Serious adverse events
|
Arm 2 |
Arm 1 |
Total subjects affected by serious adverse events
|
|
|
subjects affected / exposed
|
33 / 332 (9.94%) |
28 / 329 (8.51%) |
number of deaths (all causes)
|
207 |
232 |
number of deaths resulting from adverse events
|
13 |
8 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
Acute myeloid leukaemia
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
0 / 329 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Breast cancer
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases to meninges
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
0 / 329 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neoplasm progression
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Thyroid cancer
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular disorders
|
|
|
Aortic dissection
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial haemorrhage
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial occlusive disease
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial stenosis
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Circulatory collapse
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
0 / 329 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Embolism
|
|
|
subjects affected / exposed
|
2 / 332 (0.60%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
2 / 2 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematoma
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertension
|
|
|
subjects affected / exposed
|
11 / 332 (3.31%) |
4 / 329 (1.22%) |
occurrences causally related to treatment / all
|
13 / 13 |
4 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive crisis
|
|
|
subjects affected / exposed
|
4 / 332 (1.20%) |
3 / 329 (0.91%) |
occurrences causally related to treatment / all
|
4 / 4 |
3 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemia
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombophlebitis
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
2 / 329 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombosis
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
0 / 329 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Surgical and medical procedures
|
|
|
Catheter management
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Catheterisation venous
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hip arthroplasty
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
0 / 329 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Implantable pleural catheter insertion
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphadenectomy
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephrostomy
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
0 / 329 (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
|
1 / 332 (0.30%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chest discomfort
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
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
|
1 / 332 (0.30%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Disease progression
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Extravasation
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
0 / 329 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fatigue
|
|
|
subjects affected / exposed
|
3 / 332 (0.90%) |
2 / 329 (0.61%) |
occurrences causally related to treatment / all
|
2 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
General physical health deterioration
|
|
|
subjects affected / exposed
|
14 / 332 (4.22%) |
16 / 329 (4.86%) |
occurrences causally related to treatment / all
|
3 / 20 |
4 / 20 |
deaths causally related to treatment / all
|
2 / 2 |
2 / 2 |
Impaired healing
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
2 / 329 (0.61%) |
occurrences causally related to treatment / all
|
1 / 117 |
1 / 21 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oedema
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pain
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
3 / 329 (0.91%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyrexia
|
|
|
subjects affected / exposed
|
4 / 332 (1.20%) |
7 / 329 (2.13%) |
occurrences causally related to treatment / all
|
0 / 5 |
1 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombosis in device
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Immune system disorders
|
|
|
Drug hypersensitivity
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypersensitivity
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
9 / 329 (2.74%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Reproductive system and breast disorders
|
|
|
Female genital tract fistula
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
1 / 1 |
2 / 2 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
Vaginal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
0 / 329 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory, thoracic and mediastinal disorders
|
|
|
Dyspnoea
|
|
|
subjects affected / exposed
|
5 / 332 (1.51%) |
5 / 329 (1.52%) |
occurrences causally related to treatment / all
|
2 / 5 |
2 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Emphysema
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epistaxis
|
|
|
subjects affected / exposed
|
2 / 332 (0.60%) |
2 / 329 (0.61%) |
occurrences causally related to treatment / all
|
2 / 2 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleural effusion
|
|
|
subjects affected / exposed
|
9 / 332 (2.71%) |
6 / 329 (1.82%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumothorax
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary embolism
|
|
|
subjects affected / exposed
|
5 / 332 (1.51%) |
5 / 329 (1.52%) |
occurrences causally related to treatment / all
|
5 / 5 |
5 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psychiatric disorders
|
|
|
Completed suicide
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Confusional state
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
2 / 329 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Depression
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
2 / 329 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mood altered
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
0 / 329 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Investigations
|
|
|
Blood creatine increased
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
0 / 329 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood pressure increased
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
0 / 329 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematology test abnormal
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic enzyme increased
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neutrophil count decreased
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Platelet count decreased
|
|
|
subjects affected / exposed
|
8 / 332 (2.41%) |
10 / 329 (3.04%) |
occurrences causally related to treatment / all
|
6 / 9 |
3 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Injury, poisoning and procedural complications
|
|
|
Fall
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incisional hernia
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
2 / 329 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infusion related reaction
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal anastomosis complication
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
0 / 329 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumothorax traumatic
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal fracture
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
0 / 329 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thoracic vertebral fracture
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
0 / 329 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Toxicity to various agents
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
0 / 329 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Upper limb fracture
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urostomy complication
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
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
|
0 / 332 (0.00%) |
2 / 329 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute myocardial infarction
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
2 / 329 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrioventricular block complete
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac disorder
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
0 / 329 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac failure
|
|
|
subjects affected / exposed
|
3 / 332 (0.90%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
2 / 3 |
1 / 1 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
Cardiotoxicity
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
0 / 329 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiovascular disorder
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
0 / 329 (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
|
0 / 332 (0.00%) |
2 / 329 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinus node dysfunction
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
0 / 329 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Supraventricular tachycardia
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nervous system disorders
|
|
|
Cerebral haemorrhage
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
0 / 329 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral ischaemia
|
|
|
subjects affected / exposed
|
2 / 332 (0.60%) |
0 / 329 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebrovascular accident
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
2 / 329 (0.61%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Disturbance in attention
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhage intracranial
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhagic stroke
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
0 / 329 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Headache
|
|
|
subjects affected / exposed
|
2 / 332 (0.60%) |
3 / 329 (0.91%) |
occurrences causally related to treatment / all
|
2 / 2 |
2 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hemiparesis
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
0 / 329 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Migraine
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osmotic demyelination syndrome
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
Parkinsonism
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
0 / 329 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Posterior reversible encephalopathy syndrome
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
2 / 329 (0.61%) |
occurrences causally related to treatment / all
|
1 / 1 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Seizure
|
|
|
subjects affected / exposed
|
2 / 332 (0.60%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Syncope
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
2 / 329 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transient ischaemic attack
|
|
|
subjects affected / exposed
|
4 / 332 (1.20%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
4 / 4 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular dementia
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood and lymphatic system disorders
|
|
|
Anaemia
|
|
|
subjects affected / exposed
|
9 / 332 (2.71%) |
8 / 329 (2.43%) |
occurrences causally related to treatment / all
|
3 / 12 |
3 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood disorder
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bone marrow failure
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Febrile neutropenia
|
|
|
subjects affected / exposed
|
2 / 332 (0.60%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematotoxicity
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Leukopenia
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
2 / 329 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neutropenia
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
6 / 329 (1.82%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancytopenia
|
|
|
subjects affected / exposed
|
4 / 332 (1.20%) |
6 / 329 (1.82%) |
occurrences causally related to treatment / all
|
1 / 4 |
2 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Splenic infarction
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombocytopenia
|
|
|
subjects affected / exposed
|
7 / 332 (2.11%) |
25 / 329 (7.60%) |
occurrences causally related to treatment / all
|
5 / 10 |
8 / 32 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombotic microangiopathy
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
0 / 329 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eye disorders
|
|
|
Retinal artery occlusion
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
0 / 329 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal detachment
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal disorders
|
|
|
Abdominal hernia
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
2 / 329 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal pain
|
|
|
subjects affected / exposed
|
13 / 332 (3.92%) |
12 / 329 (3.65%) |
occurrences causally related to treatment / all
|
4 / 13 |
6 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal pain lower
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal strangulated hernia
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute abdomen
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
0 / 329 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal fistula
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
0 / 329 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ascites
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colitis
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colitis ischaemic
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
0 / 329 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Constipation
|
|
|
subjects affected / exposed
|
3 / 332 (0.90%) |
8 / 329 (2.43%) |
occurrences causally related to treatment / all
|
1 / 4 |
4 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diaphragmatic hernia
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
0 / 329 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diarrhoea
|
|
|
subjects affected / exposed
|
5 / 332 (1.51%) |
4 / 329 (1.22%) |
occurrences causally related to treatment / all
|
3 / 6 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenal ulcer
|
|
|
subjects affected / exposed
|
2 / 332 (0.60%) |
0 / 329 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Faecaloma
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Faeces discoloured
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastritis
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
2 / 329 (0.61%) |
occurrences causally related to treatment / all
|
0 / 1 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal obstruction
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal pain
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematemesis
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ileus
|
|
|
subjects affected / exposed
|
8 / 332 (2.41%) |
3 / 329 (0.91%) |
occurrences causally related to treatment / all
|
4 / 9 |
0 / 3 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
Intestinal obstruction
|
|
|
subjects affected / exposed
|
4 / 332 (1.20%) |
3 / 329 (0.91%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal perforation
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestinal perforation
|
|
|
subjects affected / exposed
|
2 / 332 (0.60%) |
0 / 329 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
Nausea
|
|
|
subjects affected / exposed
|
9 / 332 (2.71%) |
3 / 329 (0.91%) |
occurrences causally related to treatment / all
|
3 / 9 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophagitis
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
0 / 329 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumatosis intestinalis
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small intestinal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
0 / 329 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small intestinal obstruction
|
|
|
subjects affected / exposed
|
2 / 332 (0.60%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
2 / 2 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subileus
|
|
|
subjects affected / exposed
|
13 / 332 (3.92%) |
8 / 329 (2.43%) |
occurrences causally related to treatment / all
|
4 / 18 |
4 / 10 |
deaths causally related to treatment / all
|
2 / 2 |
0 / 0 |
Vomiting
|
|
|
subjects affected / exposed
|
9 / 332 (2.71%) |
8 / 329 (2.43%) |
occurrences causally related to treatment / all
|
6 / 11 |
0 / 9 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 1 |
Hepatobiliary disorders
|
|
|
Bile duct stone
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis toxic
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
0 / 329 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperbilirubinaemia
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Jaundice
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
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
|
|
|
Haemorrhage subcutaneous
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
0 / 329 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Palmar-plantar erythrodysaesthesia syndrome
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
0 / 329 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rash generalised
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
0 / 329 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin ulcer
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal and urinary disorders
|
|
|
Acute kidney injury
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
2 / 329 (0.61%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematuria
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
0 / 329 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydronephrosis
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
2 / 329 (0.61%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephrolithiasis
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephrotic syndrome
|
|
|
subjects affected / exposed
|
2 / 332 (0.60%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
2 / 2 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal colic
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal failure
|
|
|
subjects affected / exposed
|
5 / 332 (1.51%) |
0 / 329 (0.00%) |
occurrences causally related to treatment / all
|
4 / 6 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
Renal failure acute
|
|
|
subjects affected / exposed
|
3 / 332 (0.90%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Renal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
0 / 329 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal impairment
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary fistula
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary retention
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
2 / 329 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary tract obstruction
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal and connective tissue disorders
|
|
|
Back pain
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
2 / 329 (0.61%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bursitis
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fistula
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
0 / 329 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Flank pain
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
2 / 329 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral disc protrusion
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
2 / 329 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteonecrosis of jaw
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteoporosis
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
0 / 329 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infections and infestations
|
|
|
Anal abscess
|
|
|
subjects affected / exposed
|
2 / 332 (0.60%) |
0 / 329 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast abscess
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
0 / 329 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchitis
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchopneumonia
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Campylobacter gastroenteritis
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
0 / 329 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cellulitis
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clostridium difficile colitis
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cystitis
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device related infection
|
|
|
subjects affected / exposed
|
3 / 332 (0.90%) |
2 / 329 (0.61%) |
occurrences causally related to treatment / all
|
2 / 4 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endocarditis
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fascioliasis
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
0 / 329 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Febrile infection
|
|
|
subjects affected / exposed
|
2 / 332 (0.60%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal infection
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
0 / 329 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Groin abscess
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
0 / 329 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Herpes simplex
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Herpes zoster
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
0 / 329 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infection
|
|
|
subjects affected / exposed
|
6 / 332 (1.81%) |
4 / 329 (1.22%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Influenza
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung infection
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
0 / 329 (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 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pharingitis
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
2 / 329 (0.61%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pyelonephritis
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyelonephritis acute
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
0 / 329 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sepsis
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
0 / 329 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinusitis
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
2 / 329 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Staphylococcal bacteraemia
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
0 / 329 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Staphylococcal infection
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
0 / 329 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subcutaneous abscess
|
|
|
subjects affected / exposed
|
2 / 332 (0.60%) |
0 / 329 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tonsillitis
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary tract infection
|
|
|
subjects affected / exposed
|
5 / 332 (1.51%) |
9 / 329 (2.74%) |
occurrences causally related to treatment / all
|
1 / 5 |
3 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolism and nutrition disorders
|
|
|
Cachexia
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
0 / 329 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Decreased appetite
|
|
|
subjects affected / exposed
|
1 / 332 (0.30%) |
0 / 329 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dehydration
|
|
|
subjects affected / exposed
|
2 / 332 (0.60%) |
2 / 329 (0.61%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic ketoacidosis
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperglycaemia
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperkalaemia
|
|
|
subjects affected / exposed
|
2 / 332 (0.60%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyponatraemia
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
2 / 329 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
Malnutrition
|
|
|
subjects affected / exposed
|
0 / 332 (0.00%) |
1 / 329 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |