Trial Outcomes & Findings for Actual Use Trial of Atorvastatin Calcium 10 mg (NCT NCT01964326)
NCT ID: NCT01964326
Last Updated: 2021-02-21
Results Overview
Percentage of participants whose behavior was either correct or acceptable were considered to be compliant. The behavior was considered correct if participants had their LDL-C checked between Weeks 4 and 12. The behavior was considered acceptable if participants had their LDL-C checked between Weeks 2 and 3 (before Week 4) or between Weeks 13 (after Week 12) and 26 or if participants were instructed by a physician that an LDL-C test was not needed.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1311 participants
Primary outcome timeframe
Day 1 up to Week 26
Results posted on
2021-02-21
Participant Flow
Participants were screened by phone, then referred to their participating retail pharmacy site for a scheduled face-to-face interview, after which they were given an empty atorvastatin(Lipitor) over-the-counter(OTC) package to review the information on the outside of the entire package,after which decision was made to purchase the medicine by them.
Participant milestones
| Measure |
Atorvastatin
Participants after reading the drugs fact label (DFL), made a purchase decision, purchased (on Day 1) and used atorvastatin 10 milligram (mg) OTC for 26 weeks.
|
|---|---|
|
Overall Study
STARTED
|
1311
|
|
Overall Study
COMPLETED
|
1014
|
|
Overall Study
NOT COMPLETED
|
297
|
Reasons for withdrawal
| Measure |
Atorvastatin
Participants after reading the drugs fact label (DFL), made a purchase decision, purchased (on Day 1) and used atorvastatin 10 milligram (mg) OTC for 26 weeks.
|
|---|---|
|
Overall Study
Adverse Event
|
48
|
|
Overall Study
Death
|
2
|
|
Overall Study
Protocol Violation
|
4
|
|
Overall Study
Lost to Follow-up
|
88
|
|
Overall Study
Withdrawal by Subject
|
87
|
|
Overall Study
Pregnancy
|
1
|
|
Overall Study
No Longer Meets Eligibility Criteria
|
1
|
|
Overall Study
Physician Decision
|
55
|
|
Overall Study
Investigator Discretion
|
1
|
|
Overall Study
Other
|
9
|
|
Overall Study
Did not meet eligibility criteria
|
1
|
Baseline Characteristics
Actual Use Trial of Atorvastatin Calcium 10 mg
Baseline characteristics by cohort
| Measure |
Atorvastatin
n=1234 Participants
Participants after reading the drugs fact label (DFL), made a purchase decision, purchased (on Day 1) and used atorvastatin 10 milligram (mg) OTC for 26 weeks.
|
|---|---|
|
Age, Continuous
|
57.8 Years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
593 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
641 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to Week 26Population: The analysis was performed on the continuing users set which is a subset of the users set, defined as the users who continued taking the study medication for at least 6 weeks since the first date of the study treatment.
Percentage of participants whose behavior was either correct or acceptable were considered to be compliant. The behavior was considered correct if participants had their LDL-C checked between Weeks 4 and 12. The behavior was considered acceptable if participants had their LDL-C checked between Weeks 2 and 3 (before Week 4) or between Weeks 13 (after Week 12) and 26 or if participants were instructed by a physician that an LDL-C test was not needed.
Outcome measures
| Measure |
Atorvastatin
n=1041 Participants
Participants after reading the drugs fact label (DFL), made a purchase decision, purchased (on Day 1) and used atorvastatin 10 milligram (mg) OTC for 26 weeks.
|
|---|---|
|
Percentage of Participants Who Complied With the Direction to Check Their Low-density Lipoprotein Cholesterol (LDL-C) Level
|
49.7 Percentage of participants
Interval 46.6 to 52.7
|
PRIMARY outcome
Timeframe: Day 1 up to Week 26Population: The analysis was performed on continuing users who checked their LDL-C during the study.
Percentage of participants whose behavior was either correct or acceptable were considered to be compliant. The behavior was considered correct if participants self-reported an LDL-C level below 130 milligram per deciliter (mg/dL) or normal, or low and decided to continue with atorvastatin OTC or if participants self-reported an LDL-C below 130 mg/dL, or normal, or low but stopped the use because of new conditions preventing them from continuing use. The behavior was considered acceptable if participants self-report LDL-C level between 130 and 135 mg/dL and continued to use atorvastatin OTC without contacting a physician or other health care practitioner or if participants self-reported LDL-C greater than or equal to (\>=) 130 mg/dL('borderline high' or 'high' LDL-C), and contacted a physician after getting the LDL-C test results.
Outcome measures
| Measure |
Atorvastatin
n=542 Participants
Participants after reading the drugs fact label (DFL), made a purchase decision, purchased (on Day 1) and used atorvastatin 10 milligram (mg) OTC for 26 weeks.
|
|---|---|
|
Percentage of Participants Who Took Appropriate Action Based on Their LDL-C Results
|
52.6 Percentage of participants
Interval 48.4 to 56.8
|
SECONDARY outcome
Timeframe: Day 1 up to Week 26Population: The analysis was performed on the participants from the user set who reported the use of any "Ask a doctor or pharmacist before use" medication.
Percentage of participants whose behavior was either correct or acceptable were considered to be compliant. 'Ask a doctor or pharmacist before use' medication included human immunodeficiency virus (HIV) medicine, digoxin, telaprevir, rifampin, colchicine, or oral contraceptives. The behavior of the participants was considered correct if participants asked a doctor or pharmacist before use. The behavior was considered acceptable if participants contacted a doctor or pharmacist within 7 days of initiating therapy.
Outcome measures
| Measure |
Atorvastatin
n=24 Participants
Participants after reading the drugs fact label (DFL), made a purchase decision, purchased (on Day 1) and used atorvastatin 10 milligram (mg) OTC for 26 weeks.
|
|---|---|
|
Percentage of Participants Taking an "Ask a Doctor or Pharmacist Before Use" Medication Who Followed the Labeling and Contacted a Doctor or Pharmacist Before Using Study Medication
|
29.2 Percentage of participants
Interval 11.0 to 47.4
|
SECONDARY outcome
Timeframe: Day 1 up to Week 26Population: The analysis was performed on the participants from the user set who experienced any of the labeled "Stop use and ask a doctor" symptoms.
Percentage of participants whose behavior was either correct or acceptable were considered to be compliant. The "Stop use and ask a doctor" symptoms included: (a) unexplained muscle pain or weakness or tenderness, (b) unusual fatigue, (c) loss of appetite (d) upper belly pain (e) dark-colored urine or (f) yellowing of the whites of eyes or skin. The behavior of the participants was considered correct if participants stopped use and contacted a doctor within 7 days after the event (symptom development).The behavior was considered acceptable if participants either stopped use or contacted a doctor (but did not do both) within the 7 days' timeframe.
Outcome measures
| Measure |
Atorvastatin
n=118 Participants
Participants after reading the drugs fact label (DFL), made a purchase decision, purchased (on Day 1) and used atorvastatin 10 milligram (mg) OTC for 26 weeks.
|
|---|---|
|
Percentage of Participants Who Stopped Study Medication Use and Asked a Doctor if They Experienced Any of the Labeled "Stop Use and Ask a Doctor" Symptoms
|
10.2 Percentage of participants
Interval 4.7 to 15.6
|
Adverse Events
Atorvastatin
Serious events: 53 serious events
Other events: 589 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Atorvastatin
n=1234 participants at risk
Participants after reading the drugs fact label (DFL), made a purchase decision, purchased (on Day 1) and used atorvastatin 10 milligram (mg) OTC for 26 weeks.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.16%
2/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Cardiac disorders
Coronary artery disease
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Cardiac disorders
Myocardial infarction
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Endocrine disorders
Goitre
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
General disorders
Chest pain
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
General disorders
Death
|
0.16%
2/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
General disorders
Hernia
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.16%
2/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Hepatobiliary disorders
Gallbladder perforation
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Infections and infestations
Bronchitis
|
0.16%
2/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Infections and infestations
Appendicitis
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Infections and infestations
Kidney infection
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Infections and infestations
Pneumonia
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Infections and infestations
Septic arthritis staphylococcal
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Infections and infestations
Lung abscess
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Infections and infestations
Osteomyelitis
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Infections and infestations
Sepsis
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Infections and infestations
Sinusitis
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.16%
2/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.16%
2/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.24%
3/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Nervous system disorders
Syncope
|
0.16%
2/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.24%
3/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Nervous system disorders
Carotid artery disease
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Psychiatric disorders
Depression
|
0.16%
2/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Psychiatric disorders
Suicidal ideation
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.16%
2/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Renal and urinary disorders
Calculus bladder
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Renal and urinary disorders
Renal failure
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.16%
2/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord disorder
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
Other adverse events
| Measure |
Atorvastatin
n=1234 participants at risk
Participants after reading the drugs fact label (DFL), made a purchase decision, purchased (on Day 1) and used atorvastatin 10 milligram (mg) OTC for 26 weeks.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Skin and subcutaneous tissue disorders
Stasis dermatitis
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Infections and infestations
Sinusitis
|
1.5%
18/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Infections and infestations
Urinary tract infection
|
1.4%
17/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Infections and infestations
Bronchitis
|
1.2%
15/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Infections and infestations
Pneumonia
|
0.41%
5/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.32%
4/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Infections and infestations
Gastroenteritis
|
0.24%
3/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Skin and subcutaneous tissue disorders
Ingrown hair
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Skin and subcutaneous tissue disorders
Lichen planus
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.24%
3/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.16%
2/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Cardiac disorders
Palpitations
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Ear and labyrinth disorders
Vertigo
|
0.41%
5/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Ear and labyrinth disorders
Ear pain
|
0.16%
2/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.16%
2/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Endocrine disorders
Hypothyroidism
|
0.16%
2/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Eye disorders
Vision blurred
|
0.16%
2/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Eye disorders
Conjunctivitis
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Eye disorders
Eye haemorrhage
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Eye disorders
Eye irritation
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Eye disorders
Eyelid irritation
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Eye disorders
Ocular hyperaemia
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Eye disorders
Ocular icterus
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Eye disorders
Optic nerve disorder
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Eye disorders
Visual acuity reduced
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Eye disorders
Vitreous detachment
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Eye disorders
Vitreous floaters
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.2%
40/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Gastrointestinal disorders
Nausea
|
2.1%
26/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Gastrointestinal disorders
Constipation
|
1.4%
17/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.3%
16/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Gastrointestinal disorders
Vomiting
|
0.89%
11/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.73%
9/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.65%
8/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Gastrointestinal disorders
Flatulence
|
0.65%
8/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Gastrointestinal disorders
Dry mouth
|
0.49%
6/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.49%
6/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Gastrointestinal disorders
Toothache
|
0.41%
5/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.32%
4/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Gastrointestinal disorders
Dysgeusia
|
0.32%
4/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.32%
4/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.24%
3/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Gastrointestinal disorders
Colitis
|
0.16%
2/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Gastrointestinal disorders
Food poisoning
|
0.16%
2/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Gastrointestinal disorders
Breath odour
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Gastrointestinal disorders
Glossitis
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Gastrointestinal disorders
Glossodynia
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Gastrointestinal disorders
Haematochezia
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Gastrointestinal disorders
Lip dry
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Gastrointestinal disorders
Swollen tongue
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Gastrointestinal disorders
Tongue discolouration
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
General disorders
Fatigue
|
1.9%
23/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
General disorders
Peripheral swelling
|
0.73%
9/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
General disorders
Chest pain
|
0.57%
7/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
General disorders
Pain
|
0.32%
4/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
General disorders
Swelling
|
0.32%
4/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
General disorders
Asthenia
|
0.16%
2/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
General disorders
Tenderness
|
0.16%
2/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
General disorders
Thirst
|
0.16%
2/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
General disorders
Calcinosis
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
General disorders
Chest discomfort
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
General disorders
Chills
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
General disorders
Cyst
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
General disorders
Feeling abnormal
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
General disorders
Feeling jittery
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
General disorders
Influenza like illness
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
General disorders
Mass
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
General disorders
Pyrexia
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Hepatobiliary disorders
Gallbladder pain
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Hepatobiliary disorders
Hepatitis
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Immune system disorders
Seasonal allergy
|
0.49%
6/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Immune system disorders
Dermatitis allergic
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Immune system disorders
Hypersensitivity
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Infections and infestations
Nasopharyngitis
|
3.6%
44/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Infections and infestations
Influenza
|
1.5%
19/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Infections and infestations
Herpes zoster
|
0.24%
3/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Infections and infestations
Skin infection
|
0.24%
3/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Infections and infestations
Viral infection
|
0.24%
3/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Infections and infestations
Fungal infection
|
0.16%
2/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Infections and infestations
Labyrinthitis
|
0.16%
2/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Infections and infestations
Respiratory tract infection
|
0.16%
2/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Infections and infestations
Tooth abscess
|
0.16%
2/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Infections and infestations
Tooth infection
|
0.16%
2/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Infections and infestations
Vaginal infection
|
0.16%
2/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Infections and infestations
Acarodermatitis
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Infections and infestations
Bacterial vaginosis
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Infections and infestations
Bursitis infective
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Infections and infestations
Candida infection
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Infections and infestations
Cestode infection
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Infections and infestations
Diverticulitis
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Infections and infestations
Ear infection
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Infections and infestations
Folliculitis
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Infections and infestations
Gastric infection
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Infections and infestations
Genital herpes
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Infections and infestations
Hepatitis B
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Infections and infestations
Infected cyst
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Infections and infestations
Infection
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Infections and infestations
Kidney infection
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Infections and infestations
Localised infection
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Infections and infestations
Otitis media
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Infections and infestations
Skin bacterial infection
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Infections and infestations
Wound infection
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.73%
9/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.65%
8/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.57%
7/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.32%
4/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.24%
3/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.16%
2/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.16%
2/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Injury, poisoning and procedural complications
Exposure during pregnancy
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Injury, poisoning and procedural complications
Foreign body in eye
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Injury, poisoning and procedural complications
Injury
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Injury, poisoning and procedural complications
Injury corneal
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Injury, poisoning and procedural complications
Limb crushing injury
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Injury, poisoning and procedural complications
Nail injury
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Injury, poisoning and procedural complications
Rotator cuff syndrome
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Injury, poisoning and procedural complications
Splinter
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Injury, poisoning and procedural complications
Stress fracture
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Injury, poisoning and procedural complications
Wound
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Investigations
Blood pressure increased
|
0.73%
9/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Investigations
Blood glucose increased
|
0.65%
8/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Investigations
Weight increased
|
0.65%
8/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Investigations
Blood cholesterol increased
|
0.41%
5/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Investigations
Hepatic enzyme increased
|
0.24%
3/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Investigations
Heart rate increased
|
0.16%
2/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Investigations
Liver function test abnormal
|
0.16%
2/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Investigations
Blood pressure decreased
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Investigations
Blood urine present
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Investigations
Heart rate irregular
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Investigations
Platelet count increased
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Investigations
Prostate examination abnormal
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.41%
5/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.32%
4/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.16%
2/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.16%
2/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.16%
2/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.16%
2/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.3%
53/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.1%
26/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.6%
20/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.5%
18/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.97%
12/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.81%
10/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.73%
9/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Musculoskeletal and connective tissue disorders
Gout
|
0.57%
7/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.57%
7/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.24%
3/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.24%
3/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.16%
2/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Musculoskeletal and connective tissue disorders
Diastasis recti abdominis
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Musculoskeletal and connective tissue disorders
Epicondylitis
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Musculoskeletal and connective tissue disorders
Muscle fatigue
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Musculoskeletal and connective tissue disorders
Tendon discomfort
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.24%
3/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cyst
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Nervous system disorders
Headache
|
3.0%
37/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Nervous system disorders
Dizziness
|
1.1%
14/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Nervous system disorders
Migraine
|
0.41%
5/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Nervous system disorders
Hypoaesthesia
|
0.32%
4/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Nervous system disorders
Memory impairment
|
0.32%
4/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Nervous system disorders
Sciatica
|
0.32%
4/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Nervous system disorders
Burning sensation
|
0.16%
2/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Nervous system disorders
Convulsion
|
0.16%
2/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Nervous system disorders
Neuralgia
|
0.16%
2/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Nervous system disorders
Paraesthesia
|
0.16%
2/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Nervous system disorders
Anal sphincter atony
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Nervous system disorders
Disorientation
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Nervous system disorders
Disturbance in attention
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Nervous system disorders
Muscular weakness
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Nervous system disorders
Paraesthesia oral
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Nervous system disorders
Restless legs syndrome
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Nervous system disorders
Stupor
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Nervous system disorders
Syncope
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Nervous system disorders
Tremor
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Psychiatric disorders
Anxiety
|
0.65%
8/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Psychiatric disorders
Insomnia
|
0.65%
8/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Psychiatric disorders
Depression
|
0.49%
6/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Psychiatric disorders
Confusional state
|
0.16%
2/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Psychiatric disorders
Nervousness
|
0.16%
2/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Psychiatric disorders
Nightmare
|
0.16%
2/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Psychiatric disorders
Affect lability
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Psychiatric disorders
Panic attack
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Psychiatric disorders
Sleep disorder
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.49%
6/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Renal and urinary disorders
Chromaturia
|
0.32%
4/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Renal and urinary disorders
Bladder pain
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Renal and urinary disorders
Pollakiuria
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Renal and urinary disorders
Urine odour abnormal
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.32%
4/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Reproductive system and breast disorders
Breast abscess
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Reproductive system and breast disorders
Breast mass
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Reproductive system and breast disorders
Libido decreased
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Reproductive system and breast disorders
Spontaneous penile erection
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.81%
10/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.24%
3/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.24%
3/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.24%
3/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.16%
2/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.16%
2/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.16%
2/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal disorder
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.89%
11/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.49%
6/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.24%
3/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.16%
2/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Social circumstances
Victim of sexual abuse
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Vascular disorders
Flushing
|
0.16%
2/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Vascular disorders
Hypertension
|
0.16%
2/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Vascular disorders
Hypotension
|
0.16%
2/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Vascular disorders
Thrombosis
|
0.16%
2/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Vascular disorders
Arteriosclerosis
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
|
Vascular disorders
Haematoma
|
0.08%
1/1234 • Day 1 up to Week 26
Analysis was performed in the safety population defined as all participants who purchased the product and provided any exposure data.
|
Additional Information
Pfizer ClinicalTrials.gov Call Center
Pfizer, Inc.
Phone: 1--800--718--1021
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER