Serious adverse events
|
RDT - All Cohorts |
NRE Cohort - CRPC 100 mg |
NRE Cohort - CRPC 40 mg |
NRE Cohort - Ovarian Cancer |
Total subjects affected by serious adverse events
|
|
|
|
|
subjects affected / exposed
|
223 / 526 (42.40%) |
53 / 93 (56.99%) |
30 / 51 (58.82%) |
34 / 60 (56.67%) |
number of deaths (all causes)
|
54 |
12 |
12 |
11 |
number of deaths resulting from adverse events
|
|
|
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
|
|
Breast cancer
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cancer pain
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intracranial tumour haemorrhage
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Malignant pleural effusion
|
|
|
|
|
subjects affected / exposed
|
4 / 526 (0.76%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
metastases to the central nervous system
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
1 / 93 (1.08%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
metastatic pain
|
|
|
|
|
subjects affected / exposed
|
2 / 526 (0.38%) |
1 / 93 (1.08%) |
1 / 51 (1.96%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Non-small cell lung cancer
|
|
|
|
|
subjects affected / exposed
|
2 / 526 (0.38%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ovarian cancer
|
|
|
|
|
subjects affected / exposed
|
0 / 526 (0.00%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
1 / 60 (1.67%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Prostate cancer
|
|
|
|
|
subjects affected / exposed
|
0 / 526 (0.00%) |
3 / 93 (3.23%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Squamous cell carcinoma of the oral cavity
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vascular disorders
|
|
|
|
|
Bleeding varicose vein
|
|
|
|
|
subjects affected / exposed
|
0 / 526 (0.00%) |
1 / 93 (1.08%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Deep vein thrombosis
|
|
|
|
|
subjects affected / exposed
|
12 / 526 (2.28%) |
1 / 93 (1.08%) |
2 / 51 (3.92%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
5 / 12 |
0 / 1 |
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haematoma
|
|
|
|
|
subjects affected / exposed
|
0 / 526 (0.00%) |
1 / 93 (1.08%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhage
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypertension
|
|
|
|
|
subjects affected / exposed
|
3 / 526 (0.57%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
3 / 3 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypotension
|
|
|
|
|
subjects affected / exposed
|
5 / 526 (0.95%) |
1 / 93 (1.08%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypovolaemic shock
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lymphoedema
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Orthostatic hypotension
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pelvic venous thrombosis
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Venous stenosis
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Venous thrombosis
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Venous thrombosis limb
|
|
|
|
|
subjects affected / exposed
|
0 / 526 (0.00%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
1 / 60 (1.67%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
General disorders and administration site conditions
|
|
|
|
|
Acute hepatic failure
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Asthenia
|
|
|
|
|
subjects affected / exposed
|
9 / 526 (1.71%) |
1 / 93 (1.08%) |
1 / 51 (1.96%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
2 / 9 |
1 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chest pain
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
1 / 60 (1.67%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Death
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Drug withdrawal syndrome
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Fatigue
|
|
|
|
|
subjects affected / exposed
|
2 / 526 (0.38%) |
5 / 93 (5.38%) |
1 / 51 (1.96%) |
1 / 60 (1.67%) |
occurrences causally related to treatment / all
|
2 / 2 |
4 / 5 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
General physical health deterioration
|
|
|
|
|
subjects affected / exposed
|
5 / 526 (0.95%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
3 / 60 (5.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Malaise
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
multi-organ failure
|
|
|
|
|
subjects affected / exposed
|
4 / 526 (0.76%) |
1 / 93 (1.08%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
Non-cardiac chest pain
|
|
|
|
|
subjects affected / exposed
|
2 / 526 (0.38%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Oedema peripheral
|
|
|
|
|
subjects affected / exposed
|
3 / 526 (0.57%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pain
|
|
|
|
|
subjects affected / exposed
|
2 / 526 (0.38%) |
1 / 93 (1.08%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Performance status decreased
|
|
|
|
|
subjects affected / exposed
|
0 / 526 (0.00%) |
0 / 93 (0.00%) |
1 / 51 (1.96%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pyrexia
|
|
|
|
|
subjects affected / exposed
|
5 / 526 (0.95%) |
2 / 93 (2.15%) |
0 / 51 (0.00%) |
4 / 60 (6.67%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Immune system disorders
|
|
|
|
|
Anaphylactic reaction
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Drug hypersensitivity
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Reproductive system and breast disorders
|
|
|
|
|
Vaginal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 526 (0.00%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
1 / 60 (1.67%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory, thoracic and mediastinal disorders
|
|
|
|
|
Acute respiratory failure
|
|
|
|
|
subjects affected / exposed
|
0 / 526 (0.00%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
1 / 60 (1.67%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Atelectasis
|
|
|
|
|
subjects affected / exposed
|
0 / 526 (0.00%) |
1 / 93 (1.08%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bronchopleural fistula
|
|
|
|
|
subjects affected / exposed
|
0 / 526 (0.00%) |
1 / 93 (1.08%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chronic obstructive pulmonary disease
|
|
|
|
|
subjects affected / exposed
|
0 / 526 (0.00%) |
1 / 93 (1.08%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dyspnoea
|
|
|
|
|
subjects affected / exposed
|
8 / 526 (1.52%) |
4 / 93 (4.30%) |
1 / 51 (1.96%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 8 |
2 / 4 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Epistaxis
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypoxia
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
2 / 93 (2.15%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pleural effusion
|
|
|
|
|
subjects affected / exposed
|
6 / 526 (1.14%) |
1 / 93 (1.08%) |
0 / 51 (0.00%) |
1 / 60 (1.67%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonitis
|
|
|
|
|
subjects affected / exposed
|
2 / 526 (0.38%) |
1 / 93 (1.08%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumothorax
|
|
|
|
|
subjects affected / exposed
|
3 / 526 (0.57%) |
1 / 93 (1.08%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary alveolar haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 526 (0.00%) |
1 / 93 (1.08%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary embolism
|
|
|
|
|
subjects affected / exposed
|
23 / 526 (4.37%) |
7 / 93 (7.53%) |
8 / 51 (15.69%) |
1 / 60 (1.67%) |
occurrences causally related to treatment / all
|
16 / 23 |
6 / 7 |
7 / 8 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary thrombosis
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory distress
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory failure
|
|
|
|
|
subjects affected / exposed
|
7 / 526 (1.33%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
1 / 7 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Psychiatric disorders
|
|
|
|
|
Anxiety
|
|
|
|
|
subjects affected / exposed
|
0 / 526 (0.00%) |
1 / 93 (1.08%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Confusional state
|
|
|
|
|
subjects affected / exposed
|
6 / 526 (1.14%) |
2 / 93 (2.15%) |
0 / 51 (0.00%) |
1 / 60 (1.67%) |
occurrences causally related to treatment / all
|
2 / 6 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Mental status changes
|
|
|
|
|
subjects affected / exposed
|
9 / 526 (1.71%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
1 / 9 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Investigations
|
|
|
|
|
Alanine aminotransferase increased
|
|
|
|
|
subjects affected / exposed
|
0 / 526 (0.00%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
1 / 60 (1.67%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Amylase increased
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Aspartate aminotransferase increased
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
1 / 60 (1.67%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Blood sodium decreased
|
|
|
|
|
subjects affected / exposed
|
0 / 526 (0.00%) |
0 / 93 (0.00%) |
1 / 51 (1.96%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Blood uric acid increased
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lipase increased
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
1 / 51 (1.96%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Liver function test abnormal
|
|
|
|
|
subjects affected / exposed
|
0 / 526 (0.00%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
1 / 60 (1.67%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Platelet count decreased
|
|
|
|
|
subjects affected / exposed
|
0 / 526 (0.00%) |
1 / 93 (1.08%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Transaminases increased
|
|
|
|
|
subjects affected / exposed
|
0 / 526 (0.00%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
1 / 60 (1.67%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Injury, poisoning and procedural complications
|
|
|
|
|
Clavicle fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 526 (0.00%) |
1 / 93 (1.08%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hip fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
laceration
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Radiation pneumonitis
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rib fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spinal compression fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 526 (0.00%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
1 / 60 (1.67%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Subdural haematoma
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
1 / 93 (1.08%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Wound dehiscence
|
|
|
|
|
subjects affected / exposed
|
2 / 526 (0.38%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Wrist fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 526 (0.00%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
1 / 60 (1.67%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac disorders
|
|
|
|
|
Supraventricular tachycardia
|
|
|
|
|
subjects affected / exposed
|
2 / 526 (0.38%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
tachycardia
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Anaemia
|
|
|
|
|
subjects affected / exposed
|
8 / 526 (1.52%) |
4 / 93 (4.30%) |
1 / 51 (1.96%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 8 |
1 / 4 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Acute myocardial infarction
|
|
|
|
|
subjects affected / exposed
|
4 / 526 (0.76%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Angina pectoris
|
|
|
|
|
subjects affected / exposed
|
2 / 526 (0.38%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Atrial fibrillation
|
|
|
|
|
subjects affected / exposed
|
2 / 526 (0.38%) |
0 / 93 (0.00%) |
1 / 51 (1.96%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Atrioventricular block
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac arrest
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac failure congestive
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac tamponade
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Coronary artery stenosis
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Palpitations
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
pericardial effusion
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sinus bradycardia
|
|
|
|
|
subjects affected / exposed
|
0 / 526 (0.00%) |
1 / 93 (1.08%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nervous system disorders
|
|
|
|
|
6th nerve paralysis
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral haemorrhage
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cerebrovascular accident
|
|
|
|
|
subjects affected / exposed
|
2 / 526 (0.38%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
convulsion
|
|
|
|
|
subjects affected / exposed
|
3 / 526 (0.57%) |
0 / 93 (0.00%) |
1 / 51 (1.96%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Depressed level of consciousness
|
|
|
|
|
subjects affected / exposed
|
0 / 526 (0.00%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
1 / 60 (1.67%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dizziness
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Encephalopathy
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Headache
|
|
|
|
|
subjects affected / exposed
|
2 / 526 (0.38%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhage intracranial
|
|
|
|
|
subjects affected / exposed
|
0 / 526 (0.00%) |
0 / 93 (0.00%) |
1 / 51 (1.96%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic encephalopathy
|
|
|
|
|
subjects affected / exposed
|
2 / 526 (0.38%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Occipital neuralgia
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Presyncope
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sciatica
|
|
|
|
|
subjects affected / exposed
|
0 / 526 (0.00%) |
0 / 93 (0.00%) |
1 / 51 (1.96%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Speech disorder
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spinal cord compression
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
1 / 93 (1.08%) |
1 / 51 (1.96%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Subdural effusion
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Syncope
|
|
|
|
|
subjects affected / exposed
|
3 / 526 (0.57%) |
0 / 93 (0.00%) |
1 / 51 (1.96%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Transient ischaemic attack
|
|
|
|
|
subjects affected / exposed
|
3 / 526 (0.57%) |
1 / 93 (1.08%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
3 / 3 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Blood and lymphatic system disorders
|
|
|
|
|
Disseminated intravascular coagulation
|
|
|
|
|
subjects affected / exposed
|
0 / 526 (0.00%) |
1 / 93 (1.08%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
idiopathic thrombocytopenia purpura
|
|
|
|
|
subjects affected / exposed
|
0 / 526 (0.00%) |
0 / 93 (0.00%) |
1 / 51 (1.96%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Thrombocytopenia
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
1 / 51 (1.96%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ear and labyrinth disorders
|
|
|
|
|
Vertigo
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Eye disorders
|
|
|
|
|
Cataract
|
|
|
|
|
subjects affected / exposed
|
0 / 526 (0.00%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
1 / 60 (1.67%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Corneal epithelium defect
|
|
|
|
|
subjects affected / exposed
|
0 / 526 (0.00%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
1 / 60 (1.67%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Macular oedema
|
|
|
|
|
subjects affected / exposed
|
0 / 526 (0.00%) |
1 / 93 (1.08%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Parophthalmia
|
|
|
|
|
subjects affected / exposed
|
0 / 526 (0.00%) |
0 / 93 (0.00%) |
1 / 51 (1.96%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal disorders
|
|
|
|
|
Abdominal discomfort
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal distension
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal hernia
|
|
|
|
|
subjects affected / exposed
|
0 / 526 (0.00%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
1 / 60 (1.67%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal pain
|
|
|
|
|
subjects affected / exposed
|
9 / 526 (1.71%) |
2 / 93 (2.15%) |
2 / 51 (3.92%) |
7 / 60 (11.67%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 2 |
0 / 2 |
1 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal pain upper
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Anal fissure
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Anal fistula
|
|
|
|
|
subjects affected / exposed
|
0 / 526 (0.00%) |
1 / 93 (1.08%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Anal ulcer
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ascites
|
|
|
|
|
subjects affected / exposed
|
2 / 526 (0.38%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
1 / 60 (1.67%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Colitis
|
|
|
|
|
subjects affected / exposed
|
0 / 526 (0.00%) |
2 / 93 (2.15%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Constipation
|
|
|
|
|
subjects affected / exposed
|
4 / 526 (0.76%) |
1 / 93 (1.08%) |
0 / 51 (0.00%) |
3 / 60 (5.00%) |
occurrences causally related to treatment / all
|
2 / 4 |
0 / 1 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diarrhoea
|
|
|
|
|
subjects affected / exposed
|
15 / 526 (2.85%) |
2 / 93 (2.15%) |
0 / 51 (0.00%) |
3 / 60 (5.00%) |
