Trial Outcomes & Findings for A Safety and Efficacy Study of Oral Tapentadol Extended-Release in Japanese Participants (NCT NCT01309386)
NCT ID: NCT01309386
Last Updated: 2013-03-13
Results Overview
Pain control was considered to be achieved for participants who met both of the following criteria for any consecutive 3 days during the first week of treatment period: a) Change from baseline of mean 24 hour numerical rating scale (NRS) (an 11-point NRS is used to measure the pain level where 0=no pain to 10=pain as bad as you can imagine) score less than +1.5, and b) when the frequency of rescue medication was twice or less per day.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
100 participants
Primary outcome timeframe
Week 1
Results posted on
2013-03-13
Participant Flow
Participant milestones
| Measure |
Tapentadol ER
Tapentadol extended-release (ER) (JNS024ER) oral tablets 100 to 400 milligram (mg) daily for 8 weeks (maximum dose could be up to 500 mg daily), as per Investigator's discretion.
|
Morphine SR
Morphine sustained-release (SR) oral tablets 30 to 120 mg daily for 8 weeks (maximum dose could be up to 140 mg daily), as per Investigator's discretion.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
28
|
29
|
|
Overall Study
NOT COMPLETED
|
22
|
21
|
Reasons for withdrawal
| Measure |
Tapentadol ER
Tapentadol extended-release (ER) (JNS024ER) oral tablets 100 to 400 milligram (mg) daily for 8 weeks (maximum dose could be up to 500 mg daily), as per Investigator's discretion.
|
Morphine SR
Morphine sustained-release (SR) oral tablets 30 to 120 mg daily for 8 weeks (maximum dose could be up to 140 mg daily), as per Investigator's discretion.
|
|---|---|---|
|
Overall Study
Other
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Progressive disease
|
9
|
11
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Lack of Efficacy
|
3
|
1
|
|
Overall Study
Adverse Event
|
5
|
8
|
Baseline Characteristics
A Safety and Efficacy Study of Oral Tapentadol Extended-Release in Japanese Participants
Baseline characteristics by cohort
| Measure |
Tapentadol ER
n=50 Participants
Tapentadol extended-release (ER) (JNS024ER) oral tablets 100 to 400 milligram (mg) daily for 8 weeks (maximum dose could be up to 500 mg daily), as per Investigator's discretion.
|
Morphine SR
n=50 Participants
Morphine sustained-release (SR) oral tablets 30 to 120 mg daily for 8 weeks (maximum dose could be up to 140 mg daily), as per Investigator's discretion.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Less than 65 years
|
23 Participants
8.5 • n=99 Participants
|
25 Participants
9.97 • n=107 Participants
|
48 Participants
n=206 Participants
|
|
Age, Customized
More than or equal to 65 years
|
27 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Week 1Population: Full analysis set (FAS) population included all participants who were randomly assigned, received at least 1 dose of study drug and had post-baseline efficacy data.
Pain control was considered to be achieved for participants who met both of the following criteria for any consecutive 3 days during the first week of treatment period: a) Change from baseline of mean 24 hour numerical rating scale (NRS) (an 11-point NRS is used to measure the pain level where 0=no pain to 10=pain as bad as you can imagine) score less than +1.5, and b) when the frequency of rescue medication was twice or less per day.
Outcome measures
| Measure |
Tapentadol ER
n=50 Participants
Tapentadol extended-release (ER) (JNS024ER) oral tablets 100 to 400 milligram (mg) daily for 8 weeks (maximum dose could be up to 500 mg daily), as per Investigator's discretion.
|
Morphine SR
n=50 Participants
Morphine sustained-release (SR) oral tablets 30 to 120 mg daily for 8 weeks (maximum dose could be up to 140 mg daily), as per Investigator's discretion.
|
|---|---|---|
|
Percentage of Participants Who Achieved Pain Control
|
84.0 Percentage of Participants
Interval 70.89 to 92.83
|
98.0 Percentage of Participants
Interval 89.35 to 99.95
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8Population: Full analysis set (FAS) population included all participants who were randomly assigned, received at least 1 dose of study drug and had post-baseline efficacy data. Here 'n' signifies those participants evaluable for this measure at the specified time point for each arm group, respectively.
Average pain intensity was assessed using an 11-point NRS to measure the pain level for the past 24-hours where 0=no pain to 10=pain as bad as you can imagine.
Outcome measures
| Measure |
Tapentadol ER
n=50 Participants
Tapentadol extended-release (ER) (JNS024ER) oral tablets 100 to 400 milligram (mg) daily for 8 weeks (maximum dose could be up to 500 mg daily), as per Investigator's discretion.
|
Morphine SR
n=50 Participants
Morphine sustained-release (SR) oral tablets 30 to 120 mg daily for 8 weeks (maximum dose could be up to 140 mg daily), as per Investigator's discretion.
|
|---|---|---|
|
Change From Baseline in Numerical Rating Scale (NRS) at Week 1, 2, 3, 4, 5, 6, 7 and 8
Change at Week 1 (n = 50, 50)
|
0.4 Unit on scale
Standard Deviation 0.92
|
-0.2 Unit on scale
Standard Deviation 0.84
|
|
Change From Baseline in Numerical Rating Scale (NRS) at Week 1, 2, 3, 4, 5, 6, 7 and 8
Change at Week 2 (n = 45, 44)
|
0.3 Unit on scale
Standard Deviation 1.11
|
-0.3 Unit on scale
Standard Deviation 0.75
|
|
Change From Baseline in Numerical Rating Scale (NRS) at Week 1, 2, 3, 4, 5, 6, 7 and 8
Change at Week 3 (n= 41, 41)
|
0.1 Unit on scale
Standard Deviation 0.90
|
-0.1 Unit on scale
Standard Deviation 1.03
|
|
Change From Baseline in Numerical Rating Scale (NRS) at Week 1, 2, 3, 4, 5, 6, 7 and 8
Change at Week 4 (n = 38, 37)
|
0.1 Unit on scale
Standard Deviation 0.90
|
-0.3 Unit on scale
Standard Deviation 0.95
|
|
Change From Baseline in Numerical Rating Scale (NRS) at Week 1, 2, 3, 4, 5, 6, 7 and 8
Change at Week 5 (n = 36, 34)
|
0.1 Unit on scale
Standard Deviation 0.92
|
-0.1 Unit on scale
Standard Deviation 1.22
|
|
Change From Baseline in Numerical Rating Scale (NRS) at Week 1, 2, 3, 4, 5, 6, 7 and 8
Change at Week 6 (n = 36, 32)
|
0.2 Unit on scale
Standard Deviation 0.97
|
0.1 Unit on scale
Standard Deviation 1.43
|
|
Change From Baseline in Numerical Rating Scale (NRS) at Week 1, 2, 3, 4, 5, 6, 7 and 8
Change at Week 7 (n = 34, 29)
|
0.1 Unit on scale
Standard Deviation 1.00
|
0.1 Unit on scale
Standard Deviation 1.05
|
|
Change From Baseline in Numerical Rating Scale (NRS) at Week 1, 2, 3, 4, 5, 6, 7 and 8
Change at Week 8 (n = 29, 29)
|
0.0 Unit on scale
Standard Deviation 0.92
|
0.0 Unit on scale
Standard Deviation 1.21
|
SECONDARY outcome
Timeframe: Baseline up to Week 8Population: Full analysis set (FAS) population included all participants who were randomly assigned, received at least 1 dose of study drug and had post-baseline efficacy data.
Number of participants who discontinued the treatment due to lack of efficacy were assessed throughout the study.
