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| ID | Type | Description | Link |
|---|---|---|---|
| JNS020QD-JPN-C01 |
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The purpose of this study is to evaluate the safety and efficacy of fentanyl one-day transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) in participants switched from morphine preparations, oral oxycodone preparations, fentanyl citrate injection or fentanyl patch for cancer pain.
This is an open-label (all people know the identity of the intervention), multi-center (conducted in more than one center) and non-comparative study of fentanyl one-day transdermal patch. The study consists of 3 periods: Pre-treatment observation period (4-7 days), Treatment period (10 days) and Follow-up period (2 days). Treatment will be initiated at 12.5 microgram per hour (mcg/hr) and the initial dose of fentanyl will be determined based on the daily dose of the opioid analgesic taken by the participant before entering the study and will be maintained for 2 days to ensure safety of participants. Dose escalation or reduction will be as per the Investigator's discretion from Day 3 to Day 7 and thereafter dose will be again maintained from Day 7 to Day 9, ranging from 12.5 mcg/hr-100 mcg/hr and the maximum application dose will be 300 mcg/hr. The patch will be applied on areas including the chest, abdomen, upper arm or thigh and will be replaced daily for 10 days (a total of 9 applications; including the day of final patch removal). Efficacy will primarily be evaluated by visual analog scale (VAS) score. Participants' safety will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fentanyl | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fentanyl | Drug | Fentanyl 1-day application transdermal patch releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction is as per Investigator's discretion (maximum applied dose is 300 mcg/hr) up to Day 7 and then dose is fixed for next 3 days that is Day 10 (end of treatment period). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Pain Control | Pain control was assessed based on change in Visual Analog Scale (VAS) and number of daily rescue doses during 3 days before completion of study drug from 3 days before start of study drug. For VAS score, a difference of less than or equal to +15 millimeter (mm) and for rescue doses, a difference of less than or equal to 1 was considered significant to achieve pain control. Pain Intensity VAS ranged from 0 mm (no pain) to 100 mm (severest pain conceivable) and rescue dose was defined as dose of fast-acting opioid analgesic (except fentanyl preparations) used for lack of analgesic effect. | Day 10 or early discontinuation (ED) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Response Based on Patient's Global Assessment Scale | Participants were asked to assess their satisfaction with respect to the therapeutic efficacy (effectiveness) of the study drug on a 5-point scale ranging from 1 to 5, where 1 = extremely satisfied, 2 = satisfied, 3 = neither satisfied nor dissatisfied, 4 = dissatisfied and 5 = extremely dissatisfied. | Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 or ED |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Pharmaceutical K.K., Japan Clinical Trial | Janssen Pharmaceutical K.K. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kitakyushu | Japan |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fentanyl | Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator's discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fentanyl | Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator's discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period). |
| 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 | Percentage of Participants Achieving Pain Control | Pain control was assessed based on change in Visual Analog Scale (VAS) and number of daily rescue doses during 3 days before completion of study drug from 3 days before start of study drug. For VAS score, a difference of less than or equal to +15 millimeter (mm) and for rescue doses, a difference of less than or equal to 1 was considered significant to achieve pain control. Pain Intensity VAS ranged from 0 mm (no pain) to 100 mm (severest pain conceivable) and rescue dose was defined as dose of fast-acting opioid analgesic (except fentanyl preparations) used for lack of analgesic effect. | Full Analysis Set (FAS) population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Day 10 or early discontinuation (ED) |
|
From signing of informed consent up to 7 days after the completion or discontinuation of last study treatment
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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 | Fentanyl | Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator's discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Research | Janssen Research & Development, L.L.C. USA | 1 609 730-3387 |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
|
| Pain Intensity Visual Analog Scale (VAS) Score | Participants were asked to assess their resting pain intensity (severity of pain) on a 100-mm VAS with the left edge (0 mm) defined as "no pain" and the right edge (100 mm) defined as "severest pain conceivable". | Day 1 (pre-application), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 or ED |
| Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain | Participants were asked to assess their resting pain intensity (severity of pain) on a 4-point categorical scale ranging from 0 to 3 where 0 = no pain, 1 = mild pain, 2 = moderate pain and 3 = severe pain. | Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 or ED |
| Number of Participants With Total Duration of Pain Per Day | The participants assessed total painful time in 1 day on a 5-point scale ranging from 0 to 4 where 0 = less than (<) 4 hours, 1 = greater than or equal to (>=) 4 hours to less than 8 hours, 2 = greater than or equal to 8 hours to less than 12 hours, 3 = greater than or equal to 12 hours and 4 = 24 hours (all day). | Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 or ED |
| Mean Number of Rescue Doses | Rescue dose was defined as the dose of a fast-acting opioid analgesic (except fentanyl preparations) given in case of breakthrough pain or lack of analgesic effect. | Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 or ED |
| Number of Participants With Response Based on Physician's Global Assessment Scale | The treating physician assessed the therapeutic efficacy (effectiveness) of the study drug by 2-point scale of effective and ineffective. Number of participants with effective and ineffective therapeutic efficacy with respect to the study drug were reported. | Day 10 or ED |
| Worsening of underlying disease |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator's discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period). |
|
|
| Secondary | Number of Participants With Response Based on Patient's Global Assessment Scale | Participants were asked to assess their satisfaction with respect to the therapeutic efficacy (effectiveness) of the study drug on a 5-point scale ranging from 1 to 5, where 1 = extremely satisfied, 2 = satisfied, 3 = neither satisfied nor dissatisfied, 4 = dissatisfied and 5 = extremely dissatisfied. | The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug. 'n' signifies those participants who were evaluable for this measure at given time points. | Posted | Number | Participants | Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 or ED |
|
|
|
| Secondary | Pain Intensity Visual Analog Scale (VAS) Score | Participants were asked to assess their resting pain intensity (severity of pain) on a 100-mm VAS with the left edge (0 mm) defined as "no pain" and the right edge (100 mm) defined as "severest pain conceivable". | The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug. 'n' signifies those participants who were evaluable for this measure at given time points. | Posted | Mean | Standard Deviation | mm | Day 1 (pre-application), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 or ED |
|
|
|
| Secondary | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain | Participants were asked to assess their resting pain intensity (severity of pain) on a 4-point categorical scale ranging from 0 to 3 where 0 = no pain, 1 = mild pain, 2 = moderate pain and 3 = severe pain. | The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug. 'n' signifies those participants who were evaluable for this measure at given time points. | Posted | Number | Participants | Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 or ED |
|
|
|
| Secondary | Number of Participants With Total Duration of Pain Per Day | The participants assessed total painful time in 1 day on a 5-point scale ranging from 0 to 4 where 0 = less than (<) 4 hours, 1 = greater than or equal to (>=) 4 hours to less than 8 hours, 2 = greater than or equal to 8 hours to less than 12 hours, 3 = greater than or equal to 12 hours and 4 = 24 hours (all day). | The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug. 'n' signifies those participants who were evaluable for this measure at given time points. | Posted | Number | Participants | Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 or ED |
|
|
|
| Secondary | Mean Number of Rescue Doses | Rescue dose was defined as the dose of a fast-acting opioid analgesic (except fentanyl preparations) given in case of breakthrough pain or lack of analgesic effect. | The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug. 'n' signifies those participants who were evaluable for this measure at given time points. | Posted | Mean | Standard Deviation | Rescue Doses | Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 or ED |
|
|
|
| Secondary | Number of Participants With Response Based on Physician's Global Assessment Scale | The treating physician assessed the therapeutic efficacy (effectiveness) of the study drug by 2-point scale of effective and ineffective. Number of participants with effective and ineffective therapeutic efficacy with respect to the study drug were reported. | The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug. | Posted | Number | Participants | Day 10 or ED |
|
|
|
| 6 |
| 66 |
| 56 |
| 66 |
| Staphylococcal sepsis | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Metastases to lymph nodes | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Application site erythema | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Application site pruritus | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
The disclosure restriction on PI is that the Sponsor can review results communications prior to public release and can embargo communications regarding results for a period as the Sponsor requires.
| Title | Measurements |
|---|---|
|
| Day 1; Dissatisfied (n=66) |
|
| Day 1; Extremely dissatisfied (n=66) |
|
| Day 2; Extremely satisfied (n=65) |
|
| Day 2; Satisfied (n=65) |
|
| Day 2; Neither satisfied nor dissatisfied (n=65) |
|
| Day 2; Dissatisfied (n=65) |
|
| Day 2; Extremely dissatisfied (n=65) |
|
| Day 3; Extremely satisfied (n=65) |
|
| Day 3; Satisfied (n=65) |
|
| Day 3; Neither satisfied nor dissatisfied (n=65) |
|
| Day 3; Dissatisfied (n=65) |
|
| Day 3; Extremely dissatisfied (n=65) |
|
| Day 4; Extremely satisfied (n=64) |
|
| Day 4; Satisfied (n=64) |
|
| Day 4; Neither satisfied nor dissatisfied (n=64) |
|
| Day 4; Dissatisfied (n=64) |
|
| Day 4; Extremely dissatisfied (n=64) |
|
| Day 5; Extremely satisfied (n=63) |
|
| Day 5; Satisfied (n=63) |
|
| Day 5; Neither satisfied nor dissatisfied (n=63) |
|
| Day 5; Dissatisfied (n=63) |
|
| Day 5; Extremely dissatisfied (n=63) |
|
| Day 6; Extremely satisfied (n=63) |
|
| Day 6; Satisfied (n=63) |
|
| Day 6; Neither satisfied nor dissatisfied (n=63) |
|
| Day 6; Dissatisfied (n=63) |
|
| Day 6; Extremely dissatisfied (n=63) |
|
| Day 7; Extremely satisfied (n=63) |
|
| Day 7; Satisfied (n=63) |
|
| Day 7; Neither satisfied nor dissatisfied (n=63) |
|
| Day 7; Dissatisfied (n=63) |
|
| Day 7; Extremely dissatisfied (n=63) |
|
| Day 8; Extremely satisfied (n=62) |
|
| Day 8; Satisfied (n=62) |
|
| Day 8; Neither satisfied nor dissatisfied (n=62) |
|
| Day 8; Dissatisfied (n=62) |
|
| Day 8; Extremely dissatisfied (n=62) |
|
| Day 9; Extremely satisfied (n=62) |
|
| Day 9; Satisfied (n=62) |
|
| Day 9; Neither satisfied nor dissatisfied (n=62) |
|
| Day 9; Dissatisfied (n=62) |
|
| Day 9; Extremely dissatisfied (n=62) |
|
| Day 10/ED; Extremely satisfied (n=66) |
|
| Day 10/ED; Satisfied (n=66) |
|
| Day 10/ED;Neither satisfied nor dissatisfied(n=66) |
|
| Day 10/ED; Dissatisfied (n=66) |
|
| Day 10/ED; Extremely dissatisfied (n=66) |
|
| Title | Measurements |
|---|---|
|
| Day 4; (n=64) |
|
| Day 5; (n=63) |
|
| Day 6; (n=63) |
|
| Day 7; (n=63) |
|
| Day 8; (n=62) |
|
| Day 9; (n=62) |
|
| Day 10 or ED; (n=66) |
|
| Title | Measurements |
|---|---|
|
| Day 1; Severe pain (n=66) |
|
| Day 2; No pain (n=65) |
|
| Day 2; Mild pain (n=65) |
|
| Day 2; Moderate pain (n=65) |
|
| Day 2; Severe pain (n=65) |
|
| Day 3; No pain (n=65) |
|
| Day 3; Mild pain (n=65) |
|
| Day 3; Moderate pain (n=65) |
|
| Day 3; Severe pain (n=65) |
|
| Day 4; No pain (n=64) |
|
| Day 4; Mild pain (n=64) |
|
| Day 4; Moderate pain (n=64) |
|
| Day 4; Severe pain (n=64) |
|
| Day 5; No pain (n=63) |
|
| Day 5; Mild pain (n=63) |
|
| Day 5; Moderate pain (n=63) |
|
| Day 5; Severe pain (n=63) |
|
| Day 6; No pain (n=63) |
|
| Day 6; Mild pain (n=63) |
|
| Day 6; Moderate pain (n=63) |
|
| Day 6; Severe pain (n=63) |
|
| Day 7; No pain (n=63) |
|
| Day 7; Mild pain (n=63) |
|
| Day 7; Moderate pain (n=63) |
|
| Day 7; Severe pain (n=63) |
|
| Day 8; No pain (n=62) |
|
| Day 8; Mild pain (n=62) |
|
| Day 8; Moderate pain (n=62) |
|
| Day 8; Severe pain (n=62) |
|
| Day 9; No pain (n=62) |
|
| Day 9; Mild pain (n=62) |
|
| Day 9; Moderate pain (n=62) |
|
| Day 9; Severe pain (n=62) |
|
| Day 10 or ED; No pain (n=66) |
|
| Day 10 or ED; Mild pain (n=66) |
|
| Day 10 or ED; Moderate pain(n=66) |
|
| Day 10 or ED; Severe pain(n=66) |
|
| Title | Measurements |
|---|---|
|
| Day 1; >= 12 hours (n=66) |
|
| Day 1; 24 hours (n=66) |
|
| Day 2; < 4 hours (n=65) |
|
| Day 2; >= 4 to < 8 hours (n=65) |
|
| Day 2; >= 8 to < 12 hours (n=65) |
|
| Day 2; >= 12 hours (n=65) |
|
| Day 2; 24 hours (n=65) |
|
| Day 3; < 4 hours (n=65) |
|
| Day 3; >= 4 to < 8 hours (n=65) |
|
| Day 3; >= 8 to < 12 hours (n=65) |
|
| Day 3; >= 12 hours (n=65) |
|
| Day 3; 24 hours (n=65) |
|
| Day 4; < 4 hours (n=64) |
|
| Day 4; >= 4 to < 8 hours (n=64) |
|
| Day 4; >= 8 to < 12 hours (n=64) |
|
| Day 4; >= 12 hours (n=64) |
|
| Day 4; 24 hours (n=64) |
|
| Day 5; < 4 hours (n=63) |
|
| Day 5; >= 4 to < 8 hours (n=63) |
|
| Day 5; >= 8 to < 12 hours (n=63) |
|
| Day 5; >= 12 hours (n=63) |
|
| Day 5; 24 hours (n=63) |
|
| Day 6; < 4 hours (n=63) |
|
| Day 6; >= 4 to < 8 hours (n=63) |
|
| Day 6; >= 8 to < 12 hours (n=63) |
|
| Day 6; >= 12 hours (n=63) |
|
| Day 6; 24 hours (n=63) |
|
| Day 7; < 4 hours (n=63) |
|
| Day 7; >= 4 to < 8 hours (n=63) |
|
| Day 7; >= 8 to < 12 hours (n=63) |
|
| Day 7; >= 12 hours (n=63) |
|
| Day 7; 24 hours (n=63) |
|
| Day 8; < 4 hours (n=62) |
|
| Day 8; >= 4 to < 8 hours (n=62) |
|
| Day 8; >= 8 to < 12 hours (n=62) |
|
| Day 8; >= 12 hours (n=62) |
|
| Day 8; 24 hours (n=62) |
|
| Day 9; < 4 hours (n=62) |
|
| Day 9; >= 4 to < 8 hours (n=62) |
|
| Day 9; >= 8 to < 12 hours (n=62) |
|
| Day 9; >= 12 hours (n=62) |
|
| Day 9; 24 hours (n=62) |
|
| Day 10 or ED; < 4 hours (n=66) |
|
| Day 10 or ED; >=4 to < 8 hours (n=66) |
|
| Day 10 or ED; >=8 to <12 hours (n=66) |
|
| Day 10 or ED; >= 12 hours (n=66) |
|
| Day 10 or ED; 24 hours (n=66) |
|
| Title | Measurements |
|---|---|
|
| Day 4; (n=64) |
|
| Day 5; (n=63) |
|
| Day 6; (n=63) |
|
| Day 7; (n=63) |
|
| Day 8; (n=62) |
|
| Day 9; (n=62) |
|
| Day 10 or ED; (n=66) |
|