Trial Outcomes & Findings for Long-Term Safety of Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension (NCT NCT01298700)
NCT ID: NCT01298700
Last Updated: 2018-09-17
Results Overview
An adverse event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. The percentage of participants with ocular (eye) surface AEs deemed related to treatment by the investigator are reported.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
806 participants
Primary outcome timeframe
24 Months
Results posted on
2018-09-17
Participant Flow
Participant milestones
| Measure |
Bimatoprost 0.01% Ophthalmic Solution
One drop of bimatoprost 0.01% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.
|
Bimatoprost 0.03% Ophthalmic Solution
One drop of bimatoprost 0.03% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.
|
|---|---|---|
|
Overall Study
STARTED
|
403
|
403
|
|
Overall Study
Safety Population: Received Study Drug
|
400
|
398
|
|
Overall Study
COMPLETED
|
302
|
303
|
|
Overall Study
NOT COMPLETED
|
101
|
100
|
Reasons for withdrawal
| Measure |
Bimatoprost 0.01% Ophthalmic Solution
One drop of bimatoprost 0.01% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.
|
Bimatoprost 0.03% Ophthalmic Solution
One drop of bimatoprost 0.03% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.
|
|---|---|---|
|
Overall Study
Adverse Event
|
50
|
51
|
|
Overall Study
Lack of Efficacy
|
9
|
14
|
|
Overall Study
Lost to Follow-up
|
5
|
2
|
|
Overall Study
Withdrawal by Subject
|
12
|
9
|
|
Overall Study
Protocol Violation
|
6
|
4
|
|
Overall Study
Other Miscellaneous Reasons
|
16
|
15
|
|
Overall Study
Did not Receive Study Drug
|
3
|
5
|
Baseline Characteristics
Long-Term Safety of Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
Baseline characteristics by cohort
| Measure |
Bimatoprost 0.01% Ophthalmic Solution
n=400 Participants
One drop of bimatoprost 0.01% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.
|
Bimatoprost 0.03% Ophthalmic Solution
n=398 Participants
One drop of bimatoprost 0.03% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.
|
Total
n=798 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.7 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
62.2 years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
62.4 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
|
Age, Customized
< 45 years
|
22 participants
n=5 Participants
|
26 participants
n=7 Participants
|
48 participants
n=5 Participants
|
|
Age, Customized
≥ 45 years to ≤ 65 years
|
216 participants
n=5 Participants
|
211 participants
n=7 Participants
|
427 participants
n=5 Participants
|
|
Age, Customized
> 65 years
|
162 participants
n=5 Participants
|
161 participants
n=7 Participants
|
323 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
197 Participants
n=5 Participants
|
187 Participants
n=7 Participants
|
384 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
203 Participants
n=5 Participants
|
211 Participants
n=7 Participants
|
414 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 MonthsPopulation: Safety population included all participants who received at least one dose of study drug.
An adverse event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. The percentage of participants with ocular (eye) surface AEs deemed related to treatment by the investigator are reported.
Outcome measures
| Measure |
Bimatoprost 0.01% Ophthalmic Solution
n=400 Participants
One drop of bimatoprost 0.01% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.
|
Bimatoprost 0.03% Ophthalmic Solution
n=398 Participants
One drop of bimatoprost 0.03% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.
|
|---|---|---|
|
Percentage of Participants Reporting One or More Treatment-Related Ocular Surface Adverse Events
|
33.3 percentage of participants
|
37.7 percentage of participants
|
SECONDARY outcome
Timeframe: 24 MonthsPopulation: Safety population included all participants who received at least one dose of study drug.
An adverse event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. The percentage of participants with ocular (eye) surface AEs deemed related to treatment by the investigator excluding AEs with the preferred term Conjunctival hyperemia are reported.
Outcome measures
| Measure |
Bimatoprost 0.01% Ophthalmic Solution
n=400 Participants
One drop of bimatoprost 0.01% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.
|
Bimatoprost 0.03% Ophthalmic Solution
n=398 Participants
One drop of bimatoprost 0.03% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.
|
|---|---|---|
|
Percentage of Participants Reporting One or More Treatment-Related Ocular Surface Adverse Events Excluding "Conjunctival Hyperemia"
|
26.0 percentage of participants
|
29.6 percentage of participants
|
Adverse Events
Bimatoprost 0.01% Ophthalmic Solution
Serious events: 45 serious events
Other events: 167 other events
Deaths: 0 deaths
Bimatoprost 0.03% Ophthalmic Solution
Serious events: 40 serious events
Other events: 186 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bimatoprost 0.01% Ophthalmic Solution
n=400 participants at risk
One drop of bimatoprost 0.01% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.
|
Bimatoprost 0.03% Ophthalmic Solution
n=398 participants at risk
One drop of bimatoprost 0.03% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.
|
|---|---|---|
|
Investigations
Intraocular pressure fluctuation
|
1.0%
4/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.50%
2/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Eye disorders
Cataract
|
0.50%
2/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.25%
1/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.50%
2/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.25%
1/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.50%
2/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.00%
0/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Cardiac disorders
Angina pectoris
|
0.50%
2/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.00%
0/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.25%
1/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.25%
1/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Investigations
Intraocular pressure increased
|
0.25%
1/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.25%
1/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.25%
1/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.25%
1/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.25%
1/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.25%
1/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.25%
1/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.00%
0/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Infections and infestations
Anal abscess
|
0.25%
1/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.00%
0/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.25%
1/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.00%
0/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Eye disorders
Angle closure glaucoma
|
0.25%
1/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.00%
0/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.25%
1/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.00%
0/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Vascular disorders
Arteriosclerosis
|
0.25%
1/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.00%
0/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Eye disorders
Cataract cortical
|
0.25%
1/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.00%
0/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Nervous system disorders
Cervical radiculopathy
|
0.25%
1/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.00%
0/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.25%
1/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.00%
0/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.25%
1/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.00%
0/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Psychiatric disorders
Completed suicide
|
0.25%
1/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.00%
0/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Cardiac disorders
Coronary artery thrombosis
|
0.25%
1/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.00%
0/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Injury, poisoning and procedural complications
Fall
|
0.25%
1/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.00%
0/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.25%
1/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.00%
0/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.25%
1/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.00%
0/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.25%
1/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.00%
0/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.25%
1/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.00%
0/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Nervous system disorders
Hydrocephalus
|
0.25%
1/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.00%
0/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.25%
1/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.00%
0/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Vascular disorders
Hypotension
|
0.25%
1/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.00%
0/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.25%
1/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.00%
0/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal squamous cell carcinoma
|
0.25%
1/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.00%
0/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Injury, poisoning and procedural complications
Limb crushing injury
|
0.25%
1/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.00%
0/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip squamous cell carcinoma
|
0.25%
1/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.00%
0/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.25%
1/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.00%
0/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.25%
1/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.00%
0/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Eye disorders
Macular hole
|
0.25%
1/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.00%
0/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.25%
1/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.00%
0/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma benign
|
0.25%
1/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.00%
0/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Cardiac disorders
Myocardial infarction
|
0.25%
1/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.00%
0/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.25%
1/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.00%
0/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.25%
1/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.00%
0/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Infections and infestations
Peritonsillar abscess
|
0.25%
1/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.00%
0/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Infections and infestations
Pneumonia
|
0.25%
1/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.00%
0/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.25%
1/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.00%
0/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Injury, poisoning and procedural complications
Pulmonary contusion
|
0.25%
1/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.00%
0/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
General disorders
Pyrexia
|
0.25%
1/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.00%
0/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.25%
1/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.00%
0/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Eye disorders
Retinal detachment
|
0.25%
1/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.00%
0/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.25%
1/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.00%
0/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.25%
1/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.00%
0/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Spinal disorder
|
0.25%
1/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.00%
0/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Injury, poisoning and procedural complications
Subarachnoid haemorrhage
|
0.25%
1/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.00%
0/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tubular breast carcinoma
|
0.25%
1/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.00%
0/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.25%
1/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.00%
0/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.51%
1/197 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.00%
0/187 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Eye disorders
Vitreous adhesions
|
0.25%
1/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.00%
0/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Infections and infestations
Wound infection
|
0.25%
1/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.00%
0/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.50%
2/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.50%
2/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.25%
1/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.00%
0/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.25%
1/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Gastrointestinal disorders
Barrett's oesophagus
|
0.00%
0/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.25%
1/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.25%
1/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/203 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.47%
1/211 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.00%
0/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.25%
1/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.25%
1/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
General disorders
Catheter site inflammation
|
0.00%
0/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.25%
1/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.25%
1/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.25%
1/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Infections and infestations
Echinococciasis
|
0.00%
0/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.25%
1/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.25%
1/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.25%
1/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.25%
1/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.25%
1/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Eye disorders
Glaucoma
|
0.00%
0/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.25%
1/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.25%
1/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Nervous system disorders
Headache
|
0.00%
0/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.25%
1/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Gastrointestinal disorders
Inguinal hernia repair
|
0.00%
0/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.25%
1/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.25%
1/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.25%
1/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.25%
1/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.25%
1/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.00%
0/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.25%
1/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
0/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.25%
1/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.25%
1/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.25%
1/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Eye disorders
Optic neuropathy
|
0.00%
0/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.25%
1/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Gastrointestinal disorders
Pancreatitis relapsing
|
0.00%
0/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.25%
1/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.25%
1/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Gastrointestinal disorders
Peritoneal haematoma
|
0.00%
0/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.25%
1/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.25%
1/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.25%
1/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.25%
1/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.25%
1/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Injury, poisoning and procedural complications
Urostomy complication
|
0.00%
0/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.25%
1/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Infections and infestations
Vestibular neuronitis
|
0.00%
0/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.25%
1/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.25%
1/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Renal and urinary disorders
Bladder prolapse
|
0.25%
1/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.00%
0/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Surgical and medical procedures
Inguinal hernia repair
|
0.00%
0/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
0.25%
1/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
Other adverse events
| Measure |
Bimatoprost 0.01% Ophthalmic Solution
n=400 participants at risk
One drop of bimatoprost 0.01% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.
|
Bimatoprost 0.03% Ophthalmic Solution
n=398 participants at risk
One drop of bimatoprost 0.03% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.
|
|---|---|---|
|
Eye disorders
Blepharitis
|
3.5%
14/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
5.8%
23/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Eye disorders
Cataract
|
5.0%
20/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
6.0%
24/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Eye disorders
Conjunctival hyperaemia
|
20.0%
80/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
22.6%
90/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Eye disorders
Dry eye
|
9.0%
36/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
10.6%
42/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Eye disorders
Eye pain
|
5.2%
21/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
5.0%
20/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Eye disorders
Foreign body sensation in eyes
|
2.8%
11/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
5.3%
21/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Eye disorders
Punctate keratitis
|
5.5%
22/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
7.5%
30/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
|
Infections and infestations
Influenza
|
6.5%
26/400 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
5.3%
21/398 • 24 Months
Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER