Trial Outcomes & Findings for Bioequivalence of Generic Imiquimod Cream, 5% When Compared to Aldara™ (Imiquimod) Cream, 5% in the Treatment of Actinic Keratosis (NCT NCT00948428)
NCT ID: NCT00948428
Last Updated: 2020-09-04
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
462 participants
Primary outcome timeframe
Week 24
Results posted on
2020-09-04
Participant Flow
Participant milestones
| Measure |
Generic Imiquimod
Imiquimod cream, 5%
Imiquimod: 5% topical cream dispensed in individual 0.25 g sachets applied twice a week for 16 weeks
|
Aldara™
Aldara™ (imiquimod) cream, 5%
Aldara™: 5% topical cream dispensed in individual 0.25 g sachets applied twice a week for 16 weeks
|
Vehicle Cream
Vehicle cream (Actavis)
Vehicle Cream: Topical cream vehicle matching Generic imiquimod dispensed in individual 0.25 g sachets applied twice a week for 16 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
185
|
185
|
92
|
|
Overall Study
COMPLETED
|
167
|
167
|
84
|
|
Overall Study
NOT COMPLETED
|
18
|
18
|
8
|
Reasons for withdrawal
| Measure |
Generic Imiquimod
Imiquimod cream, 5%
Imiquimod: 5% topical cream dispensed in individual 0.25 g sachets applied twice a week for 16 weeks
|
Aldara™
Aldara™ (imiquimod) cream, 5%
Aldara™: 5% topical cream dispensed in individual 0.25 g sachets applied twice a week for 16 weeks
|
Vehicle Cream
Vehicle cream (Actavis)
Vehicle Cream: Topical cream vehicle matching Generic imiquimod dispensed in individual 0.25 g sachets applied twice a week for 16 weeks
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
12
|
7
|
|
Overall Study
Adverse Event
|
6
|
3
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
1
|
|
Overall Study
Death
|
2
|
0
|
0
|
|
Overall Study
Intercurrent Illness
|
1
|
0
|
0
|
|
Overall Study
Non-compliance
|
1
|
2
|
0
|
Baseline Characteristics
Bioequivalence of Generic Imiquimod Cream, 5% When Compared to Aldara™ (Imiquimod) Cream, 5% in the Treatment of Actinic Keratosis
Baseline characteristics by cohort
| Measure |
Generic Imiquimod
n=181 Participants
Imiquimod cream, 5%
Imiquimod: 5% topical cream dispensed in individual 0.25 g sachets applied twice a week for 16 weeks
|
Aldara™
n=179 Participants
Aldara™ (imiquimod) cream, 5%
Aldara™: 5% topical cream dispensed in individual 0.25 g sachets applied twice a week for 16 weeks
|
Vehicle Cream
n=89 Participants
Vehicle cream (Actavis)
Vehicle Cream: Topical cream vehicle matching Generic imiquimod dispensed in individual 0.25 g sachets applied twice a week for 16 weeks
|
Total
n=449 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Sex: Female, Male
Male
|
152 Participants
n=5 Participants
|
159 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
387 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
176 Participants
n=5 Participants
|
173 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
436 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
181 Participants
n=5 Participants
|
179 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
449 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
66.5 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
66.7 years
STANDARD_DEVIATION 10.4 • n=7 Participants
|
66.7 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
66.6 years
STANDARD_DEVIATION 10.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: Using Per-Protocol Population (PP)
Outcome measures
| Measure |
Generic Imiquimod
n=158 Participants
Imiquimod cream, 5%
Imiquimod: 5% topical cream dispensed in individual 0.25 g sachets applied twice a week for 16 weeks
|
Aldara™
n=151 Participants
Aldara™ (imiquimod) cream, 5%
Aldara™: 5% topical cream dispensed in individual 0.25 g sachets applied twice a week for 16 weeks
|
Vehicle Cream
n=76 Participants
Vehicle cream (Actavis)
Vehicle Cream: Topical cream vehicle matching Generic imiquimod dispensed in individual 0.25 g sachets applied twice a week for 16 weeks
|
|---|---|---|---|
|
Percentage of Subjects in Each Treatment Group With Complete Clearance of AK Lesions at the Test of Cure Visit (Week 24)
|
74 Participants
|
72 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Week 16Population: Using the Intent-to-Treat Population Eighteen (18) ITT subjects from Site 15 are not included due to AK lesion counts not performed post-baseline.
Outcome measures
| Measure |
Generic Imiquimod
n=173 Participants
Imiquimod cream, 5%
Imiquimod: 5% topical cream dispensed in individual 0.25 g sachets applied twice a week for 16 weeks
|
Aldara™
n=171 Participants
Aldara™ (imiquimod) cream, 5%
Aldara™: 5% topical cream dispensed in individual 0.25 g sachets applied twice a week for 16 weeks
|
Vehicle Cream
n=87 Participants
Vehicle cream (Actavis)
Vehicle Cream: Topical cream vehicle matching Generic imiquimod dispensed in individual 0.25 g sachets applied twice a week for 16 weeks
|
|---|---|---|---|
|
Percentage of Subjects With at Least a 75% Reduction in the Number of AK Lesions From Baseline to End of Treatment (EOT) Visit (Week 16).
|
110 Participants
|
114 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Week 24Population: Using Intent-to-Treat population Eighteen (18) ITT subjects from Site 15 are not included due to AK lesion counts not performed post-baseline.
Outcome measures
| Measure |
Generic Imiquimod
n=173 Participants
Imiquimod cream, 5%
Imiquimod: 5% topical cream dispensed in individual 0.25 g sachets applied twice a week for 16 weeks
|
Aldara™
n=171 Participants
Aldara™ (imiquimod) cream, 5%
Aldara™: 5% topical cream dispensed in individual 0.25 g sachets applied twice a week for 16 weeks
|
Vehicle Cream
n=87 Participants
Vehicle cream (Actavis)
Vehicle Cream: Topical cream vehicle matching Generic imiquimod dispensed in individual 0.25 g sachets applied twice a week for 16 weeks
|
|---|---|---|---|
|
Percentage of Subjects With at Least a 75% Reduction in the Number of AK Lesions From Baseline to 8 Weeks Post Treatment (Test of Cure Visit).
|
77 Participants
|
77 Participants
|
7 Participants
|
Adverse Events
Generic Imiquimod
Serious events: 4 serious events
Other events: 79 other events
Deaths: 1 deaths
Aldara™
Serious events: 2 serious events
Other events: 60 other events
Deaths: 0 deaths
Vehicle Cream
Serious events: 2 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Generic Imiquimod
n=181 participants at risk
Imiquimod cream, 5%
Imiquimod: 5% topical cream dispensed in individual 0.25 g sachets applied twice a week for 16 weeks
|
Aldara™
n=179 participants at risk
Aldara™ (imiquimod) cream, 5%
Aldara™: 5% topical cream dispensed in individual 0.25 g sachets applied twice a week for 16 weeks
|
Vehicle Cream
n=89 participants at risk
Vehicle cream (Actavis)
Vehicle Cream: Topical cream vehicle matching Generic imiquimod dispensed in individual 0.25 g sachets applied twice a week for 16 weeks
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.55%
1/181 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Cardiac disorders
Acute myocardial infarction
|
0.55%
1/181 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
General disorders
Chest pain
|
0.00%
0/181 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
1.1%
1/89 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
|
Infections and infestations
Appendicitis
|
0.00%
0/181 • 24 Weeks
Based on subjects in ITT
|
0.56%
1/179 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/181 • 24 Weeks
Based on subjects in ITT
|
0.56%
1/179 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.55%
1/181 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal neoplasm
|
0.00%
0/181 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
1.1%
1/89 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mixed hepatocellular cholangiocarcinoma
|
0.55%
1/181 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Nervous system disorders
Carotid artery atenosis
|
0.00%
0/181 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
1.1%
1/89 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.55%
1/181 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.55%
1/181 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Vascular disorders
Deep vein thrombosis
|
0.55%
1/181 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Vascular disorders
Hypotension
|
0.55%
1/181 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
Other adverse events
| Measure |
Generic Imiquimod
n=181 participants at risk
Imiquimod cream, 5%
Imiquimod: 5% topical cream dispensed in individual 0.25 g sachets applied twice a week for 16 weeks
|
Aldara™
n=179 participants at risk
Aldara™ (imiquimod) cream, 5%
Aldara™: 5% topical cream dispensed in individual 0.25 g sachets applied twice a week for 16 weeks
|
Vehicle Cream
n=89 participants at risk
Vehicle cream (Actavis)
Vehicle Cream: Topical cream vehicle matching Generic imiquimod dispensed in individual 0.25 g sachets applied twice a week for 16 weeks
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.1%
2/181 • Number of events 2 • 24 Weeks
Based on subjects in ITT
|
0.56%
1/179 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/181 • 24 Weeks
Based on subjects in ITT
|
0.56%
1/179 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Cardiac disorders
Acute myocardial infarction
|
0.55%
1/181 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/181 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
1.1%
1/89 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
|
Cardiac disorders
Coronary artery disease
|
0.55%
1/181 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
1.1%
1/89 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.55%
1/181 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/181 • 24 Weeks
Based on subjects in ITT
|
0.56%
1/179 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Eye disorders
Conjunctivitis
|
0.55%
1/181 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/181 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
1.1%
1/89 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
|
Eye disorders
Eye oedema
|
0.00%
0/181 • 24 Weeks
Based on subjects in ITT
|
0.56%
1/179 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/181 • 24 Weeks
Based on subjects in ITT
|
0.56%
1/179 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Eye disorders
Keratitis
|
0.55%
1/181 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Eye disorders
Uveitis
|
0.00%
0/181 • 24 Weeks
Based on subjects in ITT
|
0.56%
1/179 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/181 • 24 Weeks
Based on subjects in ITT
|
0.56%
1/179 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Gastrointestinal disorders
Colonic polyp
|
0.00%
0/181 • 24 Weeks
Based on subjects in ITT
|
0.56%
1/179 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Gastrointestinal disorders
Constipation
|
0.55%
1/181 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Gastrointestinal disorders
Diarrhoea
|
1.1%
2/181 • Number of events 2 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.1%
2/181 • Number of events 2 • 24 Weeks
Based on subjects in ITT
|
0.56%
1/179 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/181 • 24 Weeks
Based on subjects in ITT
|
0.56%
1/179 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/181 • 24 Weeks
Based on subjects in ITT
|
0.56%
1/179 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Gastrointestinal disorders
Nausea
|
0.55%
1/181 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
3.9%
7/179 • Number of events 7 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Gastrointestinal disorders
Stomach dicomfort
|
0.00%
0/181 • 24 Weeks
Based on subjects in ITT
|
0.56%
1/179 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/181 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
1.1%
1/89 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
2/181 • Number of events 2 • 24 Weeks
Based on subjects in ITT
|
1.1%
2/179 • Number of events 2 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
General disorders
Adverse Drug reaction
|
0.55%
1/181 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
General disorders
Application site alopecia
|
0.00%
0/181 • 24 Weeks
Based on subjects in ITT
|
0.56%
1/179 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
General disorders
Application site discomfort
|
1.1%
2/181 • Number of events 2 • 24 Weeks
Based on subjects in ITT
|
0.56%
1/179 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
General disorders
Application site pruritus
|
0.00%
0/181 • 24 Weeks
Based on subjects in ITT
|
0.56%
1/179 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
General disorders
Application site reaction
|
0.55%
1/181 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
General disorders
Asthenia
|
0.00%
0/181 • 24 Weeks
Based on subjects in ITT
|
1.1%
2/179 • Number of events 2 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
General disorders
Chest pain
|
0.00%
0/181 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
1.1%
1/89 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
|
General disorders
Chills
|
0.55%
1/181 • Number of events 3 • 24 Weeks
Based on subjects in ITT
|
0.56%
1/179 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
General disorders
Fatigue
|
0.00%
0/181 • 24 Weeks
Based on subjects in ITT
|
1.1%
2/179 • Number of events 3 • 24 Weeks
Based on subjects in ITT
|
1.1%
1/89 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
|
General disorders
Hernia
|
0.55%
1/181 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.56%
1/179 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
General disorders
Influenza like illness
|
1.1%
2/181 • Number of events 3 • 24 Weeks
Based on subjects in ITT
|
1.1%
2/179 • Number of events 5 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
General disorders
Oedema peripheral
|
0.00%
0/181 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
1.1%
1/89 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
|
General disorders
Pain
|
0.00%
0/181 • 24 Weeks
Based on subjects in ITT
|
0.56%
1/179 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
General disorders
Pyrexia
|
0.00%
0/181 • 24 Weeks
Based on subjects in ITT
|
0.56%
1/179 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/181 • 24 Weeks
Based on subjects in ITT
|
0.56%
1/179 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Infections and infestations
Appendicitis
|
0.00%
0/181 • 24 Weeks
Based on subjects in ITT
|
0.56%
1/179 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Infections and infestations
Bronchitis
|
0.55%
1/181 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.56%
1/179 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Infections and infestations
Candidiasis
|
0.00%
0/181 • 24 Weeks
Based on subjects in ITT
|
0.56%
1/179 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Infections and infestations
Diverticulitis
|
0.55%
1/181 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Infections and infestations
Folliculitis
|
0.00%
0/181 • 24 Weeks
Based on subjects in ITT
|
0.56%
1/179 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/181 • 24 Weeks
Based on subjects in ITT
|
0.56%
1/179 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Infections and infestations
Herpes zoster
|
0.55%
1/181 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
1.1%
1/89 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
|
Infections and infestations
Influenza
|
0.55%
1/181 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Infections and infestations
Localised infection
|
0.00%
0/181 • 24 Weeks
Based on subjects in ITT
|
0.56%
1/179 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Infections and infestations
Nail infection
|
0.00%
0/181 • 24 Weeks
Based on subjects in ITT
|
0.56%
1/179 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Infections and infestations
Nasopharyngitis
|
2.8%
5/181 • Number of events 5 • 24 Weeks
Based on subjects in ITT
|
3.4%
6/179 • Number of events 7 • 24 Weeks
Based on subjects in ITT
|
3.4%
3/89 • Number of events 3 • 24 Weeks
Based on subjects in ITT
|
|
Infections and infestations
Prostate infection
|
0.55%
1/181 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.56%
1/179 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Infections and infestations
Rhinitis
|
0.00%
0/181 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
1.1%
1/89 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
|
Infections and infestations
Sinusitis
|
3.3%
6/181 • Number of events 6 • 24 Weeks
Based on subjects in ITT
|
0.56%
1/179 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
1.1%
1/89 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
|
Infections and infestations
Staphylococcal skin infection
|
0.55%
1/181 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Infections and infestations
Upper respiratory tract infection
|
1.1%
2/181 • Number of events 2 • 24 Weeks
Based on subjects in ITT
|
1.1%
2/179 • Number of events 2 • 24 Weeks
Based on subjects in ITT
|
1.1%
1/89 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
|
Infections and infestations
Urinary tract infection
|
0.55%
1/181 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
2.2%
4/179 • Number of events 4 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.55%
1/181 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/181 • 24 Weeks
Based on subjects in ITT
|
0.56%
1/179 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/181 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
1.1%
1/89 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
|
Injury, poisoning and procedural complications
Contrast media reaction
|
0.00%
0/181 • 24 Weeks
Based on subjects in ITT
|
0.56%
1/179 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/181 • 24 Weeks
Based on subjects in ITT
|
0.56%
1/179 • Number of events 2 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.55%
1/181 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/181 • 24 Weeks
Based on subjects in ITT
|
0.56%
1/179 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/181 • 24 Weeks
Based on subjects in ITT
|
0.56%
1/179 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/181 • 24 Weeks
Based on subjects in ITT
|
0.56%
1/179 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.55%
1/181 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Injury, poisoning and procedural complications
Laceration
|
1.1%
2/181 • Number of events 2 • 24 Weeks
Based on subjects in ITT
|
0.56%
1/179 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/181 • 24 Weeks
Based on subjects in ITT
|
0.56%
1/179 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.55%
1/181 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.56%
1/179 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.55%
1/181 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.56%
1/179 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.00%
0/181 • 24 Weeks
Based on subjects in ITT
|
0.56%
1/179 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Investigations
Blood testosterone decreased
|
0.00%
0/181 • 24 Weeks
Based on subjects in ITT
|
0.56%
1/179 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Investigations
Prostatic specific antigen increased
|
0.55%
1/181 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Investigations
White blood cells urine positive
|
0.00%
0/181 • 24 Weeks
Based on subjects in ITT
|
0.56%
1/179 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/181 • 24 Weeks
Based on subjects in ITT
|
1.1%
2/179 • Number of events 3 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/181 • 24 Weeks
Based on subjects in ITT
|
0.56%
1/179 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Metabolism and nutrition disorders
Gout
|
1.1%
2/181 • Number of events 2 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.55%
1/181 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
1.1%
2/179 • Number of events 2 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Metabolism and nutrition disorders
Hypertrigylceridaemia
|
0.00%
0/181 • 24 Weeks
Based on subjects in ITT
|
0.56%
1/179 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.55%
1/181 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
1.1%
1/89 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.55%
1/181 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Musculoskeletal and connective tissue disorders
Muskuloskeletal pain
|
0.55%
1/181 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/181 • 24 Weeks
Based on subjects in ITT
|
0.56%
1/179 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.2%
4/181 • Number of events 4 • 24 Weeks
Based on subjects in ITT
|
0.56%
1/179 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.55%
1/181 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.56%
1/179 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.1%
2/181 • Number of events 2 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
2.8%
5/181 • Number of events 7 • 24 Weeks
Based on subjects in ITT
|
1.7%
3/179 • Number of events 4 • 24 Weeks
Based on subjects in ITT
|
2.2%
2/89 • Number of events 3 • 24 Weeks
Based on subjects in ITT
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoma in situ of skin
|
0.00%
0/181 • 24 Weeks
Based on subjects in ITT
|
0.56%
1/179 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal neoplasm
|
0.00%
0/181 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
1.1%
1/89 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Keratoacanthoma
|
0.00%
0/181 • 24 Weeks
Based on subjects in ITT
|
0.56%
1/179 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.55%
1/181 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mixed hepatocellular cholangiocarcinoma
|
0.55%
1/181 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroma
|
0.55%
1/181 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.55%
1/181 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
2.2%
4/181 • Number of events 4 • 24 Weeks
Based on subjects in ITT
|
1.1%
2/179 • Number of events 2 • 24 Weeks
Based on subjects in ITT
|
3.4%
3/89 • Number of events 4 • 24 Weeks
Based on subjects in ITT
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.55%
1/181 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Nervous system disorders
Burning sensation
|
0.55%
1/181 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/181 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
1.1%
1/89 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
|
Nervous system disorders
Dizziness
|
0.55%
1/181 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.56%
1/179 • Number of events 2 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Nervous system disorders
Headache
|
3.3%
6/181 • Number of events 8 • 24 Weeks
Based on subjects in ITT
|
2.8%
5/179 • Number of events 6 • 24 Weeks
Based on subjects in ITT
|
2.2%
2/89 • Number of events 2 • 24 Weeks
Based on subjects in ITT
|
|
Nervous system disorders
Lethargy
|
1.1%
2/181 • Number of events 3 • 24 Weeks
Based on subjects in ITT
|
1.7%
3/179 • Number of events 3 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Nervous system disorders
Migraine
|
0.55%
1/181 • Number of events 4 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Psychiatric disorders
Depression
|
0.55%
1/181 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
1.1%
1/89 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
|
Psychiatric disorders
Insomnia
|
1.1%
2/181 • Number of events 2 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/181 • 24 Weeks
Based on subjects in ITT
|
0.56%
1/179 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Renal and urinary disorders
Renal pain
|
0.55%
1/181 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Renal and urinary disorders
Benign prostatic hyperplasia
|
0.00%
0/181 • 24 Weeks
Based on subjects in ITT
|
0.56%
1/179 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/181 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
1.1%
1/89 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.1%
2/181 • Number of events 2 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/181 • 24 Weeks
Based on subjects in ITT
|
0.56%
1/179 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.55%
1/181 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
0.00%
0/181 • 24 Weeks
Based on subjects in ITT
|
0.56%
1/179 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.55%
1/181 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.55%
1/181 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/181 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
1.1%
1/89 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/181 • 24 Weeks
Based on subjects in ITT
|
0.56%
1/179 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/181 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
1.1%
1/89 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.55%
1/181 • Number of events 2 • 24 Weeks
Based on subjects in ITT
|
0.56%
1/179 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
1.1%
2/181 • Number of events 2 • 24 Weeks
Based on subjects in ITT
|
0.56%
1/179 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
2.8%
5/181 • Number of events 5 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
1.1%
1/89 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
0.55%
1/181 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/181 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
1.1%
1/89 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/181 • 24 Weeks
Based on subjects in ITT
|
0.56%
1/179 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.55%
1/181 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/181 • 24 Weeks
Based on subjects in ITT
|
0.56%
1/179 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/181 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
1.1%
1/89 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
|
Skin and subcutaneous tissue disorders
Scar pain
|
0.55%
1/181 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/181 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
1.1%
1/89 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
|
Skin and subcutaneous tissue disorders
Transient acantholytic dermatosis
|
0.55%
1/181 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Surgical and medical procedures
Blepharectomy
|
0.55%
1/181 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.55%
1/181 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Vascular disorders
Deep vein thrombosis
|
0.55%
1/181 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Vascular disorders
Hypertension
|
0.55%
1/181 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
1.1%
2/179 • Number of events 2 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
|
Vascular disorders
Hypotension
|
0.55%
1/181 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
1.1%
1/89 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
|
Vascular disorders
Varicose vein ruptured
|
0.55%
1/181 • Number of events 1 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/179 • 24 Weeks
Based on subjects in ITT
|
0.00%
0/89 • 24 Weeks
Based on subjects in ITT
|
Additional Information
Senior Director, CE Studies
Teva Pharmaceuticals USA, Inc.
Phone: 1-888-483-8279
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The results of the study may be published or presented by the Investigator(s) after the review by, and in consultation and agreement with the Sponsor, and such that confidential or proprietary information is not disclosed.
- Publication restrictions are in place
Restriction type: OTHER