Serious adverse events
|
Faricimab PTI (prior Faricimab Q8W) |
Faricimab PTI (prior Faricimab PTI) |
Faricimab PTI (prior Aflibercept Q8W) |
Total subjects affected by serious adverse events
|
|
|
|
subjects affected / exposed
|
158 / 491 (32.18%) |
124 / 500 (24.80%) |
134 / 473 (28.33%) |
number of deaths (all causes)
|
22 |
20 |
17 |
number of deaths resulting from adverse events
|
|
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
|
Chronic lymphocytic leukaemia
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Clear cell renal cell carcinoma
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Adenocarcinoma of colon
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Benign anorectal neoplasm
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
1 / 500 (0.20%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Colon cancer metastatic
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
1 / 500 (0.20%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Breast cancer
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
4 / 500 (0.80%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Breast neoplasm
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cervix carcinoma
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Bladder transitional cell carcinoma
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Endometrial cancer stage III
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastric cancer
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastric cancer stage IV
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic cancer
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Hepatocellular carcinoma
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
1 / 500 (0.20%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Leukaemia
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lung neoplasm malignant
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
1 / 500 (0.20%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Neoplasm malignant
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Neuroendocrine carcinoma of the skin
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
1 / 500 (0.20%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oesophageal cancer metastatic
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Ovarian fibroma
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatic carcinoma
|
|
|
|
subjects affected / exposed
|
2 / 491 (0.41%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Prostate cancer
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
2 / 500 (0.40%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal cancer stage IV
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
1 / 500 (0.20%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Spinal cord neoplasm
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
1 / 500 (0.20%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Uterine leiomyoma
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rectal adenocarcinoma
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vascular disorders
|
|
|
|
Angiopathy
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Hypertensive urgency
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral arterial occlusive disease
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral artery occlusion
|
|
|
|
subjects affected / exposed
|
2 / 491 (0.41%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Aortic stenosis
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
1 / 500 (0.20%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arteriosclerosis
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
1 / 500 (0.20%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Circulatory collapse
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
1 / 500 (0.20%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Deep vein thrombosis
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypertension
|
|
|
|
subjects affected / exposed
|
2 / 491 (0.41%) |
1 / 500 (0.20%) |
3 / 473 (0.63%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypertensive crisis
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypertensive emergency
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
1 / 500 (0.20%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral artery stenosis
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
1 / 500 (0.20%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral artery thrombosis
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Shock
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral vascular disorder
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
2 / 473 (0.42%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral ischaemia
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
3 / 500 (0.60%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
General disorders and administration site conditions
|
|
|
|
Chest discomfort
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Organ failure
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Death
|
|
|
|
subjects affected / exposed
|
3 / 491 (0.61%) |
5 / 500 (1.00%) |
2 / 473 (0.42%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 5 |
0 / 2 |
Hernia
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Impaired healing
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Malaise
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Multiple organ dysfunction syndrome
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
1 / 500 (0.20%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Oedema peripheral
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
2 / 500 (0.40%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chest pain
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
2 / 473 (0.42%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Systemic inflammatory response syndrome
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Immune system disorders
|
|
|
|
Food allergy
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Drug hypersensitivity
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Contrast media allergy
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
1 / 500 (0.20%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Allergy to arthropod sting
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Reproductive system and breast disorders
|
|
|
|
Orchitis noninfective
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
1 / 500 (0.20%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pelvic cyst
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Uterine polyp
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory, thoracic and mediastinal disorders
|
|
|
|
Hypoxia
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dyspnoea
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
1 / 500 (0.20%) |
2 / 473 (0.42%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Chronic respiratory failure
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
1 / 500 (0.20%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chronic obstructive pulmonary disease
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
2 / 500 (0.40%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Asthma
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Acute respiratory failure
|
|
|
|
subjects affected / exposed
|
2 / 491 (0.41%) |
1 / 500 (0.20%) |
2 / 473 (0.42%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Atelectasis
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pleural effusion
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumothorax
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary embolism
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
1 / 500 (0.20%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary fibrosis
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary oedema
|
|
|
|
subjects affected / exposed
|
2 / 491 (0.41%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory failure
|
|
|
|
subjects affected / exposed
|
2 / 491 (0.41%) |
1 / 500 (0.20%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Psychiatric disorders
|
|
|
|
Substance-induced psychotic disorder
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mental status changes
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Depression
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Product issues
|
|
|
|
Device leakage
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Investigations
|
|
|
|
Ammonia increased
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Glycosylated haemoglobin abnormal
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Heart rate increased
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
SARS-CoV-2 test positive
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Precancerous cells present
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Liver function test abnormal
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intraocular pressure increased
|
|
|
|
Additional description: SAEs occurred in the fellow eye
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Red blood cell count decreased
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
1 / 500 (0.20%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Injury, poisoning and procedural complications
|
|
|
|
Contusion
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Corneal abrasion
|
|
|
|
Additional description: SAEs occurred in the fellow eye
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
1 / 500 (0.20%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Brain contusion
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
1 / 500 (0.20%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cataract traumatic
|
|
|
|
Additional description: SAEs occurred the study eye
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
1 / 500 (0.20%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Comminuted fracture
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Eye injury
|
|
|
|
Additional description: SAEs occurred the study eye
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Fall
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
1 / 500 (0.20%) |
2 / 473 (0.42%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Femoral neck fracture
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
2 / 500 (0.40%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Femur fracture
|
|
|
|
subjects affected / exposed
|
2 / 491 (0.41%) |
1 / 500 (0.20%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Foot fracture
|
|
|
|
subjects affected / exposed
|
2 / 491 (0.41%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Foreign body
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Fracture displacement
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hand fracture
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Head injury
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Patella fracture
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ocular procedural complication
|
|
|
|
Additional description: SAEs occurred in the fellow eye
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lumbar vertebral fracture
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hip fracture
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Radius fracture
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
1 / 500 (0.20%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peritoneal dialysis complication
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
1 / 500 (0.20%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural constipation
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
1 / 500 (0.20%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural inflammation
|
|
|
|
Additional description: SAEs occurred in the fellow eye
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
1 / 500 (0.20%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pelvic fracture
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Spinal compression fracture
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
1 / 500 (0.20%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Skull fracture
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
1 / 500 (0.20%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Shoulder fracture
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Road traffic accident
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tendon rupture
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Wound necrosis
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vascular procedure complication
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Toxicity to various agents
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tibia fracture
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Wrist fracture
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
1 / 500 (0.20%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac disorders
|
|
|
|
Atrioventricular block complete
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Atrioventricular block
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
1 / 500 (0.20%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Atrial flutter
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
1 / 500 (0.20%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Atrial fibrillation
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
1 / 500 (0.20%) |
4 / 473 (0.85%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arteriosclerosis coronary artery
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Angina pectoris
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Acute myocardial infarction
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
4 / 500 (0.80%) |
3 / 473 (0.63%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Acute coronary syndrome
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
2 / 500 (0.40%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Acute left ventricular failure
|
|
|
|
subjects affected / exposed
|
2 / 491 (0.41%) |
2 / 500 (0.40%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac disorder
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
1 / 500 (0.20%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Cardiac discomfort
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac arrest
|
|
|
|
subjects affected / exposed
|
2 / 491 (0.41%) |
2 / 500 (0.40%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 0 |
Bradycardia
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
1 / 500 (0.20%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bradyarrhythmia
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Atrioventricular block second degree
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
1 / 500 (0.20%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac failure congestive
|
|
|
|
subjects affected / exposed
|
7 / 491 (1.43%) |
3 / 500 (0.60%) |
2 / 473 (0.42%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 0 |
Cardiac tamponade
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac valve disease
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
1 / 500 (0.20%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardio-respiratory arrest
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
2 / 473 (0.42%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
Cardiogenic shock
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
1 / 500 (0.20%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Cardiac failure
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
3 / 500 (0.60%) |
3 / 473 (0.63%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac failure acute
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Coronary artery disease
|
|
|
|
subjects affected / exposed
|
6 / 491 (1.22%) |
5 / 500 (1.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ventricular hypokinesia
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tachycardia
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pericardial effusion
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Myocardial ischaemia
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
1 / 500 (0.20%) |
2 / 473 (0.42%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Myocardial infarction
|
|
|
|
subjects affected / exposed
|
9 / 491 (1.83%) |
3 / 500 (0.60%) |
8 / 473 (1.69%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 3 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 3 |
Ischaemic cardiomyopathy
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
1 / 500 (0.20%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Coronary artery stenosis
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
1 / 500 (0.20%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Coronary artery occlusion
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
1 / 500 (0.20%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nervous system disorders
|
|
|
|
Carotid artery stenosis
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Amyotrophic lateral sclerosis
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
1 / 500 (0.20%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Encephalomalacia
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cerebrovascular accident
|
|
|
|
subjects affected / exposed
|
4 / 491 (0.81%) |
3 / 500 (0.60%) |
10 / 473 (2.11%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
1 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 3 |
Cerebral infarction
|
|
|
|
subjects affected / exposed
|
2 / 491 (0.41%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhage intracranial
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lethargy
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic encephalopathy
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypoaesthesia
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
1 / 500 (0.20%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypoglycaemic unconsciousness
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ischaemic stroke
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
1 / 500 (0.20%) |
2 / 473 (0.42%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhagic stroke
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Optic neuritis
|
|
|
|
Additional description: SAEs occurred in the fellow eye
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Migraine
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Leukoencephalopathy
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Paraparesis
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
1 / 500 (0.20%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Toxic encephalopathy
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Syncope
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
2 / 500 (0.40%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Status epilepticus
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Seizure
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Transient ischaemic attack
|
|
|
|
subjects affected / exposed
|
2 / 491 (0.41%) |
1 / 500 (0.20%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vertebral artery stenosis
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vocal cord paralysis
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Blood and lymphatic system disorders
|
|
|
|
Anaemia
|
|
|
|
subjects affected / exposed
|
2 / 491 (0.41%) |
2 / 500 (0.40%) |
3 / 473 (0.63%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Iron deficiency anaemia
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Leukocytosis
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Thrombocytopenia
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nephrogenic anaemia
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Normocytic anaemia
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
1 / 500 (0.20%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Neutropenia
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Eye disorders
|
|
|
|
Cataract
|
|
|
|
Additional description: SAEs occurred in both the study eye (subjects affected [exposed] occurrences = 11[491]11, 8[500]8, 15[473]15) and the fellow eye (subjects affected [exposed] occurrences = 1[491]1, 6[500]6, 0[473]0)
|
|
|
|
subjects affected / exposed
|
12 / 491 (2.44%) |
14 / 500 (2.80%) |
15 / 473 (3.17%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 14 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic retinal oedema
|
|
|
|
Additional description: SAEs occurred in both the study eye (subjects affected [exposed] occurrences = 7[491]8, 0[500]0, 2[473]2) and the fellow eye (subjects affected [exposed] occurrences = 1[491]1, 1[500]1, 2[473]2)
|
|
|
|
subjects affected / exposed
|
8 / 491 (1.63%) |
1 / 500 (0.20%) |
4 / 473 (0.85%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cataract nuclear
|
|
|
|
Additional description: SAEs occurred in the study eye
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cataract cortical
|
|
|
|
Additional description: SAEs occurred in the fellow eye
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Angle closure glaucoma
|
|
|
|
Additional description: SAEs occurred in the fellow eye
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
1 / 500 (0.20%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Neovascular age-related macular degeneration
|
|
|
|
Additional description: SAEs occurred in the fellow eye
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Posterior capsule opacification
|
|
|
|
Additional description: SAEs occurred in the study eye
|
|
|
|
subjects affected / exposed
|
2 / 491 (0.41%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Iridocyclitis
|
|
|
|
Additional description: SAEs occurred in the study eye
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Iridocele
|
|
|
|
Additional description: SAEs occurred in the study eye
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Glaucoma
|
|
|
|
Additional description: SAEs occurred in the study eye
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
1 / 500 (0.20%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rhegmatogenous retinal detachment
|
|
|
|
Additional description: SAEs occurred in the study eye
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Retinal tear
|
|
|
|
Additional description: SAEs occurred in both the study eye (subjects affected [exposed] occurrences = 0[491]0, 1[500]1, 0[473]0) and the fellow eye (subjects affected [exposed] occurrences = 0[491]0, 1[500]1, 0[473]0)
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
1 / 500 (0.20%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Retinal neovascularisation
|
|
|
|
Additional description: SAEs occurred in the fellow eye
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
1 / 500 (0.20%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tractional retinal detachment
|
|
|
|
Additional description: SAEs occurred in the fellow eye
|
|
|
|
subjects affected / exposed
|
2 / 491 (0.41%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic retinopathy
|
|
|
|
Additional description: SAEs occurred in both the study eye (subjects affected [exposed] occurrences = 0[491]0, 0[500]0, 1[473]1) and the fellow eye (subjects affected [exposed] occurrences = 2[491]2, 3[500]3, 2[473]2)
|
|
|
|
subjects affected / exposed
|
2 / 491 (0.41%) |
3 / 500 (0.60%) |
2 / 473 (0.42%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Epiretinal membrane
|
|
|
|
Additional description: SAEs occurred in both the study eye (subjects affected [exposed] occurrences = 0[491]0, 0[500]0, 1[473]1) and the fellow eye (subjects affected [exposed] occurrences = 0[491]0, 0[500]0, 2[473]2)
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
3 / 473 (0.63%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Retinal artery occlusion
|
|
|
|
Additional description: SAEs occurred in both the study eye (subjects affected [exposed] occurrences = 0[491]0, 1[500]1, 2[473]2) and the fellow eye (subjects affected [exposed] occurrences = 1[491]1, 0[500]0, 1[473]1)
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
1 / 500 (0.20%) |
3 / 473 (0.63%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Retinal detachment
|
|
|
|
Additional description: SAEs occurred in both the study eye (subjects affected [exposed] occurrences = 2[491]2, 0[500]0, 0[473]0) and the fellow eye (subjects affected [exposed] occurrences = 1[491]1, 0[500]0, 1[473]1)
|
|
|
|
subjects affected / exposed
|
3 / 491 (0.61%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Retinal vein occlusion
|
|
|
|
Additional description: SAEs occurred in the study eye
|
|
|
|
subjects affected / exposed
|
2 / 491 (0.41%) |
1 / 500 (0.20%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vitreous haemorrhage
|
|
|
|
Additional description: SAEs occurred in both the study eye (subjects affected [exposed] occurrences = 1[491]1, 1[500]1, 2[473]2) and the fellow eye (subjects affected [exposed] occurrences = 4[491]4, 3[500]3, 6[473]6)
|
|
|
|
subjects affected / exposed
|
5 / 491 (1.02%) |
4 / 500 (0.80%) |
8 / 473 (1.69%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Uveitis
|
|
|
|
Additional description: SAEs occurred in the study eye
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
1 / 500 (0.20%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal disorders
|
|
|
|
Faecaloma
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haematochezia
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhoidal haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal perforation
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nausea
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oesophagitis
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Colitis
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
1 / 500 (0.20%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Colitis ulcerative
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Constipation
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diarrhoea
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
1 / 500 (0.20%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dysphagia
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oral mucosal hypertrophy
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Small intestinal obstruction
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Umbilical hernia
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Volvulus
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vomiting
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatobiliary disorders
|
|
|
|
Portal vein thrombosis
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic cirrhosis
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
2 / 473 (0.42%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Gallbladder rupture
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Biliary tract disorder
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cholecystitis
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
1 / 500 (0.20%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cholelithiasis
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
1 / 500 (0.20%) |
2 / 473 (0.42%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Skin and subcutaneous tissue disorders
|
|
|
|
Cellulite
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic foot
|
|
|
|
subjects affected / exposed
|
2 / 491 (0.41%) |
3 / 500 (0.60%) |
2 / 473 (0.42%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Skin ulcer
|
|
|
|
subjects affected / exposed
|
3 / 491 (0.61%) |
1 / 500 (0.20%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal and urinary disorders
|
|
|
|
Diabetic nephropathy
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
1 / 500 (0.20%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chronic kidney disease
|
|
|
|
subjects affected / exposed
|
2 / 491 (0.41%) |
3 / 500 (0.60%) |
2 / 473 (0.42%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Acute kidney injury
|
|
|
|
subjects affected / exposed
|
8 / 491 (1.63%) |
5 / 500 (1.00%) |
5 / 473 (1.06%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 5 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
End stage renal disease
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
2 / 500 (0.40%) |
2 / 473 (0.42%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urinary retention
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ureterolithiasis
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Subcapsular renal haematoma
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
1 / 500 (0.20%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal impairment
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
1 / 500 (0.20%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal failure
|
|
|
|
subjects affected / exposed
|
3 / 491 (0.61%) |
1 / 500 (0.20%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nephropathy
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nephrolithiasis
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
3 / 500 (0.60%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal and connective tissue disorders
|
|
|
|
Arthritis
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
1 / 500 (0.20%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Back pain
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Spondylolisthesis
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Spinal stenosis
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pain in extremity
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Neuropathic arthropathy
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Neck pain
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal chest pain
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lumbar spinal stenosis
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
1 / 500 (0.20%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Infections and infestations
|
|
|
|
Abdominal abscess
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Appendicitis
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
1 / 500 (0.20%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Abscess limb
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
1 / 500 (0.20%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal infection
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bacteraemia
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
COVID-19
|
|
|
|
subjects affected / exposed
|
10 / 491 (2.04%) |
9 / 500 (1.80%) |
5 / 473 (1.06%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 9 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 3 |
0 / 0 |
Arthritis infective
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
1 / 500 (0.20%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arthritis bacterial
|
|
|
|
subjects affected / exposed
|
2 / 491 (0.41%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bronchitis
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
2 / 473 (0.42%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Atypical pneumonia
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic gangrene
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diverticulitis intestinal haemorrhagic
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diverticulitis
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
1 / 500 (0.20%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic foot infection
|
|
|
|
subjects affected / exposed
|
2 / 491 (0.41%) |
1 / 500 (0.20%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Device related sepsis
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Clostridium difficile colitis
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cholecystitis infective
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
1 / 500 (0.20%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cellulitis
|
|
|
|
subjects affected / exposed
|
3 / 491 (0.61%) |
4 / 500 (0.80%) |
6 / 473 (1.27%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
COVID-19 pneumonia
|
|
|
|
subjects affected / exposed
|
4 / 491 (0.81%) |
2 / 500 (0.40%) |
3 / 473 (0.63%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Erysipelas
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Endocarditis bacterial
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Endocarditis
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Endophthalmitis
|
|
|
|
Additional description: SAEs occurred in both the study eye (subjects affected [exposed] occurrences = 2[491]2, 0[500]0, 1[473]1) and the fellow eye (subjects affected [exposed] occurrences = 2[491]2, 0[500]0, 1[473]1)
|
|
|
|
subjects affected / exposed
|
4 / 491 (0.81%) |
0 / 500 (0.00%) |
2 / 473 (0.42%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Infected skin ulcer
|
|
|
|
subjects affected / exposed
|
2 / 491 (0.41%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gangrene
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
2 / 500 (0.40%) |
3 / 473 (0.63%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastroenteritis norovirus
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Infected dermal cyst
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
2 / 500 (0.40%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Febrile infection
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Neutropenic sepsis
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Localised infection
|
|
|
|
subjects affected / exposed
|
7 / 491 (1.43%) |
0 / 500 (0.00%) |
2 / 473 (0.42%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Labyrinthitis
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
1 / 500 (0.20%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Influenza
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
1 / 500 (0.20%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Osteomyelitis
|
|
|
|
subjects affected / exposed
|
7 / 491 (1.43%) |
4 / 500 (0.80%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peritonitis
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Paronychia
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
1 / 500 (0.20%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Osteomyelitis chronic
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
1 / 500 (0.20%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Osteomyelitis acute
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Septic shock
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Systemic bacterial infection
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Septic endocarditis
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sepsis
|
|
|
|
subjects affected / exposed
|
4 / 491 (0.81%) |
2 / 500 (0.40%) |
4 / 473 (0.85%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
Staphylococcal infection
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia aspiration
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
2 / 500 (0.40%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Pneumonia bacterial
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pyelonephritis
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia
|
|
|
|
subjects affected / exposed
|
5 / 491 (1.02%) |
8 / 500 (1.60%) |
3 / 473 (0.63%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 9 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Upper respiratory tract infection
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urinary tract infection
|
|
|
|
subjects affected / exposed
|
2 / 491 (0.41%) |
0 / 500 (0.00%) |
3 / 473 (0.63%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urosepsis
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Wound infection
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metabolism and nutrition disorders
|
|
|
|
Dehydration
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
1 / 500 (0.20%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Malnutrition
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypoglycaemia
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
1 / 500 (0.20%) |
2 / 473 (0.42%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Hypervolaemia
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hyperkalaemia
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
2 / 500 (0.40%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hyperglycaemic hyperosmolar nonketotic syndrome
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hyperglycaemia
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
0 / 500 (0.00%) |
1 / 473 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic ketoacidosis
|
|
|
|
subjects affected / exposed
|
1 / 491 (0.20%) |
0 / 500 (0.00%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diabetes mellitus inadequate control
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
1 / 500 (0.20%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diabetes mellitus
|
|
|
|
subjects affected / exposed
|
0 / 491 (0.00%) |
1 / 500 (0.20%) |
0 / 473 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |