Trial Outcomes & Findings for Assessment of Long-term Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation (NCT NCT01336205)
NCT ID: NCT01336205
Last Updated: 2014-10-20
Results Overview
The incidence of patients experiencing at least one AE during the randomized treatment and follow-up periods was calculated.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
844 participants
Primary outcome timeframe
Baseline (Week 0) to end of the follow-up period
Results posted on
2014-10-20
Participant Flow
This multicenter study was conducted in the United States between 18 April 2011 and 03 December 2012.
The study duration was 54 to 58 weeks. New patients underwent an initial screening period lasting up to 2 weeks and a 2-week OIC confirmation period. New patients and patients enrolling from another study (also referred to as 'roll over patients') entered the 52-week treatment period, followed by a 2 week follow-up period.
Participant milestones
| Measure |
NKTR-118 25 mg
NKTR-118 25 mg QD, oral treatment
|
Usual Care
Laxative treatment regimen for OIC determined by the investigator according to his/her best clinical judgment.
|
|---|---|---|
|
Overall Study
STARTED
|
563
|
281
|
|
Overall Study
COMPLETED
|
330
|
192
|
|
Overall Study
NOT COMPLETED
|
233
|
89
|
Reasons for withdrawal
| Measure |
NKTR-118 25 mg
NKTR-118 25 mg QD, oral treatment
|
Usual Care
Laxative treatment regimen for OIC determined by the investigator according to his/her best clinical judgment.
|
|---|---|---|
|
Overall Study
Other
|
22
|
9
|
|
Overall Study
Lost to Follow-up
|
40
|
20
|
|
Overall Study
Study-Specific Withdrawal Criteria
|
16
|
7
|
|
Overall Study
Lack of Efficacy
|
4
|
0
|
|
Overall Study
Severe noncompliance with protocol
|
9
|
2
|
|
Overall Study
Adverse Event
|
56
|
6
|
|
Overall Study
Death
|
1
|
1
|
|
Overall Study
Eligibility Criteria Not Fulfilled
|
9
|
6
|
|
Overall Study
Withdrawal by Subject
|
72
|
38
|
|
Overall Study
Did not receive treatment
|
4
|
0
|
Baseline Characteristics
Assessment of Long-term Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation
Baseline characteristics by cohort
| Measure |
NKTR-118 25 mg
n=534 Participants
NKTR-118 25 mg QD, oral treatment
|
Usual Care
n=270 Participants
Laxative treatment regimen for OIC determined by the investigator according to his/her best clinical judgment.
|
Total
n=804 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.8 Years
STANDARD_DEVIATION 10.09 • n=5 Participants
|
52.7 Years
STANDARD_DEVIATION 10.24 • n=7 Participants
|
52.7 Years
STANDARD_DEVIATION 10.13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
353 Participants
n=5 Participants
|
179 Participants
n=7 Participants
|
532 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
181 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
272 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
423 Participants
n=5 Participants
|
204 Participants
n=7 Participants
|
627 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
98 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
158 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Week 0) to end of the follow-up periodPopulation: The Safety analysis set included all randomized patients who received at least 1 dose of IP and patients who received Usual Care, with the exception of patients who were randomized multiple times within the program at different centers or patients who were randomized at sites where data integrity issues were identified.
The incidence of patients experiencing at least one AE during the randomized treatment and follow-up periods was calculated.
Outcome measures
| Measure |
NKTR-118 25 mg
n=534 Participants
NKTR-118 25 mg QD, oral treatment
|
Usual Care
n=270 Participants
Laxative treatment regimen for OIC determined by the investigator according to his/her best clinical judgment.
|
|---|---|---|
|
Incidence of Patients Experiencing at Least One Adverse Event (AE)
|
437 Participants
|
195 Participants
|
PRIMARY outcome
Timeframe: Baseline (Week 0) to end of the follow-up periodPopulation: The Safety analysis set included all randomized patients who received at least 1 dose of IP and patients who received Usual Care, with the exception of patients who were randomized multiple times within the program at different centers or patients who were randomized at sites where data integrity issues were identified.
The incidence of patients experiencing AEs that resulted in discontinuation of IP during the randomized treatment or follow-up periods was calculated.
Outcome measures
| Measure |
NKTR-118 25 mg
n=534 Participants
NKTR-118 25 mg QD, oral treatment
|
Usual Care
n=270 Participants
Laxative treatment regimen for OIC determined by the investigator according to his/her best clinical judgment.
|
|---|---|---|
|
Incidence of Patients Experiencing AEs That Resulted in Discontinuation of Investigational Product (IP)
|
56 Participants
|
NA Participants
Patients in the Usual Care group were not taking any IP and thus could not be categorized for this parameter.
|
PRIMARY outcome
Timeframe: Baseline (Week 0) to end of the follow-up periodPopulation: The Safety analysis set included all randomized patients who received at least 1 dose of IP and patients who received Usual Care, with the exception of patients who were randomized multiple times within the program at different centers or patients who were randomized at sites where data integrity issues were identified.
The incidence of patients experiencing SAEs during the randomized treatment and follow-up periods was calculated.
Outcome measures
| Measure |
NKTR-118 25 mg
n=534 Participants
NKTR-118 25 mg QD, oral treatment
|
Usual Care
n=270 Participants
Laxative treatment regimen for OIC determined by the investigator according to his/her best clinical judgment.
|
|---|---|---|
|
Incidence of Patients Experiencing Severe Adverse Events (SAEs)
|
51 Participants
|
30 Participants
|
Adverse Events
NKTR-118 25 mg
Serious events: 51 serious events
Other events: 365 other events
Deaths: 0 deaths
Usual Care
Serious events: 30 serious events
Other events: 152 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
NKTR-118 25 mg
n=534 participants at risk
|
Usual Care
n=270 participants at risk
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/534
|
0.37%
1/270 • Number of events 1
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.37%
2/534 • Number of events 2
|
0.37%
1/270 • Number of events 1
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
0.00%
0/534
|
0.37%
1/270 • Number of events 1
|
|
Cardiac disorders
MYOCARDIAL ISCHAEMIA
|
0.00%
0/534
|
0.37%
1/270 • Number of events 1
|
|
Endocrine disorders
THYROID MASS
|
0.19%
1/534 • Number of events 1
|
0.00%
0/270
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.19%
1/534 • Number of events 1
|
0.00%
0/270
|
|
Gastrointestinal disorders
COLITIS ISCHAEMIC
|
0.00%
0/534
|
0.37%
1/270 • Number of events 1
|
|
Gastrointestinal disorders
PANCREATITIS ACUTE
|
0.00%
0/534
|
0.37%
1/270 • Number of events 1
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
0.00%
0/534
|
0.37%
1/270 • Number of events 1
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
0.19%
1/534 • Number of events 1
|
0.37%
1/270 • Number of events 1
|
|
Gastrointestinal disorders
VOMITING
|
0.19%
1/534 • Number of events 1
|
0.00%
0/270
|
|
General disorders
ASTHENIA
|
0.19%
1/534 • Number of events 1
|
0.00%
0/270
|
|
General disorders
DEATH
|
0.00%
0/534
|
0.37%
1/270 • Number of events 1
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.00%
0/534
|
0.37%
1/270 • Number of events 1
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.00%
0/534
|
0.37%
1/270 • Number of events 1
|
|
Hepatobiliary disorders
CHOLELITHIASIS OBSTRUCTIVE
|
0.19%
1/534 • Number of events 1
|
0.00%
0/270
|
|
Immune system disorders
DRUG HYPERSENSITIVITY
|
0.00%
0/534
|
0.37%
1/270 • Number of events 1
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/534
|
0.37%
1/270 • Number of events 1
|
|
Infections and infestations
CELLULITIS GANGRENOUS
|
0.19%
1/534 • Number of events 1
|
0.00%
0/270
|
|
Infections and infestations
EXTRADURAL ABSCESS
|
0.00%
0/534
|
0.37%
1/270 • Number of events 1
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
0.00%
0/534
|
0.37%
1/270 • Number of events 1
|
|
Infections and infestations
LOBAR PNEUMONIA
|
0.19%
1/534 • Number of events 1
|
0.00%
0/270
|
|
Infections and infestations
PNEUMONIA
|
0.94%
5/534 • Number of events 5
|
0.37%
1/270 • Number of events 1
|
|
Infections and infestations
PYELONEPHRITIS
|
0.19%
1/534 • Number of events 1
|
0.00%
0/270
|
|
Infections and infestations
SEPSIS
|
0.00%
0/534
|
0.37%
1/270 • Number of events 1
|
|
Infections and infestations
SINUSITIS
|
0.19%
1/534 • Number of events 1
|
0.00%
0/270
|
|
Infections and infestations
STAPHYLOCOCCAL INFECTION
|
0.00%
0/534
|
0.37%
1/270 • Number of events 1
|
|
Infections and infestations
VULVAL ABSCESS
|
0.00%
0/534
|
0.37%
1/270 • Number of events 1
|
|
Injury, poisoning and procedural complications
ANKLE FRACTURE
|
0.19%
1/534 • Number of events 1
|
0.37%
1/270 • Number of events 1
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.00%
0/534
|
0.37%
1/270 • Number of events 1
|
|
Injury, poisoning and procedural complications
FALL
|
0.19%
1/534 • Number of events 1
|
0.00%
0/270
|
|
Injury, poisoning and procedural complications
FIBULA FRACTURE
|
0.37%
2/534 • Number of events 2
|
0.00%
0/270
|
|
Injury, poisoning and procedural complications
INTENTIONAL OVERDOSE
|
0.19%
1/534 • Number of events 1
|
0.00%
0/270
|
|
Injury, poisoning and procedural complications
LIMB INJURY
|
0.19%
1/534 • Number of events 1
|
0.00%
0/270
|
|
Injury, poisoning and procedural complications
OVERDOSE
|
0.19%
1/534 • Number of events 1
|
0.00%
0/270
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL COMPLICATION
|
0.19%
1/534 • Number of events 1
|
0.00%
0/270
|
|
Injury, poisoning and procedural complications
RADIUS FRACTURE
|
0.00%
0/534
|
0.37%
1/270 • Number of events 1
|
|
Injury, poisoning and procedural complications
RIB FRACTURE
|
0.19%
1/534 • Number of events 1
|
0.00%
0/270
|
|
Injury, poisoning and procedural complications
THORACIC VERTEBRAL FRACTURE
|
0.37%
2/534 • Number of events 2
|
0.00%
0/270
|
|
Injury, poisoning and procedural complications
TIBIA FRACTURE
|
0.37%
2/534 • Number of events 2
|
0.00%
0/270
|
|
Injury, poisoning and procedural complications
ULNA FRACTURE
|
0.00%
0/534
|
0.37%
1/270 • Number of events 1
|
|
Investigations
BLOOD PRESSURE DECREASED
|
0.00%
0/534
|
0.37%
1/270 • Number of events 1
|
|
Investigations
BLOOD PRESSURE INCREASED
|
0.19%
1/534 • Number of events 1
|
0.00%
0/270
|
|
Investigations
TRANSAMINASES INCREASED
|
0.19%
1/534 • Number of events 1
|
0.00%
0/270
|
|
Investigations
TROPONIN INCREASED
|
0.19%
1/534 • Number of events 1
|
0.00%
0/270
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
0.19%
1/534 • Number of events 1
|
0.37%
1/270 • Number of events 1
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
0.19%
1/534 • Number of events 1
|
0.00%
0/270
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.37%
2/534 • Number of events 2
|
0.37%
1/270 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
FLANK PAIN
|
0.00%
0/534
|
0.37%
1/270 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
LUMBAR SPINAL STENOSIS
|
0.19%
1/534 • Number of events 1
|
0.37%
1/270 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
0.00%
0/534
|
0.37%
1/270 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
0.19%
1/534 • Number of events 1
|
0.37%
1/270 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.19%
1/534 • Number of events 1
|
0.37%
1/270 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
OSTEONECROSIS
|
0.19%
1/534 • Number of events 1
|
0.00%
0/270
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.00%
0/534
|
0.37%
1/270 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
RHABDOMYOLYSIS
|
0.19%
1/534 • Number of events 1
|
0.37%
1/270 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
RHEUMATOID ARTHRITIS
|
0.19%
1/534 • Number of events 1
|
0.00%
0/270
|
|
Musculoskeletal and connective tissue disorders
ROTATOR CUFF SYNDROME
|
0.19%
1/534 • Number of events 1
|
0.00%
0/270
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
0.19%
1/534 • Number of events 1
|
0.00%
0/270
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG ADENOCARCINOMA
|
0.19%
1/534 • Number of events 1
|
0.00%
0/270
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LYMPHOMA
|
0.19%
1/534 • Number of events 1
|
0.00%
0/270
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SUPERFICIAL SPREADING MELANOMA STAGE II
|
0.00%
0/534
|
0.37%
1/270 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
THYROID CANCER RECURRENT
|
0.19%
1/534 • Number of events 1
|
0.00%
0/270
|
|
Nervous system disorders
AKATHISIA
|
0.19%
1/534 • Number of events 1
|
0.00%
0/270
|
|
Nervous system disorders
ALTERED STATE OF CONSCIOUSNESS
|
0.00%
0/534
|
0.37%
1/270 • Number of events 1
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.00%
0/534
|
0.37%
1/270 • Number of events 1
|
|
Nervous system disorders
CERVICAL NEURITIS
|
0.19%
1/534 • Number of events 1
|
0.00%
0/270
|
|
Nervous system disorders
CERVICOBRACHIAL SYNDROME
|
0.19%
1/534 • Number of events 1
|
0.00%
0/270
|
|
Nervous system disorders
COMPLICATED MIGRAINE
|
0.00%
0/534
|
0.37%
1/270 • Number of events 1
|
|
Nervous system disorders
HYPOGLYCAEMIC COMA
|
0.19%
1/534 • Number of events 1
|
0.00%
0/270
|
|
Nervous system disorders
IDIOPATHIC GENERALISED EPILEPSY
|
0.19%
1/534 • Number of events 1
|
0.00%
0/270
|
|
Nervous system disorders
ISCHAEMIC CEREBRAL INFARCTION
|
0.00%
0/534
|
0.37%
1/270 • Number of events 1
|
|
Nervous system disorders
RADICULITIS CERVICAL
|
0.19%
1/534 • Number of events 1
|
0.00%
0/270
|
|
Nervous system disorders
SYNCOPE
|
0.19%
1/534 • Number of events 1
|
0.00%
0/270
|
|
Psychiatric disorders
BIPOLAR I DISORDER
|
0.19%
1/534 • Number of events 1
|
0.00%
0/270
|
|
Psychiatric disorders
DEPRESSION
|
0.19%
1/534 • Number of events 1
|
0.00%
0/270
|
|
Psychiatric disorders
HOMICIDAL IDEATION
|
0.19%
1/534 • Number of events 1
|
0.00%
0/270
|
|
Psychiatric disorders
MAJOR DEPRESSION
|
0.00%
0/534
|
0.37%
1/270 • Number of events 1
|
|
Psychiatric disorders
PANIC ATTACK
|
0.19%
1/534 • Number of events 1
|
0.00%
0/270
|
|
Psychiatric disorders
PSYCHOTIC DISORDER
|
0.00%
0/534
|
0.37%
1/270 • Number of events 1
|
|
Psychiatric disorders
SCHIZOPHRENIA
|
0.19%
1/534 • Number of events 1
|
0.00%
0/270
|
|
Psychiatric disorders
SUICIDAL IDEATION
|
0.19%
1/534 • Number of events 1
|
0.00%
0/270
|
|
Psychiatric disorders
SUICIDE ATTEMPT
|
0.37%
2/534 • Number of events 2
|
0.00%
0/270
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
0.00%
0/534
|
1.1%
3/270 • Number of events 3
|
|
Renal and urinary disorders
RENAL INJURY
|
0.19%
1/534 • Number of events 1
|
0.00%
0/270
|
|
Reproductive system and breast disorders
ENDOMETRIAL HYPERPLASIA
|
0.19%
1/534 • Number of events 1
|
0.00%
0/270
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.19%
1/534 • Number of events 1
|
0.74%
2/270 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.56%
3/534 • Number of events 3
|
0.37%
1/270 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
0.19%
1/534 • Number of events 1
|
0.00%
0/270
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY CONGESTION
|
0.00%
0/534
|
0.37%
1/270 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
SKIN DISCOLOURATION
|
0.00%
0/534
|
0.37%
1/270 • Number of events 1
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.19%
1/534 • Number of events 1
|
0.00%
0/270
|
|
Vascular disorders
HYPOVOLAEMIC SHOCK
|
0.19%
1/534 • Number of events 1
|
0.00%
0/270
|
|
Vascular disorders
ORTHOSTATIC HYPOTENSION
|
0.19%
1/534 • Number of events 1
|
0.00%
0/270
|
|
Vascular disorders
THROMBOSIS
|
0.00%
0/534
|
0.37%
1/270 • Number of events 1
|
Other adverse events
| Measure |
NKTR-118 25 mg
n=534 participants at risk
|
Usual Care
n=270 participants at risk
|
|---|---|---|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
2.4%
13/534 • Number of events 13
|
0.37%
1/270 • Number of events 1
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
2.2%
12/534 • Number of events 12
|
1.1%
3/270 • Number of events 3
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
18.4%
98/534 • Number of events 98
|
3.3%
9/270 • Number of events 9
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
5.6%
30/534 • Number of events 30
|
1.1%
3/270 • Number of events 3
|
|
Gastrointestinal disorders
DIARRHOEA
|
13.7%
73/534 • Number of events 73
|
5.9%
16/270 • Number of events 16
|
|
Gastrointestinal disorders
FLATULENCE
|
7.3%
39/534 • Number of events 39
|
1.1%
3/270 • Number of events 3
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
2.1%
11/534 • Number of events 11
|
1.9%
5/270 • Number of events 5
|
|
Gastrointestinal disorders
NAUSEA
|
10.5%
56/534 • Number of events 56
|
4.1%
11/270 • Number of events 11
|
|
Gastrointestinal disorders
VOMITING
|
5.2%
28/534 • Number of events 28
|
5.6%
15/270 • Number of events 15
|
|
General disorders
CHILLS
|
2.1%
11/534 • Number of events 11
|
0.00%
0/270
|
|
General disorders
FATIGUE
|
3.4%
18/534 • Number of events 18
|
1.1%
3/270 • Number of events 3
|
|
General disorders
OEDEMA PERIPHERAL
|
2.4%
13/534 • Number of events 13
|
3.0%
8/270 • Number of events 8
|
|
General disorders
PYREXIA
|
2.6%
14/534 • Number of events 14
|
2.2%
6/270 • Number of events 6
|
|
Infections and infestations
BRONCHITIS
|
5.6%
30/534 • Number of events 30
|
4.4%
12/270 • Number of events 12
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
3.0%
16/534 • Number of events 16
|
1.5%
4/270 • Number of events 4
|
|
Infections and infestations
INFLUENZA
|
1.9%
10/534 • Number of events 10
|
3.0%
8/270 • Number of events 8
|
|
Infections and infestations
NASOPHARYNGITIS
|
6.2%
33/534 • Number of events 33
|
5.6%
15/270 • Number of events 15
|
|
Infections and infestations
SINUSITIS
|
4.1%
22/534 • Number of events 22
|
7.0%
19/270 • Number of events 19
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
5.8%
31/534 • Number of events 31
|
8.5%
23/270 • Number of events 23
|
|
Infections and infestations
URINARY TRACT INFECTION
|
5.2%
28/534 • Number of events 28
|
8.9%
24/270 • Number of events 24
|
|
Injury, poisoning and procedural complications
CONTUSION
|
2.1%
11/534 • Number of events 11
|
0.37%
1/270 • Number of events 1
|
|
Injury, poisoning and procedural complications
FALL
|
3.6%
19/534 • Number of events 19
|
4.4%
12/270 • Number of events 12
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.56%
3/534 • Number of events 3
|
2.2%
6/270 • Number of events 6
|
|
Metabolism and nutrition disorders
HYPERCHOLESTEROLAEMIA
|
1.1%
6/534 • Number of events 6
|
2.2%
6/270 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
6.4%
34/534 • Number of events 34
|
5.9%
16/270 • Number of events 16
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
9.0%
48/534 • Number of events 48
|
8.5%
23/270 • Number of events 23
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
3.2%
17/534 • Number of events 17
|
3.0%
8/270 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
4.1%
22/534 • Number of events 22
|
2.6%
7/270 • Number of events 7
|
|
Nervous system disorders
DIZZINESS
|
2.2%
12/534 • Number of events 12
|
1.1%
3/270 • Number of events 3
|
|
Nervous system disorders
HEADACHE
|
9.0%
48/534 • Number of events 48
|
4.8%
13/270 • Number of events 13
|
|
Psychiatric disorders
ANXIETY
|
3.2%
17/534 • Number of events 17
|
1.5%
4/270 • Number of events 4
|
|
Psychiatric disorders
DEPRESSION
|
2.4%
13/534 • Number of events 13
|
3.7%
10/270 • Number of events 10
|
|
Psychiatric disorders
INSOMNIA
|
2.8%
15/534 • Number of events 15
|
1.9%
5/270 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
5.1%
27/534 • Number of events 27
|
3.0%
8/270 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
2.8%
15/534 • Number of events 15
|
1.5%
4/270 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
3.2%
17/534 • Number of events 17
|
0.37%
1/270 • Number of events 1
|
|
Vascular disorders
HYPERTENSION
|
3.0%
16/534 • Number of events 16
|
3.3%
9/270 • Number of events 9
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60