Serious adverse events
|
Placebo |
Selexipag |
Total subjects affected by serious adverse events
|
|
|
subjects affected / exposed
|
272 / 577 (47.14%) |
252 / 575 (43.83%) |
number of deaths (all causes)
|
41 |
49 |
number of deaths resulting from adverse events
|
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
BASAL CELL CARCINOMA
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
BREAST CANCER
|
|
|
subjects affected / exposed
|
3 / 577 (0.52%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
BREAST CANCER RECURRENT
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CEREBRAL HAEMANGIOMA
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
COLORECTAL CANCER METASTATIC
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
DIFFUSE LARGE B-CELL LYMPHOMA
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
HEPATIC NEOPLASM
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
LUNG ADENOCARCINOMA
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
LYMPHANGIOSIS CARCINOMATOSA
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
MALIGNANT MELANOMA
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular disorders
|
|
|
CIRCULATORY COLLAPSE
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
2 / 575 (0.35%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
DEEP VEIN THROMBOSIS
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
2 / 575 (0.35%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
EXTREMITY NECROSIS
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
FLUSHING
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HAEMATOMA
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HAEMODYNAMIC INSTABILITY
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
HYPERTENSION
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HYPOTENSION
|
|
|
subjects affected / exposed
|
3 / 577 (0.52%) |
3 / 575 (0.52%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
HYPOVOLAEMIC SHOCK
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
ORTHOSTATIC HYPOTENSION
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PERIPHERAL ARTERY THROMBOSIS
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PERIPHLEBITIS
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
THROMBOPHLEBITIS SUPERFICIAL
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
VASCULITIS
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
2 / 575 (0.35%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
VENA CAVA THROMBOSIS
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
VENOUS INSUFFICIENCY
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
VENOUS THROMBOSIS LIMB
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Surgical and medical procedures
|
|
|
BARIATRIC GASTRIC BALLOON INSERTION
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
BLADDER NECK SUSPENSION
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CARDIAC PACEMAKER INSERTION
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CARDIOVERSION
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CERVICAL CONISATION
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CHOLECYSTECTOMY
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
DRUG THERAPY CHANGED
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
GLAUCOMA SURGERY
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HAEMODIALYSIS
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
LUNG TRANSPLANT
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
2 / 575 (0.35%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
MASTECTOMY
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
NASAL SEPTAL OPERATION
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SALPINGECTOMY
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SKIN NEOPLASM EXCISION
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
STEM CELL TRANSPLANT
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
TURBINECTOMY
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
URETHRAL OPERATION
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pregnancy, puerperium and perinatal conditions
|
|
|
PREGNANCY
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
RUPTURED ECTOPIC PREGNANCY
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
General disorders and administration site conditions
|
|
|
ASTHENIA
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
2 / 575 (0.35%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CHEST DISCOMFORT
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CHEST PAIN
|
|
|
subjects affected / exposed
|
6 / 577 (1.04%) |
6 / 575 (1.04%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
DEATH
|
|
|
subjects affected / exposed
|
2 / 577 (0.35%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
EXERCISE TOLERANCE DECREASED
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
FATIGUE
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
GENERAL PHYSICAL HEALTH DETERIORATION
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
IMPAIRED HEALING
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
INFLUENZA LIKE ILLNESS
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
MULTI-ORGAN FAILURE
|
|
|
subjects affected / exposed
|
2 / 577 (0.35%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
NON-CARDIAC CHEST PAIN
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
OEDEMA PERIPHERAL
|
|
|
subjects affected / exposed
|
4 / 577 (0.69%) |
3 / 575 (0.52%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PYREXIA
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SUDDEN CARDIAC DEATH
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
SUDDEN DEATH
|
|
|
subjects affected / exposed
|
4 / 577 (0.69%) |
5 / 575 (0.87%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 5 |
Immune system disorders
|
|
|
HYPERSENSITIVITY
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
LUNG TRANSPLANT REJECTION
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
SARCOIDOSIS
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SECONDARY IMMUNODEFICIENCY
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Reproductive system and breast disorders
|
|
|
CERVICAL DYSPLASIA
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
2 / 575 (0.35%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CYSTOCELE
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ENDOMETRIOSIS
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
MENORRHAGIA
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
OVARIAN CYST
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
OVARIAN CYST RUPTURED
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory, thoracic and mediastinal disorders
|
|
|
ACUTE LUNG INJURY
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ACUTE RESPIRATORY FAILURE
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ASTHMA
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
DYSPNOEA
|
|
|
subjects affected / exposed
|
13 / 577 (2.25%) |
17 / 575 (2.96%) |
occurrences causally related to treatment / all
|
2 / 17 |
0 / 21 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
DYSPNOEA EXERTIONAL
|
|
|
subjects affected / exposed
|
2 / 577 (0.35%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
EPISTAXIS
|
|
|
subjects affected / exposed
|
4 / 577 (0.69%) |
4 / 575 (0.70%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HAEMOPTYSIS
|
|
|
subjects affected / exposed
|
5 / 577 (0.87%) |
5 / 575 (0.87%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
HYPOXIA
|
|
|
subjects affected / exposed
|
3 / 577 (0.52%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
3 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
INTERSTITIAL LUNG DISEASE
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
ORGANISING PNEUMONIA
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ORTHOPNOEA
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PULMONARY ARTERIAL HYPERTENSION
|
|
|
subjects affected / exposed
|
127 / 577 (22.01%) |
83 / 575 (14.43%) |
occurrences causally related to treatment / all
|
2 / 183 |
2 / 106 |
deaths causally related to treatment / all
|
1 / 16 |
0 / 19 |
PULMONARY ARTERY DILATATION
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PULMONARY EMBOLISM
|
|
|
subjects affected / exposed
|
3 / 577 (0.52%) |
4 / 575 (0.70%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PULMONARY HAEMORRHAGE
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PULMONARY HYPERTENSION
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PULMONARY INFARCTION
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PULMONARY OEDEMA
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PULMONARY VENO-OCCLUSIVE DISEASE
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
2 / 575 (0.35%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
RESPIRATORY FAILURE
|
|
|
subjects affected / exposed
|
3 / 577 (0.52%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
RESPIRATORY GAS EXCHANGE DISORDER
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SLEEP APNOEA SYNDROME
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
TACHYPNOEA
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psychiatric disorders
|
|
|
ALCOHOLISM
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
MENTAL STATUS CHANGES
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SCHIZOAFFECTIVE DISORDER
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SOMNAMBULISM
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
STRESS
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SUICIDE ATTEMPT
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Investigations
|
|
|
ALANINE AMINOTRANSFERASE INCREASED
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ASPARTATE AMINOTRANSFERASE INCREASED
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
BRAIN NATRIURETIC PEPTIDE INCREASED
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CARDIAC INDEX DECREASED
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CATHETERISATION CARDIAC
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
3 / 575 (0.52%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
INTERNATIONAL NORMALISED RATIO INCREASED
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
INVESTIGATION
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
2 / 575 (0.35%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
LIVER FUNCTION TEST ABNORMAL
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
OXYGEN SATURATION DECREASED
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PULMONARY ARTERIAL PRESSURE INCREASED
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PULMONARY ARTERIAL WEDGE PRESSURE INCREASED
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
RED BLOOD CELL COUNT INCREASED
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
TRANSPLANT EVALUATION
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
WALKING DISTANCE TEST ABNORMAL
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
WEIGHT DECREASED
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
WEIGHT INCREASED
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Injury, poisoning and procedural complications
|
|
|
ACCIDENT
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ACETABULUM FRACTURE
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
BRAIN HERNIATION
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
CRANIOCEREBRAL INJURY
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
FALL
|
|
|
subjects affected / exposed
|
6 / 577 (1.04%) |
3 / 575 (0.52%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
FEMORAL NECK FRACTURE
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
FEMUR FRACTURE
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
FOOT FRACTURE
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
GINGIVAL INJURY
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HEAD INJURY
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
INJURY
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
JAW FRACTURE
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
JOINT DISLOCATION
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
LIGAMENT SPRAIN
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
LIP INJURY
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
LOWER LIMB FRACTURE
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
LUMBAR VERTEBRAL FRACTURE
|
|
|
subjects affected / exposed
|
2 / 577 (0.35%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
MULTIPLE INJURIES
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
PELVIC FRACTURE
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
POST PROCEDURAL COMPLICATION
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
POST PROCEDURAL HAEMATOMA
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
POST PROCEDURAL HAEMORRHAGE
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PROCEDURAL HAEMORRHAGE
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PUBIS FRACTURE
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
RESPIRATORY FUME INHALATION DISORDER
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ROAD TRAFFIC ACCIDENT
|
|
|
subjects affected / exposed
|
2 / 577 (0.35%) |
4 / 575 (0.70%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
SUBDURAL HAEMATOMA
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
2 / 575 (0.35%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
TOXICITY TO VARIOUS AGENTS
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
TRAUMATIC FRACTURE
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
VACCINATION COMPLICATION
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
VASCULAR PROCEDURE COMPLICATION
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
VASCULAR PSEUDOANEURYSM
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac disorders
|
|
|
ACUTE CORONARY SYNDROME
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ACUTE MYOCARDIAL INFARCTION
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ACUTE RIGHT VENTRICULAR FAILURE
|
|
|
subjects affected / exposed
|
5 / 577 (0.87%) |
2 / 575 (0.35%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 2 |
ANGINA PECTORIS
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ARRHYTHMIA
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ATRIAL FIBRILLATION
|
|
|
subjects affected / exposed
|
4 / 577 (0.69%) |
7 / 575 (1.22%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ATRIAL FLUTTER
|
|
|
subjects affected / exposed
|
5 / 577 (0.87%) |
3 / 575 (0.52%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ATRIAL TACHYCARDIA
|
|
|
subjects affected / exposed
|
2 / 577 (0.35%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ATRIAL THROMBOSIS
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ATRIOVENTRICULAR BLOCK SECOND DEGREE
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
BRADYARRHYTHMIA
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
BRADYCARDIA
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
CARDIAC ARREST
|
|
|
subjects affected / exposed
|
4 / 577 (0.69%) |
2 / 575 (0.35%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
CARDIAC FAILURE
|
|
|
subjects affected / exposed
|
2 / 577 (0.35%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CARDIAC FAILURE CONGESTIVE
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
2 / 575 (0.35%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CARDIO-RESPIRATORY ARREST
|
|
|
subjects affected / exposed
|
2 / 577 (0.35%) |
2 / 575 (0.35%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
CARDIOGENIC SHOCK
|
|
|
subjects affected / exposed
|
2 / 577 (0.35%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
CARDIOPULMONARY FAILURE
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
3 / 575 (0.52%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 3 |
CHRONIC RIGHT VENTRICULAR FAILURE
|
|
|
subjects affected / exposed
|
2 / 577 (0.35%) |
2 / 575 (0.35%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
COR PULMONALE
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
COR PULMONALE ACUTE
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
COR PULMONALE CHRONIC
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CORONARY ARTERY INSUFFICIENCY
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
CORONARY ARTERY OCCLUSION
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
CORONARY ARTERY STENOSIS
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CYANOSIS
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
MYOCARDIAL INFARCTION
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
PALPITATIONS
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
2 / 575 (0.35%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
RIGHT VENTRICULAR DYSFUNCTION
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
RIGHT VENTRICULAR FAILURE
|
|
|
subjects affected / exposed
|
41 / 577 (7.11%) |
34 / 575 (5.91%) |
occurrences causally related to treatment / all
|
1 / 49 |
1 / 42 |
deaths causally related to treatment / all
|
1 / 6 |
0 / 7 |
SUPRAVENTRICULAR TACHYCARDIA
|
|
|
subjects affected / exposed
|
4 / 577 (0.69%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
TACHYCARDIA
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
VENTRICULAR FIBRILLATION
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
3 / 575 (0.52%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
VENTRICULAR TACHYCARDIA
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Nervous system disorders
|
|
|
AGEUSIA
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
APHASIA
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ATAXIA
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
AUTONOMIC NERVOUS SYSTEM IMBALANCE
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CEREBELLAR SYNDROME
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CEREBRAL INFARCTION
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CEREBROVASCULAR ACCIDENT
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
DEMYELINATION
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
DIZZINESS
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HAEMORRHAGE INTRACRANIAL
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
HEADACHE
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
2 / 575 (0.35%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HYPOGLYCAEMIC UNCONSCIOUSNESS
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ISCHAEMIC STROKE
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
LOSS OF CONSCIOUSNESS
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
MENTAL IMPAIRMENT
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
MIGRAINE
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PARKINSON'S DISEASE
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
POST HERPETIC NEURALGIA
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PRESYNCOPE
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
2 / 575 (0.35%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SUBARACHNOID HAEMORRHAGE
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SYNCOPE
|
|
|
subjects affected / exposed
|
20 / 577 (3.47%) |
10 / 575 (1.74%) |
occurrences causally related to treatment / all
|
3 / 23 |
4 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
THALAMIC INFARCTION
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
TRANSIENT ISCHAEMIC ATTACK
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
2 / 575 (0.35%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
VOCAL CORD PARALYSIS
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood and lymphatic system disorders
|
|
|
ANAEMIA
|
|
|
subjects affected / exposed
|
3 / 577 (0.52%) |
5 / 575 (0.87%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HAEMORRHAGIC ANAEMIA
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
IDIOPATHIC THROMBOCYTOPENIC PURPURA
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
LEUKOPENIA
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
NEUTROPENIA
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
THROMBOCYTOPENIA
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ear and labyrinth disorders
|
|
|
VERTIGO
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eye disorders
|
|
|
CATARACT
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
2 / 575 (0.35%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CHOROIDITIS
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
MACULOPATHY
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
VISION BLURRED
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal disorders
|
|
|
ABDOMINAL DISCOMFORT
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ABDOMINAL DISTENSION
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ABDOMINAL HERNIA
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ABDOMINAL PAIN
|
|
|
subjects affected / exposed
|
4 / 577 (0.69%) |
5 / 575 (0.87%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ANAL HAEMORRHAGE
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ASCITES
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
2 / 575 (0.35%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
COLITIS ISCHAEMIC
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
DIARRHOEA
|
|
|
subjects affected / exposed
|
3 / 577 (0.52%) |
3 / 575 (0.52%) |
occurrences causally related to treatment / all
|
1 / 3 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
DUODENAL ULCER
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
DYSPEPSIA
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ENTERITIS
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ENTEROCELE
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
GASTRITIS
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
3 / 575 (0.52%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
GASTROINTESTINAL ANGIODYSPLASIA HAEMORRHAGIC
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
GASTROINTESTINAL HAEMORRHAGE
|
|
|
subjects affected / exposed
|
3 / 577 (0.52%) |
3 / 575 (0.52%) |
occurrences causally related to treatment / all
|
2 / 4 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
GASTROOESOPHAGEAL REFLUX DISEASE
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HAEMATEMESIS
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HAEMATOCHEZIA
|
|
|
subjects affected / exposed
|
2 / 577 (0.35%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ILEUS
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
INTESTINAL OBSTRUCTION
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
LARGE INTESTINE POLYP
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
MELAENA
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
NAUSEA
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
NECROTISING COLITIS
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
OESOPHAGEAL OBSTRUCTION
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
OESOPHAGEAL VARICES HAEMORRHAGE
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PANCREATITIS
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PANCREATITIS ACUTE
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SIGMOIDITIS
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
UPPER GASTROINTESTINAL HAEMORRHAGE
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
2 / 575 (0.35%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
VOMITING
|
|
|
subjects affected / exposed
|
2 / 577 (0.35%) |
2 / 575 (0.35%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Hepatobiliary disorders
|
|
|
ACUTE HEPATIC FAILURE
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CHOLANGITIS
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CHOLECYSTITIS ACUTE
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CHOLELITHIASIS
|
|
|
subjects affected / exposed
|
2 / 577 (0.35%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HEPATIC CIRRHOSIS
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HEPATIC CYST
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HEPATIC MASS
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HEPATORENAL SYNDROME
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
NODULAR REGENERATIVE HYPERPLASIA
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin and subcutaneous tissue disorders
|
|
|
DERMATITIS CONTACT
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
DERMATOMYOSITIS
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PAIN OF SKIN
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
RASH
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SCLERODERMA ASSOCIATED DIGITAL ULCER
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SKIN ULCER
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
TELANGIECTASIA
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal and urinary disorders
|
|
|
ACUTE PRERENAL FAILURE
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ANURIA
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
LUPUS NEPHRITIS
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
OLIGURIA
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
RENAL FAILURE
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
RENAL FAILURE ACUTE
|
|
|
subjects affected / exposed
|
6 / 577 (1.04%) |
6 / 575 (1.04%) |
occurrences causally related to treatment / all
|
1 / 6 |
0 / 6 |
deaths causally related to treatment / all
|
1 / 3 |
0 / 2 |
URETHRAL STENOSIS
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endocrine disorders
|
|
|
AUTOIMMUNE THYROIDITIS
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
BASEDOW'S DISEASE
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HYPERTHYROIDISM
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HYPOTHYROIDISM
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal and connective tissue disorders
|
|
|
BACK PAIN
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
2 / 575 (0.35%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CHONDROCALCINOSIS PYROPHOSPHATE
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CREST SYNDROME
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CRYSTAL ARTHROPATHY
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
INTERVERTEBRAL DISC PROTRUSION
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
MIXED CONNECTIVE TISSUE DISEASE
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
2 / 575 (0.35%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
MYALGIA
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
2 / 575 (0.35%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
OSTEOPOROSIS
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
OSTEOPOROTIC FRACTURE
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PAIN IN EXTREMITY
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
2 / 575 (0.35%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
POLYMYOSITIS
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
RHEUMATOID ARTHRITIS
|
|
|
subjects affected / exposed
|
2 / 577 (0.35%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
STILL'S DISEASE ADULT ONSET
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SYSTEMIC LUPUS ERYTHEMATOSUS
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
5 / 575 (0.87%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SYSTEMIC SCLEROSIS
|
|
|
subjects affected / exposed
|
2 / 577 (0.35%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Infections and infestations
|
|
|
ABDOMINAL INFECTION
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ABSCESS INTESTINAL
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ABSCESS LIMB
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ABSCESS ORAL
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
APPENDICITIS PERFORATED
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ATYPICAL PNEUMONIA
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
BRONCHITIS
|
|
|
subjects affected / exposed
|
4 / 577 (0.69%) |
6 / 575 (1.04%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
BRONCHOPNEUMONIA
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CATHETER SITE INFECTION
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CELLULITIS
|
|
|
subjects affected / exposed
|
3 / 577 (0.52%) |
3 / 575 (0.52%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CLOSTRIDIUM DIFFICILE COLITIS
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CYSTITIS ESCHERICHIA
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
DIABETIC GANGRENE
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
DIVERTICULITIS
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ENTEROCOLITIS VIRAL
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ERYSIPELAS
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
2 / 575 (0.35%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
GASTROENTERITIS
|
|
|
subjects affected / exposed
|
3 / 577 (0.52%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 3 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HEPATITIS C
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HERPES ZOSTER
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
INFECTION
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
INFLUENZA
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
2 / 575 (0.35%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
LOBAR PNEUMONIA
|
|
|
subjects affected / exposed
|
2 / 577 (0.35%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
LOCALISED INFECTION
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
LOWER RESPIRATORY TRACT INFECTION
|
|
|
subjects affected / exposed
|
4 / 577 (0.69%) |
4 / 575 (0.70%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
LUNG ABSCESS
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
LUNG INFECTION
|
|
|
subjects affected / exposed
|
2 / 577 (0.35%) |
4 / 575 (0.70%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
LYMPHANGITIS
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
NASOPHARYNGITIS
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
OSTEOMYELITIS
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PARAINFLUENZAE VIRUS INFECTION
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PAROTITIS
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PERITONITIS
|
|
|
subjects affected / exposed
|
2 / 577 (0.35%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PILONIDAL CYST
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PNEUMONIA
|
|
|
subjects affected / exposed
|
25 / 577 (4.33%) |
17 / 575 (2.96%) |
occurrences causally related to treatment / all
|
0 / 30 |
0 / 18 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
PNEUMONIA BACTERIAL
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
POST PROCEDURAL INFECTION
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
POST PROCEDURAL SEPSIS
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
PYELONEPHRITIS
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
2 / 575 (0.35%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PYELONEPHRITIS ACUTE
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
3 / 575 (0.52%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PYELONEPHRITIS CHRONIC
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
RESPIRATORY TRACT INFECTION
|
|
|
subjects affected / exposed
|
3 / 577 (0.52%) |
4 / 575 (0.70%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SEPSIS
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
3 / 575 (0.52%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
SEPTIC SHOCK
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
3 / 575 (0.52%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
STAPHYLOCOCCAL SEPSIS
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
TOOTH ABSCESS
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
TOOTH INFECTION
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
TRACHEOBRONCHITIS
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
UPPER RESPIRATORY TRACT INFECTION
|
|
|
subjects affected / exposed
|
3 / 577 (0.52%) |
4 / 575 (0.70%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
URINARY TRACT INFECTION
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
2 / 575 (0.35%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
VIRAL INFECTION
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolism and nutrition disorders
|
|
|
DEHYDRATION
|
|
|
subjects affected / exposed
|
2 / 577 (0.35%) |
2 / 575 (0.35%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
DIABETES MELLITUS INADEQUATE CONTROL
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
DYSLIPIDAEMIA
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ELECTROLYTE IMBALANCE
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
2 / 575 (0.35%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
FLUID OVERLOAD
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
FLUID RETENTION
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
GOUT
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
0 / 575 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HYPOGLYCAEMIA
|
|
|
subjects affected / exposed
|
1 / 577 (0.17%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
HYPONATRAEMIC SYNDROME
|
|
|
subjects affected / exposed
|
0 / 577 (0.00%) |
1 / 575 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |