Serious adverse events
|
EnPC |
dtEC-dtD |
Total subjects affected by serious adverse events
|
|
|
subjects affected / exposed
|
546 / 1430 (38.18%) |
394 / 1427 (27.61%) |
number of deaths (all causes)
|
0 |
2 |
number of deaths resulting from adverse events
|
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
Acute leukaemia
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute myeloid leukaemia
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular disorders
|
|
|
Capillary leak syndrome
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
1 / 1427 (0.07%) |
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
|
5 / 1430 (0.35%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
5 / 5 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Deep vein thrombosis
|
|
|
subjects affected / exposed
|
2 / 1430 (0.14%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
2 / 2 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Embolism
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertension
|
|
|
subjects affected / exposed
|
2 / 1430 (0.14%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive crisis
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypotension
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infusion site thrombosis
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Phlebitis
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
0 / 1427 (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
|
10 / 1430 (0.70%) |
7 / 1427 (0.49%) |
occurrences causally related to treatment / all
|
9 / 10 |
7 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subclavian vein thrombosis
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
1 / 1427 (0.07%) |
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 / 1430 (0.00%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombosis
|
|
|
subjects affected / exposed
|
10 / 1430 (0.70%) |
5 / 1427 (0.35%) |
occurrences causally related to treatment / all
|
7 / 10 |
4 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Venous thrombosis limb
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
General disorders and administration site conditions
|
|
|
Administration site extravasation
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Asthenia
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Catheter site extravasation
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Catheter site inflammation
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Catheter site thrombosis
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chest discomfort
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chest pain
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
4 / 1427 (0.28%) |
occurrences causally related to treatment / all
|
0 / 0 |
4 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chills
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
3 / 1427 (0.21%) |
occurrences causally related to treatment / all
|
1 / 1 |
3 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Complication associated with device
|
|
|
subjects affected / exposed
|
2 / 1430 (0.14%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device related thrombosis
|
|
|
subjects affected / exposed
|
2 / 1430 (0.14%) |
3 / 1427 (0.21%) |
occurrences causally related to treatment / all
|
1 / 2 |
2 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Extravasation
|
|
|
subjects affected / exposed
|
3 / 1430 (0.21%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fatigue
|
|
|
subjects affected / exposed
|
19 / 1430 (1.33%) |
17 / 1427 (1.19%) |
occurrences causally related to treatment / all
|
19 / 19 |
17 / 17 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gait disturbance
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
General physical health deterioration
|
|
|
subjects affected / exposed
|
42 / 1430 (2.94%) |
25 / 1427 (1.75%) |
occurrences causally related to treatment / all
|
40 / 42 |
25 / 25 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Impaired healing
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inflammation
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Influenza like illness
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infusion device issue
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malaise
|
|
|
subjects affected / exposed
|
3 / 1430 (0.21%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
3 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mucosal inflammation
|
|
|
subjects affected / exposed
|
7 / 1430 (0.49%) |
2 / 1427 (0.14%) |
occurrences causally related to treatment / all
|
7 / 7 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Multi-organ failure
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oedema peripheral
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
3 / 1427 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
3 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pain
|
|
|
subjects affected / exposed
|
7 / 1430 (0.49%) |
5 / 1427 (0.35%) |
occurrences causally related to treatment / all
|
7 / 7 |
5 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyrexia
|
|
|
subjects affected / exposed
|
60 / 1430 (4.20%) |
54 / 1427 (3.78%) |
occurrences causally related to treatment / all
|
59 / 60 |
49 / 54 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sudden death
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
Swelling
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thoracic pain
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombosis in device
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Immune system disorders
|
|
|
Anaphylactic reaction
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaphylactic shock
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypersensitivity
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
2 / 1427 (0.14%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Reproductive system and breast disorders
|
|
|
Haemorrhagic ovarian cyst
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vaginal haemorrhage
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory, thoracic and mediastinal disorders
|
|
|
Acute respiratory distress syndrome
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
Alveolitis
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cough
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
3 / 1427 (0.21%) |
occurrences causally related to treatment / all
|
0 / 1 |
3 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dyspnoea
|
|
|
subjects affected / exposed
|
7 / 1430 (0.49%) |
5 / 1427 (0.35%) |
occurrences causally related to treatment / all
|
6 / 7 |
5 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oropharyngeal pain
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleural effusion
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonitis
|
|
|
subjects affected / exposed
|
2 / 1430 (0.14%) |
4 / 1427 (0.28%) |
occurrences causally related to treatment / all
|
2 / 2 |
4 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary embolism
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary mass
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory failure
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tracheal inflammation
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psychiatric disorders
|
|
|
Adjustment disorder with mixed anxiety and depressed mood
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anxiety
|
|
|
subjects affected / exposed
|
3 / 1430 (0.21%) |
2 / 1427 (0.14%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Depression
|
|
|
subjects affected / exposed
|
2 / 1430 (0.14%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Panic attack
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psychotic disorder
|
|
|
subjects affected / exposed
|
2 / 1430 (0.14%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Suicidal behaviour
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
2 / 1427 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Suicidal ideation
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
1 / 1427 (0.07%) |
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
|
0 / 1430 (0.00%) |
2 / 1427 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Investigations
|
|
|
Alanine aminotransferase increased
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood creatinine increased
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
C-reactive protein increased
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gamma-glutamyltransferase increased
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic enzyme increased
|
|
|
subjects affected / exposed
|
2 / 1430 (0.14%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Platelet count decreased
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transaminases increased
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Weight decreased
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac disorders
|
|
|
Acute coronary syndrome
|
|
|
subjects affected / exposed
|
2 / 1430 (0.14%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
2 / 2 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Angina pectoris
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
2 / 1427 (0.14%) |
occurrences causally related to treatment / all
|
1 / 1 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrial fibrillation
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
2 / 1427 (0.14%) |
occurrences causally related to treatment / all
|
1 / 1 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrial thrombosis
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
0 / 1427 (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
|
0 / 1430 (0.00%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac failure congestive
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiomyopathy
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiovascular disorder
|
|
|
subjects affected / exposed
|
3 / 1430 (0.21%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
3 / 3 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myocardial infarction
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
2 / 1427 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Palpitations
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pericardial effusion
|
|
|
subjects affected / exposed
|
2 / 1430 (0.14%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Supraventricular tachycardia
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tachycardia
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
3 / 1427 (0.21%) |
occurrences causally related to treatment / all
|
1 / 1 |
3 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular tachycardia
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nervous system disorders
|
|
|
Ataxia
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
0 / 1427 (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
|
1 / 1430 (0.07%) |
0 / 1427 (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
|
1 / 1430 (0.07%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Convulsion
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic hyperglycaemic coma
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dizziness
|
|
|
subjects affected / exposed
|
5 / 1430 (0.35%) |
2 / 1427 (0.14%) |
occurrences causally related to treatment / all
|
5 / 5 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Guillain-Barre syndrome
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Headache
|
|
|
subjects affected / exposed
|
2 / 1430 (0.14%) |
2 / 1427 (0.14%) |
occurrences causally related to treatment / all
|
2 / 2 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuralgia
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuropathy peripheral
|
|
|
subjects affected / exposed
|
2 / 1430 (0.14%) |
2 / 1427 (0.14%) |
occurrences causally related to treatment / all
|
2 / 2 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Orthostatic intolerance
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral motor neuropathy
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral sensory neuropathy
|
|
|
subjects affected / exposed
|
4 / 1430 (0.28%) |
3 / 1427 (0.21%) |
occurrences causally related to treatment / all
|
4 / 4 |
3 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Polyneuropathy
|
|
|
subjects affected / exposed
|
3 / 1430 (0.21%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
3 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Presyncope
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Restless legs syndrome
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Seizure
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Syncope
|
|
|
subjects affected / exposed
|
4 / 1430 (0.28%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
4 / 4 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transient ischaemic attack
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood and lymphatic system disorders
|
|
|
Agranulocytosis
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaemia
|
|
|
subjects affected / exposed
|
19 / 1430 (1.33%) |
11 / 1427 (0.77%) |
occurrences causally related to treatment / all
|
19 / 19 |
11 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bone marrow failure
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Febrile neutropenia
|
|
|
subjects affected / exposed
|
143 / 1430 (10.00%) |
49 / 1427 (3.43%) |
occurrences causally related to treatment / all
|
143 / 143 |
49 / 49 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Leukocytosis
|
|
|
subjects affected / exposed
|
3 / 1430 (0.21%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
3 / 3 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Leukopenia
|
|
|
subjects affected / exposed
|
55 / 1430 (3.85%) |
42 / 1427 (2.94%) |
occurrences causally related to treatment / all
|
55 / 55 |
42 / 42 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphocytosis
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neutropenia
|
|
|
subjects affected / exposed
|
119 / 1430 (8.32%) |
50 / 1427 (3.50%) |
occurrences causally related to treatment / all
|
119 / 119 |
50 / 50 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neutrophil count decreased
|
|
|
subjects affected / exposed
|
5 / 1430 (0.35%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
5 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancytopenia
|
|
|
subjects affected / exposed
|
26 / 1430 (1.82%) |
3 / 1427 (0.21%) |
occurrences causally related to treatment / all
|
26 / 26 |
3 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombocytopenia
|
|
|
subjects affected / exposed
|
12 / 1430 (0.84%) |
5 / 1427 (0.35%) |
occurrences causally related to treatment / all
|
12 / 12 |
5 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombotic thrombocytopenic purpura
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
White blood cell count decreased
|
|
|
subjects affected / exposed
|
3 / 1430 (0.21%) |
5 / 1427 (0.35%) |
occurrences causally related to treatment / all
|
3 / 3 |
5 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ear and labyrinth disorders
|
|
|
Ear pain
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inner ear disorder
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sudden hearing loss
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tinnitus
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertigo
|
|
|
subjects affected / exposed
|
5 / 1430 (0.35%) |
5 / 1427 (0.35%) |
occurrences causally related to treatment / all
|
5 / 5 |
5 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eye disorders
|
|
|
Eye inflammation
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal detachment
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Visual impairment
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal disorders
|
|
|
Abdominal discomfort
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal pain
|
|
|
subjects affected / exposed
|
3 / 1430 (0.21%) |
5 / 1427 (0.35%) |
occurrences causally related to treatment / all
|
3 / 3 |
4 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal pain upper
|
|
|
subjects affected / exposed
|
3 / 1430 (0.21%) |
2 / 1427 (0.14%) |
occurrences causally related to treatment / all
|
3 / 3 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal fissure
|
|
|
subjects affected / exposed
|
2 / 1430 (0.14%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
2 / 2 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Constipation
|
|
|
subjects affected / exposed
|
5 / 1430 (0.35%) |
3 / 1427 (0.21%) |
occurrences causally related to treatment / all
|
5 / 5 |
3 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diarrhoea
|
|
|
subjects affected / exposed
|
18 / 1430 (1.26%) |
14 / 1427 (0.98%) |
occurrences causally related to treatment / all
|
18 / 18 |
13 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenitis
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dyspepsia
|
|
|
subjects affected / exposed
|
5 / 1430 (0.35%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
4 / 5 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterocolitis
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
2 / 1427 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric disorder
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric ulcer
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
2 / 1427 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastritis
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal toxicity
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ileus
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal perforation
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nausea
|
|
|
subjects affected / exposed
|
21 / 1430 (1.47%) |
9 / 1427 (0.63%) |
occurrences causally related to treatment / all
|
21 / 21 |
9 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophagitis
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatitis
|
|
|
subjects affected / exposed
|
2 / 1430 (0.14%) |
2 / 1427 (0.14%) |
occurrences causally related to treatment / all
|
2 / 2 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stomatitis
|
|
|
subjects affected / exposed
|
5 / 1430 (0.35%) |
3 / 1427 (0.21%) |
occurrences causally related to treatment / all
|
5 / 5 |
3 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vomiting
|
|
|
subjects affected / exposed
|
22 / 1430 (1.54%) |
20 / 1427 (1.40%) |
occurrences causally related to treatment / all
|
22 / 22 |
20 / 20 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gallbladder necrosis
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatobiliary disorders
|
|
|
Bile duct stone
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
2 / 1427 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholelithiasis
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholestasis
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gallbladder disorder
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
1 / 1427 (0.07%) |
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
|
1 / 1430 (0.07%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis chronic active
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin and subcutaneous tissue disorders
|
|
|
Cutis laxa
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dermatitis bullous
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epidermolysis
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Erythema
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
3 / 1427 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
3 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Palmar-plantar erythrodysaesthesia syndrome
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
7 / 1427 (0.49%) |
occurrences causally related to treatment / all
|
0 / 0 |
7 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rash
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin lesion
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin reaction
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Toxic skin eruption
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urticaria
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
0 / 1427 (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 kidney injury
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cystitis haemorrhagic
|
|
|
subjects affected / exposed
|
2 / 1430 (0.14%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematuria
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephrolithiasis
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
1 / 1427 (0.07%) |
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
|
3 / 1430 (0.21%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
3 / 3 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal pain
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal and connective tissue disorders
|
|
|
Arthralgia
|
|
|
subjects affected / exposed
|
2 / 1430 (0.14%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
2 / 2 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Back pain
|
|
|
subjects affected / exposed
|
2 / 1430 (0.14%) |
4 / 1427 (0.28%) |
occurrences causally related to treatment / all
|
1 / 2 |
3 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bone pain
|
|
|
subjects affected / exposed
|
6 / 1430 (0.42%) |
9 / 1427 (0.63%) |
occurrences causally related to treatment / all
|
4 / 6 |
9 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscular weakness
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal pain
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
1 / 1 |
1 / 1 |
Myalgia
|
|
|
subjects affected / exposed
|
2 / 1430 (0.14%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pain in extremity
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal pain
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infections and infestations
|
|
|
Abscess
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abscess limb
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute sinusitis
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal abscess
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atypical pneumonia
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
3 / 1427 (0.21%) |
occurrences causally related to treatment / all
|
1 / 1 |
3 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacteraemia
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast abscess
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
0 / 1427 (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
|
0 / 1430 (0.00%) |
3 / 1427 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
3 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchitis bacterial
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
1 / 1427 (0.07%) |
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 / 1430 (0.00%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cystitis
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cytomegalovirus infection
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
1 / 1427 (0.07%) |
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
|
5 / 1430 (0.35%) |
5 / 1427 (0.35%) |
occurrences causally related to treatment / all
|
1 / 5 |
4 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulitis
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterocolitis infectious
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Erysipelas
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
2 / 1427 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Febrile infection
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis
|
|
|
subjects affected / exposed
|
2 / 1430 (0.14%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
1 / 2 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis norovirus
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal infection
|
|
|
subjects affected / exposed
|
2 / 1430 (0.14%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Genital herpes
|
|
|
subjects affected / exposed
|
2 / 1430 (0.14%) |
2 / 1427 (0.14%) |
occurrences causally related to treatment / all
|
2 / 2 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis B
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
157 / 1427 (11.00%) |
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
|
5 / 1430 (0.35%) |
2 / 1427 (0.14%) |
occurrences causally related to treatment / all
|
5 / 5 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Impetigo
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Implant site infection
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infected dermal cyst
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infected seroma
|
|
|
subjects affected / exposed
|
3 / 1430 (0.21%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infection
|
|
|
subjects affected / exposed
|
10 / 1430 (0.70%) |
12 / 1427 (0.84%) |
occurrences causally related to treatment / all
|
9 / 10 |
11 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Influenza
|
|
|
subjects affected / exposed
|
5 / 1430 (0.35%) |
3 / 1427 (0.21%) |
occurrences causally related to treatment / all
|
4 / 5 |
2 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infusion site infection
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laryngitis
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung infection
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mastitis
|
|
|
subjects affected / exposed
|
5 / 1430 (0.35%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
4 / 5 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nail infection
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neutropenic infection
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
2 / 1427 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Paronychia
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pharyngitis
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumocystis jirovecii infection
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumocystis jirovecii pneumonia
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia
|
|
|
subjects affected / exposed
|
14 / 1430 (0.98%) |
19 / 1427 (1.33%) |
occurrences causally related to treatment / all
|
9 / 14 |
19 / 19 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyelonephritis
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory tract infection
|
|
|
subjects affected / exposed
|
3 / 1430 (0.21%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
3 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sepsis
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
2 / 1427 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinusitis
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
2 / 1427 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin infection
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Soft tissue infection
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
2 / 1427 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subcutaneous abscess
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Superinfection
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tonsillitis
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tooth abscess
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
2 / 1427 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Upper respiratory tract infection
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urethritis
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary tract infection
|
|
|
subjects affected / exposed
|
3 / 1430 (0.21%) |
2 / 1427 (0.14%) |
occurrences causally related to treatment / all
|
3 / 3 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urogenital infection bacterial
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Viral upper respiratory tract infection
|
|
|
subjects affected / exposed
|
2 / 1430 (0.14%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vulval abscess
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound infection
|
|
|
subjects affected / exposed
|
3 / 1430 (0.21%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
3 / 3 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bowen's disease
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolism and nutrition disorders
|
|
|
Cachexia
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
0 / 1427 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dehydration
|
|
|
subjects affected / exposed
|
1 / 1430 (0.07%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypercalcaemia
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
1 / 1427 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperglycaemia
|
|
|
subjects affected / exposed
|
0 / 1430 (0.00%) |
2 / 1427 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |