Trial Outcomes & Findings for A Long-term Efficacy and Safety Study of Tramadol Hydrochloride Plus Acetaminophen (JNS013) in Japanese Participants With Chronic Pain (NCT NCT00736957)
NCT ID: NCT00736957
Last Updated: 2014-07-02
Results Overview
Pain over the last 24 hours was assessed by using VAS score ranges from 0 millimeter (mm)=no pain to 100 mm=worst possible pain. An increase in score from baseline represented disease progression and decrease represented improvement.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
219 participants
Primary outcome timeframe
Baseline and Week 4
Results posted on
2014-07-02
Participant Flow
219 participants were enrolled in this study out of which 29 participants did not meet the criteria to transfer to treatment period 1.
Participant milestones
| Measure |
Tramadol Hydrochloride Plus Acetaminophen (JNS013)
Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.
|
|---|---|
|
Overall Study
STARTED
|
219
|
|
Overall Study
Treated
|
190
|
|
Overall Study
COMPLETED
|
97
|
|
Overall Study
NOT COMPLETED
|
122
|
Reasons for withdrawal
| Measure |
Tramadol Hydrochloride Plus Acetaminophen (JNS013)
Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.
|
|---|---|
|
Overall Study
Adverse Event
|
43
|
|
Overall Study
Withdrawal by Subject
|
49
|
|
Overall Study
violation of eligibility criteria
|
2
|
|
Overall Study
did not attend hospital appointments
|
1
|
|
Overall Study
not eligible for Treatment Period I
|
22
|
|
Overall Study
Physician Decision
|
5
|
Baseline Characteristics
A Long-term Efficacy and Safety Study of Tramadol Hydrochloride Plus Acetaminophen (JNS013) in Japanese Participants With Chronic Pain
Baseline characteristics by cohort
| Measure |
Tramadol Hydrochloride Plus Acetaminophen (JNS013)
n=190 Participants
Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.
|
|---|---|
|
Age, Continuous
|
64.3 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
106 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
84 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 4Population: Full analysis set included all participants who met the eligibility criteria, received study medication and had at least one post-treatment efiicacy assessment.
Pain over the last 24 hours was assessed by using VAS score ranges from 0 millimeter (mm)=no pain to 100 mm=worst possible pain. An increase in score from baseline represented disease progression and decrease represented improvement.
Outcome measures
| Measure |
Tramadol Hydrochloride Plus Acetaminophen (JNS013)
n=190 Participants
Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.
|
|---|---|
|
Change From Baseline in Visual Analogue Scale (VAS24) Score at Week 4
Baseline
|
65.80 millimeter
Standard Deviation 11.629
|
|
Change From Baseline in Visual Analogue Scale (VAS24) Score at Week 4
Change at Week 4
|
-22.28 millimeter
Standard Deviation 21.189
|
PRIMARY outcome
Timeframe: Baseline and Week 52Population: Full analysis set included all participants who met the eligibility criteria, received study medication and had at least one post-treatment efiicacy assessment.
Pain over the last 24 hours was assessed by using VAS score ranges from 0 mm=no pain to 100 mm=worst possible pain. An increase in score from baseline represented disease progression and decrease represented improvement.
Outcome measures
| Measure |
Tramadol Hydrochloride Plus Acetaminophen (JNS013)
n=190 Participants
Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.
|
|---|---|
|
Change From Baseline in VAS24 Score at Week 52
Baseline
|
65.80 millimeter
Standard Deviation 11.629
|
|
Change From Baseline in VAS24 Score at Week 52
Change at Week 52
|
-36.54 millimeter
Standard Deviation 21.936
|
SECONDARY outcome
Timeframe: Week 4 and 52Population: Full analysis set included all participants who met the eligibility criteria, received study medication and had at least one post-treatment efiicacy assessment. Last Observation Carried Forward (LOCF) method was used.
Pain over the last 24 hours was assessed by using VAS score ranges from 0 mm=no pain to 100 mm=worst possible pain. An increase in score from baseline represented disease progression and decrease represented improvement.
Outcome measures
| Measure |
Tramadol Hydrochloride Plus Acetaminophen (JNS013)
n=190 Participants
Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.
|
|---|---|
|
Number of Participants With Improvement From Baseline in VAS24 Score
Improvement of 30 percent or more at Week 4
|
76 participants
|
|
Number of Participants With Improvement From Baseline in VAS24 Score
Improvement of 50 percent or more at Week 4
|
51 participants
|
|
Number of Participants With Improvement From Baseline in VAS24 Score
Improvement of 30 percent or more at Week 52
|
110 participants
|
|
Number of Participants With Improvement From Baseline in VAS24 Score
Improvement of 50 percent or more at Week 52
|
77 participants
|
SECONDARY outcome
Timeframe: Week 4Population: Full analysis set included all participants who met the eligibility criteria, received study medication and had at least one post-treatment efiicacy assessment. Participants showing a Pain Intensity (PI) value of 0 prior to dosing at each evaluation time point were not included in the analysis.
PID is defined as the amount of change in the pain intensity at each evaluation time point (at 2 and 4 hours after the study drug dosing) from the baseline for each participant. Pain Intensity was evaluated on a 4-stage scale ranging from 3=severe pain to 0=no pain. PID ranges from -3 (the worst) to +3 (the most improved).
Outcome measures
| Measure |
Tramadol Hydrochloride Plus Acetaminophen (JNS013)
n=135 Participants
Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.
|
|---|---|
|
Pain Intensity Difference (PID) at Week 4
2 hours after dosing at Week 4
|
0.1 units on a scale
Standard Deviation 0.35
|
|
Pain Intensity Difference (PID) at Week 4
4 hours after dosing at Week 4
|
0.1 units on a scale
Standard Deviation 0.44
|
SECONDARY outcome
Timeframe: Week 4Population: Full analysis set included all participants who met the eligibility criteria, received study medication and had at least one post-treatment efiicacy assessment. Participants showing a Pain Intensity (PI) value of 0 prior to dosing at each evaluation time point were not included in the analysis.
Pain relief was evaluated based on a 5-stage scale from 4 (complete relief) to 0 (no relief). An increase in score represented improvement and decrease represented disease progression
Outcome measures
| Measure |
Tramadol Hydrochloride Plus Acetaminophen (JNS013)
n=135 Participants
Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.
|
|---|---|
|
Pain Relief (PAR) Score at Week 4
2 hours after dosing at Week 4
|
1.3 units on a scale
Standard Deviation 0.91
|
|
Pain Relief (PAR) Score at Week 4
4 hours after dosing at Week 4
|
1.3 units on a scale
Standard Deviation 0.99
|
SECONDARY outcome
Timeframe: Week 4Population: Full analysis set included all participants who met the eligibility criteria, received study medication and had at least one post-treatment efiicacy assessment. Participants showing a Pain Intensity (PI) value of 0 prior to dosing at each evaluation time point were not included in the analysis.
PRID was sum of the PID and PAR for each participant at each evaluation time point (2 hours after dosing, 4 hours after dosing). Pain Intensity was evaluated on a 4-stage scale ranges from 3=severe pain to 0=no pain and PID ranges from -3 (the worst) to +3 (the most improved). PAR ranges from 0 (no improved) to +4 (the most improved). PRID ranges from -3 (the worst) to +7 (the most improved).
Outcome measures
| Measure |
Tramadol Hydrochloride Plus Acetaminophen (JNS013)
n=135 Participants
Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.
|
|---|---|
|
Pain Relief Combined With Pain Intensity Difference (PRID) at Week 4
2 hours after dosing at Week 4
|
1.3 units on scale
Standard Deviation 1.06
|
|
Pain Relief Combined With Pain Intensity Difference (PRID) at Week 4
4 hours after dosing at Week 4
|
1.4 units on scale
Standard Deviation 1.20
|
SECONDARY outcome
Timeframe: Baseline, Week 4 and 52Population: Full analysis set included all participants who met the eligibility criteria, received study medication and had at least one post-treatment efiicacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure and n = the number of participants with measurements for that time point.
SF-36 is a metric for general health and Quality of Life (QOL), consists of 8 sub-scale indices related to health and QOL (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, mental health). Each of the sub-scale scores ranged from 0 to 100, where higher values indicate a better health status or a better mental status.
Outcome measures
| Measure |
Tramadol Hydrochloride Plus Acetaminophen (JNS013)
n=190 Participants
Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.
|
|---|---|
|
Change From Baseline in Short Form-36 (SF-36) Score
Physical functioning:Baseline
|
33.7 units on a scale
Standard Deviation 17.03
|
|
Change From Baseline in Short Form-36 (SF-36) Score
Physical functioning:Change at Week 4 (n=150)
|
2.9 units on a scale
Standard Deviation 9.06
|
|
Change From Baseline in Short Form-36 (SF-36) Score
Physical functioning:Change at Week 52 (n=96)
|
4.1 units on a scale
Standard Deviation 12.00
|
|
Change From Baseline in Short Form-36 (SF-36) Score
Role-physical:Baseline
|
35.0 units on a scale
Standard Deviation 15.43
|
|
Change From Baseline in Short Form-36 (SF-36) Score
Role-physical:Change at Week 4 (n=150)
|
3.2 units on a scale
Standard Deviation 11.51
|
|
Change From Baseline in Short Form-36 (SF-36) Score
Role-physical:Change at Week 52 (n=96)
|
6.0 units on a scale
Standard Deviation 13.76
|
|
Change From Baseline in Short Form-36 (SF-36) Score
Bodily pain:Baseline
|
33.7 units on a scale
Standard Deviation 6.70
|
|
Change From Baseline in Short Form-36 (SF-36) Score
Bodily pain:Change at Week 4 (n=150)
|
5.5 units on a scale
Standard Deviation 7.12
|
|
Change From Baseline in Short Form-36 (SF-36) Score
Bodily pain:Change at Week 52 (n=96)
|
9.0 units on a scale
Standard Deviation 8.74
|
|
Change From Baseline in Short Form-36 (SF-36) Score
General health:Baseline
|
42.1 units on a scale
Standard Deviation 10.42
|
|
Change From Baseline in Short Form-36 (SF-36) Score
General health:Change at Week 4 (n=150)
|
1.5 units on a scale
Standard Deviation 7.74
|
|
Change From Baseline in Short Form-36 (SF-36) Score
General health:Change at Week 52 (n=96)
|
3.9 units on a scale
Standard Deviation 8.92
|
|
Change From Baseline in Short Form-36 (SF-36) Score
Vitality:Baseline
|
44.0 units on a scale
Standard Deviation 9.82
|
|
Change From Baseline in Short Form-36 (SF-36) Score
Vitality:Change at Week 4 (n=150)
|
2.1 units on a scale
Standard Deviation 8.37
|
|
Change From Baseline in Short Form-36 (SF-36) Score
Vitality:Change at Week 52 (n=96)
|
4.9 units on a scale
Standard Deviation 9.38
|
|
Change From Baseline in Short Form-36 (SF-36) Score
Social functioning:Baseline
|
41.0 units on a scale
Standard Deviation 13.61
|
|
Change From Baseline in Short Form-36 (SF-36) Score
Social functioning:Change at Week 4 (n=150)
|
2.7 units on a scale
Standard Deviation 11.36
|
|
Change From Baseline in Short Form-36 (SF-36) Score
Social functioning:Change at Week 52 (n=96)
|
6.0 units on a scale
Standard Deviation 11.57
|
|
Change From Baseline in Short Form-36 (SF-36) Score
Role-emotional:Baseline
|
39.4 units on a scale
Standard Deviation 14.97
|
|
Change From Baseline in Short Form-36 (SF-36) Score
Role-emotional:Change at Week 4 (n=150)
|
2.6 units on a scale
Standard Deviation 12.43
|
|
Change From Baseline in Short Form-36 (SF-36) Score
Role-emotional:Change at Week 52 (n=96)
|
5.2 units on a scale
Standard Deviation 14.44
|
|
Change From Baseline in Short Form-36 (SF-36) Score
Mental health:Baseline
|
43.9 units on a scale
Standard Deviation 11.50
|
|
Change From Baseline in Short Form-36 (SF-36) Score
Mental health:Change at Week 4 (n=150)
|
2.5 units on a scale
Standard Deviation 8.73
|
|
Change From Baseline in Short Form-36 (SF-36) Score
Mental health:Change at Week 52 (n=96)
|
5.5 units on a scale
Standard Deviation 10.11
|
Adverse Events
Tramadol Hydrochloride Plus Acetaminophen (JNS013)
Serious events: 24 serious events
Other events: 189 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tramadol Hydrochloride Plus Acetaminophen (JNS013)
n=190 participants at risk
Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.
|
|---|---|
|
Infections and infestations
Bronchitis
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Infections and infestations
Gastroenteritis
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Infections and infestations
Pyelonephritis
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Nervous system disorders
Cerebral infarction
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Nervous system disorders
Diabetic autonomic nerve neuropathy
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Nervous system disorders
Dizziness
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Nervous system disorders
Loss of consciousness
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Ear and labyrinth disorders
Sudden deafness
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Cardiac disorders
Prinzmetal's angina
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Vascular disorders
Arteriosclerosis obliterans
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Gastrointestinal disorders
Vomiting
|
1.6%
3/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Gastrointestinal disorders
Colon polyps
|
1.1%
2/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Gastrointestinal disorders
Nausea
|
1.1%
2/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Gastrointestinal disorders
Ileus
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Gastrointestinal disorders
Melena
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Gastrointestinal disorders
Upper gastrointestinal tract hemorrhage
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal canal stenosis
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Musculoskeletal and connective tissue disorders
Ossification of the spinal ligaments
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Renal and urinary disorders
Ureteral calculus
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Renal and urinary disorders
Dysuria
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Renal and urinary disorders
Ureteropathy
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Injury, poisoning and procedural complications
Fall/tumble
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Injury, poisoning and procedural complications
Open fracture
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Injury, poisoning and procedural complications
Subdural hematoma
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
Other adverse events
| Measure |
Tramadol Hydrochloride Plus Acetaminophen (JNS013)
n=190 participants at risk
Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
25.8%
49/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Infections and infestations
Gastroenteritis
|
2.6%
5/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Infections and infestations
Cystitis
|
2.1%
4/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Infections and infestations
Pharyngitis
|
2.1%
4/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Infections and infestations
Oral herpes
|
2.1%
4/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Infections and infestations
Bronchitis
|
1.1%
2/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Infections and infestations
Rhinitis
|
1.1%
2/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Infections and infestations
Tinea pedis
|
1.1%
2/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Infections and infestations
Bronchiectasis
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Infections and infestations
Furuncle
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Infections and infestations
Gastrointestinal candidiasis
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Infections and infestations
Herpes zoster
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Infections and infestations
Influenza
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Infections and infestations
Onychomycosis
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Infections and infestations
Paronychia
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Infections and infestations
Urinary tract infection
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Infections and infestations
Helicobacter infection
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Infections and infestations
Tinea infection
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Infections and infestations
Oral fungal infection
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Infections and infestations
Purulence
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Blood and lymphatic system disorders
Anaemia
|
3.7%
7/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Immune system disorders
Seasonal allergy
|
1.6%
3/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Metabolism and nutrition disorders
Anorexia
|
8.9%
17/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
4.7%
9/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
2.1%
4/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Metabolism and nutrition disorders
Dehydration
|
1.1%
2/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
1.1%
2/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Psychiatric disorders
Insomnia
|
7.9%
15/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Psychiatric disorders
Delusion
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Psychiatric disorders
Depressed mood
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Psychiatric disorders
Hallucination, auditory
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Psychiatric disorders
Hallucination, visual
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Psychiatric disorders
Listless
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Psychiatric disorders
Sleep disorder
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Psychiatric disorders
Depressive symptom
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Psychiatric disorders
Affect lability
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Psychiatric disorders
Anxiety disorder
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Nervous system disorders
Dizziness
|
27.4%
52/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Nervous system disorders
Somnolence
|
20.0%
38/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Nervous system disorders
Headache
|
14.7%
28/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Nervous system disorders
Dysgeusia
|
2.1%
4/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Nervous system disorders
Hypoaesthesia
|
2.1%
4/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Nervous system disorders
Cervicobrachial syndrome
|
1.6%
3/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Nervous system disorders
Carpal tunnel syndrome
|
1.1%
2/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Nervous system disorders
Cerebral infarction
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Nervous system disorders
Dizziness postural
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Nervous system disorders
Dyskinesia
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Nervous system disorders
Head discomfort
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Nervous system disorders
Hypertonia
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Nervous system disorders
Intracranial aneurysm
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Nervous system disorders
IVth nerve paralysis
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Nervous system disorders
Memory impairment
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Nervous system disorders
Paraesthesia
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Nervous system disorders
Parosmia
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Nervous system disorders
Sciatica
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Nervous system disorders
Occipital neuralgia
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Eye disorders
Conjunctivitis allergic
|
2.1%
4/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Eye disorders
Conjunctival haemorrhage
|
1.1%
2/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Eye disorders
Diabetic retinopathy
|
1.1%
2/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Eye disorders
Blepharitis
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Eye disorders
Cataract
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Eye disorders
Conjunctivitis
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Eye disorders
Eye haemorrhage
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Eye disorders
Keratitis
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Eye disorders
Posterior capsule opacification
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Eye disorders
Vitreous detachment
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Ear and labyrinth disorders
Ear discomfort
|
1.1%
2/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Ear and labyrinth disorders
Tinnitus
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Ear and labyrinth disorders
Vertigo
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Cardiac disorders
Palpitations
|
2.1%
4/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Cardiac disorders
Angina pectoris
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Cardiac disorders
Bundle branch block left
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Cardiac disorders
Tachycardia
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Vascular disorders
Hypertension
|
7.4%
14/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Vascular disorders
Hot flush
|
2.1%
4/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Vascular disorders
Blood pressure fluctuation
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Vascular disorders
Hypotension
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Vascular disorders
Arteriosclerosis obliterans
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
2.6%
5/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
1.1%
2/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.1%
2/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
1.1%
2/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cyst
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Sputum retention
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal mucosal disorder
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Gastrointestinal disorders
Nausea
|
53.2%
101/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Gastrointestinal disorders
Constipation
|
39.5%
75/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Gastrointestinal disorders
Vomiting
|
35.8%
68/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Gastrointestinal disorders
Stomach discomfort
|
9.5%
18/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Gastrointestinal disorders
Diarrhoea
|
8.9%
17/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.4%
16/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Gastrointestinal disorders
Gastritis
|
4.7%
9/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Gastrointestinal disorders
Stomatitis
|
4.7%
9/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Gastrointestinal disorders
Dyspepsia
|
4.2%
8/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Gastrointestinal disorders
Dry mouth
|
3.2%
6/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Gastrointestinal disorders
Reflux oesophagitis
|
2.1%
4/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Gastrointestinal disorders
Abdominal distension
|
1.6%
3/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Gastrointestinal disorders
Abdominal pain
|
1.6%
3/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Gastrointestinal disorders
Gastric ulcer
|
1.6%
3/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Gastrointestinal disorders
Periodontitis
|
1.6%
3/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.1%
2/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Gastrointestinal disorders
Anal fistula
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Gastrointestinal disorders
Cheilitis
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Gastrointestinal disorders
Colonic polyp
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Gastrointestinal disorders
Dental caries
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Gastrointestinal disorders
Gingivitis
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Gastrointestinal disorders
Glossitis
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Gastrointestinal disorders
Melanosis coli
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Gastrointestinal disorders
Oral discomfort
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Gastrointestinal disorders
Gastrointestinal hypermotility
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Gastrointestinal disorders
Gastric mucosal lesion
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Gastrointestinal disorders
Oral mucosa erosion
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.1%
2/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Hepatobiliary disorders
Liver disorder
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.3%
12/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.8%
11/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Skin and subcutaneous tissue disorders
Eczema
|
4.7%
9/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.2%
8/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
2.6%
5/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
2.1%
4/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.1%
4/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
1.1%
2/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
1.1%
2/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Skin and subcutaneous tissue disorders
Prurigo
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Skin and subcutaneous tissue disorders
Senile pruritus
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Skin and subcutaneous tissue disorders
Skin chapped
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Skin and subcutaneous tissue disorders
Skin erosion
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Skin and subcutaneous tissue disorders
Skin swelling
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Skin and subcutaneous tissue disorders
Diabetic bullosis
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.7%
7/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
3.2%
6/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.6%
5/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.1%
4/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
2.1%
4/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.6%
3/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
1.1%
2/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
1.1%
2/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
1.1%
2/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Musculoskeletal and connective tissue disorders
Fasciitis
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Musculoskeletal and connective tissue disorders
Upper extremity mass
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Musculoskeletal and connective tissue disorders
Spinal ligament ossification
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Renal and urinary disorders
Dysuria
|
3.7%
7/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Renal and urinary disorders
Haematuria
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Renal and urinary disorders
Micturition disorder
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Renal and urinary disorders
Proteinuria
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Renal and urinary disorders
Urinary retention
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
1.1%
2/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
General disorders
Malaise
|
7.9%
15/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
General disorders
Feeling abnormal
|
6.8%
13/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
General disorders
Thirst
|
6.3%
12/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
General disorders
Pyrexia
|
4.2%
8/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
General disorders
Oedema peripheral
|
3.7%
7/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
General disorders
Chest discomfort
|
1.6%
3/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
General disorders
Oedema
|
1.1%
2/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
General disorders
Application site dermatitis
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
General disorders
Asthenia
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
General disorders
Chills
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
General disorders
Feeling cold
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
General disorders
Injection site haematoma
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
General disorders
Pain
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
General disorders
Peripheral coldness
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
General disorders
Vessel puncture site haematoma
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Investigations
Weight decreased
|
12.1%
23/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Investigations
Gamma-glutamyltransferase increased
|
11.1%
21/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Investigations
Blood creatine phosphokinase increased
|
10.0%
19/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Investigations
Blood triglycerides increased
|
7.4%
14/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Investigations
Blood pressure increased
|
5.8%
11/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Investigations
Blood urea increased
|
5.3%
10/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Investigations
Alanine aminotransferase increased
|
4.7%
9/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Investigations
Glucose urine present
|
3.7%
7/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Investigations
Blood urine present
|
3.7%
7/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Investigations
Aspartate aminotransferase increased
|
3.2%
6/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Investigations
Blood alkaline phosphatase increased
|
3.2%
6/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Investigations
Blood potassium increased
|
2.6%
5/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Investigations
Liver function test abnormal
|
2.6%
5/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Investigations
Eosinophil percentage increased
|
2.6%
5/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Investigations
White blood cell count increased
|
2.1%
4/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Investigations
Haemoglobin decreased
|
1.6%
3/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Investigations
Weight increased
|
1.6%
3/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Investigations
Protein urine present
|
1.6%
3/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Investigations
Albumin urine present
|
1.1%
2/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Investigations
Blood creatinine increased
|
1.1%
2/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Investigations
Blood pressure systolic increased
|
1.1%
2/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Investigations
C-reactive protein increased
|
1.1%
2/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Investigations
Red blood cell count decreased
|
1.1%
2/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Investigations
Platelet count increased
|
1.1%
2/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Investigations
Blood cholesterol increased
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Investigations
Blood glucose increased
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Investigations
Blood pressure diastolic decreased
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Investigations
Blood uric acid increased
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Investigations
Monocyte count increased
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Investigations
Platelet count decreased
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Investigations
Neutrophil percentage decreased
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Injury, poisoning and procedural complications
Fall
|
5.8%
11/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Injury, poisoning and procedural complications
Wound
|
2.6%
5/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Injury, poisoning and procedural complications
Excoriation
|
1.6%
3/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Injury, poisoning and procedural complications
Thermal burn
|
1.6%
3/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Injury, poisoning and procedural complications
Joint sprain
|
1.1%
2/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Injury, poisoning and procedural complications
Back injury
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Injury, poisoning and procedural complications
Foreign body in eye
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Injury, poisoning and procedural complications
Contusion
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.53%
1/190 • From signing of informed consent until study completion (up to 54 weeks)
|
|
Investigations
Blood lactate dehydrogenase increased
|
1.1%
2/190 • From signing of informed consent until study completion (up to 54 weeks)
|
Additional Information
Medical Director
Neuroscience Department, Clinical Science Division, R&D, JANSSEN PHARMACEUTICAL. K.K. 5-2, Nishi-kanda 3-chome, Cyiyoda-ku, Tokyo 101-0065 JAPAN
Phone: +81-3-4411-5509
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release.
- Publication restrictions are in place
Restriction type: OTHER