Trial Outcomes & Findings for An Efficacy and Safety Study of Hydromorphone Oral Osmotic System (OROS) in Korean Participants With Cancer Pain (NCT NCT00766831)
NCT ID: NCT00766831
Last Updated: 2013-10-23
Results Overview
Percentage of treatment response in sleep disturbance caused by cancer pain was reported. Treatment response in sleep disturbance was measured by Numeric Rating Scale (NRS) ranging from 0=no disturbance to 10=extreme disturbance.
COMPLETED
PHASE4
190 participants
Day 15 or Early withdrawal
2013-10-23
Participant Flow
Participant milestones
| Measure |
Hydromorphone OROS
Participants received hydromorphone oral osmotic system OROS (8 milligram \[mg\] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator's discretion for additional 84 days of extension phase.
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|---|---|
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Overall Study
STARTED
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190
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|
Overall Study
COMPLETED
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75
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Overall Study
NOT COMPLETED
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115
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Reasons for withdrawal
| Measure |
Hydromorphone OROS
Participants received hydromorphone oral osmotic system OROS (8 milligram \[mg\] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator's discretion for additional 84 days of extension phase.
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|---|---|
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Overall Study
Withdrawal by Subject
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4
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Overall Study
Lost to Follow-up
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3
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Overall Study
Adverse Event
|
20
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|
Overall Study
Protocol Violation
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15
|
|
Overall Study
Physician Decision
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5
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|
Overall Study
Withdrawal of consent
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26
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|
Overall Study
Non cooperation by participants
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14
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Overall Study
Other
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28
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Baseline Characteristics
An Efficacy and Safety Study of Hydromorphone Oral Osmotic System (OROS) in Korean Participants With Cancer Pain
Baseline characteristics by cohort
| Measure |
Hydromorphone OROS
n=190 Participants
Participants received hydromorphone oral osmotic system OROS (8 milligram \[mg\] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator's discretion for additional 84 days of extension phase.
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|---|---|
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Age Continuous
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56.1 Years
STANDARD_DEVIATION 11.20 • n=5 Participants
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Sex: Female, Male
Female
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61 Participants
n=5 Participants
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Sex: Female, Male
Male
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129 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Day 15 or Early withdrawalPopulation: Intent to treat (ITT) population included all the participants who received study medication at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. Last observation carried forward (LOCF) was used.
Percentage of treatment response in sleep disturbance caused by cancer pain was reported. Treatment response in sleep disturbance was measured by Numeric Rating Scale (NRS) ranging from 0=no disturbance to 10=extreme disturbance.
Outcome measures
| Measure |
Hydromorphone OROS
n=82 Participants
Participants received hydromorphone oral osmotic system OROS (8 milligram \[mg\] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator's discretion for additional 84 days of extension phase.
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|---|---|
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Percentage of Treatment Response in Sleep Disturbance Caused by Cancer Pain
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34.9 Percentage of treatment response
Interval 27.8 to 41.9
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SECONDARY outcome
Timeframe: Baseline and Day 15Population: ITT population included all the participants who received at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used.
The Investigator evaluated sleep disturbance through the participant's answers to below question in "yes" or "no" response: 'Did you need to take an analgesic for pain relief in order to go to sleep last night?'
Outcome measures
| Measure |
Hydromorphone OROS
n=82 Participants
Participants received hydromorphone oral osmotic system OROS (8 milligram \[mg\] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator's discretion for additional 84 days of extension phase.
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|---|---|
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Sleep Disturbance Questionnaire: Analgesic Administration
Baseline : Yes
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37 Participants
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Sleep Disturbance Questionnaire: Analgesic Administration
Baseline: No
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45 Participants
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Sleep Disturbance Questionnaire: Analgesic Administration
Day 15: Yes
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25 Participants
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|
Sleep Disturbance Questionnaire: Analgesic Administration
Day 15: No
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57 Participants
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SECONDARY outcome
Timeframe: Baseline and Day 15Population: ITT population included all the participants who received at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used. Here 'n' signifies participants who were evaluated for this outcome measure at a particular time point.
The Investigator evaluated sleep disturbance through the participant's answers to below question: How many times did you wake up while sleeping late night (frequency \[once, 2 times, 3 times, 4 times, 5 times, couldn't fall asleep at all\] of waking up due to pain last night).
Outcome measures
| Measure |
Hydromorphone OROS
n=82 Participants
Participants received hydromorphone oral osmotic system OROS (8 milligram \[mg\] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator's discretion for additional 84 days of extension phase.
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|---|---|
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Sleep Disturbance Questionnaire: Frequency of Waking Up
Baseline: once (n=77)
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8 Participants
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Sleep Disturbance Questionnaire: Frequency of Waking Up
Baseline: 2 times (n=77)
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29 Participants
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|
Sleep Disturbance Questionnaire: Frequency of Waking Up
Baseline: 3 times (n=77)
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21 Participants
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|
Sleep Disturbance Questionnaire: Frequency of Waking Up
Baseline: 4 times (n=77)
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6 Participants
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|
Sleep Disturbance Questionnaire: Frequency of Waking Up
Baseline: 5 times (n=77)
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13 Participants
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Sleep Disturbance Questionnaire: Frequency of Waking Up
Day 15: once (n=58)
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23 Participants
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Sleep Disturbance Questionnaire: Frequency of Waking Up
Day 15: 2 times (n=58)
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17 Participants
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Sleep Disturbance Questionnaire: Frequency of Waking Up
Day 15: 3 times (n=58)
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7 Participants
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|
Sleep Disturbance Questionnaire: Frequency of Waking Up
Day 15: 4 times (n=58)
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7 Participants
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Sleep Disturbance Questionnaire: Frequency of Waking Up
Day 15: 5 times (n=58)
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4 Participants
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SECONDARY outcome
Timeframe: Baseline and Day 15Population: ITT population included all the participants who received at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used.
The Investigator evaluated sleep disturbance through the participant's answers to below question in "yes" or "no" response: 'Did you wake up because of unbearable pain this morning?'
Outcome measures
| Measure |
Hydromorphone OROS
n=82 Participants
Participants received hydromorphone oral osmotic system OROS (8 milligram \[mg\] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator's discretion for additional 84 days of extension phase.
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|---|---|
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Sleep Disturbance Questionnaire: Wake up Due to Unbearable Pain
Day 15: Yes
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15 Participants
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Sleep Disturbance Questionnaire: Wake up Due to Unbearable Pain
Day 15: No
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67 Participants
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Sleep Disturbance Questionnaire: Wake up Due to Unbearable Pain
Baseline: Yes
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32 Participants
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Sleep Disturbance Questionnaire: Wake up Due to Unbearable Pain
Baseline: No
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50 Participants
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SECONDARY outcome
Timeframe: Baseline and Day 15Population: ITT population included all the participants who received at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used. Here 'n' signifies the number of participant who were evaluated for particular category at particular time point.
K-BPI is a questionnaire designed to measure the degree of pain severity and the impact of pain in performing daily routines. K-BPI comprises of 9 items out of which 6 items were assessed. Score of each item ranges from 0 to 10, where 0=no pain/impact and 10=severe pain/impact. The 6 items that were assessed are: a) level of pain worst in last 24 hours; b) level of pain weakest in last 24 hours; c) level of pain average in last 24 hours; d) level of pain right now; e) how much pain reduced with the therapy taken; sixth item was further classified into 7 categories: i) general activities ii) mood iii) ambulatory ability iv) routine works v) interpersonal relation vi) sleep vii) life enjoyment.
Outcome measures
| Measure |
Hydromorphone OROS
n=82 Participants
Participants received hydromorphone oral osmotic system OROS (8 milligram \[mg\] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator's discretion for additional 84 days of extension phase.
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|---|---|
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Korean Brief Pain Inventory (K-BPI) Questionnaire Score
Baseline: Ambulatory ability (n=75)
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5.0 Units on a scale
Standard Deviation 2.3
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Korean Brief Pain Inventory (K-BPI) Questionnaire Score
Baseline: Routine works (n=76)
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5.6 Units on a scale
Standard Deviation 2.2
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Korean Brief Pain Inventory (K-BPI) Questionnaire Score
Baseline: Interpersonal relation (n=76)
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4.8 Units on a scale
Standard Deviation 2.6
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Korean Brief Pain Inventory (K-BPI) Questionnaire Score
Baseline: Sleep (n=76)
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5.9 Units on a scale
Standard Deviation 1.8
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Korean Brief Pain Inventory (K-BPI) Questionnaire Score
Day 15: Worst pain in last 24 hours (n=75)
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5.4 Units on a scale
Standard Deviation 2.0
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Korean Brief Pain Inventory (K-BPI) Questionnaire Score
Day 15: Average pain in last 24 hours (n=74)
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4.1 Units on a scale
Standard Deviation 1.9
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Korean Brief Pain Inventory (K-BPI) Questionnaire Score
Day 15: Level of pain right now (n=75)
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3.7 Units on a scale
Standard Deviation 2.0
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Korean Brief Pain Inventory (K-BPI) Questionnaire Score
Day 15: Pain reduced from therapy taken (n=75)
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0.5 Units on a scale
Standard Deviation 0.3
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Korean Brief Pain Inventory (K-BPI) Questionnaire Score
Day 15: General activities (n=75)
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5.0 Units on a scale
Standard Deviation 2.0
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Korean Brief Pain Inventory (K-BPI) Questionnaire Score
Day 15: Mood (n=75)
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4.6 Units on a scale
Standard Deviation 2.3
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Korean Brief Pain Inventory (K-BPI) Questionnaire Score
Day 15: Ambulatory ability (n=75)
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4.5 Units on a scale
Standard Deviation 2.6
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Korean Brief Pain Inventory (K-BPI) Questionnaire Score
Day 15: Routine works (n=75)
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4.9 Units on a scale
Standard Deviation 2.4
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Korean Brief Pain Inventory (K-BPI) Questionnaire Score
Day 15: Interpersonal relation (n=76)
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4.6 Units on a scale
Standard Deviation 2.7
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Korean Brief Pain Inventory (K-BPI) Questionnaire Score
Day 15: Life enjoyment (n=75)
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5.0 Units on a scale
Standard Deviation 2.6
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Korean Brief Pain Inventory (K-BPI) Questionnaire Score
Baseline: Life enjoyment (n=76)
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5.5 Units on a scale
Standard Deviation 2.5
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Korean Brief Pain Inventory (K-BPI) Questionnaire Score
Day 15: Weakest pain in last 24 hours (n=75)
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2.9 Units on a scale
Standard Deviation 1.9
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Korean Brief Pain Inventory (K-BPI) Questionnaire Score
Day 15: Sleep (n=74)
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4.2 Units on a scale
Standard Deviation 2.5
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Korean Brief Pain Inventory (K-BPI) Questionnaire Score
Baseline: Worst pain in last 24 hours (n=74)
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6.7 Units on a scale
Standard Deviation 1.9
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Korean Brief Pain Inventory (K-BPI) Questionnaire Score
Baseline: Weakest pain in last 24 hours (n=74)
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3.6 Units on a scale
Standard Deviation 2.1
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Korean Brief Pain Inventory (K-BPI) Questionnaire Score
Baseline: Average pain in last 24 hours (n=74)
|
5.2 Units on a scale
Standard Deviation 1.6
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|
Korean Brief Pain Inventory (K-BPI) Questionnaire Score
Baseline: Level of pain right now (n=76)
|
4.4 Units on a scale
Standard Deviation 1.8
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|
Korean Brief Pain Inventory (K-BPI) Questionnaire Score
Baseline: Pain reduced from therapy taken (n=76)
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0.4 Units on a scale
Standard Deviation 0.3
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Korean Brief Pain Inventory (K-BPI) Questionnaire Score
Baseline: General activities (n=76)
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5.0 Units on a scale
Standard Deviation 2.0
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Korean Brief Pain Inventory (K-BPI) Questionnaire Score
Baseline: Mood (n=76)
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5.1 Units on a scale
Standard Deviation 2.0
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SECONDARY outcome
Timeframe: Baseline and Day 15Population: ITT population included all the participants who received at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used.
Participant's pain intensity was measured using NRS ranging from 0=no pain to 10=unimaginable extreme pain. Participants maintained pain diary for 3 days before Baseline until Day 15 and pain intensity was measured twice daily (morning and afternoon). Here average pain intensity is reported. Average pain intensity was calculated as mean of morning pain intensity and evening pain intensity for each baseline and Day 15.
Outcome measures
| Measure |
Hydromorphone OROS
n=82 Participants
Participants received hydromorphone oral osmotic system OROS (8 milligram \[mg\] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator's discretion for additional 84 days of extension phase.
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|---|---|
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Participant's Pain Intensity
Baseline
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5.3 Units on a scale
Standard Deviation 1.7
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Participant's Pain Intensity
Day 15
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4.1 Units on a scale
Standard Deviation 1.8
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SECONDARY outcome
Timeframe: Baseline and Day 15Population: ITT population included all the participants who received at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used. Here 'N' signifies participants who were evaluated for this outcome measure.
The participants recorded the frequency of short acting opioid analgesic taken for treating breakthrough pain among the pains suffered by the participants. Here frequency means number of times the short-acting opioid analgesic administered for breakthrough pain from baseline to Day 15
Outcome measures
| Measure |
Hydromorphone OROS
n=76 Participants
Participants received hydromorphone oral osmotic system OROS (8 milligram \[mg\] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator's discretion for additional 84 days of extension phase.
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|---|---|
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Number of Times the Short-Acting Opioid Analgesic Administered for Breakthrough Pain
Baseline
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0.92 Frequency of breakthrough pain drug
Standard Deviation 1.29
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Number of Times the Short-Acting Opioid Analgesic Administered for Breakthrough Pain
Day 15
|
0.36 Frequency of breakthrough pain drug
Standard Deviation 0.93
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SECONDARY outcome
Timeframe: Baseline and Day 15Population: ITT population included all the participants who received at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used.
The ECOG performance status was used to evaluate participant's disease progression and the effect of the disease on the participant's activities of daily living. ECOG performance status score ranges from Grade 0 to 4, where Grade 0=Fully active, Grade 1=restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, Grade 2=ambulatory and capable of all self-care but unable to carry out any work activities, Grade 3=capable of only limited self-care, confined to bed or chair, and Grade 4=completely disabled.
Outcome measures
| Measure |
Hydromorphone OROS
n=82 Participants
Participants received hydromorphone oral osmotic system OROS (8 milligram \[mg\] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator's discretion for additional 84 days of extension phase.
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|---|---|
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Number of Participants With Each Grade of Eastern Cooperative Oncology Group (ECOG) Performance Status Score
Baseline: Grade 1
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53 Participants
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Number of Participants With Each Grade of Eastern Cooperative Oncology Group (ECOG) Performance Status Score
Baseline: Grade 3
|
4 Participants
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Number of Participants With Each Grade of Eastern Cooperative Oncology Group (ECOG) Performance Status Score
Baseline: Grade 4
|
1 Participants
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Number of Participants With Each Grade of Eastern Cooperative Oncology Group (ECOG) Performance Status Score
Day 15: Grade 1
|
52 Participants
|
|
Number of Participants With Each Grade of Eastern Cooperative Oncology Group (ECOG) Performance Status Score
Day 15: Grade 2
|
22 Participants
|
|
Number of Participants With Each Grade of Eastern Cooperative Oncology Group (ECOG) Performance Status Score
Day 15: Grade 3
|
5 Participants
|
|
Number of Participants With Each Grade of Eastern Cooperative Oncology Group (ECOG) Performance Status Score
Day 15: Grade 4
|
3 Participants
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|
Number of Participants With Each Grade of Eastern Cooperative Oncology Group (ECOG) Performance Status Score
Baseline: Grade 0
|
1 Participants
|
|
Number of Participants With Each Grade of Eastern Cooperative Oncology Group (ECOG) Performance Status Score
Baseline: Grade 2
|
23 Participants
|
SECONDARY outcome
Timeframe: Day 15Population: ITT population included all the participants who received at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used.
The CGI-Improvement score evaluates how much the participant's condition is improved compared to Baseline. The score ranges from 1 to 7, where 1=improved very much, 2=Improved much, 3=Improved a little, 4=No change, 5=Aggravated a little,6=Aggravated much and 7=aggravated very much.
Outcome measures
| Measure |
Hydromorphone OROS
n=82 Participants
Participants received hydromorphone oral osmotic system OROS (8 milligram \[mg\] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator's discretion for additional 84 days of extension phase.
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|---|---|
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Number of Participants With Clinical Global Impression-Improvement (CGI-Improvement) Score
Improved a little
|
37 Participants
|
|
Number of Participants With Clinical Global Impression-Improvement (CGI-Improvement) Score
Improved very much
|
1 Participants
|
|
Number of Participants With Clinical Global Impression-Improvement (CGI-Improvement) Score
Improved much
|
21 Participants
|
|
Number of Participants With Clinical Global Impression-Improvement (CGI-Improvement) Score
No change
|
20 Participants
|
|
Number of Participants With Clinical Global Impression-Improvement (CGI-Improvement) Score
Aggravated a little
|
2 Participants
|
|
Number of Participants With Clinical Global Impression-Improvement (CGI-Improvement) Score
Aggravated much
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 15Population: ITT population included all the participants who received at least one dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used.
Participants evaluated overall efficacy of study drug according to the rating of 1=not effective, 2=average, 3=effective, 4=very effective and 5=extremely effective.
Outcome measures
| Measure |
Hydromorphone OROS
n=82 Participants
Participants received hydromorphone oral osmotic system OROS (8 milligram \[mg\] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator's discretion for additional 84 days of extension phase.
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|---|---|
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Number of Participants in Each Category of Global Assessment of Overall Efficacy of Study Drug Assessed by Participants
Not effective
|
7 Participants
|
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Number of Participants in Each Category of Global Assessment of Overall Efficacy of Study Drug Assessed by Participants
Average
|
29 Participants
|
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Number of Participants in Each Category of Global Assessment of Overall Efficacy of Study Drug Assessed by Participants
Effective
|
38 Participants
|
|
Number of Participants in Each Category of Global Assessment of Overall Efficacy of Study Drug Assessed by Participants
Very effective
|
8 Participants
|
SECONDARY outcome
Timeframe: Day 15Population: ITT population included all the participants who received at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used.
Investigator evaluated overall efficacy of study drug according to the rating of 1=not effective, 2=average, 3=effective, 4=very effective and 5=extremely effective.
Outcome measures
| Measure |
Hydromorphone OROS
n=82 Participants
Participants received hydromorphone oral osmotic system OROS (8 milligram \[mg\] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator's discretion for additional 84 days of extension phase.
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|---|---|
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Number of Participants in Each Category of Global Assessment of Overall Efficacy of Study Drug Assessed by Investigators
Not effective
|
7 Participants
|
|
Number of Participants in Each Category of Global Assessment of Overall Efficacy of Study Drug Assessed by Investigators
Average
|
32 Participants
|
|
Number of Participants in Each Category of Global Assessment of Overall Efficacy of Study Drug Assessed by Investigators
Effective
|
32 Participants
|
|
Number of Participants in Each Category of Global Assessment of Overall Efficacy of Study Drug Assessed by Investigators
Very effective
|
10 Participants
|
|
Number of Participants in Each Category of Global Assessment of Overall Efficacy of Study Drug Assessed by Investigators
Extremely effective
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 15Population: ITT population included all the participants who received at least one dose of study medicaation and had the data on sleep disturbance caused by pain at Day 15. Last observation carried forward (LOCF) was used.
Participant's preferences between the oral long-action opioids analgesic and the study drug was reported.
Outcome measures
| Measure |
Hydromorphone OROS
n=82 Participants
Participants received hydromorphone oral osmotic system OROS (8 milligram \[mg\] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator's discretion for additional 84 days of extension phase.
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|---|---|
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Percentage of Participants Who Preferred the Oral Long-Action Opioids Analgesic or Study Drug
Hydromorphone hydrochloride OROS tablets
|
80.5 Percentage of participants
|
|
Percentage of Participants Who Preferred the Oral Long-Action Opioids Analgesic or Study Drug
Previously administered strong opioid analgesic
|
19.5 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 15Population: ITT population included all the participants who received at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used.
Participants reasons for preference between the long acting oral opioid analgesic and the study drug administered were reported. Reasonos for preferences were "I experienced a certain pain relief effect during the administration of the drug", "I didn't wake up due to pain while sleeping", "It was more convenient because the number of administrations was reduced", "I could reduce the administration of short acting narcotic analgesic to treat breakthrough pain" and "other".
Outcome measures
| Measure |
Hydromorphone OROS
n=82 Participants
Participants received hydromorphone oral osmotic system OROS (8 milligram \[mg\] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator's discretion for additional 84 days of extension phase.
|
|---|---|
|
Percentage of Participants With Different Reasons for Their Preference for Oral Long-Action Opioids Analgesic or Study Drug
Hydromorphone OROS: reduced doses
|
54.6 Percentage of participants
|
|
Percentage of Participants With Different Reasons for Their Preference for Oral Long-Action Opioids Analgesic or Study Drug
Previously administered analgesic: reduced doses
|
12.5 Percentage of participants
|
|
Percentage of Participants With Different Reasons for Their Preference for Oral Long-Action Opioids Analgesic or Study Drug
Hydromorphone OROS: could reduce administration
|
12.1 Percentage of participants
|
|
Percentage of Participants With Different Reasons for Their Preference for Oral Long-Action Opioids Analgesic or Study Drug
Previously taken analgesic: reduce administration
|
0 Percentage of participants
|
|
Percentage of Participants With Different Reasons for Their Preference for Oral Long-Action Opioids Analgesic or Study Drug
Hydromorphone OROS: pain relief
|
1.5 Percentage of participants
|
|
Percentage of Participants With Different Reasons for Their Preference for Oral Long-Action Opioids Analgesic or Study Drug
Previously administered analgesic: pain relief
|
37.5 Percentage of participants
|
|
Percentage of Participants With Different Reasons for Their Preference for Oral Long-Action Opioids Analgesic or Study Drug
Hydromorphone OROS: couldn't wake up
|
31.8 Percentage of participants
|
|
Percentage of Participants With Different Reasons for Their Preference for Oral Long-Action Opioids Analgesic or Study Drug
Previously administered analgesic:couldn
|
50.0 Percentage of participants
|
Adverse Events
Hydromorphone OROS
Serious adverse events
| Measure |
Hydromorphone OROS
n=120 participants at risk
Participants received hydromorphone oral osmotic system OROS (8 milligram \[mg\] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator's discretion for additional 84 days of extension phase.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.83%
1/120 • Baseline up to Day 15
Safety analysis population included all the participants who received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.83%
1/120 • Baseline up to Day 15
Safety analysis population included all the participants who received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Abdominal pain
|
0.83%
1/120 • Baseline up to Day 15
Safety analysis population included all the participants who received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Constipation
|
0.83%
1/120 • Baseline up to Day 15
Safety analysis population included all the participants who received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.83%
1/120 • Baseline up to Day 15
Safety analysis population included all the participants who received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.83%
1/120 • Baseline up to Day 15
Safety analysis population included all the participants who received at least 1 dose of study medication
|
|
Gastrointestinal disorders
ileus
|
0.83%
1/120 • Baseline up to Day 15
Safety analysis population included all the participants who received at least 1 dose of study medication
|
|
General disorders
Pain
|
0.83%
1/120 • Baseline up to Day 15
Safety analysis population included all the participants who received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Cholangitis
|
1.7%
2/120 • Baseline up to Day 15
Safety analysis population included all the participants who received at least 1 dose of study medication
|
|
Infections and infestations
Pneumonia
|
0.83%
1/120 • Baseline up to Day 15
Safety analysis population included all the participants who received at least 1 dose of study medication
|
|
Infections and infestations
Sepsis
|
0.83%
1/120 • Baseline up to Day 15
Safety analysis population included all the participants who received at least 1 dose of study medication
|
|
Infections and infestations
Septic shock
|
1.7%
2/120 • Baseline up to Day 15
Safety analysis population included all the participants who received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.83%
1/120 • Baseline up to Day 15
Safety analysis population included all the participants who received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Shock hypoglycaemic
|
0.83%
1/120 • Baseline up to Day 15
Safety analysis population included all the participants who received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.83%
1/120 • Baseline up to Day 15
Safety analysis population included all the participants who received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.83%
1/120 • Baseline up to Day 15
Safety analysis population included all the participants who received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.83%
1/120 • Baseline up to Day 15
Safety analysis population included all the participants who received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.83%
1/120 • Baseline up to Day 15
Safety analysis population included all the participants who received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.83%
1/120 • Baseline up to Day 15
Safety analysis population included all the participants who received at least 1 dose of study medication
|
|
Nervous system disorders
Depressed level of consciousness
|
0.83%
1/120 • Baseline up to Day 15
Safety analysis population included all the participants who received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.83%
1/120 • Baseline up to Day 15
Safety analysis population included all the participants who received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.83%
1/120 • Baseline up to Day 15
Safety analysis population included all the participants who received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Diarrhoea
|
0.83%
1/120 • Baseline up to Day 15
Safety analysis population included all the participants who received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign breast neoplasm
|
0.83%
1/120 • Baseline up to Day 15
Safety analysis population included all the participants who received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma recurrent
|
0.83%
1/120 • Baseline up to Day 15
Safety analysis population included all the participants who received at least 1 dose of study medication
|
|
Nervous system disorders
Somnolence
|
0.83%
1/120 • Baseline up to Day 15
Safety analysis population included all the participants who received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.83%
1/120 • Baseline up to Day 15
Safety analysis population included all the participants who received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.83%
1/120 • Baseline up to Day 15
Safety analysis population included all the participants who received at least 1 dose of study medication
|
|
General disorders
Disease progression
|
2.5%
3/120 • Baseline up to Day 15
Safety analysis population included all the participants who received at least 1 dose of study medication
|
Other adverse events
| Measure |
Hydromorphone OROS
n=120 participants at risk
Participants received hydromorphone oral osmotic system OROS (8 milligram \[mg\] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator's discretion for additional 84 days of extension phase.
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
41.7%
50/120 • Baseline up to Day 15
Safety analysis population included all the participants who received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Nausea
|
27.5%
33/120 • Baseline up to Day 15
Safety analysis population included all the participants who received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
24/120 • Baseline up to Day 15
Safety analysis population included all the participants who received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Diarrhoea
|
5.8%
7/120 • Baseline up to Day 15
Safety analysis population included all the participants who received at least 1 dose of study medication
|
|
Nervous system disorders
Somnolence
|
50.8%
61/120 • Baseline up to Day 15
Safety analysis population included all the participants who received at least 1 dose of study medication
|
|
Nervous system disorders
Dizziness
|
35.8%
43/120 • Baseline up to Day 15
Safety analysis population included all the participants who received at least 1 dose of study medication
|
|
General disorders
Asthenia
|
37.5%
45/120 • Baseline up to Day 15
Safety analysis population included all the participants who received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
18.3%
22/120 • Baseline up to Day 15
Safety analysis population included all the participants who received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.0%
6/120 • Baseline up to Day 15
Safety analysis population included all the participants who received at least 1 dose of study medication
|
Additional Information
Clinical Research Associate
Medical Affairs
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place