Serious adverse events
|
Control group |
Experimental clofarabine |
Total subjects affected by serious adverse events
|
|
|
subjects affected / exposed
|
112 / 186 (60.22%) |
142 / 188 (75.53%) |
number of deaths (all causes)
|
78 |
72 |
number of deaths resulting from adverse events
|
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
Admission based on ebv lymfoproliferative disorder
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
Neoplasm malignant
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
EBV + lymphomatoid granulomatosis
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular disorders
|
|
|
Thromboembolic event, pulmonary embolism
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bleeding
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Collaps
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Deep vein thrombosis
|
|
|
subjects affected / exposed
|
2 / 186 (1.08%) |
2 / 188 (1.06%) |
occurrences causally related to treatment / all
|
2 / 2 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prolonged clotting times (PT/aPTT)
|
|
|
alternative dictionary used: MedDRA
3
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thromboembolic event
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombosis
|
|
|
subjects affected / exposed
|
2 / 186 (1.08%) |
4 / 188 (2.13%) |
occurrences causally related to treatment / all
|
2 / 2 |
3 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombus mass in the right jugular vein &inf vena subclavion
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Surgical and medical procedures
|
|
|
Cholecystectomy
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nefrectomy left
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
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
|
|
|
Death
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Death nos
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
Extravasation
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fever
|
|
|
subjects affected / exposed
|
9 / 186 (4.84%) |
2 / 188 (1.06%) |
occurrences causally related to treatment / all
|
3 / 10 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fever (not neutropenic)
|
|
|
subjects affected / exposed
|
2 / 186 (1.08%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fever e.c.i
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Loss of strength in both legs
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung infection
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
2 / 188 (1.06%) |
occurrences causally related to treatment / all
|
1 / 1 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malaise
|
|
|
subjects affected / exposed
|
3 / 186 (1.61%) |
2 / 188 (1.06%) |
occurrences causally related to treatment / all
|
3 / 3 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mucositis
|
|
|
subjects affected / exposed
|
5 / 186 (2.69%) |
5 / 188 (2.66%) |
occurrences causally related to treatment / all
|
5 / 6 |
7 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atypical pain thorax
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Edema
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Immune system disorders
|
|
|
AGvHD
|
|
|
subjects affected / exposed
|
2 / 186 (1.08%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
GHVD
|
|
|
subjects affected / exposed
|
5 / 186 (2.69%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
3 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Allergic reaction
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
2 / 188 (1.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
GvHD skin
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
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
|
|
|
Peri-engraftment respiratory distress syndrome
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonthorax
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary embolism
|
|
|
subjects affected / exposed
|
3 / 186 (1.61%) |
3 / 188 (1.60%) |
occurrences causally related to treatment / all
|
1 / 3 |
2 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory insufficiency
|
|
|
subjects affected / exposed
|
3 / 186 (1.61%) |
5 / 188 (2.66%) |
occurrences causally related to treatment / all
|
2 / 3 |
3 / 5 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
Lung embolism
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
2 / 188 (1.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleural effusion
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchopulmonary hemorrage
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
2 / 188 (1.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dyspnea
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoxemia
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psychiatric disorders
|
|
|
Confusion
|
|
|
subjects affected / exposed
|
2 / 186 (1.08%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
1 / 2 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Delirium
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mood alteration: depression
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psychosis
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Suicide
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mania
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Investigations
|
|
|
ASAT/ALAT elevation
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
3 / 188 (1.60%) |
occurrences causally related to treatment / all
|
1 / 1 |
3 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood/billirubin increased
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
GGT increased
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Increased liver enzymes
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
3 / 188 (1.60%) |
occurrences causally related to treatment / all
|
1 / 1 |
3 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic enzyme disorder
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transaminases elevated
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Injury, poisoning and procedural complications
|
|
|
Allergic reaction on trombocyte transfusion
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Morfine-intoxication
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteoporotic vertebral collapse
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Second osteoporotic fracture
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subdural hematoma bilateral
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CNS hemorrhage
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Femur fracture
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radiation pneumonitis
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spontaneous rupture of the spleen
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subcapital fracture left hip
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular access complication
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac disorders
|
|
|
Myocard infarction
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pericarditis
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tachycardia
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute coronary syndrome
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrial flutter
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac arrest
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac arrest seizure
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nervous system disorders
|
|
|
CVA
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral thrombosis
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Consvulsive syncope
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Critical illness neuropathy (motor-neuropathy)
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Drug toxicity
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (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
|
1 / 186 (0.54%) |
7 / 188 (3.72%) |
occurrences causally related to treatment / all
|
0 / 1 |
2 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischemia cerebrovascular
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nervous system disorder transient cerebral dysfunction
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neurological symptoms
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuropathy
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Seizure
|
|
|
subjects affected / exposed
|
2 / 186 (1.08%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinus thrombosis
|
|
|
subjects affected / exposed
|
2 / 186 (1.08%) |
2 / 188 (1.06%) |
occurrences causally related to treatment / all
|
2 / 2 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vasovagal episode
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute serotenergic syndrome
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Insult
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Admission for dizziness
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CSF leak
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral encephalopathy
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cortical vein thrombosis (left)
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Encephalopathy
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Idiopathic cranial hypertension
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Periferal motor tremor neuropathy (PNP)
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
2 / 188 (1.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Posterior reversible encephalopathy syndrome
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
2 / 188 (1.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radicular syndrome
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stroke (heamorrhagic)
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood and lymphatic system disorders
|
|
|
Coagulopathy
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (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
|
11 / 186 (5.91%) |
14 / 188 (7.45%) |
occurrences causally related to treatment / all
|
11 / 11 |
14 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hemolytic anemia
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Leukopenia
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neutropenic fever
|
|
|
subjects affected / exposed
|
7 / 186 (3.76%) |
10 / 188 (5.32%) |
occurrences causally related to treatment / all
|
6 / 7 |
10 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subfebrile neutropenia
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anemia
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Febrile non-neutropenia
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancytopenia
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
2 / 188 (1.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal disorders
|
|
|
Abdominal perforation
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute pancreatitis
|
|
|
subjects affected / exposed
|
2 / 186 (1.08%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
2 / 2 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colitis
|
|
|
subjects affected / exposed
|
2 / 186 (1.08%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colitis, infectious
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Constipation
|
|
|
subjects affected / exposed
|
3 / 186 (1.61%) |
2 / 188 (1.06%) |
occurrences causally related to treatment / all
|
1 / 3 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diarrhea
|
|
|
subjects affected / exposed
|
4 / 186 (2.15%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Distal ileitis
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterocolitis
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hematemesis
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hemorrhagic gastritis
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nausea vomiting
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nausea, throw up
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Obstruction colon
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oral mucositis
|
|
|
subjects affected / exposed
|
2 / 186 (1.08%) |
2 / 188 (1.06%) |
occurrences causally related to treatment / all
|
1 / 2 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oral mucositis grade 3
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (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
|
1 / 186 (0.54%) |
3 / 188 (1.60%) |
occurrences causally related to treatment / all
|
1 / 1 |
3 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vomiting
|
|
|
subjects affected / exposed
|
3 / 186 (1.61%) |
4 / 188 (2.13%) |
occurrences causally related to treatment / all
|
3 / 3 |
3 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gingivostomatitis
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ileus/ileum
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stomach antral vascular ectasia
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Drug induced stomatitis
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastro intestinal bleeding
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
High esophageal ulceration
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal mucositis
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischemic colitis
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Left sacro ileitis
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mucocutaneous ulcer small intestine
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nausea
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal reflux
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Paralytic ileus
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post punctional pain
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stomatitis and ulcerative oesophagitis with herpes infection
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatobiliary disorders
|
|
|
Cholecycstitis (acalculeuze)
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic failure
|
|
|
subjects affected / exposed
|
2 / 186 (1.08%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
Hepatic impairment
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic veno-occlusive disease
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Liver function disorder
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
7 / 188 (3.72%) |
occurrences causally related to treatment / all
|
1 / 1 |
6 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Drug induced hepatitis
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatoxicity
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
2 / 188 (1.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Liver failure
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
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
|
|
|
Rash/desquamation
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Decubitus
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal and urinary disorders
|
|
|
Acute renal insufficiency
|
|
|
subjects affected / exposed
|
3 / 186 (1.61%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 3 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal failure
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary retention
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute renal toxicity
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Kidney failure
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Kidney stone
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Obstruction ureter urolithiase
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endocrine disorders
|
|
|
Adrenal insufficiency
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal and connective tissue disorders
|
|
|
Muscle pain
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Backpain
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bone pain
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
2 / 188 (1.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pain hip
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pain right flank
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infections and infestations
|
|
|
Abdominal infection
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Airway infection
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacteremia (Enterobacter cloacae)
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CVL infection (Hickman)
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Catheter related infection
|
|
|
subjects affected / exposed
|
2 / 186 (1.08%) |
2 / 188 (1.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Catheter sepsis
|
|
|
subjects affected / exposed
|
2 / 186 (1.08%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cellulitis orbita sinistra
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dental infection
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device related infection
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
E. Coli sepsis
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fungal infection
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastro enteritis
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HHV6 pneumonia
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
Infection
|
|
|
subjects affected / exposed
|
2 / 186 (1.08%) |
2 / 188 (1.06%) |
occurrences causally related to treatment / all
|
2 / 2 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infection (CVC with normal ANC)
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infection candida
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
2 / 188 (1.06%) |
occurrences causally related to treatment / all
|
1 / 1 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infection catheter related
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infection - wound (retrosternal)
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infection wound (retrosternal)
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infection catheter related (CVC)
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infection e.c.i.
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infection gastrointestinal (norovirus)
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infection grade 4 ANC
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infection normal ANC
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infection skin: erysipelas
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infection with normal ANC general: blood and pleural
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infection urinary tract
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neutropenic sepsis
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Opportunistic infection (oesophagus)
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PJP infection
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia
|
|
|
subjects affected / exposed
|
4 / 186 (2.15%) |
11 / 188 (5.85%) |
occurrences causally related to treatment / all
|
4 / 5 |
11 / 13 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
Pulmonal aspergillus infection
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
2 / 188 (1.06%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
Respiratory infection
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rota virus infection
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sepsis with pseudomonas aeruginosa
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Septic shock
|
|
|
subjects affected / exposed
|
3 / 186 (1.61%) |
5 / 188 (2.66%) |
occurrences causally related to treatment / all
|
2 / 3 |
3 / 6 |
deaths causally related to treatment / all
|
1 / 2 |
0 / 0 |
Sinusitis
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
1 / 1 |
3 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spondylodiscitis
|
|
|
subjects affected / exposed
|
2 / 186 (1.08%) |
2 / 188 (1.06%) |
occurrences causally related to treatment / all
|
1 / 2 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tonsillitis
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Upper respiratory infection
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (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
|
2 / 186 (1.08%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urosepsis
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infection with grade 4 neutrophils
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Perianal abscess
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
2 / 188 (1.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Viral infection
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Appendicular abcess
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CMV reactivation
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
2 / 188 (1.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CNS bacteriamia
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
3 / 188 (1.60%) |
occurrences causally related to treatment / all
|
0 / 0 |
3 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clostridium difficile colitis
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
E coli urinary tract infection and e faecalis
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
E.coli bacterimia
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Escherichia coli sepsis
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sepsis
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
4 / 188 (2.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
Herpes simplex infection
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infection candidaemia
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infection central venous catheter
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infection lung pneumocystis jirovecii
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mucormycosis (zymycosis) of sinus
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pansinusitis
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pharyngitis
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumococcus pneumonia
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory syncytical virus infection
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
S.aureus bacteremia
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Septic arthritis at right sacroiliac joint
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Staphylococcus epidermidis septicemia
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Varicella zoster virus infection
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Viral pulmonary infection
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolism and nutrition disorders
|
|
|
Dehydration
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Glucose intolerance
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertriglyceridaemia
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
2 / 188 (1.06%) |
occurrences causally related to treatment / all
|
1 / 1 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoalbuminaemia
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
0 / 188 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyponatremia
|
|
|
subjects affected / exposed
|
1 / 186 (0.54%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anorexia
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetes
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypesthesia lower body
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypokalemia
|
|
|
subjects affected / exposed
|
0 / 186 (0.00%) |
1 / 188 (0.53%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |