Trial Outcomes & Findings for An Efficacy and Safety Study of Fentanyl in Participants With Chronic Pain (NCT NCT00788372)
NCT ID: NCT00788372
Last Updated: 2013-06-26
Results Overview
Questionnaire of opioid withdrawal symptoms is a clinician rated 11-item scale that primarily evaluates the physical components of opioid withdrawal and is based on questions and clinical observations. The total score of questionnaire of opioid withdrawal symptoms is the sum of all individual items, with less than (\<) 5 points = no withdrawal, 5 to 12 points = mild withdrawal, 13 to 24 points = moderate withdrawal, 25 to 36 points = moderately severe withdrawal and greater than (\>) 36 points = severe withdrawal.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
142 participants
Primary outcome timeframe
Week 52 or endpoint (1 week after last treatment or early discontinuation)
Results posted on
2013-06-26
Participant Flow
148 participants were screened, of which 142 participants entered the treatment period.
Participant milestones
| Measure |
Fentanyl
Fentanyl transdermal patch (JNS020QD, patch containing a drug that is put on the skin so the drug will enter the body through the skin) was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators' discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
|
|---|---|
|
Period 1 (up to 4 Weeks)
STARTED
|
142
|
|
Period 1 (up to 4 Weeks)
COMPLETED
|
111
|
|
Period 1 (up to 4 Weeks)
NOT COMPLETED
|
31
|
|
Period 2 (Week 4 to Week 52)
STARTED
|
111
|
|
Period 2 (Week 4 to Week 52)
COMPLETED
|
79
|
|
Period 2 (Week 4 to Week 52)
NOT COMPLETED
|
32
|
Reasons for withdrawal
| Measure |
Fentanyl
Fentanyl transdermal patch (JNS020QD, patch containing a drug that is put on the skin so the drug will enter the body through the skin) was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators' discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
|
|---|---|
|
Period 1 (up to 4 Weeks)
Adverse Event
|
18
|
|
Period 1 (up to 4 Weeks)
Ineligible for transfer to period 2
|
9
|
|
Period 1 (up to 4 Weeks)
Withdrawal of informed consent
|
4
|
|
Period 2 (Week 4 to Week 52)
Adverse Event
|
13
|
|
Period 2 (Week 4 to Week 52)
Physician Decision
|
9
|
|
Period 2 (Week 4 to Week 52)
Withdrawal of informed consent
|
9
|
|
Period 2 (Week 4 to Week 52)
Aggravated symptoms
|
1
|
Baseline Characteristics
An Efficacy and Safety Study of Fentanyl in Participants With Chronic Pain
Baseline characteristics by cohort
| Measure |
Fentanyl
n=142 Participants
Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators' discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
|
|---|---|
|
Age Continuous
|
61.4 years
STANDARD_DEVIATION 14.98 • n=93 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
78 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Week 52 or endpoint (1 week after last treatment or early discontinuation)Population: Safety population included all the participants who received at least one patch application of the investigational product. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.
Questionnaire of opioid withdrawal symptoms is a clinician rated 11-item scale that primarily evaluates the physical components of opioid withdrawal and is based on questions and clinical observations. The total score of questionnaire of opioid withdrawal symptoms is the sum of all individual items, with less than (\<) 5 points = no withdrawal, 5 to 12 points = mild withdrawal, 13 to 24 points = moderate withdrawal, 25 to 36 points = moderately severe withdrawal and greater than (\>) 36 points = severe withdrawal.
Outcome measures
| Measure |
Fentanyl
n=140 Participants
Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators' discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
|
|---|---|
|
Questionnaire of Opioid Withdrawal Symptoms
>=13 to <=24 points
|
1 participants
|
|
Questionnaire of Opioid Withdrawal Symptoms
>=25 to <=36 points
|
0 participants
|
|
Questionnaire of Opioid Withdrawal Symptoms
>=37 points
|
0 participants
|
|
Questionnaire of Opioid Withdrawal Symptoms
< 5 points
|
137 participants
|
|
Questionnaire of Opioid Withdrawal Symptoms
>=5 to <=12 points
|
2 participants
|
PRIMARY outcome
Timeframe: Week 52 or end point (early discontinuation)Population: Safety population included all the participants who received at least one patch application of the investigational product. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.
The DQ is a clinician rated 5-item scale that evaluates dependence on drug and based on questions (Q). Based on participant's answer to Q in questionnaire, Investigator assessed whether drug dependence occurred. It comprises 5 Q which are: continuing drug for reason other than pain, using drug in more dosage than prescribed to have effect other than treatment of pain, have ever used drug with more dosage than prescribed for other purpose, anxiety with the thought of stopping drug for reason other than aggravation of symptoms by stopping this drug and feeling to violate law to get this drug.
Outcome measures
| Measure |
Fentanyl
n=140 Participants
Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators' discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
|
|---|---|
|
Dependence Questionnaire (DQ)
Q1:Continue to use drug for reason other than pain
|
1 units on a scale
|
|
Dependence Questionnaire (DQ)
Q 2: Wanted to use more dosage than prescribed
|
0 units on a scale
|
|
Dependence Questionnaire (DQ)
Q3: Used drug with more dosage than prescribed
|
0 units on a scale
|
|
Dependence Questionnaire (DQ)
Q4: Anxious with thought of stopping drug
|
1 units on a scale
|
|
Dependence Questionnaire (DQ)
Q5: Feeling to violate law to get this drug
|
0 units on a scale
|
|
Dependence Questionnaire (DQ)
Judgment by doctor: Dependent and abuse
|
0 units on a scale
|
|
Dependence Questionnaire (DQ)
Judgement by doctor: Not dependent and no abuse
|
140 units on a scale
|
PRIMARY outcome
Timeframe: Week 52 or end point (early discontinuation)Population: Full Analysis Set (FAS) population included all the participants with the exception of participants with violation of eligibility criteria, participants with no treatment with the patch of fentanyl and participants without efficacy data after initiation of patch application.
Pain visual analog scale was used to assess the amount of pain experienced by the participant throughout the day by marking a slash through the line of a 100 millimeter (mm) scale measuring pain from "no pain (0 mm)" to "worst possible pain (100 mm)".
Outcome measures
| Measure |
Fentanyl
n=142 Participants
Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators' discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
|
|---|---|
|
Pain Visual Analogue Scale Score
|
58.3 mm
Standard Deviation 24.72 • Interval 0.0 to 99.0
|
PRIMARY outcome
Timeframe: Week 52 or final evaluation (early discontinuation)Population: The FAS population included all participants with the exception of participants with violation of eligibility criteria, participants with no treatment with the patch of fentanyl and participants without efficacy data after initiation of patch application. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.
Pain intensity was measured by assessing the average intensity of pain experienced by the participant in daily living throughout the day by 4 grades: no pain at all, mild (slightly painful, but not worried), moderate (painful, but bearable) and severe (painful and unbearable).
Outcome measures
| Measure |
Fentanyl
n=141 Participants
Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators' discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
|
|---|---|
|
Number of Participants With Pain Assessed by Categorical Scale for Pain
No pain
|
1 participants
|
|
Number of Participants With Pain Assessed by Categorical Scale for Pain
Mild pain
|
21 participants
|
|
Number of Participants With Pain Assessed by Categorical Scale for Pain
Moderate pain
|
101 participants
|
|
Number of Participants With Pain Assessed by Categorical Scale for Pain
Severe pain
|
18 participants
|
PRIMARY outcome
Timeframe: Week 52 or final evaluation (early discontinuation)Population: The FAS population included all participants with the exception of participants with violation of eligibility criteria, participants with no treatment with the patch of fentanyl and participants without efficacy data after initiation of patch application. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.
The participants assessed total painful time in 1 day by the following 5 grades: less than 4 hours, 4 hours to less than 8 hours, 8 hours to less than 12 hours, 12 hours or more and all day.
Outcome measures
| Measure |
Fentanyl
n=141 Participants
Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators' discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
|
|---|---|
|
Number of Participants With Total Painful Time Per Day
Less than 4 hours
|
17 participants
|
|
Number of Participants With Total Painful Time Per Day
4 hours to less than 8 hours
|
29 participants
|
|
Number of Participants With Total Painful Time Per Day
8 hours to less than 12 hours
|
23 participants
|
|
Number of Participants With Total Painful Time Per Day
12 hours or more
|
40 participants
|
|
Number of Participants With Total Painful Time Per Day
All day
|
32 participants
|
PRIMARY outcome
Timeframe: Week 52 or final evaluation (early discontinuation)Population: The FAS population included all participants with the exception of participants with violation of eligibility criteria, participants with no treatment with the patch of fentanyl and participants without efficacy data after initiation of patch application. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.
The quality of sleep was assessed by participants that how well they have slept from the previous assessment to current assessment time by the following 4 grades: can sleep well, can sleep moderately well, cannot sleep much and cannot sleep at all.
Outcome measures
| Measure |
Fentanyl
n=141 Participants
Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators' discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
|
|---|---|
|
Number of Participants With Quality of Sleep
Can sleep well
|
28 participants
|
|
Number of Participants With Quality of Sleep
Can sleep moderately well
|
67 participants
|
|
Number of Participants With Quality of Sleep
Cannot sleep much
|
40 participants
|
|
Number of Participants With Quality of Sleep
Cannot sleep at all
|
6 participants
|
PRIMARY outcome
Timeframe: Week 52 or final evaluation (early discontinuation)Population: The FAS population included all the participants with the exception of participants with violation of eligibility criteria, participants with no treatment with the patch of fentanyl and participants without efficacy data after initiation of patch application.
Rescue treatment was used for participants with lack of analgesic efficacy, to have relief from breakthrough pain and in cases where withdrawal symptoms occur. The reference one-time rescue dose used was oral morphine 5 milligram (mg) for the investigational product fentanyl one-day transdermal patch 12.5 mcg per hr. The number of rescue treatments per day were reported.
Outcome measures
| Measure |
Fentanyl
n=142 Participants
Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators' discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
|
|---|---|
|
Number of Rescue Treatments
|
1.0 treatments per day
Standard Deviation 1.13
|
PRIMARY outcome
Timeframe: Week 52 or final evaluation (early discontinuation)Population: The FAS population included all participants with the exception of participants with violation of eligibility criteria, participants with no treatment with the patch of fentanyl and participants without efficacy data after initiation of patch application. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.
The SF-36 is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; role emotional, social functioning and mental health contribute to mental component; and social functioning, vitality, and general health contribute to both. All scores are based on a scale from 0 to 100, with higher scores defining more favorable health state.
Outcome measures
| Measure |
Fentanyl
n=141 Participants
Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators' discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
|
|---|---|
|
Short-Form 36-Item Health Survey (SF-36) Scores
Physical health (summary score)
|
23.0 units on a scale
Standard Deviation 17.49
|
|
Short-Form 36-Item Health Survey (SF-36) Scores
Mental health (summary score)
|
42.1 units on a scale
Standard Deviation 9.82
|
PRIMARY outcome
Timeframe: Week 52 or final evaluation (early discontinuation)Population: The FAS population included all the participants with the exception of participants with violation of eligibility criteria, participants with no treatment with the patch of fentanyl and participants without efficacy data after initiation of patch application.
The treating physician assessed the therapeutic efficacy of the treatment by 2 grades: effective and ineffective. Numbers of participants with effective and ineffective therapeutic efficacy with the treatment were reported.
Outcome measures
| Measure |
Fentanyl
n=142 Participants
Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators' discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
|
|---|---|
|
Physician's Global Assessment Scale
Ineffective
|
36 participants
|
|
Physician's Global Assessment Scale
Effective
|
106 participants
|
PRIMARY outcome
Timeframe: Week 52 or final evaluation (early discontinuation)Population: The FAS population included all participants with the exception of participants with violation of eligibility criteria, participants with no treatment with the patch of fentanyl and participants without efficacy data after initiation of patch application. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.
The participants assessed their satisfaction with therapeutic efficacy by 5 grades: satisfied very much, satisfied, equivocal, dissatisfied and dissatisfied very much. Percentage of participants who were at least satisfied (satisfied, satisfied very much) or at least neither satisfied nor dissatisfied (dissatisfied, dissatisfied very much) were reported.
Outcome measures
| Measure |
Fentanyl
n=141 Participants
Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators' discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
|
|---|---|
|
Participants Overall Assessment
Satisfied
|
31.2 percentage of participants
Interval 23.7 to 39.5
|
|
Participants Overall Assessment
Neither satisfied nor dissatisfied
|
66.7 percentage of participants
Interval 58.2 to 74.4
|
PRIMARY outcome
Timeframe: Week 52 or final evaluation (early discontinuation)Population: The FAS population included all participants with the exception of participants with violation of eligibility criteria, participants with no treatment with the patch of fentanyl and participants without efficacy data after initiation of patch application. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.
The BPI-SF is a self-report questionnaire designed to assess the severity and impact of pain on daily functions. It includes pain interference score which is mean value for scores for 9 BPI-SF questions ranging between 0 (does not interfere) to 10 (completely interferes) and pain subscale score which is mean value for scores for BPI-SF questions 3 to 6 ranging between 0 (no pain) to 10 (pain as bad as can imagine). Total BPI-SF score is an average of pain interference score and pain subscale score and ranges from 0 to 10; higher score indicates more pain or pain interference.
Outcome measures
| Measure |
Fentanyl
n=141 Participants
Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators' discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
|
|---|---|
|
Brief Pain Inventory-Short Form (BPI-SF) Total Score
|
5.1 units on a scale
Standard Deviation 2.24
|
Adverse Events
Fentanyl
Serious events: 38 serious events
Other events: 140 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fentanyl
n=142 participants at risk
Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators' discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
|
|---|---|
|
Infections and infestations
Pneumonia
|
2.8%
4/142 • Baseline up to 7 days post last dose of study drug
|
|
Infections and infestations
Acute tonsillitis
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Infections and infestations
Herpes zoster
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Infections and infestations
Pharyngitis
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Infections and infestations
Pneumonia chlamydial
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Infections and infestations
Pneumonia bacterial
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of testis
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thymoma
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.4%
2/142 • Baseline up to 7 days post last dose of study drug
|
|
Metabolism and nutrition disorders
Dehydration
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Psychiatric disorders
Completed suicide
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Psychiatric disorders
Depression
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Nervous system disorders
Somnolence
|
1.4%
2/142 • Baseline up to 7 days post last dose of study drug
|
|
Nervous system disorders
Altered state of consciousness
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Nervous system disorders
Dizziness
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Nervous system disorders
Loss of consciousness
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Ear and labyrinth disorders
Vertigo
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Gastrointestinal disorders
Nausea
|
4.2%
6/142 • Baseline up to 7 days post last dose of study drug
|
|
Gastrointestinal disorders
Vomiting
|
1.4%
2/142 • Baseline up to 7 days post last dose of study drug
|
|
Gastrointestinal disorders
Melaena
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Skin and subcutaneous tissue disorders
Sweat gland disorder
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Renal and urinary disorders
Dysuria
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
General disorders
Malaise
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
General disorders
Pyrexia
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
1.4%
2/142 • Baseline up to 7 days post last dose of study drug
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
Other adverse events
| Measure |
Fentanyl
n=142 participants at risk
Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators' discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
24.6%
35/142 • Baseline up to 7 days post last dose of study drug
|
|
Infections and infestations
Cystitis
|
2.1%
3/142 • Baseline up to 7 days post last dose of study drug
|
|
Infections and infestations
Tinea pedis
|
2.1%
3/142 • Baseline up to 7 days post last dose of study drug
|
|
Infections and infestations
Gastroenteritis
|
1.4%
2/142 • Baseline up to 7 days post last dose of study drug
|
|
Infections and infestations
Pharyngitis
|
1.4%
2/142 • Baseline up to 7 days post last dose of study drug
|
|
Infections and infestations
Sinusitis
|
1.4%
2/142 • Baseline up to 7 days post last dose of study drug
|
|
Infections and infestations
Acute tonsillitis
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Infections and infestations
Bronchitis
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Infections and infestations
Cellulitis
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Infections and infestations
Folliculitis
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Infections and infestations
Hordeolum
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Infections and infestations
Impetigo
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Infections and infestations
Postoperative wound infection
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Infections and infestations
Upper respiratory tract infection
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Infections and infestations
Urinary tract infection
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Infections and infestations
Vestibular neuronitis
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Infections and infestations
Pharyngotonsillitis
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Infections and infestations
Arthritis bacterial
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Infections and infestations
Gastroenteritis bacterial
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Infections and infestations
Herpes dermatitis
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Infections and infestations
Urogenital infection fungal
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Infections and infestations
Oral herpes
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Blood and lymphatic system disorders
Anaemia
|
1.4%
2/142 • Baseline up to 7 days post last dose of study drug
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Endocrine disorders
Hyperprolactinaemia
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Metabolism and nutrition disorders
Decreased appetite
|
12.7%
18/142 • Baseline up to 7 days post last dose of study drug
|
|
Metabolism and nutrition disorders
Dehydration
|
2.8%
4/142 • Baseline up to 7 days post last dose of study drug
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Psychiatric disorders
Insomnia
|
7.0%
10/142 • Baseline up to 7 days post last dose of study drug
|
|
Psychiatric disorders
Anxiety
|
2.8%
4/142 • Baseline up to 7 days post last dose of study drug
|
|
Psychiatric disorders
Delirium
|
2.1%
3/142 • Baseline up to 7 days post last dose of study drug
|
|
Psychiatric disorders
Disorientation
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Psychiatric disorders
Dissociative disorder
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Psychiatric disorders
Hallucination
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Psychiatric disorders
Nightmare
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Psychiatric disorders
Sleep disorder
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Nervous system disorders
Somnolence
|
54.9%
78/142 • Baseline up to 7 days post last dose of study drug
|
|
Nervous system disorders
Dizziness
|
27.5%
39/142 • Baseline up to 7 days post last dose of study drug
|
|
Nervous system disorders
Headache
|
8.5%
12/142 • Baseline up to 7 days post last dose of study drug
|
|
Nervous system disorders
Akathisia
|
1.4%
2/142 • Baseline up to 7 days post last dose of study drug
|
|
Nervous system disorders
Dysarthria
|
1.4%
2/142 • Baseline up to 7 days post last dose of study drug
|
|
Nervous system disorders
Extrapyramidal disorder
|
1.4%
2/142 • Baseline up to 7 days post last dose of study drug
|
|
Nervous system disorders
Amnesia
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Nervous system disorders
Autonomic nervous system imbalance
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Nervous system disorders
Cholinergic syndrome
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Nervous system disorders
Depressed level of consciousness
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Nervous system disorders
Disturbance in attention
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Nervous system disorders
Dysgeusia
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Nervous system disorders
Dyskinesia
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Nervous system disorders
Dyslalia
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Nervous system disorders
Hypoaesthesia
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Nervous system disorders
Parkinsonism
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Nervous system disorders
Stupor
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Nervous system disorders
Tremor
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Eye disorders
Cataract
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Eye disorders
Conjunctival haemorrhage
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Eye disorders
Conjunctivitis
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Eye disorders
Diplopia
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Eye disorders
Dry eye
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Eye disorders
Conjunctival hyperaemia
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Eye disorders
Corneal disorder
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Ear and labyrinth disorders
Vertigo
|
2.1%
3/142 • Baseline up to 7 days post last dose of study drug
|
|
Ear and labyrinth disorders
Motion sickness
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Ear and labyrinth disorders
Tinnitus
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Cardiac disorders
Bradycardia
|
1.4%
2/142 • Baseline up to 7 days post last dose of study drug
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Cardiac disorders
Cardiac failure congestive
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Cardiac disorders
Palpitations
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Cardiac disorders
Tachycardia
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Vascular disorders
Hypertension
|
3.5%
5/142 • Baseline up to 7 days post last dose of study drug
|
|
Vascular disorders
Flushing
|
1.4%
2/142 • Baseline up to 7 days post last dose of study drug
|
|
Vascular disorders
Pallor
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
4.9%
7/142 • Baseline up to 7 days post last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.1%
3/142 • Baseline up to 7 days post last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Gastrointestinal disorders
Constipation
|
51.4%
73/142 • Baseline up to 7 days post last dose of study drug
|
|
Gastrointestinal disorders
Nausea
|
50.0%
71/142 • Baseline up to 7 days post last dose of study drug
|
|
Gastrointestinal disorders
Vomiting
|
13.4%
19/142 • Baseline up to 7 days post last dose of study drug
|
|
Gastrointestinal disorders
Diarrhoea
|
12.7%
18/142 • Baseline up to 7 days post last dose of study drug
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.2%
6/142 • Baseline up to 7 days post last dose of study drug
|
|
Gastrointestinal disorders
Stomatitis
|
4.2%
6/142 • Baseline up to 7 days post last dose of study drug
|
|
Gastrointestinal disorders
Toothache
|
2.8%
4/142 • Baseline up to 7 days post last dose of study drug
|
|
Gastrointestinal disorders
Dental caries
|
2.1%
3/142 • Baseline up to 7 days post last dose of study drug
|
|
Gastrointestinal disorders
Gastritis
|
2.1%
3/142 • Baseline up to 7 days post last dose of study drug
|
|
Gastrointestinal disorders
Periodontitis
|
2.1%
3/142 • Baseline up to 7 days post last dose of study drug
|
|
Gastrointestinal disorders
Abdominal distension
|
1.4%
2/142 • Baseline up to 7 days post last dose of study drug
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
1.4%
2/142 • Baseline up to 7 days post last dose of study drug
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.4%
2/142 • Baseline up to 7 days post last dose of study drug
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Gastrointestinal disorders
Abdominal pain
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Gastrointestinal disorders
Anorectal disorder
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Gastrointestinal disorders
Cheilitis
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Gastrointestinal disorders
Colonic polyp
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Gastrointestinal disorders
Faecal incontinence
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Gastrointestinal disorders
Haematemesis
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Gastrointestinal disorders
Melaena
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Gastrointestinal disorders
Tongue coated
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Gastrointestinal disorders
Dyschezia
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Gastrointestinal disorders
Gastrointestinal hypomotility
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Gastrointestinal disorders
Gastrointestinal hypermotility
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Gastrointestinal disorders
Contact stomatitis
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
1.4%
2/142 • Baseline up to 7 days post last dose of study drug
|
|
Hepatobiliary disorders
Liver disorder
|
1.4%
2/142 • Baseline up to 7 days post last dose of study drug
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.7%
18/142 • Baseline up to 7 days post last dose of study drug
|
|
Skin and subcutaneous tissue disorders
Eczema
|
5.6%
8/142 • Baseline up to 7 days post last dose of study drug
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
4.9%
7/142 • Baseline up to 7 days post last dose of study drug
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.2%
6/142 • Baseline up to 7 days post last dose of study drug
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.8%
4/142 • Baseline up to 7 days post last dose of study drug
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.8%
4/142 • Baseline up to 7 days post last dose of study drug
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
2.1%
3/142 • Baseline up to 7 days post last dose of study drug
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
1.4%
2/142 • Baseline up to 7 days post last dose of study drug
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.4%
2/142 • Baseline up to 7 days post last dose of study drug
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
1.4%
2/142 • Baseline up to 7 days post last dose of study drug
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
1.4%
2/142 • Baseline up to 7 days post last dose of study drug
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Skin and subcutaneous tissue disorders
Eczema nummular
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.9%
7/142 • Baseline up to 7 days post last dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.5%
5/142 • Baseline up to 7 days post last dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.8%
4/142 • Baseline up to 7 days post last dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.8%
4/142 • Baseline up to 7 days post last dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
2.1%
3/142 • Baseline up to 7 days post last dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Myofascial pain syndrome
|
2.1%
3/142 • Baseline up to 7 days post last dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Myofascitis
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Renal and urinary disorders
Dysuria
|
7.0%
10/142 • Baseline up to 7 days post last dose of study drug
|
|
Renal and urinary disorders
Urinary retention
|
2.8%
4/142 • Baseline up to 7 days post last dose of study drug
|
|
Renal and urinary disorders
Pollakiuria
|
2.1%
3/142 • Baseline up to 7 days post last dose of study drug
|
|
Renal and urinary disorders
Bladder irritation
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Renal and urinary disorders
Incontinence
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Renal and urinary disorders
Post streptococcal glomerulonephritis
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Renal and urinary disorders
Urinary incontinence
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Renal and urinary disorders
Bladder disorder
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Reproductive system and breast disorders
Menstruation delayed
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
General disorders
Application site pruritus
|
10.6%
15/142 • Baseline up to 7 days post last dose of study drug
|
|
General disorders
Pyrexia
|
7.7%
11/142 • Baseline up to 7 days post last dose of study drug
|
|
General disorders
Thirst
|
7.0%
10/142 • Baseline up to 7 days post last dose of study drug
|
|
General disorders
Malaise
|
7.0%
10/142 • Baseline up to 7 days post last dose of study drug
|
|
General disorders
Feeling abnormal
|
4.9%
7/142 • Baseline up to 7 days post last dose of study drug
|
|
General disorders
Drug withdrawal syndrome
|
4.2%
6/142 • Baseline up to 7 days post last dose of study drug
|
|
General disorders
Oedema peripheral
|
4.2%
6/142 • Baseline up to 7 days post last dose of study drug
|
|
General disorders
Application site erythema
|
2.8%
4/142 • Baseline up to 7 days post last dose of study drug
|
|
General disorders
Application site dermatitis
|
2.1%
3/142 • Baseline up to 7 days post last dose of study drug
|
|
General disorders
Chest pain
|
2.1%
3/142 • Baseline up to 7 days post last dose of study drug
|
|
General disorders
Asthenia
|
1.4%
2/142 • Baseline up to 7 days post last dose of study drug
|
|
General disorders
Chest discomfort
|
1.4%
2/142 • Baseline up to 7 days post last dose of study drug
|
|
General disorders
Irritability
|
1.4%
2/142 • Baseline up to 7 days post last dose of study drug
|
|
General disorders
Feeling cold
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
General disorders
Gait disturbance
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
General disorders
Loss of control of legs
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
General disorders
Oedema
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
General disorders
Application site urticaria
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
General disorders
Device failure
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Investigations
Weight decreased
|
4.2%
6/142 • Baseline up to 7 days post last dose of study drug
|
|
Investigations
Blood pressure decreased
|
2.8%
4/142 • Baseline up to 7 days post last dose of study drug
|
|
Investigations
Alanine aminotransferase increased
|
2.1%
3/142 • Baseline up to 7 days post last dose of study drug
|
|
Investigations
Blood creatinine increased
|
2.1%
3/142 • Baseline up to 7 days post last dose of study drug
|
|
Investigations
Blood urea increased
|
2.1%
3/142 • Baseline up to 7 days post last dose of study drug
|
|
Investigations
Gamma-glutamyltransferase increased
|
2.1%
3/142 • Baseline up to 7 days post last dose of study drug
|
|
Investigations
Liver function test abnormal
|
2.1%
3/142 • Baseline up to 7 days post last dose of study drug
|
|
Investigations
Blood creatine phosphokinase increased
|
1.4%
2/142 • Baseline up to 7 days post last dose of study drug
|
|
Investigations
Urobilin urine present
|
1.4%
2/142 • Baseline up to 7 days post last dose of study drug
|
|
Investigations
Blood alkaline phosphatase increased
|
1.4%
2/142 • Baseline up to 7 days post last dose of study drug
|
|
Investigations
Aspartate aminotransferase increased
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Investigations
Blood pressure increased
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Investigations
Monocyte count increased
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Investigations
Protein total decreased
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Investigations
White blood cell count decreased
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Investigations
Electrocardiogram ST-T segment abnormal
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Investigations
Protein urine present
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Investigations
Oxygen saturation decreased
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Injury, poisoning and procedural complications
Fall
|
4.2%
6/142 • Baseline up to 7 days post last dose of study drug
|
|
Injury, poisoning and procedural complications
Foot fracture
|
1.4%
2/142 • Baseline up to 7 days post last dose of study drug
|
|
Injury, poisoning and procedural complications
Joint sprain
|
1.4%
2/142 • Baseline up to 7 days post last dose of study drug
|
|
Injury, poisoning and procedural complications
Excoriation
|
1.4%
2/142 • Baseline up to 7 days post last dose of study drug
|
|
Injury, poisoning and procedural complications
Thermal burn
|
1.4%
2/142 • Baseline up to 7 days post last dose of study drug
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
1.4%
2/142 • Baseline up to 7 days post last dose of study drug
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Injury, poisoning and procedural complications
Postoperative hernia
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Injury, poisoning and procedural complications
Contusion
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Injury, poisoning and procedural complications
Post procedural haematuria
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Injury, poisoning and procedural complications
Procedural vomiting
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Injury, poisoning and procedural complications
Heat illness
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.70%
1/142 • Baseline up to 7 days post last dose of study drug
|
Additional Information
Director, Clinical Research
Janssen Research & Development, L.L.C. USA
Phone: 1 609 730-3387
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