Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To investigate efficacy, safety and tolerability of Celecoxib in patients with posttraumatic pain for the duration of 8 days.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Celecoxib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celecoxib | Drug | Day 1
Days 2 to 8 (Study drug should be taken until the dose scheduled after breakfast on the day of Day 8) - Celecoxib 200mg twice daily |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Impressions at Final Visit (the Number of Participants Who Have Rated "Excellent" and "Good") | The patient impression of the study medication was entered in the patient diary based on the following categories: "excellent," "good," "fair" and "poor." Efficacy was based on the patient impression of the study medication ("excellent" and "good") from the first study medication until Final Visit. | 8 days |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Impressions Within 8 Days Post-first Dose (the Number of Subjects Who Have Rated "Excellent" and "Good") | The patient impression of the study medication was entered in the patient diary based on the following categories: "excellent," "good," "fair" and "poor." Efficacy was based on the patient impression of the study medication ("excellent" and "good") from the first study medication until each time point. |
Not provided
Inclusion Criteria:
"Pain" Pain intensity (Categorical): "Moderate pain" or "Severe pain" Pain intensity (VAS): 45.0 mm or more
"Inflammation" Categorical: "Mild", "Moderate" or "Severe"
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Funabashi | Chiba | Japan | |||
| Pfizer Investigational Site |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Not provided
Subjects were screened at 12 centers in Japan.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Celecoxib | Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID (twice daily) for up to 7 days from Day 2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Celecoxib | Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2. |
| 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 | Patient Impressions at Final Visit (the Number of Participants Who Have Rated "Excellent" and "Good") | The patient impression of the study medication was entered in the patient diary based on the following categories: "excellent," "good," "fair" and "poor." Efficacy was based on the patient impression of the study medication ("excellent" and "good") from the first study medication until Final Visit. | The full analysis set (FAS) consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the last observation carried forward (LOCF) was used. | Posted | Number | Participants | 8 days |
|
8 days
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Celecoxib | Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 6 hours post first dose and before sleep on Day 1, before sleep on Day 2, Day 4 (Visit 2) and Day 8 (Visit 3) |
| Pain Intensity (PI) of Pain at Rest (Spontaneous Pain) as Measured by Visual Analog Scale (VAS) Within 8 Days Post-first Dose | The PI of pain at rest (spontaneous pain) was recorded on the 100 mm VAS in the patient diary, where 0 mm=no pain, 100 mm=worst possible pain. | Baseline, 2, 4 and 6 hours post first dose, and before sleep on Day 1, on awakening and before sleep on Days 2 to 7, on awakening on Day 8 and Visit 3 (Day 8) |
| PI of Pain on Active Movement as Measured by VAS Within 8 Days Post-first Dose | The PI of pain on active movement was recorded on the 100 mm VAS in the patient diary, where 0 mm=no pain, 100 mm=worst possible pain. | Baseline, 2, 4 and 6 hours post first dose, and before sleep on Day 1, on awakening and before sleep on Days 2 to 7, on awakening on Day 8 and Visit 3 (Day 8) |
| Pain Intensity Differences (PID) in Pain at Rest (Spontaneous Pain) Within 8 Days Post-first Dose | The PID score was obtained by subtracting the PI (by VAS: 0 mm=no pain, 100 mm=worst possible pain) at each time point from the Baseline PI score. Increase in PID scores indicated a lessening of subjects' pain compared to baseline scores; higher scores indicated a greater reduction in pain. | Two, 4 and 6 hours post first dose, and before sleep on Day 1, on awakening and before sleep on Days 2 to 7, on awakening on Day 8 and Visit 3 (Day 8) |
| PID in Pain on Active Movement Within 8 Days Post-first Dose | The PID score was obtained by subtracting the PI at each time point from the Baseline PI score. Increase in scores indicated a lessening of subjects' pain compared to baseline scores; higher scores indicated a greater reduction in pain. | 2, 4 and 6 hours post first dose, and before sleep on Day 1, on awakening and before sleep on Days 2 to 7, on awakening on Day 8 and Visit 3 (Day 8) |
| Sum of Pain Intensity Differences (SPID) for Pain at Rest (Spontaneous Pain) and on Active Movement Until 6 Hours Post-first Dose | The SPID was derived according to the following rule: each PID was weighted by the width of time interval between previous and current time points in hours and summed up to 6 hours post-first dose | 6 hours |
| Peak Pain Intensity Difference (PPID) for Pain at Rest (Spontaneous Pain) and on Active Movement Until 6 Hours Post-first Dose | The PPID was obtained by subtracting the maximum value of pain intensity (PI) at a time point among 2 to 6 hours post first dose from baseline value of PI for each patient. | Two, 4 and 6 hours post first dose |
| Severity of Inflammatory Symptoms (Swelling) Within 8 Days Post-first Dose | The investigator assessed the swelling, using the categories "None," "Mild," "Moderate," and "Severe" at Baseline, Visit 2 (Day 4), Visit 3 (Day 8) and Final Visit. | Baseline, Days 4 (Visit 2) and 8 (Visit 3) |
| Severity of Inflammatory Symptoms (Redness) Within 8 Days Post-first Dose | The investigator assessed the redness, using the categories "None," "Mild," "Moderate," and "Severe" at Baseline, Visit 2 (Day 4), Visit 3 (Day 8) and Final Visit. | Baseline, Days 4 (Visit 2) and 8 (Visit 3) |
| Severity of Inflammatory Symptoms (Localized Warmth) Within 8 Days Post First Dose | The investigator assessed the localized warmth, using the categories "None," "Mild," "Moderate," and "Severe" at Baseline, Visit 2 (Day 4), Visit 3 (Day 8) and Final Visit. | Baseline, Days 4 (Visit 2) and 8 (Visit 3) |
| Withdrawal Due to Lack of Efficacy | The number of subjects who withdrew due to insufficient clinical response was evaluated. | 8 days |
| Summary of Adverse Events | The number of subjects who experienced adverse events (AEs; all-causality and treatment-related) based on safety assessment was summarized. The severity and seriousness of treatment-emergent AEs as well as discontinuations, dose reductions and temporary discontinuations (DR/TD) due to treatment-emergent AEs were also summarized. | 8 days |
| Ichikawa |
| Chiba |
| Japan |
| Pfizer Investigational Site | Matsudo | Chiba | Japan |
| Pfizer Investigational Site | Sagamihara | Kanagawa | Japan |
| Pfizer Investigational Site | Ageo | Saitama | Japan |
| Pfizer Investigational Site | Saitama-shi | Saitama | Japan |
| Pfizer Investigational Site | Edogawaku | Tokyo | Japan |
| Pfizer Investigational Site | Kotoku | Tokyo | Japan |
| Pfizer Investigational Site | Nerimaku | Tokyo | Japan |
| Pfizer Investigational Site | Toshimaku | Tokyo | Japan |
| Pfizer Investigational Site | Kofu | Yamanashi | Japan |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Patient Impressions Within 8 Days Post-first Dose (the Number of Subjects Who Have Rated "Excellent" and "Good") | The patient impression of the study medication was entered in the patient diary based on the following categories: "excellent," "good," "fair" and "poor." Efficacy was based on the patient impression of the study medication ("excellent" and "good") from the first study medication until each time point. | The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. | Posted | Number | Participants | 6 hours post first dose and before sleep on Day 1, before sleep on Day 2, Day 4 (Visit 2) and Day 8 (Visit 3) |
|
|
|
| Secondary | Pain Intensity (PI) of Pain at Rest (Spontaneous Pain) as Measured by Visual Analog Scale (VAS) Within 8 Days Post-first Dose | The PI of pain at rest (spontaneous pain) was recorded on the 100 mm VAS in the patient diary, where 0 mm=no pain, 100 mm=worst possible pain. | The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the LOCF was used. | Posted | Mean | Standard Deviation | mm | Baseline, 2, 4 and 6 hours post first dose, and before sleep on Day 1, on awakening and before sleep on Days 2 to 7, on awakening on Day 8 and Visit 3 (Day 8) |
|
|
|
| Secondary | PI of Pain on Active Movement as Measured by VAS Within 8 Days Post-first Dose | The PI of pain on active movement was recorded on the 100 mm VAS in the patient diary, where 0 mm=no pain, 100 mm=worst possible pain. | The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the LOCF was used. | Posted | Mean | Standard Deviation | mm | Baseline, 2, 4 and 6 hours post first dose, and before sleep on Day 1, on awakening and before sleep on Days 2 to 7, on awakening on Day 8 and Visit 3 (Day 8) |
|
|
|
| Secondary | Pain Intensity Differences (PID) in Pain at Rest (Spontaneous Pain) Within 8 Days Post-first Dose | The PID score was obtained by subtracting the PI (by VAS: 0 mm=no pain, 100 mm=worst possible pain) at each time point from the Baseline PI score. Increase in PID scores indicated a lessening of subjects' pain compared to baseline scores; higher scores indicated a greater reduction in pain. | The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the LOCF was used. | Posted | Mean | Standard Deviation | mm | Two, 4 and 6 hours post first dose, and before sleep on Day 1, on awakening and before sleep on Days 2 to 7, on awakening on Day 8 and Visit 3 (Day 8) |
|
|
|
| Secondary | PID in Pain on Active Movement Within 8 Days Post-first Dose | The PID score was obtained by subtracting the PI at each time point from the Baseline PI score. Increase in scores indicated a lessening of subjects' pain compared to baseline scores; higher scores indicated a greater reduction in pain. | The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the LOCF was used. | Posted | Mean | Standard Deviation | mm | 2, 4 and 6 hours post first dose, and before sleep on Day 1, on awakening and before sleep on Days 2 to 7, on awakening on Day 8 and Visit 3 (Day 8) |
|
|
|
| Secondary | Sum of Pain Intensity Differences (SPID) for Pain at Rest (Spontaneous Pain) and on Active Movement Until 6 Hours Post-first Dose | The SPID was derived according to the following rule: each PID was weighted by the width of time interval between previous and current time points in hours and summed up to 6 hours post-first dose | The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement. If a patient withdrew the study before 6 hours on Day 1 and the measurement of the PI at 6 hours on Day 1 was missing, the LOCF method was used for the PI at 6 hours on Day 1 to derive the SPID. | Posted | Mean | 95% Confidence Interval | mm | 6 hours |
|
|
|
| Secondary | Peak Pain Intensity Difference (PPID) for Pain at Rest (Spontaneous Pain) and on Active Movement Until 6 Hours Post-first Dose | The PPID was obtained by subtracting the maximum value of pain intensity (PI) at a time point among 2 to 6 hours post first dose from baseline value of PI for each patient. | The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. | Posted | Mean | 95% Confidence Interval | mm | Two, 4 and 6 hours post first dose |
|
|
|
| Secondary | Severity of Inflammatory Symptoms (Swelling) Within 8 Days Post-first Dose | The investigator assessed the swelling, using the categories "None," "Mild," "Moderate," and "Severe" at Baseline, Visit 2 (Day 4), Visit 3 (Day 8) and Final Visit. | The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the LOCF was used. | Posted | Number | Participants | Baseline, Days 4 (Visit 2) and 8 (Visit 3) |
|
|
|
| Secondary | Severity of Inflammatory Symptoms (Redness) Within 8 Days Post-first Dose | The investigator assessed the redness, using the categories "None," "Mild," "Moderate," and "Severe" at Baseline, Visit 2 (Day 4), Visit 3 (Day 8) and Final Visit. | The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the LOCF was used. | Posted | Number | Participants | Baseline, Days 4 (Visit 2) and 8 (Visit 3) |
|
|
|
| Secondary | Severity of Inflammatory Symptoms (Localized Warmth) Within 8 Days Post First Dose | The investigator assessed the localized warmth, using the categories "None," "Mild," "Moderate," and "Severe" at Baseline, Visit 2 (Day 4), Visit 3 (Day 8) and Final Visit. | The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the LOCF was used. | Posted | Number | Participants | Baseline, Days 4 (Visit 2) and 8 (Visit 3) |
|
|
|
| Secondary | Withdrawal Due to Lack of Efficacy | The number of subjects who withdrew due to insufficient clinical response was evaluated. | The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. | Posted | Number | Participants | 8 days |
|
|
|
| Secondary | Summary of Adverse Events | The number of subjects who experienced adverse events (AEs; all-causality and treatment-related) based on safety assessment was summarized. The severity and seriousness of treatment-emergent AEs as well as discontinuations, dose reductions and temporary discontinuations (DR/TD) due to treatment-emergent AEs were also summarized. | The safety analysis set consisted of all patients who had taken at least one study medication. | Posted | Number | Participants | 8 days |
|
|
|
| 0 |
| 80 |
| 10 |
| 80 |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Beta 2 microglobulin urine increased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Beta-N-acetyl-D-glucosaminidase increased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Urobilin urine present | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 12.1 | 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.
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| Title | Measurements |
|---|---|
|
| Visit 2 (Day 4), (n=80) |
|
| Visit 3 (Day 8), (n=68) |
|
| Title | Measurements |
|---|---|
|
| Day 1, 6 hours post first dose (n=80) |
|
| Day 1, before sleep (n=80) |
|
| Day 2, on awakening (n=80) |
|
| Day 2, before sleep (n=80) |
|
| Day 3, on awakening (n=80) |
|
| Day 3, before sleep (n=78) |
|
| Day 4, on awakening (n=78) |
|
| Day 4, before sleep (n=73) |
|
| Day 5, on awakening (n=73) |
|
| Day 5, before sleep (n=68) |
|
| Day 6, on awakening (n=68) |
|
| Day 6, before sleep (n=68) |
|
| Day 7, on awakening (n=68) |
|
| Day 7, before sleep (n=55) |
|
| Day 8, on awakening (n=55) |
|
| Visit 3 (Day 8) (n=73) |
|
| Final Visit (LOCF, n=80) |
|
| Title | Measurements |
|---|---|
|
| Day 1, 6 hours post first dose (n=77) |
|
| Day 1, before sleep (n=77) |
|
| Day 2, on awakening (n=77) |
|
| Day 2, before sleep (n=77) |
|
| Day 3, on awakening (n=77) |
|
| Day 3, before sleep (n=75) |
|
| Day 4, on awakening (n=75) |
|
| Day 4, before sleep (n=70) |
|
| Day 5, on awakening (n=70) |
|
| Day 5, before sleep (n=66) |
|
| Day 6, on awakening (n=66) |
|
| Day 6, before sleep (n=66) |
|
| Day 7, on awakening (n=66) |
|
| Day 7, before sleep (n=55) |
|
| Day 8, on awakening (n=55) |
|
| Visit 3 (Day8) (n=71) |
|
| Final Visit (LOCF, n=78) |
|
|
| Day 1, before sleep (n=80) |
|
| Day 2, on awakening (n=80) |
|
| Day 2, before sleep (n=80) |
|
| Day 3, on awakening (n=80) |
|
| Day 3, before sleep (n=78) |
|
| Day 4, on awakening (n=78) |
|
| Day 4, before sleep (n=73) |
|
| Day 5, on awakening (n=73) |
|
| Day 5, before sleep (n=68) |
|
| Day 6, on awakening (n=68) |
|
| Day 6, before sleep (n=68) |
|
| Day 7, on awakening (n=68) |
|
| Day 7, before sleep (n=55) |
|
| Day 8, on awakening (n=55) |
|
| Visit 3 (Day 8) (n=73) |
|
| Final Visit (LOCF, n=80) |
|
|
| Day 1, before sleep (n=77) |
|
| Day 2, on awakening (n=77) |
|
| Day 2, before sleep (n=77) |
|
| Day 3, on awakening (n=77) |
|
| Day 3, before sleep (n=75) |
|
| Day 4, on awakening (n=75) |
|
| Day 4, before sleep (n=70) |
|
| Day 5, on awakening (n=70) |
|
| Day 5, before sleep (n=66) |
|
| Day 6, on awakening (n=66) |
|
| Day 6, before sleep (n=66) |
|
| Day 7, on awakening (n=66) |
|
| Day 7, before sleep (n=55) |
|
| Day 8, on awakening (n=55) |
|
| Visit 3 (Day 8) (n=71) |
|
| Final Visit (LOCF, n=78) |
|
| Title | Measurements |
|---|---|
|
| None at Final Visit (n=80) |
|
| Mild at Baseline (n=80) |
|
| Mild at Visit 2 (Day 4) (n=80) |
|
| Mild at Visit 3 (Day 8) (n=68) |
|
| Mild at Final Visit (n=80) |
|
| Moderate at Baseline (n=80) |
|
| Moderate at Visit 2 (Day 4) (n=80) |
|
| Moderate at Visit 3 (Day 8) (n=68) |
|
| Moderate at Final Visit (n=80) |
|
| Severe at Baseline (n=80) |
|
| Severe at Visit 2 (Day 4) (n=80) |
|
| Severe at Visit 3 (Day 8) (n=68) |
|
| Severe at Final Visit (n=80) |
|
| Title | Measurements |
|---|---|
|
| None at Final Visit (n=80) |
|
| Mild at Baseline (n=80) |
|
| Mild at Visit 2 (Day 4) (n=80) |
|
| Mild at Visit 3 (Day 8) (n=68) |
|
| Mild at Final Visit (n=80) |
|
| Moderate at Baseline (n=80) |
|
| Moderate at Visit 2 (Day 4) (n=80) |
|
| Moderate at Visit 3 (Day 8) (n=68) |
|
| Moderate at Final Visit (n=80) |
|
| Severe at Baseline (n=80) |
|
| Severe at Visit 2 (Day 4) (n=80) |
|
| Severe at Visit 3 (Day 8) (n=68) |
|
| Severe at Final Visit (n=80) |
|
| Title | Measurements |
|---|---|
|
| None at Final Visit (n=80) |
|
| Mild at Baseine (n=80) |
|
| Mild at Visit 2 (Day 4) (n=80) |
|
| Mild at Visit 3 (Day 8) (n=68) |
|
| Mild at Final Visit (n=80) |
|
| Moderate at Baseine (n=80) |
|
| Moderate at Visit 2 (Day 4) (n=80) |
|
| Moderate at Visit 3 (Day 8) (n=68) |
|
| Moderate at Final Visit (n=80) |
|
| Severe at Baseine (n=80) |
|
| Severe at Visit 2 (Day 4) (n=80) |
|
| Severe at Visit 3 (Day 8) (n=68) |
|
| Severe at Final Visit (n=80) |
|
| Title | Measurements |
|---|---|
|
| Severe AEs: treatment-realted |
|
| Serious AEs: all-causality |
|
| Serious AEs: treatment-related |
|
| Discontinuation due to all-causality AEs |
|
| Discontinuation due to treatment-related AEs |
|
| DR/TD due to all-causality AEs |
|
| DR/TD due to treatment-related AEs |
|