Percentage of participants with decrease in dosing frequency by 33 percent or more in breakthrough pain (acute pain that comes on rapidly despite the use of pain medication) was determined at final visit (Day 15) compared to Baseline (Day 1 - when the administration of study drug was started).

The intent-to-treat (ITT) analysis population included all the participants who received at least 1 dose of study drug and had available data in the dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. Last observation carried forward (LOCF) was used.

Frequency of experiencing 3 types of breakthrough pain: Idiopathic pain (pain of unknown cause), incidental pain (pain that arises as a result of activity, such as movement of an arthritic joint, stretching a wound) and end-of-dose failure pain was reported.

The ITT analysis population included all the as participants who received at least 1 dose of study drug and had available data in the dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. LOCF was used.

K-BPI is an inventory designed to measure the degree of pain severity and the impact of pain in performing daily routines. K-BPI comprises of total 9 items in total, and the ninth item consisting of 7 sub-items is a question asking the degree of disturbance due to pain. The score ranges from 0 to 10, where 0=no pain, 1 to 4=mild pain, 5 to 6=moderate pain and 7 to 10=severe pain.

The ITT analysis population included all the participants who received at least 1 dose of study drug and had available data in the dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. LOCF was used.

Average Pain intensity score experienced by Participant over the last 24 hours of Day 3 and Day 13 was recorded. Pain intensity was measured using numerical rating scale (NRS) ranging from 0=no pain to 10=most severe pain.

The ITT analysis population included all the participants who received at least 1 dose of study drug and had available data in the dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. LOCF was used. Here 'n' signifies participants evaluable for this outcome measure at given time point.

Investigator evaluated overall efficacy of study drug and the responses were categorized as: 'ineffective response', 'average response', 'effective response', 'very effectiveresponse', and 'highly effective response'.

The ITT analysis population included all the participants who received at least 1 dose of study drug and had available data in the dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. LOCF was used. Here "N" signifies participants evaluated for this outcome measure.

Participants evaluated overall efficacy of study drug and the responses were categorized as: 'ineffective response', 'average response', 'effective response', 'very effectiveresponse', and 'highly effective response'.

The ITT analysis population included all the participants who received at least 1 dose of study drug and had available data in the dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. LOCF was used. Here "N" signifies participants evaluated for this outcome measure.

The number of participants who preferred oral long-acting narcotic analgesics or previously administered oral opioid analgesic were reported along with detailed and specific reasons such as consistent analgesic effect during administration, sleep undisturbed by pain, reduced intake of medication frequency, reduce intake of immediate-release opioid analgesic for breakthrough pain treatment, other and no response, for their preferences. Same participant may have multiple reason for their preference.

The ITT analysis population included all participants who received at least 1 dose of study drug and had available data in dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. LOCF was used. Here 'N'=participants evaluated for this outcome measure and 'n'=participants who took hydromorphone OROS/oral opioid.

Investigators evaluated the overall improvement of the participant's condition using CGI scale. The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=greatly improved; 2=somewhat improved; 3=slightly improved; 4=no change; 5=slightly aggravated ; 6=somewhat aggravated; 7=greatly aggarvated.

The ITT analysis population included all the participants who received at least 1 dose of study drug and had available data in the dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. LOCF was used. Here 'N'=participants evaluated for this outcome measure.

EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties) which are based on 4-point scale (1=Not at all to 4=Very much); and global health status and quality of life scale based on 7-point scale (1=very poor to 7=Excellent). All scales and items are averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptomatology or problems.

The ITT analysis population included all the participants who received at least 1 dose of study drug and had available data in the dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. LOCF was used. Here 'n' signifies participants evaluable for this outcome measure at given time point.