Outcome measures
| Measure |
Tapentadol ER
n=50 Participants
Tapentadol extended-release (ER) (JNS024ER) oral tablets 100 to 400 milligram (mg) daily for 8 weeks (maximum dose could be up to 500 mg daily), as per Investigator's discretion.
|
Morphine SR
n=50 Participants
Morphine sustained-release (SR) oral tablets 30 to 120 mg daily for 8 weeks (maximum dose could be up to 140 mg daily), as per Investigator's discretion.
|
|---|---|---|
|
Number of Participants Who Discontinued Study Treatment Due to Lack of Efficacy
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Week 1, 4 and 8Population: Full analysis set (FAS) population; here 'N' signifies those participants evaluable for this outcome measure and 'n' signifies those participants evaluable for this measure at the specified time point for each arm group, respectively.
The PGIC is a single-item questionnaire designed to provide an overall assessment of treatment from the participant's perspective since the start of the study. It is measured on a 7-point scale, where 1=very much improved and 7=very much worse. A participant is considered a responder if they have a response of "very much improved" or "much improved".
Outcome measures
| Measure |
Tapentadol ER
n=48 Participants
Tapentadol extended-release (ER) (JNS024ER) oral tablets 100 to 400 milligram (mg) daily for 8 weeks (maximum dose could be up to 500 mg daily), as per Investigator's discretion.
|
Morphine SR
n=48 Participants
Morphine sustained-release (SR) oral tablets 30 to 120 mg daily for 8 weeks (maximum dose could be up to 140 mg daily), as per Investigator's discretion.
|
|---|---|---|
|
Number of Participants With Patient Global Impression of Change (PGIC)
Week 1 (very much improved) (n=48,48)
|
1 Participants
|
2 Participants
|
|
Number of Participants With Patient Global Impression of Change (PGIC)
Week 1 (much improved) (n=48,48)
|
1 Participants
|
4 Participants
|
|
Number of Participants With Patient Global Impression of Change (PGIC)
Week 1 (minimally improved) (n=48,48)
|
11 Participants
|
7 Participants
|
|
Number of Participants With Patient Global Impression of Change (PGIC)
Week 1 (not changed) (n=48,48)
|
24 Participants
|
29 Participants
|
|
Number of Participants With Patient Global Impression of Change (PGIC)
Week 1 (minimally worse) (n=48,48)
|
9 Participants
|
6 Participants
|
|
Number of Participants With Patient Global Impression of Change (PGIC)
Week 1 (much worse) (n=48,48)
|
2 Participants
|
0 Participants
|
|
Number of Participants With Patient Global Impression of Change (PGIC)
Week 1 (very much worse) (n=48,48)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Patient Global Impression of Change (PGIC)
Week 4 (very much improved) (n=37,37)
|
1 Participants
|
3 Participants
|
|
Number of Participants With Patient Global Impression of Change (PGIC)
Week 4 (much improved) (n=37,37)
|
2 Participants
|
5 Participants
|
|
Number of Participants With Patient Global Impression of Change (PGIC)
Week 4 (minimally improved) (n=37,37)
|
9 Participants
|
7 Participants
|
|
Number of Participants With Patient Global Impression of Change (PGIC)
Week 4 (not changed) (n=37,37)
|
22 Participants
|
19 Participants
|
|
Number of Participants With Patient Global Impression of Change (PGIC)
Week 4 (minimally worse) (n=37,37)
|
3 Participants
|
3 Participants
|
|
Number of Participants With Patient Global Impression of Change (PGIC)
Week 4 (much worse) (n=37,37)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Patient Global Impression of Change (PGIC)
Week 4 (very much worse) (n=37,37)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Patient Global Impression of Change (PGIC)
Week 8 (very much improved) (n=28,28)
|
0 Participants
|
3 Participants
|
|
Number of Participants With Patient Global Impression of Change (PGIC)
Week 8 (much improved) (n=28,28)
|
3 Participants
|
2 Participants
|
|
Number of Participants With Patient Global Impression of Change (PGIC)
Week 8 (minimally improved) (n=28,28)
|
8 Participants
|
4 Participants
|
|
Number of Participants With Patient Global Impression of Change (PGIC)
Week 8 (not changed) (n=28,28)
|
15 Participants
|
13 Participants
|
|
Number of Participants With Patient Global Impression of Change (PGIC)
Week 8 (minimally worse) (n=28,28)
|
2 Participants
|
4 Participants
|
|
Number of Participants With Patient Global Impression of Change (PGIC)
Week 8 (much worse) (n=28,28)
|
0 Participants
|
2 Participants
|
|
Number of Participants With Patient Global Impression of Change (PGIC)
Week 8 (very much worse) (n=28,28)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 8Population: Full analysis set (FAS) population included all participants who were randomly assigned, received at least 1 dose of study drug and had post-baseline efficacy data.
Total number of days of rescue medication over time were assessed. Rescue medications are medicines that are administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation. Supplemental analgesics (drug used to control pain) were used as rescue medication.
Outcome measures
| Measure |
Tapentadol ER
n=50 Participants
Tapentadol extended-release (ER) (JNS024ER) oral tablets 100 to 400 milligram (mg) daily for 8 weeks (maximum dose could be up to 500 mg daily), as per Investigator's discretion.
|
Morphine SR
n=50 Participants
Morphine sustained-release (SR) oral tablets 30 to 120 mg daily for 8 weeks (maximum dose could be up to 140 mg daily), as per Investigator's discretion.
|
|---|---|---|
|
Total Number of Days of Rescue Medication Over Time
|
15.9 Days
Standard Deviation 19.58
|
9.2 Days
Standard Deviation 12.76
|
SECONDARY outcome
Timeframe: Baseline up to Week 8Population: Full analysis set (FAS) population included all participants who were randomly assigned, received at least 1 dose of study drug and had post-baseline efficacy data.
Number of doses of rescue medication over time were assessed. Rescue medications are medicines that are administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation. Supplemental analgesics (drug used to control pain) were used as rescue medication.
Outcome measures
| Measure |
Tapentadol ER
n=50 Participants
Tapentadol extended-release (ER) (JNS024ER) oral tablets 100 to 400 milligram (mg) daily for 8 weeks (maximum dose could be up to 500 mg daily), as per Investigator's discretion.
|
Morphine SR
n=50 Participants
Morphine sustained-release (SR) oral tablets 30 to 120 mg daily for 8 weeks (maximum dose could be up to 140 mg daily), as per Investigator's discretion.
|
|---|---|---|
|
Number of Doses of Rescue Medication Over Time
|
0.7 Morphine-equivalent doses
Standard Deviation 0.89
|
0.4 Morphine-equivalent doses
Standard Deviation 0.53
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8Population: Full analysis set (FAS) population included all participants who were randomly assigned, received at least 1 dose of study drug and had post-baseline efficacy data.
Rescue medications are medicines that are administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation. Supplemental analgesics (drug used to control pain) were used as rescue medication. Average amount was the averages of all doses recorded during the baseline period or during each week (Week 1, 2, 3, 4, 5, 6, 7 and 8).
Outcome measures
| Measure |
Tapentadol ER
n=50 Participants
Tapentadol extended-release (ER) (JNS024ER) oral tablets 100 to 400 milligram (mg) daily for 8 weeks (maximum dose could be up to 500 mg daily), as per Investigator's discretion.
|
Morphine SR
n=50 Participants
Morphine sustained-release (SR) oral tablets 30 to 120 mg daily for 8 weeks (maximum dose could be up to 140 mg daily), as per Investigator's discretion.
|
|---|---|---|
|
Average Change From Baseline in Amount of Rescue Medication Over Time
|
3.02 Milligram (mg)
Standard Deviation 8.303
|
-0.15 Milligram (mg)
Standard Deviation 5.038
|
Adverse Events
Tapentadol ER
Serious events: 16 serious events
Other events: 43 other events
Deaths: 0 deaths
Morphine SR
Serious events: 16 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tapentadol ER
n=50 participants at risk
Tapentadol extended-release (ER) (JNS024ER) oral tablets 100 to 400 milligram (mg) daily for 8 weeks (maximum dose could be up to 500 mg daily), as per Investigator's discretion.
|
Morphine SR
n=50 participants at risk
Morphine sustained-release (SR) oral tablets 30 to 120 mg daily for 8 weeks (maximum dose could be up to 140 mg daily), as per Investigator's discretion.
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
2.0%
1/50
|
0.00%
0/50
|
|
Infections and infestations
Urinary tract infection
|
2.0%
1/50
|
0.00%
0/50
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
2.0%
1/50
|
2.0%
1/50
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
2.0%
1/50
|
0.00%
0/50
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.0%
1/50
|
2.0%
1/50
|
|
Nervous system disorders
Dyskinesia
|
2.0%
1/50
|
0.00%
0/50
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
2.0%
1/50
|
0.00%
0/50
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
1/50
|
6.0%
3/50
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
2.0%
1/50
|
0.00%
0/50
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/50
|
2.0%
1/50
|
|
Hepatobiliary disorders
Cholangitis
|
2.0%
1/50
|
0.00%
0/50
|
|
Reproductive system and breast disorders
Genital haemorrhage
|
0.00%
0/50
|
2.0%
1/50
|
|
General disorders
Disease progression
|
20.0%
10/50
|
20.0%
10/50
|
|
General disorders
Condition aggravated
|
0.00%
0/50
|
2.0%
1/50
|
|
General disorders
Malaise
|
2.0%
1/50
|
0.00%
0/50
|
|
Injury, poisoning and procedural complications
Fall
|
4.0%
2/50
|
0.00%
0/50
|
Other adverse events
| Measure |
Tapentadol ER
n=50 participants at risk
Tapentadol extended-release (ER) (JNS024ER) oral tablets 100 to 400 milligram (mg) daily for 8 weeks (maximum dose could be up to 500 mg daily), as per Investigator's discretion.
|
Morphine SR
n=50 participants at risk
Morphine sustained-release (SR) oral tablets 30 to 120 mg daily for 8 weeks (maximum dose could be up to 140 mg daily), as per Investigator's discretion.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
2.0%
1/50
|
2.0%
1/50
|
|
Infections and infestations
Pneumonia
|
2.0%
1/50
|
2.0%
1/50
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/50
|
2.0%
1/50
|
|
Infections and infestations
Cellulitis
|
0.00%
0/50
|
2.0%
1/50
|
|
Infections and infestations
Oral candidiasis
|
2.0%
1/50
|
0.00%
0/50
|
|
Infections and infestations
Paronychia
|
2.0%
1/50
|
0.00%
0/50
|
|
Infections and infestations
Rhinitis
|
2.0%
1/50
|
0.00%
0/50
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/50
|
2.0%
1/50
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
2.0%
1/50
|
0.00%
0/50
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to skin
|
2.0%
1/50
|
0.00%
0/50
|
|
Blood and lymphatic system disorders
Anaemia
|
8.0%
4/50
|
2.0%
1/50
|
|
Blood and lymphatic system disorders
Leukopenia
|
4.0%
2/50
|
2.0%
1/50
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.0%
2/50
|
2.0%
1/50
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.00%
0/50
|
2.0%
1/50
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.0%
1/50
|
0.00%
0/50
|
|
Psychiatric disorders
Insomnia
|
8.0%
4/50
|
0.00%
0/50
|
|
Psychiatric disorders
Delirium
|
0.00%
0/50
|
2.0%
1/50
|
|
Psychiatric disorders
Generalised anxiety disorder
|
0.00%
0/50
|
2.0%
1/50
|
|
Psychiatric disorders
Senile psychosis
|
2.0%
1/50
|
0.00%
0/50
|
|
Psychiatric disorders
Adjustment disorder
|
2.0%
1/50
|
0.00%
0/50
|
|
Nervous system disorders
Somnolence
|
16.0%
8/50
|
20.0%
10/50
|
|
Nervous system disorders
Headache
|
2.0%
1/50
|
8.0%
4/50
|
|
Nervous system disorders
Dizziness
|
4.0%
2/50
|
2.0%
1/50
|
|
Nervous system disorders
Lethargy
|
4.0%
2/50
|
0.00%
0/50
|
|
Nervous system disorders
Neuropathy peripheral
|
4.0%
2/50
|
0.00%
0/50
|
|
Nervous system disorders
Autonomic nervous system imbalance
|
2.0%
1/50
|
0.00%
0/50
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/50
|
2.0%
1/50
|
|
Nervous system disorders
Dysgeusia
|
2.0%
1/50
|
0.00%
0/50
|
|
Nervous system disorders
Hypoaesthesia
|
2.0%
1/50
|
0.00%
0/50
|
|
Nervous system disorders
Muscle contractions involuntary
|
2.0%
1/50
|
0.00%
0/50
|
|
Nervous system disorders
Slow response to stimuli
|
0.00%
0/50
|
2.0%
1/50
|
|
Nervous system disorders
Vocal cord paralysis
|
2.0%
1/50
|
0.00%
0/50
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/50
|
2.0%
1/50
|
|
Eye disorders
Diplopia
|
2.0%
1/50
|
0.00%
0/50
|
|
Eye disorders
Visual impairment
|
2.0%
1/50
|
0.00%
0/50
|
|
Ear and labyrinth disorders
Motion sickness
|
2.0%
1/50
|
0.00%
0/50
|
|
Cardiac disorders
Angina pectoris
|
2.0%
1/50
|
0.00%
0/50
|
|
Vascular disorders
Hypertension
|
0.00%
0/50
|
2.0%
1/50
|
|
Vascular disorders
Hypotension
|
0.00%
0/50
|
2.0%
1/50
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/50
|
2.0%
1/50
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.0%
2/50
|
0.00%
0/50
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/50
|
2.0%
1/50
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
0.00%
0/50
|
2.0%
1/50
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/50
|
2.0%
1/50
|
|
Gastrointestinal disorders
Constipation
|
12.0%
6/50
|
20.0%
10/50
|
|
Gastrointestinal disorders
Nausea
|
14.0%
7/50
|
14.0%
7/50
|
|
Gastrointestinal disorders
Vomiting
|
4.0%
2/50
|
22.0%
11/50
|
|
Gastrointestinal disorders
Diarrhoea
|
6.0%
3/50
|
8.0%
4/50
|
|
Gastrointestinal disorders
Stomatitis
|
4.0%
2/50
|
2.0%
1/50
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/50
|
2.0%
1/50
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/50
|
2.0%
1/50
|
|
Gastrointestinal disorders
Gastric ulcer
|
2.0%
1/50
|
0.00%
0/50
|
|
Gastrointestinal disorders
Hiatus hernia
|
2.0%
1/50
|
0.00%
0/50
|
|
Gastrointestinal disorders
Lip dry
|
2.0%
1/50
|
0.00%
0/50
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/50
|
2.0%
1/50
|
|
Gastrointestinal disorders
Periodontitis
|
0.00%
0/50
|
2.0%
1/50
|
|
Gastrointestinal disorders
Toothache
|
2.0%
1/50
|
0.00%
0/50
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
2.0%
1/50
|
2.0%
1/50
|
|
Hepatobiliary disorders
Cholangitis
|
2.0%
1/50
|
0.00%
0/50
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.0%
1/50
|
8.0%
4/50
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
4.0%
2/50
|
2.0%
1/50
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/50
|
6.0%
3/50
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.0%
1/50
|
2.0%
1/50
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.0%
1/50
|
0.00%
0/50
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
2.0%
1/50
|
0.00%
0/50
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/50
|
2.0%
1/50
|
|
Skin and subcutaneous tissue disorders
Skin erosion
|
2.0%
1/50
|
0.00%
0/50
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.0%
1/50
|
0.00%
0/50
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
2.0%
1/50
|
0.00%
0/50
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.0%
1/50
|
2.0%
1/50
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.0%
1/50
|
0.00%
0/50
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/50
|
2.0%
1/50
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/50
|
2.0%
1/50
|
|
Renal and urinary disorders
Haematuria
|
2.0%
1/50
|
2.0%
1/50
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/50
|
4.0%
2/50
|
|
Renal and urinary disorders
Chromaturia
|
2.0%
1/50
|
0.00%
0/50
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/50
|
2.0%
1/50
|
|
Renal and urinary disorders
Hydronephrosis
|
2.0%
1/50
|
0.00%
0/50
|
|
Renal and urinary disorders
Urobilinuria
|
0.00%
0/50
|
2.0%
1/50
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
2.0%
1/50
|
0.00%
0/50
|
|
Reproductive system and breast disorders
Vaginal discharge
|
2.0%
1/50
|
0.00%
0/50
|
|
General disorders
Pyrexia
|
6.0%
3/50
|
8.0%
4/50
|
|
General disorders
Disease progression
|
18.0%
9/50
|
16.0%
8/50
|
|
General disorders
Chest pain
|
0.00%
0/50
|
2.0%
1/50
|
|
General disorders
Feeling abnormal
|
2.0%
1/50
|
0.00%
0/50
|
|
General disorders
Catheter site haemorrhage
|
2.0%
1/50
|
0.00%
0/50
|
|
General disorders
Catheter site pain
|
2.0%
1/50
|
0.00%
0/50
|
|
General disorders
Catheter site swelling
|
2.0%
1/50
|
0.00%
0/50
|
|
Investigations
Gamma-glutamyltransferase increased
|
2.0%
1/50
|
8.0%
4/50
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/50
|
4.0%
2/50
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/50
|
4.0%
2/50
|
|
Investigations
Blood creatine phosphokinase increased
|
2.0%
1/50
|
2.0%
1/50
|
|
Investigations
Blood lactate dehydrogenase increased
|
2.0%
1/50
|
2.0%
1/50
|
|
Investigations
Blood triglycerides increased
|
2.0%
1/50
|
2.0%
1/50
|
|
Investigations
Glucose urine present
|
0.00%
0/50
|
4.0%
2/50
|
|
Investigations
Neutrophil count increased
|
0.00%
0/50
|
4.0%
2/50
|
|
Investigations
Platelet count decreased
|
2.0%
1/50
|
2.0%
1/50
|
|
Investigations
Protein urine present
|
0.00%
0/50
|
4.0%
2/50
|
|
Investigations
Blood urea increased
|
0.00%
0/50
|
2.0%
1/50
|
|
Investigations
Differential white blood cell count abnormal
|
0.00%
0/50
|
2.0%
1/50
|
|
Investigations
Blood urine present
|
2.0%
1/50
|
0.00%
0/50
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/50
|
2.0%
1/50
|
|
Investigations
White blood cell count decreased
|
2.0%
1/50
|
0.00%
0/50
|
|
Investigations
Platelet count increased
|
0.00%
0/50
|
2.0%
1/50
|
|
Investigations
Urine output decreased
|
2.0%
1/50
|
0.00%
0/50
|
|
Injury, poisoning and procedural complications
Fall
|
4.0%
2/50
|
2.0%
1/50
|
|
Injury, poisoning and procedural complications
Post gastric surgery syndrome
|
0.00%
0/50
|
2.0%
1/50
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/50
|
2.0%
1/50
|
|
Injury, poisoning and procedural complications
Post procedural haematuria
|
0.00%
0/50
|
2.0%
1/50
|
|
General disorders
Malaise
|
6.0%
3/50
|
0.00%
0/50
|
|
Investigations
Blood alkaline phosphatase increased
|
2.0%
1/50
|
4.0%
2/50
|
|
Investigations
Weight decreased
|
0.00%
0/50
|
2.0%
1/50
|
Additional Information
Manager
Neuroscience department, Clinical science department, R&D in Janssen, Chiyodaku, Tokyo 101-0065, Japan
Phone: +81-3-4411-5509
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER