Trial Outcomes & Findings for Study Comparing Imiquimod Cream, 3.75% to Zyclara® (Imiquimod) Cream, 3.75% in the Treatment of Actinic Keratosis (NCT NCT01686152)
NCT ID: NCT01686152
Last Updated: 2020-11-24
Results Overview
The primary efficacy endpoint is the proportion of subjects with treatment success at Visit 5/Week 14 (8 weeks post-treatment). Treatment success is defined as 100% clearance of all AK lesions (baseline AK lesions and any new AK lesions) within the treatment area.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
589 participants
Primary outcome timeframe
14 Weeks
Results posted on
2020-11-24
Participant Flow
Participant milestones
| Measure |
Investigational Test Product
Imiquimod Cream, 3.75% (Teva)
|
Reference Listed Drug
Zyclara® (imiquimod Cream), 3.75% (Medicis)
|
Vehicle
Vehicle of Test Product (Teva)
|
|---|---|---|---|
|
Overall Study
STARTED
|
252
|
253
|
84
|
|
Overall Study
COMPLETED
|
211
|
218
|
75
|
|
Overall Study
NOT COMPLETED
|
41
|
35
|
9
|
Reasons for withdrawal
| Measure |
Investigational Test Product
Imiquimod Cream, 3.75% (Teva)
|
Reference Listed Drug
Zyclara® (imiquimod Cream), 3.75% (Medicis)
|
Vehicle
Vehicle of Test Product (Teva)
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
11
|
11
|
3
|
|
Overall Study
Drug Code Unblinded
|
0
|
1
|
0
|
|
Overall Study
Protocol Violation
|
6
|
1
|
0
|
|
Overall Study
Adverse Event
|
12
|
11
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
1
|
|
Overall Study
IP Non-compliance
|
5
|
5
|
0
|
|
Overall Study
Lost to Follow-up
|
7
|
6
|
5
|
Baseline Characteristics
Study Comparing Imiquimod Cream, 3.75% to Zyclara® (Imiquimod) Cream, 3.75% in the Treatment of Actinic Keratosis
Baseline characteristics by cohort
| Measure |
Investigational Test Product
n=247 Participants
Imiquimod Cream, 3.75% (Teva)
|
Reference Listed Drug
n=249 Participants
Zyclara® (imiquimod Cream), 3.75% (Medicis)
|
Vehicle
n=80 Participants
Vehicle of Test Product (Teva)
|
Total
n=576 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
67.8 years
STANDARD_DEVIATION 9.12 • n=5 Participants
|
68.6 years
STANDARD_DEVIATION 9.79 • n=7 Participants
|
68.7 years
STANDARD_DEVIATION 10.23 • n=5 Participants
|
68.3 years
STANDARD_DEVIATION 9.57 • n=4 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
84 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
203 Participants
n=5 Participants
|
222 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
492 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
237 Participants
n=5 Participants
|
237 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
552 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 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
|
246 Participants
n=5 Participants
|
249 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
575 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
|
|
Location of Lesion
Scalp
|
115 Participants
n=5 Participants
|
135 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
285 Participants
n=4 Participants
|
|
Location of Lesion
Face
|
132 Participants
n=5 Participants
|
114 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
291 Participants
n=4 Participants
|
|
Size (cm^2) of Lesion
|
317.5 cm2
STANDARD_DEVIATION 178.53 • n=5 Participants
|
305.8 cm2
STANDARD_DEVIATION 180.78 • n=7 Participants
|
335.7 cm2
STANDARD_DEVIATION 183.78 • n=5 Participants
|
315 cm2
STANDARD_DEVIATION 180.20 • n=4 Participants
|
|
Number of Visible or Palpable Lesions
|
10.6 lesions
STANDARD_DEVIATION 3.98 • n=5 Participants
|
10.7 lesions
STANDARD_DEVIATION 4.16 • n=7 Participants
|
11.0 lesions
STANDARD_DEVIATION 4.35 • n=5 Participants
|
10.7 lesions
STANDARD_DEVIATION 4.11 • n=4 Participants
|
PRIMARY outcome
Timeframe: 14 WeeksPopulation: Per-Protocol Population
The primary efficacy endpoint is the proportion of subjects with treatment success at Visit 5/Week 14 (8 weeks post-treatment). Treatment success is defined as 100% clearance of all AK lesions (baseline AK lesions and any new AK lesions) within the treatment area.
Outcome measures
| Measure |
Investigational Test Product
n=178 Participants
Imiquimod Cream, 3.75% (Teva)
|
Reference Listed Drug
n=179 Participants
Zyclara® (imiquimod Cream), 3.75% (Medicis)
|
Vehicle
n=64 Participants
Vehicle of Test Product (Teva)
|
|---|---|---|---|
|
Number of Participants With Treatment Success/Failure at Visit 5/Week 14
Success (100% clearance of AK lesions)
|
42 Participants
|
40 Participants
|
6 Participants
|
|
Number of Participants With Treatment Success/Failure at Visit 5/Week 14
Failure <100% clearance of AK lesions
|
136 Participants
|
139 Participants
|
58 Participants
|
Adverse Events
Investigational Test Product
Serious events: 6 serious events
Other events: 81 other events
Deaths: 1 deaths
Reference Listed Drug
Serious events: 8 serious events
Other events: 77 other events
Deaths: 0 deaths
Vehicle
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Investigational Test Product
n=247 participants at risk
Imiquimod Cream, 3.75% (Teva)
|
Reference Listed Drug
n=249 participants at risk
Zyclara® (imiquimod Cream), 3.75% (Medicis)
|
Vehicle
n=80 participants at risk
Vehicle of Test Product (Teva)
|
|---|---|---|---|
|
Cardiac disorders
Cerebrovascular accident
|
0.40%
1/247 • Number of events 1 • 12 months
|
0.00%
0/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Cardiac disorders
Myocardial Infarction
|
0.40%
1/247 • Number of events 1 • 12 months
|
0.00%
0/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Skin and subcutaneous tissue disorders
Squamous cell carcinoma of skin
|
0.81%
2/247 • Number of events 2 • 12 months
|
0.00%
0/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Pregnancy, puerperium and perinatal conditions
Umbilical Hernia
|
0.40%
1/247 • Number of events 1 • 12 months
|
0.00%
0/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Cardiac disorders
Chest Pain
|
0.00%
0/247 • 12 months
|
0.40%
1/249 • Number of events 1 • 12 months
|
0.00%
0/80 • 12 months
|
|
Injury, poisoning and procedural complications
Laceration (scalp)
|
0.00%
0/247 • 12 months
|
0.40%
1/249 • Number of events 1 • 12 months
|
0.00%
0/80 • 12 months
|
|
Cardiac disorders
Syncope
|
0.00%
0/247 • 12 months
|
0.40%
1/249 • Number of events 1 • 12 months
|
0.00%
0/80 • 12 months
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/247 • 12 months
|
0.00%
0/249 • 12 months
|
1.2%
1/80 • Number of events 1 • 12 months
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/247 • 12 months
|
0.40%
1/249 • Number of events 1 • 12 months
|
0.00%
0/80 • 12 months
|
|
Gastrointestinal disorders
Colitis Ischemic
|
0.00%
0/247 • 12 months
|
0.40%
1/249 • Number of events 1 • 12 months
|
0.00%
0/80 • 12 months
|
|
Blood and lymphatic system disorders
Pleural Effusion
|
0.00%
0/247 • 12 months
|
0.40%
1/249 • Number of events 1 • 12 months
|
0.00%
0/80 • 12 months
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/247 • 12 months
|
0.40%
1/249 • Number of events 1 • 12 months
|
0.00%
0/80 • 12 months
|
|
Endocrine disorders
Diabetic Gastroparesis
|
0.00%
0/247 • 12 months
|
0.40%
1/249 • Number of events 1 • 12 months
|
0.00%
0/80 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Ligament Rupture
|
0.00%
0/247 • 12 months
|
0.40%
1/249 • Number of events 1 • 12 months
|
0.00%
0/80 • 12 months
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/247 • 12 months
|
0.00%
0/249 • 12 months
|
1.2%
1/80 • Number of events 1 • 12 months
|
|
Infections and infestations
Viral Infection
|
0.00%
0/247 • 12 months
|
0.00%
0/249 • 12 months
|
1.2%
1/80 • Number of events 1 • 12 months
|
Other adverse events
| Measure |
Investigational Test Product
n=247 participants at risk
Imiquimod Cream, 3.75% (Teva)
|
Reference Listed Drug
n=249 participants at risk
Zyclara® (imiquimod Cream), 3.75% (Medicis)
|
Vehicle
n=80 participants at risk
Vehicle of Test Product (Teva)
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.40%
1/247 • 12 months
|
1.2%
3/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Cardiac disorders
Atrial Fibrillation
|
0.40%
1/247 • 12 months
|
0.40%
1/249 • 12 months
|
1.2%
1/80 • 12 months
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/247 • 12 months
|
0.40%
1/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.00%
0/247 • 12 months
|
0.00%
0/249 • 12 months
|
1.2%
1/80 • 12 months
|
|
Cardiac disorders
Cardiomegaly
|
0.00%
0/247 • 12 months
|
0.40%
1/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Cardiac disorders
Myocardial Infarction
|
0.40%
1/247 • 12 months
|
0.00%
0/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/247 • 12 months
|
0.40%
1/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/247 • 12 months
|
0.40%
1/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Eye disorders
Eye Irritation
|
0.40%
1/247 • 12 months
|
0.00%
0/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Eye disorders
Eye Pain
|
0.40%
1/247 • 12 months
|
0.00%
0/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Eye disorders
Eyelid Oedema
|
0.40%
1/247 • 12 months
|
0.40%
1/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Eye disorders
Lacrimation Increased
|
0.40%
1/247 • 12 months
|
0.00%
0/249 • 12 months
|
1.2%
1/80 • 12 months
|
|
Eye disorders
Ocular Hyperaemia
|
0.40%
1/247 • 12 months
|
0.00%
0/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Eye disorders
Retinal Tear
|
0.40%
1/247 • 12 months
|
0.00%
0/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.40%
1/247 • 12 months
|
0.00%
0/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/247 • 12 months
|
0.40%
1/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Gastrointestinal disorders
Colitis Ischaemic
|
0.00%
0/247 • 12 months
|
0.40%
1/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Gastrointestinal disorders
Colonic Polyp
|
0.40%
1/247 • 12 months
|
0.40%
1/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Gastrointestinal disorders
Diabetic Gastroparesis
|
0.00%
0/247 • 12 months
|
0.40%
1/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.81%
2/247 • 12 months
|
0.00%
0/249 • 12 months
|
1.2%
1/80 • 12 months
|
|
Gastrointestinal disorders
Diverticulum
|
0.40%
1/247 • 12 months
|
0.00%
0/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/247 • 12 months
|
0.40%
1/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Gastrointestinal disorders
Gingival Inflammation
|
0.40%
1/247 • 12 months
|
0.00%
0/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/247 • 12 months
|
0.40%
1/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Gastrointestinal disorders
Lip Erosion
|
0.40%
1/247 • 12 months
|
0.40%
1/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Gastrointestinal disorders
Lip Pain
|
0.81%
2/247 • 12 months
|
0.00%
0/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Gastrointestinal disorders
Lip Swelling
|
0.40%
1/247 • 12 months
|
0.00%
0/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Gastrointestinal disorders
Nausea
|
1.2%
3/247 • 12 months
|
1.6%
4/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Gastrointestinal disorders
Oral Pain
|
0.40%
1/247 • 12 months
|
0.00%
0/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Gastrointestinal disorders
Pancreatic Cyst
|
0.00%
0/247 • 12 months
|
0.40%
1/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Gastrointestinal disorders
Stomatitis
|
0.40%
1/247 • 12 months
|
0.00%
0/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Gastrointestinal disorders
Umbilical Hernia
|
0.40%
1/247 • 12 months
|
0.00%
0/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Gastrointestinal disorders
Vomiting
|
0.81%
2/247 • 12 months
|
0.00%
0/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
General disorders
Application Site Dermatitis
|
0.81%
2/247 • 12 months
|
0.00%
0/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
General disorders
Application Site Erythema
|
0.40%
1/247 • 12 months
|
0.00%
0/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
General disorders
Application Site Haemorrhage
|
0.40%
1/247 • 12 months
|
0.00%
0/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
General disorders
Application Site Pain
|
0.81%
2/247 • 12 months
|
1.6%
4/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
General disorders
Application Site Pruritus
|
0.00%
0/247 • 12 months
|
0.80%
2/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
General disorders
Application Site Reaction
|
0.00%
0/247 • 12 months
|
0.80%
2/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
General disorders
Asthenia
|
0.40%
1/247 • 12 months
|
0.00%
0/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
General disorders
Chest Discomfort
|
0.40%
1/247 • 12 months
|
0.00%
0/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
General disorders
Chest Pain
|
0.40%
1/247 • 12 months
|
0.40%
1/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
General disorders
Chills
|
1.2%
3/247 • 12 months
|
0.80%
2/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
General disorders
Discomfort
|
0.40%
1/247 • 12 months
|
0.00%
0/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
General disorders
Fatigue
|
2.0%
5/247 • 12 months
|
1.6%
4/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
General disorders
Influenza Like Illness
|
2.0%
5/247 • 12 months
|
4.0%
10/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
General disorders
Local Swelling
|
0.00%
0/247 • 12 months
|
0.40%
1/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
General disorders
Malaise
|
1.2%
3/247 • 12 months
|
0.40%
1/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
General disorders
Oedema Mucosal
|
0.40%
1/247 • 12 months
|
0.00%
0/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
General disorders
Pyrexia
|
1.2%
3/247 • 12 months
|
0.40%
1/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
General disorders
Tenderness
|
0.00%
0/247 • 12 months
|
0.40%
1/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.40%
1/247 • 12 months
|
0.40%
1/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Hepatobiliary disorders
Hepatic Steatosis
|
0.40%
1/247 • 12 months
|
0.00%
0/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Immune system disorders
Allergy to Arthropod Sting
|
0.00%
0/247 • 12 months
|
0.00%
0/249 • 12 months
|
1.2%
1/80 • 12 months
|
|
Infections and infestations
Acute Sinusitis
|
0.40%
1/247 • 12 months
|
0.00%
0/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Infections and infestations
Adenoviral Upper Respiratory Infection
|
0.40%
1/247 • 12 months
|
0.00%
0/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Infections and infestations
Application Site Cellulitis
|
0.40%
1/247 • 12 months
|
0.00%
0/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Infections and infestations
Application Site Infection
|
0.40%
1/247 • 12 months
|
0.00%
0/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Infections and infestations
Bacterial Infections
|
0.00%
0/247 • 12 months
|
0.40%
1/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Infections and infestations
Bronchitis
|
0.40%
1/247 • 12 months
|
0.40%
1/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Infections and infestations
Dental Fistula
|
0.00%
0/247 • 12 months
|
0.40%
1/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Infections and infestations
Diverticulitis
|
0.40%
1/247 • 12 months
|
0.00%
0/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Infections and infestations
Gastroenteritis Viral
|
0.00%
0/247 • 12 months
|
1.2%
3/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/247 • 12 months
|
0.80%
2/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Infections and infestations
Influenza
|
0.40%
1/247 • 12 months
|
0.00%
0/249 • 12 months
|
1.2%
1/80 • 12 months
|
|
Infections and infestations
Nasopharyngitis
|
1.6%
4/247 • 12 months
|
0.80%
2/249 • 12 months
|
1.2%
1/80 • 12 months
|
|
Infections and infestations
Oral Herpes
|
1.2%
3/247 • 12 months
|
1.2%
3/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Infections and infestations
Periodontitis
|
0.00%
0/247 • 12 months
|
0.00%
0/249 • 12 months
|
1.2%
1/80 • 12 months
|
|
Infections and infestations
Rash Pustular
|
0.40%
1/247 • 12 months
|
0.00%
0/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Infections and infestations
Rhinitis
|
0.40%
1/247 • 12 months
|
0.00%
0/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Infections and infestations
Sinusitis
|
1.2%
3/247 • 12 months
|
0.80%
2/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Infections and infestations
Skin Infection
|
0.00%
0/247 • 12 months
|
0.40%
1/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Infections and infestations
Staphylococcal Skin Infection
|
0.40%
1/247 • 12 months
|
0.00%
0/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Infections and infestations
Tooth Abscess
|
0.00%
0/247 • 12 months
|
0.80%
2/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Infections and infestations
Upper Respiratory Infection
|
0.81%
2/247 • 12 months
|
2.0%
5/249 • 12 months
|
2.5%
2/80 • 12 months
|
|
Infections and infestations
Urinary Tract Infection
|
0.40%
1/247 • 12 months
|
0.00%
0/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Infections and infestations
Viral Infection
|
0.00%
0/247 • 12 months
|
0.00%
0/249 • 12 months
|
2.5%
2/80 • 12 months
|
|
Injury, poisoning and procedural complications
Arthropod Bite
|
0.00%
0/247 • 12 months
|
0.00%
0/249 • 12 months
|
1.2%
1/80 • 12 months
|
|
Injury, poisoning and procedural complications
Contusion
|
0.40%
1/247 • 12 months
|
0.40%
1/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.40%
1/247 • 12 months
|
0.00%
0/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/247 • 12 months
|
0.40%
1/249 • 12 months
|
1.2%
1/80 • 12 months
|
|
Injury, poisoning and procedural complications
Foreign Body
|
0.00%
0/247 • 12 months
|
0.40%
1/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Injury, poisoning and procedural complications
Injury
|
0.40%
1/247 • 12 months
|
0.00%
0/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Injury, poisoning and procedural complications
Laceration
|
0.40%
1/247 • 12 months
|
0.40%
1/249 • 12 months
|
1.2%
1/80 • 12 months
|
|
Injury, poisoning and procedural complications
Ligament Rupture
|
0.00%
0/247 • 12 months
|
0.40%
1/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
0.40%
1/247 • 12 months
|
0.40%
1/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.00%
0/247 • 12 months
|
0.80%
2/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Injury, poisoning and procedural complications
Skin Injuries
|
0.00%
0/247 • 12 months
|
0.40%
1/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Injury, poisoning and procedural complications
Superficial Injury of Eye
|
0.00%
0/247 • 12 months
|
0.40%
1/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
1.2%
3/247 • 12 months
|
0.00%
0/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/247 • 12 months
|
0.40%
1/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.40%
1/247 • 12 months
|
0.00%
0/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.2%
3/247 • 12 months
|
0.00%
0/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.81%
2/247 • 12 months
|
0.00%
0/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Degeneration
|
0.00%
0/247 • 12 months
|
0.40%
1/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.81%
2/247 • 12 months
|
0.00%
0/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.81%
2/247 • 12 months
|
0.80%
2/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/247 • 12 months
|
0.40%
1/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.40%
1/247 • 12 months
|
1.6%
4/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Keratoacanthoma
|
0.40%
1/247 • 12 months
|
0.00%
0/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Melanoma
|
0.00%
0/247 • 12 months
|
0.40%
1/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.40%
1/247 • 12 months
|
0.00%
0/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin Papilloma
|
0.40%
1/247 • 12 months
|
0.00%
0/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma of Skin
|
2.0%
5/247 • 12 months
|
2.8%
7/249 • 12 months
|
1.2%
1/80 • 12 months
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.40%
1/247 • 12 months
|
0.00%
0/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Nervous system disorders
Dizziness
|
1.6%
4/247 • 12 months
|
2.0%
5/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Nervous system disorders
Headache
|
3.2%
8/247 • 12 months
|
3.2%
8/249 • 12 months
|
1.2%
1/80 • 12 months
|
|
Nervous system disorders
Lethargy
|
0.81%
2/247 • 12 months
|
0.00%
0/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Nervous system disorders
Sciatica
|
0.40%
1/247 • 12 months
|
0.00%
0/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Nervous system disorders
Syncope
|
0.00%
0/247 • 12 months
|
0.40%
1/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Psychiatric disorders
Anxiety
|
0.40%
1/247 • 12 months
|
0.00%
0/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Psychiatric disorders
Disorientation
|
0.40%
1/247 • 12 months
|
0.00%
0/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Psychiatric disorders
Insomnia
|
0.81%
2/247 • 12 months
|
0.00%
0/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Psychiatric disorders
Nightmare
|
0.81%
2/247 • 12 months
|
0.40%
1/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/247 • 12 months
|
0.40%
1/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.00%
0/247 • 12 months
|
0.40%
1/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.40%
1/247 • 12 months
|
0.00%
0/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.2%
3/247 • 12 months
|
0.40%
1/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/247 • 12 months
|
0.40%
1/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/247 • 12 months
|
0.40%
1/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
1.2%
3/247 • 12 months
|
0.00%
0/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/247 • 12 months
|
0.40%
1/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Aspiration
|
0.00%
0/247 • 12 months
|
0.00%
0/249 • 12 months
|
1.2%
1/80 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.40%
1/247 • 12 months
|
0.00%
0/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper-Airway Cough Syndrome
|
0.00%
0/247 • 12 months
|
0.40%
1/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Skin and subcutaneous tissue disorders
Actinic Keratosis
|
0.00%
0/247 • 12 months
|
0.40%
1/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.40%
1/247 • 12 months
|
0.00%
0/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/247 • 12 months
|
0.40%
1/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Skin and subcutaneous tissue disorders
Drug Eruption
|
0.40%
1/247 • 12 months
|
0.00%
0/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.40%
1/247 • 12 months
|
0.00%
0/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Skin and subcutaneous tissue disorders
Hair Growth Abnormal
|
0.40%
1/247 • 12 months
|
0.00%
0/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.40%
1/247 • 12 months
|
0.00%
0/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Skin and subcutaneous tissue disorders
Lichen Sclerosus
|
0.40%
1/247 • 12 months
|
0.00%
0/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.40%
1/247 • 12 months
|
0.40%
1/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Skin and subcutaneous tissue disorders
Pruritus Generalised
|
0.00%
0/247 • 12 months
|
0.80%
2/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/247 • 12 months
|
0.40%
1/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.81%
2/247 • 12 months
|
0.40%
1/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Skin and subcutaneous tissue disorders
Skin Erosion
|
0.40%
1/247 • 12 months
|
0.00%
0/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/247 • 12 months
|
0.40%
1/249 • 12 months
|
0.00%
0/80 • 12 months
|
|
Vascular disorders
Hypertension
|
0.40%
1/247 • 12 months
|
0.40%
1/249 • 12 months
|
0.00%
0/80 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PIs may not publish results from this generic (ANDA) study unless reviewed and approved by sponsor.
- Publication restrictions are in place
Restriction type: OTHER