Trial Outcomes & Findings for An Open-label Extension Study With Flexible Dosing of Extended-release (ER) Tapentadol (CG5503) to Treat Patients With Moderate to Severe Chronic Pain (NCT NCT00487435)
NCT ID: NCT00487435
Last Updated: 2014-05-09
Results Overview
The number of subjects who reported a TEAE during the treatment period. TEAE was defined as any adverse event that started or worsened on or after the start of the study medication and up to 3 days after the discontinuation of the study medication.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1166 participants
Primary outcome timeframe
52 weeks
Results posted on
2014-05-09
Participant Flow
The recruitment period for this out-patient, multicenter study occurred between 4 June 2007 and 29 June 2009.
Participant milestones
| Measure |
Tapentadol (CG5503) Extended Release (ER)
Tapentadol (CG5503) extended release (ER) 100 to 250mg oral tablet twice daily (BID) for up to one year
|
|---|---|
|
Overall Study
STARTED
|
1154
|
|
Overall Study
COMPLETED
|
669
|
|
Overall Study
NOT COMPLETED
|
485
|
Reasons for withdrawal
| Measure |
Tapentadol (CG5503) Extended Release (ER)
Tapentadol (CG5503) extended release (ER) 100 to 250mg oral tablet twice daily (BID) for up to one year
|
|---|---|
|
Overall Study
Adverse Event
|
146
|
|
Overall Study
Death
|
2
|
|
Overall Study
Lack of Efficacy
|
33
|
|
Overall Study
Lost to Follow-up
|
54
|
|
Overall Study
Pregnancy
|
2
|
|
Overall Study
Withdrawal by Subject
|
132
|
|
Overall Study
Resolution Of Pain
|
1
|
|
Overall Study
Study Medication Non-Compliant
|
32
|
|
Overall Study
Other
|
83
|
Baseline Characteristics
An Open-label Extension Study With Flexible Dosing of Extended-release (ER) Tapentadol (CG5503) to Treat Patients With Moderate to Severe Chronic Pain
Baseline characteristics by cohort
| Measure |
Tapentadol (CG5503) Extended Release (ER)
n=1154 Participants
Tapentadol (CG5503) extended release (ER) 100 to 250mg oral tablet twice daily (BID) for up to one year
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
954 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
200 Participants
n=99 Participants
|
|
Age, Continuous
|
54.3 years
STANDARD_DEVIATION 11.43 • n=99 Participants
|
|
Sex: Female, Male
Female
|
668 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
486 Participants
n=99 Participants
|
|
Region Enroll
Australia
|
15 participants
n=99 Participants
|
|
Region Enroll
Canada
|
178 participants
n=99 Participants
|
|
Region Enroll
New Zealand
|
10 participants
n=99 Participants
|
|
Region Enroll
United States of America
|
951 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 52 weeksPopulation: Safety analysis set (All randomized subjects who took at least one dose of study medication).
The number of subjects who reported a TEAE during the treatment period. TEAE was defined as any adverse event that started or worsened on or after the start of the study medication and up to 3 days after the discontinuation of the study medication.
Outcome measures
| Measure |
Tapentadol (CG5503) Extended Release (ER)
n=1154 Participants
Tapentadol (CG5503) extended release (ER) 100 to 250mg oral tablet twice daily (BID) for up to one year
|
|---|---|
|
Number of Subjects With Treatment-emergent Adverse Events (TEAE)
|
907 participants
|
SECONDARY outcome
Timeframe: Baseline, 52 weeksPopulation: observed cases
The subjects indicated the average level of pain experienced, at each study visit, over the previous 24 hours on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".
Outcome measures
| Measure |
Tapentadol (CG5503) Extended Release (ER)
n=711 Participants
Tapentadol (CG5503) extended release (ER) 100 to 250mg oral tablet twice daily (BID) for up to one year
|
|---|---|
|
Change From Baseline in Average Pain Intensity Scores at Week 52 Using the Numerical Rating Scale (NRS)
|
-0.26 Scores on a Scale
Standard Deviation 2.129
|
Adverse Events
Tapentadol (CG5503) Extended Release (ER)
Serious events: 84 serious events
Other events: 659 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tapentadol (CG5503) Extended Release (ER)
n=1154 participants at risk
Tapentadol (CG5503) extended release (ER) 100 to 250mg oral tablet twice daily (BID) for up to one year
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.61%
7/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.09%
1/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.09%
1/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.09%
1/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Chest wall mass
|
0.09%
1/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.09%
1/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.09%
1/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.09%
1/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.17%
2/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Cardiac disorders
Atrial fibrillation
|
0.17%
2/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.17%
2/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Cardiac disorders
Myocardial infarction
|
0.17%
2/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.09%
1/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Cardiac disorders
Angina pectoris
|
0.09%
1/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Cardiac disorders
Angina unstable
|
0.09%
1/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Cardiac disorders
Atrial flutter
|
0.09%
1/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Cardiac disorders
Cardiac arrest
|
0.09%
1/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Cardiac disorders
Cor pulmonale
|
0.09%
1/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Cardiac disorders
Coronary artery disease
|
0.09%
1/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
General disorders
Chest pain
|
0.17%
2/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
General disorders
Non-cardiac chest pain
|
0.17%
2/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
General disorders
Asthenia
|
0.09%
1/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
General disorders
Chest discomfort
|
0.09%
1/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
General disorders
Drug withdrawal syndrome
|
0.09%
1/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
General disorders
Hernia obstructive
|
0.09%
1/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
General disorders
Influenza like illness
|
0.09%
1/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Infections and infestations
Gastroenteritis viral
|
0.17%
2/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Infections and infestations
Bronchitis
|
0.09%
1/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Infections and infestations
Bursitis infective
|
0.09%
1/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Infections and infestations
Diverticulitis
|
0.09%
1/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Infections and infestations
Mastitis
|
0.09%
1/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Infections and infestations
Pneumonia
|
0.09%
1/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Infections and infestations
Pyelonephritis
|
0.09%
1/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Injury, poisoning and procedural complications
Fall
|
0.26%
3/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Injury, poisoning and procedural complications
Abdominal injury
|
0.09%
1/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.09%
1/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.09%
1/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.09%
1/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.09%
1/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Nervous system disorders
Coma
|
0.17%
2/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Nervous system disorders
Syncope
|
0.17%
2/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Nervous system disorders
Altered state of consciousness
|
0.09%
1/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.09%
1/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.09%
1/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Nervous system disorders
Hypoaesthesia
|
0.09%
1/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Nervous system disorders
Intraventricular haemorrhage
|
0.09%
1/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Psychiatric disorders
Suicidal ideation
|
0.17%
2/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Psychiatric disorders
Withdrawal syndrome
|
0.17%
2/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Psychiatric disorders
Completed suicide
|
0.09%
1/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Psychiatric disorders
Psychotic disorder
|
0.09%
1/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Psychiatric disorders
Suicidal behaviour
|
0.09%
1/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.09%
1/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.09%
1/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.09%
1/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma metastatic
|
0.09%
1/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer stage unspecified
|
0.09%
1/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.09%
1/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.17%
2/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Gastrointestinal disorders
Vomiting
|
0.17%
2/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.09%
1/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.09%
1/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Gastrointestinal disorders
Nausea
|
0.09%
1/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.17%
2/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.09%
1/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.09%
1/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.09%
1/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Metabolism and nutrition disorders
Obesity
|
0.09%
1/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.17%
2/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Reproductive system and breast disorders
Cystocele
|
0.09%
1/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Reproductive system and breast disorders
Menometrorrhagia
|
0.09%
1/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.09%
1/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.09%
1/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Investigations
Lipase increased
|
0.09%
1/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Investigations
Platelet count decreased
|
0.09%
1/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Vascular disorders
Deep vein thrombosis
|
0.09%
1/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Vascular disorders
Haematoma
|
0.09%
1/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.09%
1/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.09%
1/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Surgical and medical procedures
Colectomy
|
0.09%
1/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
Other adverse events
| Measure |
Tapentadol (CG5503) Extended Release (ER)
n=1154 participants at risk
Tapentadol (CG5503) extended release (ER) 100 to 250mg oral tablet twice daily (BID) for up to one year
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
11.7%
135/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Gastrointestinal disorders
Constipation
|
11.1%
128/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Gastrointestinal disorders
Diarrhoea
|
9.5%
110/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
71/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Nervous system disorders
Headache
|
13.1%
151/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Nervous system disorders
Dizziness
|
8.5%
98/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Nervous system disorders
Somnolence
|
5.3%
61/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Infections and infestations
Nasopharyngitis
|
6.7%
77/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.2%
71/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Infections and infestations
Sinusitis
|
5.5%
63/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Infections and infestations
Urinary tract infection
|
5.5%
63/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Psychiatric disorders
Insomnia
|
8.7%
100/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Psychiatric disorders
Anxiety
|
5.3%
61/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
General disorders
Fatigue
|
6.7%
77/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.5%
63/1154
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
Additional Information
Senior Director, Clinical Leader
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Phone: 609-730-4537
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60