Serious adverse events
|
Volulyte |
Ionolyte |
Total subjects affected by serious adverse events
|
|
|
subjects affected / exposed
|
296 / 977 (30.30%) |
291 / 981 (29.66%) |
number of deaths (all causes)
|
32 |
31 |
number of deaths resulting from adverse events
|
0 |
1 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
Colon neoplasm
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases to peritoneum
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
2 / 977 (0.20%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Neoplasm progression
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Ovarian neoplasm
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder cancer
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholangiocarcinoma
|
|
|
Additional description: Cholangiocarcinoma
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Malignant neoplasm progression
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
3 / 981 (0.31%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Oesophageal carcinoma
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Ureteral neoplasm
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular disorders
|
|
|
Arterial haemorrhage
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (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
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
2 / 981 (0.20%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematoma
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemodynamic instability
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
2 / 981 (0.20%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhage
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
4 / 977 (0.41%) |
2 / 981 (0.20%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Hypotension
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypovolaemic shock
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
2 / 977 (0.20%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Lymphocele
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
7 / 977 (0.72%) |
9 / 981 (0.92%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphorrhoea
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral ischaemia
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
2 / 977 (0.20%) |
2 / 981 (0.20%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Shock haemorrhagic
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
9 / 977 (0.92%) |
5 / 981 (0.51%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
Peripheral arterial occlusive disease
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery occlusion
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Venous thrombosis limb
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Surgical and medical procedures
|
|
|
Therapy cessation
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Thyroid operation
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
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
|
|
|
Chest pain
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Death
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
General physical health deterioration
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
2 / 981 (0.20%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Multiple organ dysfunction syndrome
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
2 / 977 (0.20%) |
5 / 981 (0.51%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 5 |
deaths causally related to treatment / all
|
0 / 2 |
1 / 5 |
Pyrexia
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
4 / 977 (0.41%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Systemic inflammatory response syndrome
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Impaired healing
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
3 / 981 (0.31%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inflammation
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Localised oedema
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pain
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
2 / 981 (0.20%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sudden death
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Immune system disorders
|
|
|
Contrast media allergy
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Reproductive system and breast disorders
|
|
|
Vaginal fistula
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pelvic haematoma
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Respiratory, thoracic and mediastinal disorders
|
|
|
Acute pulmonary oedema
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute respiratory distress syndrome
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
6 / 977 (0.61%) |
3 / 981 (0.31%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Acute respiratory failure
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
2 / 977 (0.20%) |
2 / 981 (0.20%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Chronic obstructive pulmonary disease
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
2 / 977 (0.20%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chylothorax
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemothorax
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoxia
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung disorder
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleural effusion
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
8 / 977 (0.82%) |
9 / 981 (0.92%) |
occurrences causally related to treatment / all
|
1 / 9 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumothorax
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
2 / 977 (0.20%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary embolism
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
9 / 977 (0.92%) |
7 / 981 (0.71%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Pulmonary oedema
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory failure
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
7 / 977 (0.72%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atelectasis
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleurisy
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
2 / 981 (0.20%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psychiatric disorders
|
|
|
Delirium
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Product issues
|
|
|
Device dislocation
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device occlusion
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Investigations
|
|
|
Blood creatine increased
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
International normalised ratio increased
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oxygen saturation decreased
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SARS-CoV-2 test positive
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
3 / 977 (0.31%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 0 |
Transaminases increased
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
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
|
|
|
Anastomotic fistula
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
2 / 977 (0.20%) |
2 / 981 (0.20%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anastomotic haemorrhage
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anastomotic leak
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
26 / 977 (2.66%) |
15 / 981 (1.53%) |
occurrences causally related to treatment / all
|
1 / 26 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Femoral nerve injury
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Flap necrosis
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
2 / 977 (0.20%) |
3 / 981 (0.31%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal anastomotic complication
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal anastomotic leak
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
7 / 977 (0.72%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal stoma complication
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
2 / 977 (0.20%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incisional hernia
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal anastomosis complication
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatic leak
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
4 / 977 (0.41%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripancreatic fluid collection
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural bile leak
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
4 / 981 (0.41%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural complication
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural fever
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
2 / 977 (0.20%) |
3 / 981 (0.31%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural haemorrhage
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
9 / 977 (0.92%) |
8 / 981 (0.82%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural pulmonary embolism
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural urine leak
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
2 / 977 (0.20%) |
2 / 981 (0.20%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural haemorrhage
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
4 / 977 (0.41%) |
3 / 981 (0.31%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural intestinal perforation
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural pain
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural shock
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stoma complication
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Suture related complication
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ureteric injury
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vaginal cuff dehiscence
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound dehiscence
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound evisceration
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
2 / 977 (0.20%) |
3 / 981 (0.31%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound haematoma
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal wound dehiscence
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
2 / 981 (0.20%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Craniocerebral injury
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Drain site complication
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural fistula
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural stroke
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative ileus
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative renal failure
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
2 / 981 (0.20%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative respiratory failure
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural pneumothorax
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Seroma
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
2 / 981 (0.20%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Suture rupture
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
2 / 981 (0.20%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Toxicity to various agents
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vena cava injury
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound necrosis
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
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
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
2 / 981 (0.20%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Arrhythmia
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrial fibrillation
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
7 / 977 (0.72%) |
3 / 981 (0.31%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrial flutter
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
3 / 977 (0.31%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Bradyarrhythmia
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cardiac arrest
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
2 / 977 (0.20%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cardio-respiratory arrest
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
4 / 977 (0.41%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 0 |
Cardiovascular disorder
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pericardial effusion
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Supraventricular tachycardia
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Torsade de pointes
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
Cardiac failure
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cardiac failure congestive
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
2 / 981 (0.20%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myocardial infarction
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myocardial ischaemia
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
2 / 981 (0.20%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulseless electrical activity
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nervous system disorders
|
|
|
Cerebral infarction
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Embolic stroke
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Hemiparesis
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hemiplegia
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic encephalopathy
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Syncope
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
2 / 981 (0.20%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain stem syndrome
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epilepsy
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
2 / 981 (0.20%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood and lymphatic system disorders
|
|
|
Anaemia
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
2 / 977 (0.20%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neutropenia
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Splenic haemorrhage
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal disorders
|
|
|
Abdominal hernia
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal pain
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
2 / 981 (0.20%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal pain upper
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal haemorrhage
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ascites
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
2 / 977 (0.20%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colitis
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diarrhoea
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
2 / 977 (0.20%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterocutaneous fistula
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterovesical fistula
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Functional gastrointestinal disorder
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric perforation
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
2 / 977 (0.20%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Gastric ulcer
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal haemorrhage
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
6 / 977 (0.61%) |
2 / 981 (0.20%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Haemoperitoneum
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
2 / 981 (0.20%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ileus
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ileus paralytic
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
20 / 977 (2.05%) |
21 / 981 (2.14%) |
occurrences causally related to treatment / all
|
0 / 21 |
0 / 21 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Impaired gastric emptying
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
6 / 977 (0.61%) |
5 / 981 (0.51%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal haemorrhage
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal ischaemia
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
2 / 977 (0.20%) |
5 / 981 (0.51%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
Intestinal obstruction
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
9 / 977 (0.92%) |
3 / 981 (0.31%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal perforation
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intra-abdominal fluid collection
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
14 / 977 (1.43%) |
15 / 981 (1.53%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intra-abdominal haemorrhage
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
3 / 977 (0.31%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Jejunal perforation
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestine perforation
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
3 / 977 (0.31%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mechanical ileus
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
3 / 977 (0.31%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Melaena
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
3 / 977 (0.31%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mesenteric haemorrhage
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophagopleural fistula
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatic fistula
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
4 / 977 (0.41%) |
5 / 981 (0.51%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatic pseudocyst
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatitis acute
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peptic ulcer haemorrhage
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal wall haematoma
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diaphragmatic hernia
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenal obstruction
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenal perforation
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dysphagia
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastritis
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroduodenal haemorrhage
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal necrosis
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
2 / 981 (0.20%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrooesophageal reflux disease
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematemesis
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inguinal hernia
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal fistula
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
2 / 981 (0.20%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intra-abdominal haematoma
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatic failure
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatitis
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
2 / 981 (0.20%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatitis necrotising
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumatosis intestinalis
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tooth disorder
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vomiting
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retroperitoneal haematoma
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatobiliary disorders
|
|
|
Acute hepatic failure
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
2 / 981 (0.20%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Cholangitis
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
2 / 977 (0.20%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholestasis
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic artery aneurysm
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (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
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic vascular thrombosis
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Hepatorenal failure
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Ischaemic hepatitis
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (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
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
2 / 977 (0.20%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholelithiasis
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemobilia
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Hepatic artery occlusion
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic haemorrhage
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Renal and urinary disorders
|
|
|
Acute kidney injury
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
21 / 977 (2.15%) |
38 / 981 (3.87%) |
occurrences causally related to treatment / all
|
1 / 21 |
1 / 42 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder tamponade
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
2 / 981 (0.20%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic kidney disease
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematuria
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
3 / 977 (0.31%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephrolithiasis
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephropathy toxic
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postrenal failure
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prerenal failure
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal impairment
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ureteric perforation
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary retention
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
3 / 981 (0.31%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary tract obstruction
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
2 / 977 (0.20%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinoma
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder perforation
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydronephrosis
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
2 / 981 (0.20%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal failure
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urogenital fistula
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endocrine disorders
|
|
|
Hyperthyroidism
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (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
|
|
|
Compartment syndrome
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Back pain
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infections and infestations
|
|
|
Abdominal abscess
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
5 / 977 (0.51%) |
6 / 981 (0.61%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal infection
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
4 / 977 (0.41%) |
2 / 981 (0.20%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Abdominal sepsis
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
3 / 977 (0.31%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal wall abscess
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacteraemia
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacterial sepsis
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Biliary sepsis
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
COVID-19
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
2 / 977 (0.20%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Catheter site infection
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholangitis infective
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clostridium difficile colitis
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cystitis
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device related infection
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
3 / 977 (0.31%) |
2 / 981 (0.20%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device related sepsis
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
2 / 977 (0.20%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incision site abscess
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infection
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
6 / 977 (0.61%) |
4 / 981 (0.41%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral discitis
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Liver abscess
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
2 / 977 (0.20%) |
2 / 981 (0.20%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower respiratory tract infection
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nosocomial infection
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
2 / 977 (0.20%) |
2 / 981 (0.20%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteomyelitis
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Paraspinal abscess
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pelvic abscess
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
4 / 977 (0.41%) |
4 / 981 (0.41%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pelvic infection
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Perihepatic abscess
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Perineal abscess
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Perinephric abscess
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peritonitis
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
7 / 977 (0.72%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
8 / 977 (0.82%) |
9 / 981 (0.92%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pneumonia aspiration
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
2 / 981 (0.20%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Post procedural infection
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative abscess
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperativ wound infection
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
17 / 977 (1.74%) |
19 / 981 (1.94%) |
occurrences causally related to treatment / all
|
0 / 17 |
0 / 19 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
Pyelonephritis
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
4 / 977 (0.41%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyelonephritis acute
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
2 / 977 (0.20%) |
2 / 981 (0.20%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sepsis
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
8 / 977 (0.82%) |
6 / 981 (0.61%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Septic shock
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
2 / 977 (0.20%) |
7 / 981 (0.71%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Skin infection
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subdiaphragmatic abscess
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Systemic candida
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary tract infection
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
14 / 977 (1.43%) |
11 / 981 (1.12%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urosepsis
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
2 / 977 (0.20%) |
3 / 981 (0.31%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal abscess
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
COVID-19 pneumonia
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Empyema
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epididymitis
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gallbladder abscess
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestine infection
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatic abscess
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
2 / 981 (0.20%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Perirectal abscess
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia pseudomonal
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural sepsis
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Staphylococcal bacteraemia
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound infection
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolism and nutrition disorders
|
|
|
Hypokalaemia
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
2 / 977 (0.20%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypovolaemia
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
1 / 977 (0.10%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lactic acidosis
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
2 / 977 (0.20%) |
0 / 981 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Dehydration
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fluid retention
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyponatraemia
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malnutrition
|
|
|
Additional description: Treatment-emergent
|
|
|
subjects affected / exposed
|
0 / 977 (0.00%) |
1 / 981 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |