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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-000902-12 | EudraCT Number |
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To assess the efficacy and safety of a 400 mg ibuprofen/100 mg caffeine tablet in comparison to a 400 mg ibuprofen tablet for the treatment of acute lower back or neck pain. To assess the safety and tolerability of a 400 mg ibuprofen/100 mg caffeine tablet in comparison to a 400 mg ibuprofen tablet and a placebo tablet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ibuprofen + caffeine | Experimental | Fixed Dose Combination |
|
| ibuprofen | Active Comparator |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ibuprofen | Drug |
| ||
| caffeine |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain on Movement (POM) With Regard to the Worst Procedure (WP) Between Baseline and Day 2 (Morning, 2 Hours After Drug Intake) | The change in pain on movement (POM) with regard to the worst procedure (WP), i.e. the procedure with the highest pain score at baseline (POMwp), between baseline (morning of Day 1, pre-dosing) and Day 2 (morning, 2 hour (h) after drug intake). POM was assessed by the patient at the performance of one standardized, muscle group specific movement and was measured by a numerical rating scale ranging from 0 = 'no pain'to 10 = 'worst pain possible for this condition'. The procedure resulting in highest POM at baseline (worst procedure, POMWP) was repeated for an individual patient. If 2 or more procedures gave the same highest POM, the patient was asked which of the procedures giving the highest POM scores he/she considered the most unpleasant. Change in POMwp was calculated as baseline POMwp - POMwp at Day 2 - indicating a reduction in POMwp, where the result is positive. | Baseline and Day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| The Area Under the Curve (AUC) for Pain on Movement (POM) With Regard to the Worst Procedure (POMwp) Between Baseline and Day 4 (Morning) (POMwpAUC72hour (h)) | This is a key secondary endpoint. The area under the curve (AUC) for pain on movement (POM) with regard to the worst procedure (POMwp) between baseline and Day 4 (morning), (POMwpAUC72h ). POM was assessed by the patient at the performance of one standardized, muscle group specific movement and was measured by a numerical rating scale ranging from 0 = 'no pain'to 10 = 'worst pain possible for this condition'. A higher AUC value indicates higher POMwp |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dünnwaldpraxis, Köln | Cologne | 51069 | Germany | |||
| Praxis Dr. Steinebach, Essen |
All patients were screened for eligibility to participate in the trial. Patients attended specialist sites to ensure that all patients met all inclusion/exclusion criteria. Patients were not to be entered/randomised to trial treatment if any one of the specific entry criteria were not met.
This was a randomized, placebo and active-controlled, double-blind, 3-arm, parallel trial, comparing the effect of the fixed dose combination of 400 milligram (mg) ibuprofen&100 mg caffeine versus 400 mg ibuprofen and placebo in patients with acute neck or back pain randomly assigned in 2:2:1 ratio respectively.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Patients were administered placebo matching ibuprofen and ibuprofen/caffeine film-coated tablets orally 3 times daily with intervals of 6 to 8 hours (while awake) on Day 1 until the morning of Day 6. |
| FG001 | Ibuprofen | Patients were administered film-coated tablets orally containing 400 mg ibuprofen 3 times daily with intervals of 6 to 8 hours (while awake) on Day 1 until the morning of Day 6. |
| FG002 | Ibuprofen and Caffeine | Patients were administered film-coated tablets orally containing 400 mg ibuprofen and 100 mg caffeine 3 times daily with intervals of 6 to 8 hours (while awake) on Day 1 until the morning of Day 6. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Treated Set (TS): The TS comprised all randomised patients who took at least 1 dose of trial medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Patients were administered placebo matching ibuprofen and ibuprofen/caffeine film-coated tablets orally 3 times daily with intervals of 6 to 8 hours (while awake) on Day 1 until the morning of Day 6. |
| BG001 | Ibuprofen |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age at the time of signing informed consent form is presented. |
| 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 | Change in Pain on Movement (POM) With Regard to the Worst Procedure (WP) Between Baseline and Day 2 (Morning, 2 Hours After Drug Intake) | The change in pain on movement (POM) with regard to the worst procedure (WP), i.e. the procedure with the highest pain score at baseline (POMwp), between baseline (morning of Day 1, pre-dosing) and Day 2 (morning, 2 hour (h) after drug intake). POM was assessed by the patient at the performance of one standardized, muscle group specific movement and was measured by a numerical rating scale ranging from 0 = 'no pain'to 10 = 'worst pain possible for this condition'. The procedure resulting in highest POM at baseline (worst procedure, POMWP) was repeated for an individual patient. If 2 or more procedures gave the same highest POM, the patient was asked which of the procedures giving the highest POM scores he/she considered the most unpleasant. Change in POMwp was calculated as baseline POMwp - POMwp at Day 2 - indicating a reduction in POMwp, where the result is positive. | Full analysis set (FAS): FAS comprised all patients in the TS who provided a baseline value for POMWP at Visit 1 (before drug intake) and at least 1 POMWP post-treatment value at Visit 1 (Day 1 morning, 2 h after drug intake) and at Visit 2 (Day 2, morning, 2 h after drug intake). | Posted | Least Squares Mean | Standard Error | Unit on scale | Baseline and Day 2 |
From first drug administration until 24 hour after last intake of trial medication, up to 7 days.
Treated Set (TS) (The TS comprised all randomised patients who took at least 1 dose of trial medication) was used for adverse event reporting.
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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 | Patients were administered placebo matching ibuprofen and ibuprofen/caffeine film-coated tablets orally 3 times daily with intervals of 6 to 8 hours (while awake) on Day 1 until the morning of Day 6. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Centre | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 29, 2017 | Sep 26, 2018 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Aug 5, 2016 | Sep 26, 2018 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D001416 | Back Pain |
| D019547 | Neck Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| D002110 | Caffeine |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| placebo | Drug |
|
| Baseline, Day 1, Day 2 and Day 4 (morning) |
| The Area Under the Curve (AUC) for the Procedure With the Highest Pain Score at Baseline (POMWP) Between Baseline and Day 6 (Morning) (POM(WP)AUC(120h)) | This is a key secondary endpoint. The area under the curve for pain on movement with regard to the worst procedure between baseline and Day 6 (morning) (POM(WP)AUC(120h). POM was assessed by the patient at the performance of one standardized, muscle group specific movement and was measured by a numerical rating scale ranging from 0 = 'no pain'to 10 = 'worst pain possible for this condition'. A higher AUC value indicates higher POMwp. | Baseline, Day 1, Day 2, Day 4 and Day 6 (morning) |
| Change in Pressure Algometry Between Baseline and Day 2 (Morning, 2 Hour After Drug Intake) | Change in pressure algometry between baseline and Day 2 (morning, 2 h after drug intake). Pressure algometry was determined by the investigator as the pressure value (N/cm2) at a defined trigger point which is located in the area of POMWP. The measurement was performed by using a Somedic Algometer (Somedic AB, Sweden) or an equivalent calibrated and certified device. The pain reaction was determined by placing the algometer on the trigger point, i.e. an area of 1 cm² for which the patient indicated most painful tenderness. The pressure was constantly increased until the patient asked not to increase the pressure anymore. Upon this pain reaction, the corresponding pressure value was documented in the Electronic case report form (eCRF). The trigger point was to be marked with a ball pen to be able to repeat the subsequent assessment at the same position. Change in pressure was calculated as baseline pressure - pressure at Day 2, with a negative result indicating an improvement. | Baseline and Day 2 (morning, 2 h after drug intake) |
| Global Assessment of Efficacy by the Patient at the End of Treatment (Morning of Day 6) | Global assessment of efficacy by the patient at the end of treatment (morning of Day 6) is presented. The patient/investigator assessed the overall efficacy of the trial treatment on a 4-point verbal rating scale by answering the question: "How would you rate the overall effect of the trial medication for relieving back or neck pain?" (0 = poor; 1 = fair; 2 = good; 3 = very good). | At the end of treatment (morning of Day 6) |
| Number of Patients With a Decrease in POMwp of at Least 30% or 50% Between Baseline and Day 2 (Morning, 2 h After Drug Intake) | Number of patients with a decrease in POMwp of at least 30% or 50% between baseline and Day 2 (morning, 2 h after drug intake. | Baseline and Day 2 (morning, 2 h after drug intake) |
| Time to First Meaningful POMwp Relief Within 2 h After the First Dose of Trial Medication | Time to event analysis of patients with first meaningful POMwp relief within 2 h after the first dose of trial medication. The percentage of observed patients with a meaningful POMwp relief within 2 h after the first dose of trial medication was reported. The procedure which resulted in the highest POM at baseline (POMwp) was repeated by the investigator 10, 20, 30, 60 and 120 min after the first dose of trial medication. The POMwp relief score (POMwpRS) was assessed by the patient at each of these time points by using a 5-point verbal rating scale (0 = no POMwp relief; 1 = little or perceptible POMwp relief; 2 = meaningful POMwp relief; 3 = a lot of POMwp relief; 4 = complete POMwp relief). The time to first meaningful POMWP relief was the earliest assessment time point after the first application of the trial medication at which the patient reported a score of ≥2. | Within 2 h after the first dose of trial medication |
| Essen |
| 45277 |
| Germany |
| Praxis Dr. Schaefer, 45355 Essen | Essen | 45355 | Germany |
| Studienzentrum Bocholderstraße | Essen | 45355 | Germany |
| Unterfrintroper Hausarztzentrum | Essen | 45359 | Germany |
| Praxis Dr. Pabst, Gilching | Gilching | 82205 | Germany |
| Praxis Kai Gastl | Gilching | 82205 | Germany |
| medicoKIT GmbH | Goch | 47574 | Germany |
| Clinical Research Dr. Martz | Hamburg | 22143 | Germany |
| Praxis Dr. Dahmen, 22415 Hamburg | Hamburg | 22415 | Germany |
| Praxis Dr. Chevts, 76199 Karlsruhe | Karlsruhe | 76199 | Germany |
| Praxis Dr. Klein, Künzing | Künzing | 94550 | Germany |
| Anästhesiologie Rheinbach | Rheinbach | 53359 | Germany |
| Praxis Dr. Sauter | Wangen | 88239 | Germany |
| Neurologie und Psychiatrie / Psychotherapie | Westerstede | 26655 | Germany |
| State Healthcare Institution, City Out-Patient's Clinic #109 | Saint Petersburg | 192283 | Russia |
| Medical Centre "Reavita Med SPb" LLC | Saint Petersburg | 194325 | Russia |
| City Outpatient dep.no.107;clinc.pharmacology,st.petersburg | Saint Petersburg | 195030 | Russia |
| Non-compliant with protocol |
|
| Refused to continue medication |
|
| Other than listed |
|
Patients were administered film-coated tablets orally containing 400 mg ibuprofen 3 times daily with intervals of 6 to 8 hours (while awake) on Day 1 until the morning of Day 6.
| BG002 | Ibuprofen and Caffeine | Patients were administered film-coated tablets orally containing 400 mg ibuprofen and 100 mg caffeine 3 times daily with intervals of 6 to 8 hours (while awake) on Day 1 until the morning of Day 6. |
| BG003 | Total | Total of all reporting groups |
TS
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Number of subjects is categorized as Male or Female. | TS | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Number of subjects is categorized for ethnicity data. | TS | Count of Participants | Participants |
|
| Race (NIH/OMB) | Number of subjects is categorized for race data. | TS | Count of Participants | Participants |
|
| Pain on movement worst procedure score (0-10) | POM was assessed by the patient at the performance of one standardized, muscle group specific movement and was measured by a numerical rating scale ranging from 0 = 'no pain'to 10 = 'worst pain possible for this condition'. | Treated Set | Mean | Standard Deviation | Unit on scale |
|
|
|
|
|
| Secondary | The Area Under the Curve (AUC) for Pain on Movement (POM) With Regard to the Worst Procedure (POMwp) Between Baseline and Day 4 (Morning) (POMwpAUC72hour (h)) | This is a key secondary endpoint. The area under the curve (AUC) for pain on movement (POM) with regard to the worst procedure (POMwp) between baseline and Day 4 (morning), (POMwpAUC72h ). POM was assessed by the patient at the performance of one standardized, muscle group specific movement and was measured by a numerical rating scale ranging from 0 = 'no pain'to 10 = 'worst pain possible for this condition'. A higher AUC value indicates higher POMwp | Treated Set (TS): The TS comprised all randomised patients who took at least 1 dose of trial medication. | Posted | Least Squares Mean | Standard Error | Unit on scale | Baseline, Day 1, Day 2 and Day 4 (morning) |
|
|
|
|
| Secondary | The Area Under the Curve (AUC) for the Procedure With the Highest Pain Score at Baseline (POMWP) Between Baseline and Day 6 (Morning) (POM(WP)AUC(120h)) | This is a key secondary endpoint. The area under the curve for pain on movement with regard to the worst procedure between baseline and Day 6 (morning) (POM(WP)AUC(120h). POM was assessed by the patient at the performance of one standardized, muscle group specific movement and was measured by a numerical rating scale ranging from 0 = 'no pain'to 10 = 'worst pain possible for this condition'. A higher AUC value indicates higher POMwp. | TS | Posted | Least Squares Mean | Standard Error | Unit on scale | Baseline, Day 1, Day 2, Day 4 and Day 6 (morning) |
|
|
|
|
| Secondary | Change in Pressure Algometry Between Baseline and Day 2 (Morning, 2 Hour After Drug Intake) | Change in pressure algometry between baseline and Day 2 (morning, 2 h after drug intake). Pressure algometry was determined by the investigator as the pressure value (N/cm2) at a defined trigger point which is located in the area of POMWP. The measurement was performed by using a Somedic Algometer (Somedic AB, Sweden) or an equivalent calibrated and certified device. The pain reaction was determined by placing the algometer on the trigger point, i.e. an area of 1 cm² for which the patient indicated most painful tenderness. The pressure was constantly increased until the patient asked not to increase the pressure anymore. Upon this pain reaction, the corresponding pressure value was documented in the Electronic case report form (eCRF). The trigger point was to be marked with a ball pen to be able to repeat the subsequent assessment at the same position. Change in pressure was calculated as baseline pressure - pressure at Day 2, with a negative result indicating an improvement. | TS | Posted | Least Squares Mean | Standard Error | newton/centimeter² (N/cm^2) | Baseline and Day 2 (morning, 2 h after drug intake) |
|
|
|
|
| Secondary | Global Assessment of Efficacy by the Patient at the End of Treatment (Morning of Day 6) | Global assessment of efficacy by the patient at the end of treatment (morning of Day 6) is presented. The patient/investigator assessed the overall efficacy of the trial treatment on a 4-point verbal rating scale by answering the question: "How would you rate the overall effect of the trial medication for relieving back or neck pain?" (0 = poor; 1 = fair; 2 = good; 3 = very good). | TS including participants with available data for global assessment of efficacy | Posted | Number | Participants | At the end of treatment (morning of Day 6) |
|
|
|
|
| Secondary | Number of Patients With a Decrease in POMwp of at Least 30% or 50% Between Baseline and Day 2 (Morning, 2 h After Drug Intake) | Number of patients with a decrease in POMwp of at least 30% or 50% between baseline and Day 2 (morning, 2 h after drug intake. | TS | Posted | Number | Participants | Baseline and Day 2 (morning, 2 h after drug intake) |
|
|
|
|
| Secondary | Time to First Meaningful POMwp Relief Within 2 h After the First Dose of Trial Medication | Time to event analysis of patients with first meaningful POMwp relief within 2 h after the first dose of trial medication. The percentage of observed patients with a meaningful POMwp relief within 2 h after the first dose of trial medication was reported. The procedure which resulted in the highest POM at baseline (POMwp) was repeated by the investigator 10, 20, 30, 60 and 120 min after the first dose of trial medication. The POMwp relief score (POMwpRS) was assessed by the patient at each of these time points by using a 5-point verbal rating scale (0 = no POMwp relief; 1 = little or perceptible POMwp relief; 2 = meaningful POMwp relief; 3 = a lot of POMwp relief; 4 = complete POMwp relief). The time to first meaningful POMWP relief was the earliest assessment time point after the first application of the trial medication at which the patient reported a score of ≥2. | TS | Posted | Number | Percentage of participants | Within 2 h after the first dose of trial medication |
|
|
|
|
| 0 |
| 126 |
| 0 |
| 126 |
| 0 |
| 126 |
| EG001 | Ibuprofen | Patients were administered film-coated tablets orally containing 400 mg ibuprofen 3 times daily with intervals of 6 to 8 hours (while awake) on Day 1 until the morning of Day 6. | 0 | 253 | 0 | 253 | 0 | 253 |
| EG002 | Ibuprofen and Caffeine | Patients were administered film-coated tablets orally containing 400 mg ibuprofen and 100 mg caffeine 3 times daily with intervals of 6 to 8 hours (while awake) on Day 1 until the morning of Day 6. | 0 | 256 | 0 | 256 | 0 | 256 |
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| D014970 |
| Xanthines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| ANCOVA | The ANCOVA included treatment, country, and worst procedure site as fixed effects and baseline POMwp as a continuous covariate. | 0.6658 | No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05. | Mean Difference (Final Values) | 0.051 | 2-Sided | 95 | -0.180 | 0.282 | Adjusted mean ibuprofen and caffeine - Adjusted mean ibuprofen. A negative result favors ibuprofen and caffeine. | Superiority |
| ANCOVA | The ANCOVA included treatment, country, and worst procedure site as fixed effects and baseline POMwp as a continuous covariate. | 0.6387 | No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05. | Mean Difference (Final Values) | 0.058 | 2-Sided | 95 | -0.185 | 0.302 | Adjusted mean ibuprofen and caffeine - Adjusted mean ibuprofen. A negative result favors ibuprofen and caffeine | Superiority |
| Superiority |
| MMRM includes fixed, categorical effects of treatment, country, worst procedure site, time and interaction terms for treatment-by-time as well as the continuous fixed covariates of baseline pressure algometry and baseline-by-time interaction, using unstructured covariance matrix. | Mixed effect Model Repeat Measurement | 0.7911 | No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05. | Mean Difference (Final Values) | 0.156 | 2-Sided | 95 | -1.002 | 1.314 | Adjusted mean change ibuprofen and caffeine - Adjusted mean change ibuprofen. A negative result favors ibuprofen and caffeine. | Superiority |
| Title | Measurements |
|---|---|
|
| Fair |
|
| Poor |
|
| Regression, Logistic | An ordinal logistic regression model adjusting for country and worst procedure site. | 0.9603 | No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05. | Odds Ratio (OR) | 1.008 | 2-Sided | 95 | 0.732 | 1.389 | An odds ratio >1 indicates better efficacy for ibuprofen and caffeine than for the comparator | Superiority |
|
Results are based on the Logistic regression. Logistic regression model was adjusted for the categorical covariates country and worst procedure site.
| likelihood-ratio test | The likelihood-ratio test was used to test treatment differences for patients with a decrease of ≥30%. | 0.3129 | No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05. | Odds Ratio (OR) | 0.834 | 2-Sided | 95 | 0.586 | 1.187 | An odds ratio >1 indicates better efficacy for ibuprofen and caffeine than for the comparator. | Superiority | Results are based on the Logistic regression. Logistic regression model was adjusted for the categorical covariates country and worst procedure site. |
| likelihood-ratio test | The likelihood-ratio test was used to test treatment differences for patients with a decrease of ≥50%. | 0.3301 | No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05. | Odds Ratio (OR) | 1.354 | 2-Sided | 95 | 0.736 | 2.494 | An odds ratio >1 indicates better efficacy for ibuprofen and caffeine than for the comparator | Superiority | Results are based on the Logistic regression. Logistic regression model was adjusted for the categorical covariates country and worst procedure site. |
| likelihood-ratio test | The likelihood-ratio test was used to test treatment differences for patients with a decrease of ≥50%. | 0.0864 | No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05. | Odds Ratio (OR) | 0.680 | 2-Sided | 95 | 0.437 | 1.057 | An odds ratio >1 indicates better efficacy for ibuprofen and caffeine than for the comparator | Superiority | Results are based on the Logistic regression. Logistic regression model was adjusted for the categorical covariates country and worst procedure site. |
| Title | Measurements |
|---|---|
|
| >20 to ≤30 min |
|
| >30 to ≤60 min |
|
| >60 to <=120 |
|
| >120 min |
|
p-value based on a stratified log-rank test |
| 0.3534 |
No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05. |
| Superiority |