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| ID | Type | Description | Link |
|---|---|---|---|
| GEMINI IF | Other Identifier | Alias Study Number |
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This is a single dose study that will evaluate the efficacy and safety of a Fixed Dose Combination Ibuprofen 250 mg/ Acetaminophen 500 mg tablet in healthy male patients with fever. Results for the Fixed Dose Combination product will be compared to the individual components Ibuprofen 250 mg and Acetaminophen 500 mg and also compared to placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ibuprofen 250 mg / Acetaminophen 500 mg | Experimental | Single dose of 2 caplets of Ibuprofen 125 mg / Acetaminophen 250 mg by mouth |
|
| Ibuprofen 250 mg | Active Comparator | Single dose of 2 caplets of IBU 125 mg by mouth |
|
| Acetaminophen 500 mg | Active Comparator | Single dose of 1 APAP 500 mg caplet + 1 placebo caplet by mouth |
|
| Placebo | Placebo Comparator | Single dose of 2 caplets of Placebo by mouth |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibuprofen 250 mg / Acetaminophen 500 mg | Drug | Ibuprofen 250 mg / Acetaminophen 500 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time Weighted Sum of Temperature Difference (WSTD) From 0 to 8 Hours | WSTD 0-8 was defined as time-weighted sum of temperature differences over 8 hours, weighted by time elapsed between each 2 consecutive time points post treatment (10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110 minutes, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5 and 8 hours). Temperature difference was defined as baseline temperature (at 0 hour) minus the post-baseline temperature at each time point up to 8 hours (10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110 minutes, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5 and 8 hours). | 0 to 8 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Time Weighted Sum of Temperature Differences (WSTD) From Baseline Through Hours 2, 4 and 6 | WSTD 0-2, 0-4 and 0-6 was defined as time-weighted sum of temperature differences over each specified time interval (0-2 hour, 0-4 hour and 0-6 hour), weighted by time elapsed between each 2 consecutive time points post treatment (10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110 minutes, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6 hour), within each time interval. Temperature difference was defined as baseline temperature (at 0 hour) minus the post-baseline temperature at each time point within each specified time interval: 1) 0-2 hour (20, 30, 40, 50, 60, 70, 80, 90, 100, 110 minutes) , 2) 0-4 hour (10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110 minutes, 2, 2.5, 3, 3.5, 4 hour), 3) 0-6 hour (10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110 minutes, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6 hour). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (AEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between first dose of study drug and up to 24 hours after discharge (up to 32 hours) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Orleans Center for Clinical Research | Knoxville | Tennessee | 37920 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34304913 | Derived | Smith W, Leyva R, Kellstein D, Arthur E, Cruz-Rivera M. Efficacy of a Fixed-Dose Combination of Ibuprofen and Acetaminophen Compared With Individual Monocomponents in Adult Male Subjects With Endotoxin-Induced Fever: A Randomized Controlled Trial. Clin Ther. 2021 Jul;43(7):1213-1227. doi: 10.1016/j.clinthera.2021.05.004. Epub 2021 Jul 23. |
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Information relating to our policy on data sharing and the process for requesting data can be found at the following link:
http://www.pfizer.com/research/clinical\_trials/trial\_data\_and\_results/data\_requests
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In this study, participants were administered at least 1 test dose of reference standard endotoxin (RSE) intravenously, based on their body weight before randomization, to induce pyrexia in them.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received placebo as single oral dose tablets during the treatment duration of 8 hours. Participants were discharged after completion of study treatment. |
| FG001 | Ibuprofen 250 mg+Acetaminophen 500 mg | Participants received single oral dose of a fixed dose combination of ibuprofen 250 milligram (mg) and acetaminophen 500 mg tablets during the treatment duration of 8 hours. Participants were discharged after completion of study treatment. |
| FG002 | Ibuprofen 250 mg | Participants received single oral dose of ibuprofen 250 mg tablet during the treatment duration of 8 hours. Participants were discharged after completion of study treatment. |
| FG003 | Acetaminophen 500 mg | Participants received single oral dose of acetaminophen 500 mg tablet during the treatment duration of 8 hours. Participants were discharged after completion of study treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety analysis set included all participants who received study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received placebo as single oral dose tablets during the treatment duration of 8 hours. Participants were discharged after completion of study treatment. |
| BG001 | Ibuprofen 250 mg+Acetaminophen 500 mg |
| 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 Temperature Difference (WSTD) From 0 to 8 Hours | WSTD 0-8 was defined as time-weighted sum of temperature differences over 8 hours, weighted by time elapsed between each 2 consecutive time points post treatment (10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110 minutes, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5 and 8 hours). Temperature difference was defined as baseline temperature (at 0 hour) minus the post-baseline temperature at each time point up to 8 hours (10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110 minutes, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5 and 8 hours). | Modified intent to treat (mITT) population included all randomized participants who were dosed with the study medication and RSE per procedures specified in protocol post amendment 4 and had a baseline assessment. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | degrees fahrenheit | 0 to 8 hours post-dose |
|
Baseline up to 24 hours after discharge (up to 32 hours)
Safety analysis set included all participants who received study medication.
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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 | Participants received placebo as single oral dose tablets during the treatment duration of 8 hours. Participants were discharged after completion of study treatment. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear pain | Ear and labyrinth disorders | MedDRA 20.1 | 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 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 21, 2017 | Nov 8, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 1, 2017 | Nov 8, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D005334 | Fever |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Ibuprofen 250 mg | Drug | Ibuprofen 250 mg |
|
|
| Acetaminophen 500 mg | Drug | 1 APAP 500 mg caplet |
|
|
| Placebo | Drug | Placebo tablet |
|
| 0 to 2 hours postdose, 0 to 4 hours postdose, 0 to 6 hours postdose |
| Time to Return to Normal Body Temperature | Time to return to normal body temperature was defined as time from initial measurement of normal body temperature (at baseline; before administration of first test dose of RSE to induce pyrexia) till the time at which normal temperature was achieved again after pyrexia. Normal body temperature was defined as the last non-missing body temperature value, assessed prior to or at the time of first RSE test dose. | Baseline (pre-dose) up to 8 hours post dose |
| Time to Rescue Medication | Time to rescue medication (other than study treatment) (in minutes) was defined as time from first dosing of study medication to the time a participant first takes a rescue medication, or to the end of the study time for participants that do not take any rescue medication prior to the end of the study. The rescue medication was defined as medication received for the treatment of fever during the time period from the administration of study medication to the time of end of the study. | 0 to 8 hours post dose |
| Time Weighted Sum of Temperature Difference From 6 to 8 Hours | WSTD 6-8 was defined as time-weighted sum of temperature differences between 6 to 8 hours post-dose, weighted by time elapsed between each 2 consecutive time points within 6 to 8 hours (6.5, 7, 7.5 and 8 hours). Temperature difference was defined as temperature at 6 hours minus the temperature at specified time points (6.5, 7, 7.5 and 8 hours). | 6 to 8 hours postdose |
| Baseline up to 24 hours after discharge (up to 32 hours) |
| To obtain contact information for a study center near you, click here. | View source |
| Withdrawal by Subject |
|
| Other |
|
Participants received single oral dose of a fixed dose combination of ibuprofen 250 mg and acetaminophen 500 mg tablets during the treatment duration of 8 hours. Participants were discharged after completion of study treatment.
| BG002 | Ibuprofen 250 mg | Participants received single oral dose of ibuprofen 250 mg tablet during the treatment duration of 8 hours. Participants were discharged after completion of study treatment. |
| BG003 | Acetaminophen 500 mg | Participants received single oral dose of acetaminophen 500 mg tablet during the treatment duration of 8 hours. Participants were discharged after completion of study treatment. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Placebo |
Participants received placebo as single oral dose tablets during the treatment duration of 8 hours. Participants were discharged after completion of study treatment. |
| OG001 | Ibuprofen 250 mg+Acetaminophen 500 mg | Participants received single oral dose of a fixed dose combination of ibuprofen 250 mg and acetaminophen 500 mg tablets during the treatment duration of 8 hours. Participants were discharged after completion of study treatment. |
| OG002 | Ibuprofen 250 mg | Participants received single oral dose of ibuprofen 250 mg tablet during the treatment duration of 8 hours. Participants were discharged after completion of study treatment. |
| OG003 | Acetaminophen 500 mg | Participants received single oral dose of acetaminophen 500 mg tablet during the treatment duration of 8 hours. Participants were discharged after completion of study treatment. |
|
|
|
| Secondary | Time Weighted Sum of Temperature Differences (WSTD) From Baseline Through Hours 2, 4 and 6 | WSTD 0-2, 0-4 and 0-6 was defined as time-weighted sum of temperature differences over each specified time interval (0-2 hour, 0-4 hour and 0-6 hour), weighted by time elapsed between each 2 consecutive time points post treatment (10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110 minutes, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6 hour), within each time interval. Temperature difference was defined as baseline temperature (at 0 hour) minus the post-baseline temperature at each time point within each specified time interval: 1) 0-2 hour (20, 30, 40, 50, 60, 70, 80, 90, 100, 110 minutes) , 2) 0-4 hour (10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110 minutes, 2, 2.5, 3, 3.5, 4 hour), 3) 0-6 hour (10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110 minutes, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6 hour). | mITT population included all randomized participants who were dosed with the study medication and RSE per procedures specified in protocol post amendment 4 and had a baseline assessment. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | degrees fahrenheit | 0 to 2 hours postdose, 0 to 4 hours postdose, 0 to 6 hours postdose |
|
|
|
|
| Secondary | Time to Return to Normal Body Temperature | Time to return to normal body temperature was defined as time from initial measurement of normal body temperature (at baseline; before administration of first test dose of RSE to induce pyrexia) till the time at which normal temperature was achieved again after pyrexia. Normal body temperature was defined as the last non-missing body temperature value, assessed prior to or at the time of first RSE test dose. | mITT population included all randomized participants who were dosed with the study medication and RSE per procedures specified in protocol post amendment 4 and had a baseline assessment. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | minutes | Baseline (pre-dose) up to 8 hours post dose |
|
|
|
|
| Secondary | Time to Rescue Medication | Time to rescue medication (other than study treatment) (in minutes) was defined as time from first dosing of study medication to the time a participant first takes a rescue medication, or to the end of the study time for participants that do not take any rescue medication prior to the end of the study. The rescue medication was defined as medication received for the treatment of fever during the time period from the administration of study medication to the time of end of the study. | mITT population included all randomized participants who were dosed with the study medication and RSE per procedures specified in protocol post amendment 4 and had a baseline assessment. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | minutes | 0 to 8 hours post dose |
|
|
|
|
| Secondary | Time Weighted Sum of Temperature Difference From 6 to 8 Hours | WSTD 6-8 was defined as time-weighted sum of temperature differences between 6 to 8 hours post-dose, weighted by time elapsed between each 2 consecutive time points within 6 to 8 hours (6.5, 7, 7.5 and 8 hours). Temperature difference was defined as temperature at 6 hours minus the temperature at specified time points (6.5, 7, 7.5 and 8 hours). | mITT population included all randomized participants who were dosed with the study medication and RSE per procedures specified in protocol post amendment 4 and had a baseline assessment. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | degrees fahrenheit | 6 to 8 hours postdose |
|
|
|
|
| Other Pre-specified | Number of Participants With Treatment Emergent Adverse Events (AEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between first dose of study drug and up to 24 hours after discharge (up to 32 hours) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs. | Safety analysis set included all participants who received study medication. | Posted | Count of Participants | Participants | Baseline up to 24 hours after discharge (up to 32 hours) |
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 1 |
| 29 |
| EG001 | Ibuprofen 250 mg+Acetaminophen 500 mg | Participants received single oral dose of a fixed dose combination of ibuprofen 250 mg and acetaminophen 500 mg tablets during the treatment duration of 8 hours. Participants were discharged after completion of study treatment. | 0 | 87 | 0 | 87 | 1 | 87 |
| EG002 | Ibuprofen 250 mg | Participants received single oral dose of ibuprofen 250 mg tablet during the treatment duration of 8 hours. Participants were discharged after completion of study treatment. | 0 | 87 | 0 | 87 | 0 | 87 |
| EG003 | Acetaminophen 500 mg | Participants received single oral dose of acetaminophen 500 mg tablet during the treatment duration of 8 hours. Participants were discharged after completion of study treatment. | 0 | 87 | 0 | 87 | 0 | 87 |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 20.1 | 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.
| D000083 |
| Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| WSTD 0-4 |
|
| WSTD 0-6 |
|
WSTD 0-2 hours |
| ANCOVA |
| 0.078 |
| LSM difference |
| 0.39 |
| 2-Sided |
| 95 |
| -0.04 |
| 0.82 |
| Superiority |
Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature. |
| WSTD 0-2 hours | ANCOVA | 0.172 | LSM difference | 0.30 | 2-Sided | 95 | -0.13 | 0.74 | Superiority | Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature. |
| WSTD 0-2 hours | ANCOVA | 0.098 | LSM difference | 0.51 | 2-Sided | 95 | -0.10 | 1.13 | Superiority | Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature. |
| WSTD 0-2 hours | ANCOVA | 0.054 | LSM difference | 0.60 | 2-Sided | 95 | -0.01 | 1.21 | Superiority | Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature. |
| WSTD 0-2 hours | ANCOVA | 0.692 | LSM difference | -0.09 | 2-Sided | 95 | -0.52 | 0.34 | Superiority | Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature. |
| WSTD 0-4 hours | ANCOVA | < 0.001 | LSM difference | 1.87 | 2-Sided | 95 | 0.86 | 2.88 | Superiority | Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature. |
| WSTD 0-4 hours | ANCOVA | 0.094 | LSM difference | 0.61 | 2-Sided | 95 | -0.10 | 1.33 | Superiority | Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature. |
| WSTD 0-4 hours | ANCOVA | 0.217 | LSM difference | 0.45 | 2-Sided | 95 | -0.27 | 1.17 | Superiority | Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature. |
| WSTD 0-4 hours | ANCOVA | 0.015 | Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature. | LSM difference | 1.26 | 2-Sided | 95 | 0.24 | 2.27 | Superiority |
| WSTD 0-4 hours | ANCOVA | 0.006 | LSM difference | 1.42 | 2-Sided | 95 | 0.40 | 2.44 | Superiority | Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature. |
| WSTD 0-4 hours | ANCOVA | 0.659 | LSM difference | -0.16 | 2-Sided | 95 | -0.87 | 0.55 | Superiority | Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature. |
| WSTD 0-6 hours | ANCOVA | < 0.001 | LSM difference | 2.62 | 2-Sided | 95 | 1.16 | 4.08 | Superiority | Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature. |
| WSTD 0-6 hours | ANCOVA | 0.135 | LSM difference | 0.79 | 2-Sided | 95 | -0.25 | 1.82 | Superiority | Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature. |
| WSTD 0-6 hours | ANCOVA | 0.186 | LSM difference | 0.70 | 2-Sided | 95 | -0.34 | 1.74 | Superiority | Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature. |
| WSTD 0-6 hours | ANCOVA | 0.014 | LSM difference | 1.83 | 2-Sided | 95 | 0.37 | 3.29 | Superiority | Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature. |
| WSTD 0-6 hours | ANCOVA | 0.011 | LSM difference | 1.92 | 2-Sided | 95 | 0.45 | 3.39 | Superiority | Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature. |
| WSTD 0-6 hours | ANCOVA | 0.865 | LSM difference | -0.09 | 2-Sided | 95 | -1.12 | 0.94 | Superiority | Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature. |
| 0.142 |
Generalized log-rank test based on interval-censored survival analysis using nonparametric survival method. |
| Superiority |
| Log Rank | 0.822 | Generalized log-rank test based on interval-censored survival analysis using nonparametric survival method. | Superiority |
| Log Rank | 0.671 | Generalized log-rank test based on interval-censored survival analysis using nonparametric survival method. | Superiority |
| Log Rank | 0.514 | Generalized log-rank test based on interval-censored survival analysis using nonparametric survival method. | Superiority |
| Log Rank | 0.191 | Generalized log-rank test based on interval-censored survival analysis using nonparametric survival method. | Superiority |
| 0.998 |
P-value, HR and corresponding 95% CI were calculated based on the PH model with treatment term in the model. |
| Superiority |
| Hazard Ratio | 0.997 | P-value, HR and corresponding 95% CI were calculated based on the PH model with treatment term in the model. | Superiority |
| ANCOVA |
| 0.582 |
| LSM difference |
| 0.16 |
| 2-Sided |
| 95 |
| -0.41 |
| 0.73 |
| Superiority |
Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature. |
| Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature. | ANCOVA | 0.614 | LSM difference | 0.15 | 2-Sided | 95 | -0.43 | 0.72 | Superiority |
| ANCOVA | 0.212 | LSM difference | 0.51 | 2-Sided | 95 | -0.29 | 1.32 | Superiority | Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature. |
| ANCOVA | 0.202 | LSM difference | 0.53 | 2-Sided | 95 | -0.28 | 1.34 | Superiority | Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature. |
| ANCOVA | 0.965 | LSM difference | -0.01 | 2-Sided | 95 | -0.58 | 0.55 | Superiority | Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature. |