Serious adverse events
|
EVR/TAC group |
TAC group |
Total subjects affected by serious adverse events
|
|
|
subjects affected / exposed
|
111 / 169 (65.68%) |
101 / 164 (61.59%) |
number of deaths (all causes)
|
3 |
4 |
number of deaths resulting from adverse events
|
1 |
2 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
ACUTE MYELOID LEUKAEMIA
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
CHRONIC MYELOID LEUKAEMIA
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HEPATOCELLULAR CARCINOMA
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
3 / 164 (1.83%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
LYMPHOMA
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
PROSTATE CANCER
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SQUAMOUS CELL CARCINOMA OF SKIN
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular disorders
|
|
|
ANGIODYSPLASIA
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ARTERY DISSECTION
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
DIABETIC VASCULAR DISORDER
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HAEMATOMA
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HYPERTENSIVE CRISIS
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
INFERIOR VENA CAVA STENOSIS
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
INTERNAL HAEMORRHAGE
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
LYMPHATIC FISTULA
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE
|
|
|
subjects affected / exposed
|
2 / 169 (1.18%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
POOR PERIPHERAL CIRCULATION
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
THROMBOSIS
|
|
|
subjects affected / exposed
|
2 / 169 (1.18%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
VENA CAVA THROMBOSIS
|
|
|
subjects affected / exposed
|
2 / 169 (1.18%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pregnancy, puerperium and perinatal conditions
|
|
|
ABORTION SPONTANEOUS
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
General disorders and administration site conditions
|
|
|
CHILLS
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
GENERAL PHYSICAL HEALTH DETERIORATION
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
IMPAIRED HEALING
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
3 / 164 (1.83%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
INCARCERATED HERNIA
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
MALAISE
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
MUCOSAL INFLAMMATION
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
MULTIPLE ORGAN DYSFUNCTION SYNDROME
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
NON-CARDIAC CHEST PAIN
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
OEDEMA PERIPHERAL
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
2 / 164 (1.22%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PYREXIA
|
|
|
subjects affected / exposed
|
4 / 169 (2.37%) |
2 / 164 (1.22%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SURGICAL FAILURE
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Immune system disorders
|
|
|
LIVER TRANSPLANT REJECTION
|
|
|
subjects affected / exposed
|
12 / 169 (7.10%) |
9 / 164 (5.49%) |
occurrences causally related to treatment / all
|
4 / 14 |
1 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
Respiratory, thoracic and mediastinal disorders
|
|
|
ACUTE RESPIRATORY DISTRESS SYNDROME
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ASTHMA
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
DYSPNOEA
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HAEMOPTYSIS
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
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
|
4 / 169 (2.37%) |
5 / 164 (3.05%) |
occurrences causally related to treatment / all
|
1 / 4 |
1 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
PLEURISY
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PNEUMONIA ASPIRATION
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PNEUMOTHORAX
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PULMONARY EMBOLISM
|
|
|
subjects affected / exposed
|
2 / 169 (1.18%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
RESPIRATORY FAILURE
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psychiatric disorders
|
|
|
DISORIENTATION
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Product issues
|
|
|
DEVICE OCCLUSION
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Investigations
|
|
|
ALANINE AMINOTRANSFERASE INCREASED
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
2 / 164 (1.22%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ASPARTATE AMINOTRANSFERASE INCREASED
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
2 / 164 (1.22%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
BLOOD ALKALINE PHOSPHATASE INCREASED
|
|
|
subjects affected / exposed
|
2 / 169 (1.18%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
BLOOD BILIRUBIN INCREASED
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
BLOOD CREATINE PHOSPHOKINASE INCREASED
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
BLOOD CREATININE INCREASED
|
|
|
subjects affected / exposed
|
3 / 169 (1.78%) |
3 / 164 (1.83%) |
occurrences causally related to treatment / all
|
2 / 4 |
3 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
BLOOD POTASSIUM INCREASED
|
|
|
subjects affected / exposed
|
2 / 169 (1.18%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
C-REACTIVE PROTEIN INCREASED
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
5 / 164 (3.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CHEST X-RAY ABNORMAL
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
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
|
3 / 169 (1.78%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
GLUTAMATE DEHYDROGENASE INCREASED
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HAEMOGLOBIN DECREASED
|
|
|
subjects affected / exposed
|
2 / 169 (1.18%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HEPATIC ARTERY FLOW DECREASED
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HEPATIC ENZYME INCREASED
|
|
|
subjects affected / exposed
|
6 / 169 (3.55%) |
7 / 164 (4.27%) |
occurrences causally related to treatment / all
|
1 / 6 |
2 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
LIVER FUNCTION TEST INCREASED
|
|
|
subjects affected / exposed
|
3 / 169 (1.78%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
TRANSAMINASES INCREASED
|
|
|
subjects affected / exposed
|
2 / 169 (1.18%) |
6 / 164 (3.66%) |
occurrences causally related to treatment / all
|
0 / 3 |
2 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
TROPONIN INCREASED
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
WHITE BLOOD CELL COUNT INCREASED
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Injury, poisoning and procedural complications
|
|
|
ABDOMINAL WOUND DEHISCENCE
|
|
|
subjects affected / exposed
|
3 / 169 (1.78%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ACCIDENTAL OVERDOSE
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ANASTOMOTIC STENOSIS
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
BILIARY ANASTOMOSIS COMPLICATION
|
|
|
subjects affected / exposed
|
8 / 169 (4.73%) |
13 / 164 (7.93%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
BRAIN CONTUSION
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
COMPLICATIONS OF TRANSPLANTED LIVER
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CONCUSSION
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
FALL
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
FEMUR FRACTURE
|
|
|
subjects affected / exposed
|
2 / 169 (1.18%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
GRAFT LOSS
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
INCARCERATED INCISIONAL HERNIA
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
INCISIONAL HERNIA
|
|
|
subjects affected / exposed
|
11 / 169 (6.51%) |
4 / 164 (2.44%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
LUMBAR VERTEBRAL FRACTURE
|
|
|
subjects affected / exposed
|
2 / 169 (1.18%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
OVERDOSE
|
|
|
subjects affected / exposed
|
2 / 169 (1.18%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
PELVIC FRACTURE
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
POST PROCEDURAL BILE LEAK
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
3 / 164 (1.83%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SPINAL COMPRESSION FRACTURE
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SPINAL FRACTURE
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SUBARACHNOID HAEMORRHAGE
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
THORACIC VERTEBRAL FRACTURE
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
TRANSPLANT FAILURE
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
ULNA FRACTURE
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
VASCULAR PSEUDOANEURYSM
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
WEANING FAILURE
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
WOUND DEHISCENCE
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac disorders
|
|
|
ACUTE MYOCARDIAL INFARCTION
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ATRIAL FIBRILLATION
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CARDIOGENIC SHOCK
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
CORONARY ARTERY DISEASE
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
MITRAL VALVE INCOMPETENCE
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
PERICARDIAL EFFUSION
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SUPRAVENTRICULAR TACHYCARDIA
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
3 / 164 (1.83%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
TACHYCARDIA
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
VENTRICULAR EXTRASYSTOLES
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
VENTRICULAR TACHYCARDIA
|
|
|
subjects affected / exposed
|
2 / 169 (1.18%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nervous system disorders
|
|
|
CEREBROVASCULAR ACCIDENT
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
EPILEPSY
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HEMIPARESIS
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
LACUNAR STROKE
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
NERVOUS SYSTEM DISORDER
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PARAPARESIS
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
POLYNEUROPATHY
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PRESYNCOPE
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (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 / 169 (1.18%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SYNCOPE
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
TRANSIENT ISCHAEMIC ATTACK
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
TREMOR
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
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
|
|
|
ANAEMIA
|
|
|
subjects affected / exposed
|
4 / 169 (2.37%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
BONE MARROW TOXICITY
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
EVANS SYNDROME
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HYPOCHROMIC ANAEMIA
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
IRON DEFICIENCY ANAEMIA
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
LYMPHOCYTOSIS
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PANCYTOPENIA
|
|
|
subjects affected / exposed
|
3 / 169 (1.78%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
2 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
THROMBOCYTOPENIA
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ear and labyrinth disorders
|
|
|
VERTIGO
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eye disorders
|
|
|
MYDRIASIS
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal disorders
|
|
|
ABDOMINAL HERNIA
|
|
|
subjects affected / exposed
|
3 / 169 (1.78%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ABDOMINAL PAIN
|
|
|
subjects affected / exposed
|
2 / 169 (1.18%) |
2 / 164 (1.22%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ABDOMINAL PAIN UPPER
|
|
|
subjects affected / exposed
|
2 / 169 (1.18%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
APHTHOUS ULCER
|
|
|
subjects affected / exposed
|
2 / 169 (1.18%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ASCITES
|
|
|
subjects affected / exposed
|
5 / 169 (2.96%) |
5 / 164 (3.05%) |
occurrences causally related to treatment / all
|
1 / 6 |
1 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
COLITIS
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
DENTAL CARIES
|
|
|
subjects affected / exposed
|
2 / 169 (1.18%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
DIARRHOEA
|
|
|
subjects affected / exposed
|
5 / 169 (2.96%) |
4 / 164 (2.44%) |
occurrences causally related to treatment / all
|
1 / 8 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
DUODENAL ULCER
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (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
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
FAECES DISCOLOURED
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
GASTRIC ULCER HAEMORRHAGE
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
GASTRITIS
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
GASTROINTESTINAL ANGIODYSPLASIA HAEMORRHAGIC
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
GASTROINTESTINAL HAEMORRHAGE
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
GASTROINTESTINAL INFLAMMATION
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
GASTROINTESTINAL NECROSIS
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
IMPAIRED GASTRIC EMPTYING
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
INCARCERATED INGUINAL HERNIA
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
INCARCERATED UMBILICAL HERNIA
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
INGUINAL HERNIA
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
INTESTINAL INFARCTION
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
INTESTINAL ISCHAEMIA
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
INTESTINAL PERFORATION
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
INTRA-ABDOMINAL FLUID COLLECTION
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
MESENTERIC VEIN THROMBOSIS
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
MESENTERIC VENOUS OCCLUSION
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
NAUSEA
|
|
|
subjects affected / exposed
|
3 / 169 (1.78%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
2 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PANCREATITIS
|
|
|
subjects affected / exposed
|
2 / 169 (1.18%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PANCREATITIS ACUTE
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SUBILEUS
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SWOLLEN TONGUE
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
UMBILICAL HERNIA
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
VOMITING
|
|
|
subjects affected / exposed
|
4 / 169 (2.37%) |
2 / 164 (1.22%) |
occurrences causally related to treatment / all
|
2 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatobiliary disorders
|
|
|
ACUTE HEPATIC FAILURE
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
BILE DUCT STENOSIS
|
|
|
subjects affected / exposed
|
5 / 169 (2.96%) |
6 / 164 (3.66%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
BILE DUCT STONE
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
BILIARY ISCHAEMIA
|
|
|
subjects affected / exposed
|
5 / 169 (2.96%) |
4 / 164 (2.44%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
BILIARY TRACT DISORDER
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
BILOMA
|
|
|
subjects affected / exposed
|
2 / 169 (1.18%) |
2 / 164 (1.22%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CHOLANGITIS
|
|
|
subjects affected / exposed
|
13 / 169 (7.69%) |
7 / 164 (4.27%) |
occurrences causally related to treatment / all
|
1 / 22 |
2 / 9 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
CHOLANGITIS ACUTE
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CHOLELITHIASIS
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CHOLESTASIS
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
4 / 164 (2.44%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
DRUG-INDUCED LIVER INJURY
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HEPATIC ARTERY ANEURYSM
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
HEPATIC ARTERY STENOSIS
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HEPATIC ARTERY THROMBOSIS
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
HEPATIC FAILURE
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HEPATIC FUNCTION ABNORMAL
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HEPATIC HAEMATOMA
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HEPATIC HAEMORRHAGE
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HEPATIC INFARCTION
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HEPATIC ISCHAEMIA
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
HEPATIC LESION
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HEPATIC NECROSIS
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HEPATIC STEATOSIS
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HEPATITIS TOXIC
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HEPATOTOXICITY
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
LIVER DISORDER
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
NON-ALCOHOLIC STEATOHEPATITIS
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PORTAL VEIN THROMBOSIS
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
2 / 164 (1.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
VANISHING BILE DUCT SYNDROME
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin and subcutaneous tissue disorders
|
|
|
ANGIOEDEMA
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
DIABETIC FOOT
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PRURITUS
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (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
|
10 / 169 (5.92%) |
8 / 164 (4.88%) |
occurrences causally related to treatment / all
|
5 / 12 |
3 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ALBUMINURIA
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CYSTITIS HAEMORRHAGIC
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
IGA NEPHROPATHY
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
OLIGURIA
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PRERENAL FAILURE
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PROTEINURIA
|
|
|
subjects affected / exposed
|
2 / 169 (1.18%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
RENAL FAILURE
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
2 / 164 (1.22%) |
occurrences causally related to treatment / all
|
1 / 1 |
2 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
RENAL IMPAIRMENT
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
2 / 164 (1.22%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endocrine disorders
|
|
|
GOITRE
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
TOXIC NODULAR GOITRE
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (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
|
|
|
BACK PAIN
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
MUSCULOSKELETAL DISORDER
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
MYOPATHY
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
OSTEOCHONDROSIS
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infections and infestations
|
|
|
ABDOMINAL ABSCESS
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ABDOMINAL WALL ABSCESS
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ABSCESS JAW
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ANAL ABSCESS
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
APPENDICITIS
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ATYPICAL PNEUMONIA
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
2 / 164 (1.22%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
BACTERAEMIA
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
BACTERIAL INFECTION
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
BILIARY ABSCESS
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
BILIARY TRACT INFECTION
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
BRONCHOPULMONARY ASPERGILLOSIS
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CELLULITIS
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CHOLANGITIS INFECTIVE
|
|
|
subjects affected / exposed
|
6 / 169 (3.55%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
1 / 23 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CLOSTRIDIUM DIFFICILE INFECTION
|
|
|
subjects affected / exposed
|
2 / 169 (1.18%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CYTOMEGALOVIRUS COLITIS
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
2 / 164 (1.22%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CYTOMEGALOVIRUS HEPATITIS
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CYTOMEGALOVIRUS INFECTION
|
|
|
subjects affected / exposed
|
6 / 169 (3.55%) |
3 / 164 (1.83%) |
occurrences causally related to treatment / all
|
3 / 6 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CYTOMEGALOVIRUS SYNDROME
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CYTOMEGALOVIRUS VIRAEMIA
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (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
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
EMPYEMA
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ENTERITIS INFECTIOUS
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ENTEROCOCCAL INFECTION
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
EPIDIDYMITIS
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
EPSTEIN-BARR VIRUS INFECTION
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ESCHERICHIA INFECTION
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
FEBRILE INFECTION
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
FOLLICULITIS
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
FUNGAL INFECTION
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
GASTROENTERITIS
|
|
|
subjects affected / exposed
|
3 / 169 (1.78%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
GASTROENTERITIS CLOSTRIDIAL
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
GASTROENTERITIS CRYPTOSPORIDIAL
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
GASTROENTERITIS ROTAVIRUS
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
GASTROINTESTINAL INFECTION
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
GASTROINTESTINAL VIRAL INFECTION
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HAEMATOMA INFECTION
|
|
|
subjects affected / exposed
|
2 / 169 (1.18%) |
3 / 164 (1.83%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HEPATITIS C
|
|
|
subjects affected / exposed
|
2 / 169 (1.18%) |
5 / 164 (3.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HERPES ZOSTER
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
2 / 164 (1.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HUMAN HERPESVIRUS 6 INFECTION
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
INFECTED SEROMA
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
INFECTION
|
|
|
subjects affected / exposed
|
4 / 169 (2.37%) |
3 / 164 (1.83%) |
occurrences causally related to treatment / all
|
2 / 4 |
2 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
LIVER ABSCESS
|
|
|
subjects affected / exposed
|
5 / 169 (2.96%) |
4 / 164 (2.44%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
LOCALISED INFECTION
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
LUNG INFECTION
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PARONYCHIA
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
PERITONITIS
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PERITONITIS BACTERIAL
|
|
|
subjects affected / exposed
|
2 / 169 (1.18%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PHARYNGEAL ABSCESS
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PILONIDAL CYST
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PNEUMONIA
|
|
|
subjects affected / exposed
|
10 / 169 (5.92%) |
7 / 164 (4.27%) |
occurrences causally related to treatment / all
|
5 / 15 |
2 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
PSEUDOMONAS INFECTION
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
RESPIRATORY TRACT INFECTION
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SCARLET FEVER
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SEPSIS
|
|
|
subjects affected / exposed
|
2 / 169 (1.18%) |
4 / 164 (2.44%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
SEPTIC SHOCK
|
|
|
subjects affected / exposed
|
2 / 169 (1.18%) |
3 / 164 (1.83%) |
occurrences causally related to treatment / all
|
1 / 2 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 3 |
STAPHYLOCOCCAL INFECTION
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
TRANSPLANT ABSCESS
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
3 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
URINARY TRACT INFECTION
|
|
|
subjects affected / exposed
|
2 / 169 (1.18%) |
5 / 164 (3.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
VARICELLA
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
VIRAL INFECTION
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
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 / 169 (1.18%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
WOUND INFECTION
|
|
|
subjects affected / exposed
|
3 / 169 (1.78%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
WOUND INFECTION STAPHYLOCOCCAL
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolism and nutrition disorders
|
|
|
ACIDOSIS HYPERCHLORAEMIC
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
DEHYDRATION
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
DIABETIC COMPLICATION
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
FLUID RETENTION
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
GOUT
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HYPERGLYCAEMIA
|
|
|
subjects affected / exposed
|
3 / 169 (1.78%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
1 / 4 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HYPERINSULINAEMIC HYPOGLYCAEMIA
|
|
|
subjects affected / exposed
|
0 / 169 (0.00%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HYPERKALAEMIA
|
|
|
subjects affected / exposed
|
3 / 169 (1.78%) |
1 / 164 (0.61%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HYPONATRAEMIA
|
|
|
subjects affected / exposed
|
1 / 169 (0.59%) |
0 / 164 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |