Supplementary Tables
Table 5 Ocular (study eye) and non-ocular serious adverse events and adverse events
up to Month 12 occurring in at least 2 patients (Safety analysis set)*
Death
Ocular SAE
Ocular AEs
Intraocular pressure increased
Conjunctival hemorrhage
Conjunctivitis
Conjunctival hyperemia
Drug hypersensitivity
Keratitis
Visual acuity reduced
Visual impairment
Non-ocular SAE(s)
Coronary artery disease**
Non-ocular AE(s)
White blood cells urine positive
Hypertension
Red blood cells urine positive
Dizziness
Nasopharyngitis
Oropharyngeal pain
Pyrexia
Urinary tract infection
Coronary artery disease**
Cough
Diabetes mellitus
Ear infection
Muscle strain
Ranibizumab 0.5 mg
N = 114
n (%)
0 (0.0)
0 (0.0)
32 (28.1)
11 (9.6)
8 (7.0)
6 (5.3)
2 (1.8)
2 (1.8)
2 (1.8)
2 (1.8)
2 (1.8)
10 (8.8)
2 (1.8)
52 (45.6)
6 (5.3)
5 (4.4)
5 (4.4)
4 (3.5)
4 (3.5)
4 (3.5)
4 (3.5)
3 (2.6)
2 (1.8)
2 (1.8)
2 (1.8)
2 (1.8)
2 (1.8)
AE = adverse event, N = total number of patients, n = number of patients,
SAE = serious adverse event
A patient with multiple occurrences of an AE/SAE is counted only once within the preferred term
*consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety
assessment
** initially reported as AE and later as SAE
Table 6 Ocular (study eye) adverse events up to Month 12 (Safety analysis set)*
Ranibizumab 0.5 mg
N = 114
n (%)
32 (28.1)
11 (9.6)
8 (7.0 )
6 (5.3)
2 (1.8)
2 (1.8)
2 (1.8)
2 (1.8)
2 (1.8)
1 (0.9)
1 (0.9)
1 (0.9)
1 (0.9)
1 (0.9)
1 (0.9)
1 (0.9)
1 (0.9)
1 (0.9)
Total
Intraocular pressure increased
Conjunctival hemorrhage
Conjunctivitis
Conjunctival hyperemia
Drug hypersensitivity
Visual impairment
Keratitis
Visual acuity reduced
Blepharitis
Cataract
Exophthalmos
Eyelid edema
Retinal hemorrhage
Subretinal fibrosis
Vitreous floaters
Vitreous hemorrhage
Vitreous opacities
N = total number of patients, n = number of patients
A patient with multiple occurrences of an adverse event is counted only once within the preferred term
*consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety
assessment
Table 7 Non-ocular adverse events up to Month 12 (Safety analysis set)*
Total
White blood cells urine positive
Red blood cells urine positive
Hypertension
Nasopharyngitis
Dizziness
Pyrexia
Oropharyngeal pain
Urinary tract infection
Ear infection
Muscle strain
Cough
Coronary artery disease**
Diabetes mellitus
Blood glucose increased
Blood uric acid increased
Glucose urine present
Protein urine present
Urine analysis abnormal
White blood cell count increased
Folliculitis
Gastroenteritis
Pneumonia
Cerebral artery stenosis
Cerebral thrombosis
Polyneuropathy
Sciatica
Transient ischemic attack
Face edema
Non-cardiac chest pain
Edema peripheral
Fracture
Injury
Muscle injury
Skin laceration
Ranibizumab 0.5 mg
N = 114
n (%)
52 (45.6)
6 (5.3)
5 (4.4)
5 (4.4)
4 (3.5)
4 (3.5)
4 (3.5)
4 (3.5)
3 (2.6)
2 (1.8)
2 (1.8)
2 (1.8)
2 (1.8)
2 (1.8)
1 (0.9)
1 (0.9)
1 (0.9)
1 (0.9)
1 (0.9)
1 (0.9)
1 (0.9)
1 (0.9)
1 (0.9)
1 (0.9)
1 (0.9)
1 (0.9)
1 (0.9)
1 (0.9)
1 (0.9)
1 (0.9)
1 (0.9)
1 (0.9)
1 (0.9)
1 (0.9)
1 (0.9)
Table 7 (Continued) Non-ocular adverse events up to Month 12 (Safety analysis set)*
Ranibizumab 0.5 mg
N = 114
n (%)
1 (0.9)
1 (0.9)
1 (0.9)
1 (0.9)
1 (0.9)
1 (0.9)
1 (0.9)
1 (0.9)
1 (0.9)
1 (0.9)
1 (0.9)
1 (0.9)
1 (0.9)
1 (0.9)
1 (0.9)
1 (0.9)
1 (0.9)
1 (0.9)
1 (0.9)
1 (0.9)
Subdural hemotoma
Chronic obstructive pulmonary disease
Hypotension
Vena cava thrombosis
Extrasystoles
Hyperlipidemia
Arthralgia
Bone formation increased
Pain in jaw
Spinal osteoarthritis
Diarrhoea
Enteritis
Hemorrhoids
Proctocolitis
Cholangitis acute
Cholecystitis
Lung adenocarcinoma metastatic
Multiple myeloma
Agitation
Hematuria
N = total number of patients, n = number of patients
A patient with multiple occurrences of an adverse event is counted only once within the preferred term
*consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety
assessment
** initially reported as AE and later as SAE
Table 8 Non-ocular serious adverse events up to Month 12 (Safety analysis set)*
Ranibizumab 0.5 mg
N = 114
n (%)
10 (8.8)
2 (1.8)
1 (0.9)
1 (0.9)
1 (0.9)
1 (0.9)
1 (0.9)
1 (0.9)
1 (0.9)
1 (0.9)
1 (0.9)
1 (0.9)
1 (0.9)
Total
Coronary artery disease
Cerebral artery stenosis
Cerebral thrombosis
Cholangitis acute
Cholecystitis
Chronic obstructive pulmonary disease
Hypertension
Lung adenocarcinoma metastatic
Multiple myeloma
Pneumonia
Subdural hematoma
Transient ischemic attack
N = total number of patients, n = number of patients
A patient with multiple occurrences of a serious adverse event is counted only once within the preferred term
*consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety
assessment