, -6 (worst) to 18 (best) for SPID 0-6, -8 (worst) to 24 (best) for SPID 0-8. PID: baseline pain severity score minus pain severity score at a given time point (pain severity 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 | 0-2, 0-3, 0-6, 0-8 hours |
|
|
|
|
| Secondary | Time-weighted Sum of Pain Relief Rating (TOTPAR) | TOTPAR: time-weighted sum of PRR scores over 2, 3, 6 and 8 hours. TOTPAR score range was 0 (worst) to 8 (best) for TOTPAR 0-2, 0 (worst) to 12 (best) for TOTPAR 0-3, 0 (worst) to 24 (best) for TOTPAR 0-6, 0 (worst) to 32 (best) for TOTPAR 0-8. PRR was evaluated at different time points during the study up to 8 hours, and immediately after taking rescue medication (if necessary). PRR was assessed on a 5-point categorical pain relief rating scale wherein 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 | 0-2, 0-3, 0-6, 0-8 hours |
|
|
|
|
| Secondary | Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID) | SPRID: time-weighted sum of PRID over 2, 3, 6 and 8 hours. SPRID score range:-2 (worst) to 14(best) for SPRID 0-2, -3(worst) to 21(best) for SPRID 0-3, -6(worst) to 42(best) for SPRID 0-6, -8(worst) to 56(best) for SPRID 0-8. 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 given time(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: scored 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 | 0-2, 0-3, 0-6, 0-8 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 the participant first began to experience meaningful relief. Stopwatch was active up to 8 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, 7, 8 hours |
|
|
|
|
| Secondary | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | Percentage of participants with first perceptible relief was evaluated by stopping a stopwatch labeled 'first perceptible relief' at the moment the participant first began to experience any relief. Stopwatch was active up to 8 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 | Number | Percentage of participants | 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours |
|
|
|
|
| Secondary | Time to Treatment Failure | Median time of dropping out of the participants from the study due to lack of efficacy or rescue medication, whichever came first. | ITT population included all randomized participants who received study medication and provided a baseline assessment. | Posted | Median | 95% Confidence Interval | Hours | 0 to 8 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, 7, 8 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, 7, 8 hours |
|
|
|
|
| Secondary | Participant Global Evaluation of Study Medication | Participant global evaluation of study medication was performed at the 8-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 | 8 hours |
|
|
|
|
| 0 |
| 48 |
| 8 |
| 48 |
| EG001 | Ibuprofen Sodium | Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen. | 0 | 95 | 10 | 95 |
| EG002 | Ibuprofen (Advil) | Single oral dose of 2 ibuprofen (Advil) 200 mg tablets (total dose of 400 mg ibuprofen). | 0 | 86 | 12 | 86 |
| EG003 | Ibuprofen (Motrin IB) | Single oral dose of 2 ibuprofen [Motrin ibuprofen (IB)] 200 mg tablets (total dose of 400 mg ibuprofen). | 0 | 87 | 10 | 87 |
| Chest discomfort | Cardiac disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Dyspnoea | Cardiac disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Diarrhoea not otherwise specified | Gastrointestinal disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Feeling hot | General disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Feeling cold | General disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Hot flush | General disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Hyperhidrosis | General disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Lethargy | General disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA v13.0 | 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.
| 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 primary endpoints sequentially: IBU Na vs. Placebo for SPRID 0-8 then TMR, IBU Na vs. IBU (Advil and Motrin IB) for TMR. If comparison at preceding step was significant only then subsequent comparisons were significant. | Proportional hazards model | <0.001 | p-value was calculated using the PH model with treatment, baseline PSR and gender terms. | Hazard Ratio (HR) | 1.59 | 2-Sided | 95 | 1.22 | 2.06 | 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 the PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). |
| Hazard Ratio (HR) |
| 1.80 |
| 2-Sided |
| 95 |
| 1.38 |
| 2.34 |
| No |
| Superiority or Other |
|
| 1 hour |
|
| 1.5 hours |
|
| 2 hours |
|
| 3 hours |
|
| 4 hours |
|
| 5 hours |
|
| 6 hours |
|
| 7 hours |
|
| 8 hours |
|
0.25 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS mean from the ANOVA model. |
| ANOVA |
| 0.010 |
p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). |
| LS mean difference |
| 0.24 |
| 2-Sided |
| 95 |
| 0.06 |
| 0.42 |
| No |
| Superiority or Other |
| 0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95 % CI were calculated based on LS mean from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 1.47 | 2-Sided | 95 | 1.10 | 1.84 | No | Superiority or Other |
| 0.5 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS mean from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 0.53 | 2-Sided | 95 | 0.27 | 0.80 | No | Superiority or Other |
| 1 hour: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 2.22 | 2-Sided | 95 | 1.84 | 2.60 | No | Superiority or Other |
| 1 hour: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS mean from the ANOVA model. | ANOVA | 0.006 | p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 0.39 | 2-Sided | 95 | 0.12 | 0.66 | No | Superiority or Other |
| 1.5 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 2.39 | 2-Sided | 95 | 2.00 | 2.77 | No | Superiority or Other |
| 1.5 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS mean from the ANOVA model. | ANOVA | 0.022 | p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 0.33 | 2-Sided | 95 | 0.05 | 0.60 | No | Superiority or Other |
| 2 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 2.39 | 2-Sided | 95 | 2.00 | 2.79 | No | Superiority or Other |
| 2 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS mean from the ANOVA model. | ANOVA | 0.369 | p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 0.13 | 2-Sided | 95 | -0.15 | 0.41 | No | Superiority or Other |
| 3 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 2.19 | 2-Sided | 95 | 1.78 | 2.60 | No | Superiority or Other |
| 3 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS mean from the ANOVA model. | ANOVA | 0.420 | p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | -0.12 | 2-Sided | 95 | -0.42 | 0.17 | No | Superiority or Other |
| 4 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 2.02 | 2-Sided | 95 | 1.58 | 2.45 | No | Superiority or Other |
| 4 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS mean from the ANOVA model. | ANOVA | 0.151 | p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | -0.23 | 2-Sided | 95 | -0.54 | 0.08 | No | Superiority or Other |
| 5 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 1.88 | 2-Sided | 95 | 1.43 | 2.33 | No | Superiority or Other |
| 5 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS mean from the ANOVA model. | ANOVA | 0.160 | p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | -0.23 | 2-Sided | 95 | -0.56 | 0.09 | No | Superiority or Other |
| 6 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 1.63 | 2-Sided | 95 | 1.16 | 2.10 | No | Superiority or Other |
| 6 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS mean from the ANOVA model. | ANOVA | 0.055 | p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | -0.33 | 2-Sided | 95 | -0.67 | 0.01 | No | Superiority or Other |
| 7 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR and gender PSR terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 1.39 | 2-Sided | 95 | 0.91 | 1.88 | No | Superiority or Other |
| 7 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS mean from the ANOVA model. | ANOVA | 0.040 | p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | -0.37 | 2-Sided | 95 | -0.71 | -0.02 | No | Superiority or Other |
| 8 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 1.20 | 2-Sided | 95 | 0.71 | 1.69 | No | Superiority or Other |
| 8 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS mean from the ANOVA model. | ANOVA | 0.015 | p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | -0.44 | 2-Sided | 95 | -0.79 | -0.08 | No | Superiority or Other |
|
| 1 hour |
|
| 1.5 hour |
|
| 2 hours |
|
| 3 hours |
|
| 4 hours |
|
| 5 hours |
|
| 6 hours |
|
| 7 hours |
|
| 8 hours |
|
0.25 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] 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 and gender terms. Statistical testing was done at 5% significance level (2-sided). |
| LS mean difference |
| 0.22 |
| 2-Sided |
| 95 |
| 0.11 |
| 0.34 |
| 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 and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 0.94 | 2-Sided | 95 | 0.70 | 1.19 | No | Superiority or Other |
| 0.5 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] 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 and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 0.38 | 2-Sided | 95 | 0.20 | 0.55 | 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 and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 1.46 | 2-Sided | 95 | 1.18 | 1.75 | No | Superiority or Other |
| 1 hour: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.017 | p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 0.25 | 2-Sided | 95 | 0.04 | 0.45 | 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 and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 1.67 | 2-Sided | 95 | 1.39 | 1.96 | No | Superiority or Other |
| 1.5 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] 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 and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 0.25 | 2-Sided | 95 | 0.05 | 0.46 | 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 and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 1.69 | 2-Sided | 95 | 1.41 | 1.98 | No | Superiority or Other |
| 2 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.362 | p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 0.09 | 2-Sided | 95 | -0.11 | 0.30 | 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 and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 1.56 | 2-Sided | 95 | 1.27 | 1.86 | No | Superiority or Other |
| 3 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.472 | p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | -0.08 | 2-Sided | 95 | -0.29 | 0.14 | 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 and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 1.39 | 2-Sided | 95 | 1.07 | 1.70 | No | Superiority or Other |
| 4 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.134 | p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | -0.17 | 2-Sided | 95 | -0.40 | 0.05 | 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 and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 1.31 | 2-Sided | 95 | 1.00 | 1.63 | No | Superiority or Other |
| 5 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.135 | p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | -0.17 | 2-Sided | 95 | -0.40 | 0.05 | 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 and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 1.17 | 2-Sided | 95 | 0.84 | 1.50 | No | Superiority or Other |
| 6 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.036 | p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | -0.25 | 2-Sided | 95 | -0.49 | -0.02 | No | Superiority or Other |
| 7 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 and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 0.93 | 2-Sided | 95 | 0.61 | 1.26 | No | Superiority or Other |
| 7 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.064 | p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | -0.22 | 2-Sided | 95 | -0.46 | 0.01 | No | Superiority or Other |
| 8 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 and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 0.85 | 2-Sided | 95 | 0.52 | 1.18 | No | Superiority or Other |
| 8 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.074 | p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | -0.22 | 2-Sided | 95 | -0.46 | 0.02 | No | Superiority or Other |
|
| 1 hour |
|
| 1.5 hours |
|
| 2 hours |
|
| 3 hours |
|
| 4 hours |
|
| 5 hours |
|
| 6 hours |
|
| 7 hours |
|
| 8 hours |
|
0.25 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] 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 and gender terms. Statistical testing was done at 5% significance level (2-sided). |
| LS mean difference |
| 0.46 |
| 2-Sided |
| 95 |
| 0.18 |
| 0.75 |
| 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 and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 2.41 | 2-Sided | 95 | 1.82 | 3.01 | No | Superiority or Other |
| 0.5 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] 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 and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 0.91 | 2-Sided | 95 | 0.48 | 1.34 | 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 and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 3.68 | 2-Sided | 95 | 3.03 | 4.33 | No | Superiority or Other |
| 1 hour: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] 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 and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 0.64 | 2-Sided | 95 | 0.17 | 1.11 | 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 and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 4.06 | 2-Sided | 95 | 3.40 | 4.72 | No | Superiority or Other |
| 1.5 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.017 | p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 0.58 | 2-Sided | 95 | 0.10 | 1.06 | 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 and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 4.09 | 2-Sided | 95 | 3.42 | 4.75 | No | Superiority or Other |
| 2 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.359 | p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 0.22 | 2-Sided | 95 | -0.26 | 0.70 | 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 and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 3.75 | 2-Sided | 95 | 3.06 | 4.45 | No | Superiority or Other |
| 3 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.436 | p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | -0.20 | 2-Sided | 95 | -0.70 | 0.30 | 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 and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 3.40 | 2-Sided | 95 | 2.66 | 4.14 | No | Superiority or Other |
| 4 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.139 | p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | -0.40 | 2-Sided | 95 | -0.93 | 0.13 | 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 and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 3.20 | 2-Sided | 95 | 2.44 | 3.95 | No | Superiority or Other |
| 5 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.144 | p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | -0.41 | 2-Sided | 95 | -0.95 | 0.14 | 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 and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 2.80 | 2-Sided | 95 | 2.01 | 3.58 | No | Superiority or Other |
| 6 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.043 | p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | -0.58 | 2-Sided | 95 | -1.15 | -0.02 | No | Superiority or Other |
| 7 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 and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 2.33 | 2-Sided | 95 | 1.53 | 3.12 | No | Superiority or Other |
| 7 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.044 | p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | -0.59 | 2-Sided | 95 | -1.16 | -0.02 | No | Superiority or Other |
| 8 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 and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 2.05 | 2-Sided | 95 | 1.25 | 2.85 | No | Superiority or Other |
| 8 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.027 | p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | -0.65 | 2-Sided | 95 | -1.23 | -0.08 | No | Superiority or Other |
|
| SPID 0-6 |
|
| SPID 0-8 |
|
SPID 0-2: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] 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 and gender terms. Statistical testing was done at 5% significance level (2-sided). |
| LS mean difference |
| 0.45 |
| 2-Sided |
| 95 |
| 0.12 |
| 0.78 |
| 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 and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 4.29 | 2-Sided | 95 | 3.60 | 4.98 | No | Superiority or Other |
| SPID 0-3: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.144 | p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 0.37 | 2-Sided | 95 | -0.13 | 0.87 | 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 and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 8.16 | 2-Sided | 95 | 6.66 | 9.66 | No | Superiority or Other |
| SPID 0-6: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.679 | p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | -0.23 | 2-Sided | 95 | -1.31 | 0.85 | No | Superiority or Other |
| SPID 0-8: 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 and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 9.94 | 2-Sided | 95 | 7.92 | 11.96 | No | Superiority or Other |
| SPID 0-8: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.367 | p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | -0.67 | 2-Sided | 95 | -2.12 | 0.79 | No | Superiority or Other |
|
| TOTPAR 0-6 |
|
| TOTPAR 0-8 |
|
TOTPAR 0-2: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] 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 and gender terms. Statistical testing was done at 5% significance level (2-sided). |
| LS mean difference |
| 0.62 |
| 2-Sided |
| 95 |
| 0.16 |
| 1.07 |
| 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 and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 6.15 | 2-Sided | 95 | 5.18 | 7.12 | No | Superiority or Other |
| TOTPAR 0-3: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.166 | p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 0.49 | 2-Sided | 95 | -0.21 | 1.20 | 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 and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 11.67 | 2-Sided | 95 | 9.54 | 13.81 | No | Superiority or Other |
| TOTPAR 0-6: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.703 | p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | -0.30 | 2-Sided | 95 | -1.84 | 1.24 | No | Superiority or Other |
| TOTPAR 0-8: 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 and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 14.27 | 2-Sided | 95 | 11.36 | 17.18 | No | Superiority or Other |
| TOTPAR 0-8: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.303 | p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | -1.10 | 2-Sided | 95 | -3.20 | 1.00 | No | Superiority or Other |
|
| SPRID 0-6 |
|
| SPRID 0-8 |
|
SPRID 0-2: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS mean from the ANOVA model. |
| ANOVA |
| 0.007 |
p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). |
| LS mean difference |
| 1.06 |
| 2-Sided |
| 95 |
| 0.29 |
| 1.84 |
| No |
| Superiority or Other |
| SPRID 0-3: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 10.43 | 2-Sided | 95 | 8.79 | 12.08 | No | Superiority or Other |
| SPRID 0-3: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS mean from the ANOVA model. | ANOVA | 0.152 | p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 0.87 | 2-Sided | 95 | -0.32 | 2.05 | No | Superiority or Other |
| SPRID 0-6: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 19.83 | 2-Sided | 95 | 16.23 | 23.43 | No | Superiority or Other |
| SPRID 0-6: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS mean from the ANOVA model. | ANOVA | 0.690 | p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | -0.53 | 2-Sided | 95 | -3.12 | 2.07 | No | Superiority or Other |
| SPRID 0-8 Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS mean from the ANOVA model. | ANOVA | 0.323 | p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | -1.77 | 2-Sided | 95 | -5.29 | 1.75 | No | Superiority or Other |
| Title | Measurements |
|---|---|
|
| 1 hour |
|
| 1.5 hours |
|
| 2 hours |
|
| 3 hours |
|
| 4 hours |
|
| 5 hours |
|
| 6 hours |
|
| 7 hours |
|
| 8 hours |
|
| 0.25 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.623 | p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 0.54 | 2-Sided | 95 | -1.88 | 2.95 | No | Superiority or Other |
| 0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% 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 which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 24.36 | 2-Sided | 95 | 13.51 | 35.22 | No | Superiority or Other |
| 0.5 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.023 | p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 11.82 | 2-Sided | 95 | 1.15 | 22.48 | No | Superiority or Other |
| 1 hour: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% 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 which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 61.35 | 2-Sided | 95 | 48.99 | 73.70 | No | Superiority or Other |
| 1 hour: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% 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 which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 21.25 | 2-Sided | 95 | 9.58 | 32.92 | No | Superiority or Other |
| 1.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% 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 which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 72.65 | 2-Sided | 95 | 61.59 | 83.71 | No | Superiority or Other |
| 1.5 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% 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 which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 17.44 | 2-Sided | 95 | 7.83 | 27.06 | No | Superiority or Other |
| 2 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% 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 which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 72.63 | 2-Sided | 95 | 61.14 | 84.11 | No | Superiority or Other |
| 2 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.013 | p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 11.70 | 2-Sided | 95 | 3.47 | 19.93 | No | Superiority or Other |
| 3 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% 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 which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 73.58 | 2-Sided | 95 | 61.83 | 85.33 | No | Superiority or Other |
| 3 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.041 | p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 8.01 | 2-Sided | 95 | 1.27 | 14.75 | No | Superiority or Other |
| 4 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% 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 which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 73.58 | 2-Sided | 95 | 61.83 | 85.33 | No | Superiority or Other |
| 4 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% 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 which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 6.79 | 2-Sided | 95 | 0.23 | 13.36 | No | Superiority or Other |
| 5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% 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 which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 73.58 | 2-Sided | 95 | 61.83 | 85.33 | No | Superiority or Other |
| 5 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% 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 which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 6.79 | 2-Sided | 95 | 0.23 | 13.36 | No | Superiority or Other |
| 6 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% 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 which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 73.58 | 2-Sided | 95 | 61.83 | 85.33 | No | Superiority or Other |
| 6 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% 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 which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 6.79 | 2-Sided | 95 | 0.23 | 13.36 | No | Superiority or Other |
| 7 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% 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 which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 74.71 | 2-Sided | 95 | 63.14 | 86.27 | No | Superiority or Other |
| 7 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.035 | p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 7.84 | 2-Sided | 95 | 1.57 | 14.10 | No | Superiority or Other |
| 8 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% 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 which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 72.61 | 2-Sided | 95 | 61.05 | 84.17 | No | Superiority or Other |
| 8 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.047 | p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 7.28 | 2-Sided | 95 | 1.07 | 13.48 | No | Superiority or Other |
| Title | Measurements |
|---|---|
|
| 1 hour |
|
| 1.5 hours |
|
| 2 hours |
|
| 3 hours |
|
| 4 hours |
|
| 5 hours |
|
| 6 hours |
|
| 7 hours |
|
| 8 hours |
|
| 0.25 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.003 | p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 14.35 | 2-Sided | 95 | 4.26 | 24.43 | No | Superiority or Other |
| 0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% 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 which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 69.53 | 2-Sided | 95 | 57.67 | 81.40 | No | Superiority or Other |
| 0.5 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% 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 which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 23.45 | 2-Sided | 95 | 13.16 | 33.75 | No | Superiority or Other |
| 1 hour: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% 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 which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 73.72 | 2-Sided | 95 | 62.77 | 84.67 | No | Superiority or Other |
| 1 hour: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.014 | p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 10.14 | 2-Sided | 95 | 3.21 | 17.08 | No | Superiority or Other |
| 1.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% 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 which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 72.61 | 2-Sided | 95 | 61.05 | 84.17 | No | Superiority or Other |
| 1.5 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.028 | p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 8.35 | 2-Sided | 95 | 2.02 | 14.68 | No | Superiority or Other |
| 2 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% 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 which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 72.61 | 2-Sided | 95 | 61.05 | 84.17 | No | Superiority or Other |
| 2 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.036 | p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 7.81 | 2-Sided | 95 | 1.54 | 14.08 | No | Superiority or Other |
| 3 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% 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 which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 72.61 | 2-Sided | 95 | 61.05 | 84.17 | No | Superiority or Other |
| 3 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.047 | p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 7.28 | 2-Sided | 95 | 1.07 | 13.48 | No | Superiority or Other |
| 4 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% 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 which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 72.61 | 2-Sided | 95 | 61.05 | 84.17 | No | Superiority or Other |
| 4 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.047 | p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 7.28 | 2-Sided | 95 | 1.07 | 13.48 | No | Superiority or Other |
| 5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% 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 which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 72.61 | 2-Sided | 95 | 61.05 | 84.17 | No | Superiority or Other |
| 5 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.047 | p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 7.28 | 2-Sided | 95 | 1.07 | 13.48 | No | Superiority or Other |
| 6 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% 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 which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 72.61 | 2-Sided | 95 | 61.05 | 84.17 | No | Superiority or Other |
| 6 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.047 | p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 7.28 | 2-Sided | 95 | 1.07 | 13.48 | No | Superiority or Other |
| 7 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% 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 which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 72.61 | 2-Sided | 95 | 61.05 | 84.17 | No | Superiority or Other |
| 7 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.047 | p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 7.28 | 2-Sided | 95 | 1.07 | 13.48 | No | Superiority or Other |
| 8 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% 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 which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 72.61 | 2-Sided | 95 | 61.05 | 84.17 | No | Superiority or Other |
| 8 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.047 | p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 7.28 | 2-Sided | 95 | 1.07 | 13.48 | No | Superiority or Other |
HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model. |
| Proportional hazards model |
| 0.281 |
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) |
| 1.33 |
| 2-Sided |
| 95 |
| 0.79 |
| 2.22 |
| No |
| Superiority or Other |
| Title | Measurements |
|---|---|
|
| 1 hour |
|
| 1.5 hours |
|
| 2 hours |
|
| 3 hours |
|
| 4 hours |
|
| 5 hours |
|
| 6 hours |
|
| 7 hours |
|
| 8 hours |
|
| 1.5 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.483 | p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | -1.21 | 2-Sided | 95 | -4.12 | 1.70 | No | Superiority or Other |
| 2 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% 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 which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | -51.93 | 2-Sided | 95 | -65.63 | -38.22 | No | Superiority or Other |
| 2 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.174 | p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | -3.61 | 2-Sided | 95 | -7.97 | 0.75 | No | Superiority or Other |
| 3 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% 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 which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | -66.58 | 2-Sided | 95 | -79.80 | -53.35 | No | Superiority or Other |
| 3 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.240 | p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | -3.75 | 2-Sided | 95 | -9.38 | 1.89 | No | Superiority or Other |
| 4 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% 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 which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | -61.36 | 2-Sided | 95 | -75.21 | -47.50 | No | Superiority or Other |
| 4 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.668 | p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 1.52 | 2-Sided | 95 | -5.47 | 8.52 | No | Superiority or Other |
| 5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% 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 which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | -60.31 | 2-Sided | 95 | -74.28 | -46.34 | No | Superiority or Other |
| 5 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.980 | p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 1.10 | 2-Sided | 95 | -7.44 | 7.63 | No | Superiority or Other |
| 6 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% 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 which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | -59.28 | 2-Sided | 95 | -73.05 | -45.50 | No | Superiority or Other |
| 6 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.711 | p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 1.56 | 2-Sided | 95 | -6.68 | 9.81 | No | Superiority or Other |
| 7 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% 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 which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | -56.84 | 2-Sided | 95 | -70.84 | -42.85 | No | Superiority or Other |
| 7 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.445 | p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 3.72 | 2-Sided | 95 | -5.94 | 13.38 | No | Superiority or Other |
| 8 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% 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 which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | -52.79 | 2-Sided | 95 | -66.77 | -38.81 | No | Superiority or Other |
| 8 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.256 | p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 6.05 | 2-Sided | 95 | -4.75 | 16.84 | No | Superiority or Other |
| Title | Measurements |
|---|---|
|
| 1 hour |
|
| 1.5 hours |
|
| 2 hours |
|
| 3 hours |
|
| 4 hours |
|
| 5 hours |
|
| 6 hours |
|
| 7 hours |
|
| 8 hours |
|
| 0.5 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.303 | p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 2.74 | 2-Sided | 95 | -3.01 | 8.49 | No | Superiority or Other |
| 1 hour: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% 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 which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 27.24 | 2-Sided | 95 | 18.14 | 36.34 | No | Superiority or Other |
| 1 hour: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.217 | p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 6.66 | 2-Sided | 95 | -4.31 | 17.63 | No | Superiority or Other |
| 1.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% 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 which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 41.16 | 2-Sided | 95 | 31.20 | 51.12 | No | Superiority or Other |
| 1.5 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.149 | p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 8.86 | 2-Sided | 95 | -3.33 | 21.04 | No | Superiority or Other |
| 2 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% 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 which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 48.61 | 2-Sided | 95 | 38.49 | 58.73 | No | Superiority or Other |
| 2 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.477 | p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 4.55 | 2-Sided | 95 | -8.03 | 17.13 | No | Superiority or Other |
| 3 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% 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 which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 52.81 | 2-Sided | 95 | 42.63 | 62.99 | No | Superiority or Other |
| 3 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.739 | p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | -2.14 | 2-Sided | 95 | -14.77 | 10.50 | No | Superiority or Other |
| 4 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% 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 which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 48.53 | 2-Sided | 95 | 36.29 | 60.77 | No | Superiority or Other |
| 4 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.280 | p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | -6.80 | 2-Sided | 95 | -19.24 | 5.65 | No | Superiority or Other |
| 5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% 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 which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 48.53 | 2-Sided | 95 | 36.29 | 60.77 | No | Superiority or Other |
| 5 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.202 | p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | -8.01 | 2-Sided | 95 | -20.44 | 4.41 | No | Superiority or Other |
| 6 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% 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 which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 48.53 | 2-Sided | 95 | 36.29 | 60.77 | No | Superiority or Other |
| 6 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.170 | p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | -8.61 | 2-Sided | 95 | -21.02 | 3.80 | No | Superiority or Other |
| 7 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% 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 which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 48.53 | 2-Sided | 95 | 36.29 | 60.77 | No | Superiority or Other |
| 7 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.140 | p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | -9.23 | 2-Sided | 95 | -21.62 | 3.16 | No | Superiority or Other |
| 8 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% 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 which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 48.53 | 2-Sided | 95 | 36.29 | 60.77 | No | Superiority or Other |
| 8 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.140 | p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | -9.23 | 2-Sided | 95 | -21.62 | 3.16 | No | Superiority or Other |
|
HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model. |
| Proportional hazards model |
| 0.667 |
p-value was calculated using the PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided). |
| Hazard Ratio (HR) |
| 0.04 |
| 2-Sided |
| 95 |
| -0.15 |
| 0.24 |
| No |
| Superiority or Other |