occurrences causally related to treatment / all
|
11 / 15 |
2 / 2 |
0 / 0 |
2 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diverticular perforation
|
|
|
|
|
subjects affected / exposed
|
2 / 526 (0.38%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Duodenal ulcer haemorrhage
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dyspepsia
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dysphagia
|
|
|
|
|
subjects affected / exposed
|
0 / 526 (0.00%) |
1 / 93 (1.08%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Enterocutaneous fistula
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Enterovesical fistula
|
|
|
|
|
subjects affected / exposed
|
0 / 526 (0.00%) |
1 / 93 (1.08%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastric ulcer
|
|
|
|
|
subjects affected / exposed
|
0 / 526 (0.00%) |
1 / 93 (1.08%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrooesophageal reflux disease
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
5 / 526 (0.95%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
1 / 5 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haematemesis
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhoids
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ileus paralytic
|
|
|
|
|
subjects affected / exposed
|
0 / 526 (0.00%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
1 / 60 (1.67%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Inflammatory bowel disease
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Inguinal hernia
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal obstruction
|
|
|
|
|
subjects affected / exposed
|
3 / 526 (0.57%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
4 / 60 (6.67%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal perforation
|
|
|
|
|
subjects affected / exposed
|
4 / 526 (0.76%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
3 / 4 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Lower gastrointestinal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Melaena
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nausea
|
|
|
|
|
subjects affected / exposed
|
12 / 526 (2.28%) |
9 / 93 (9.68%) |
0 / 51 (0.00%) |
8 / 60 (13.33%) |
occurrences causally related to treatment / all
|
10 / 12 |
6 / 9 |
0 / 0 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Obstruction gastric
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Oesophagitis
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatitis
|
|
|
|
|
subjects affected / exposed
|
2 / 526 (0.38%) |
0 / 93 (0.00%) |
1 / 51 (1.96%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatitis acute
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
peritoneal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumoperitoneum
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Proctalgia
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
1 / 93 (1.08%) |
0 / 51 (0.00%) |
1 / 60 (1.67%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rectal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rectal obstruction
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rectal stenosis
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Retroperitoneal haematoma
|
|
|
|
|
subjects affected / exposed
|
0 / 526 (0.00%) |
0 / 93 (0.00%) |
1 / 51 (1.96%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Small intestinal obstruction
|
|
|
|
|
subjects affected / exposed
|
5 / 526 (0.95%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
5 / 60 (8.33%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
0 / 0 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Upper gastrointestinal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 526 (0.00%) |
1 / 93 (1.08%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vomiting
|
|
|
|
|
subjects affected / exposed
|
15 / 526 (2.85%) |
7 / 93 (7.53%) |
0 / 51 (0.00%) |
11 / 60 (18.33%) |
occurrences causally related to treatment / all
|
10 / 15 |
3 / 7 |
0 / 0 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Jaundice cholestatic
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatobiliary disorders
|
|
|
|
|
bile duct obstruction
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
2 / 51 (3.92%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cholangitis
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cholecystitis
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
1 / 60 (1.67%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cholestasis
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic failure
|
|
|
|
|
subjects affected / exposed
|
5 / 526 (0.95%) |
1 / 93 (1.08%) |
0 / 51 (0.00%) |
1 / 60 (1.67%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 1 |
Hyperbilirubinaemia
|
|
|
|
|
subjects affected / exposed
|
2 / 526 (0.38%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Portal vein thrombosis
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
2 / 93 (2.15%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
2 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Skin and subcutaneous tissue disorders
|
|
|
|
|
Decubitus ulcer
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Palmar-plantar erythrodysaesthesia syndrome
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Psoriasis
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rash
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rash pruritic
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal and urinary disorders
|
|
|
|
|
acute prerenal failure
|
|
|
|
|
subjects affected / exposed
|
2 / 526 (0.38%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haematuria
|
|
|
|
|
subjects affected / exposed
|
3 / 526 (0.57%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhage urinary tract
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hydronephrosis
|
|
|
|
|
subjects affected / exposed
|
3 / 526 (0.57%) |
1 / 93 (1.08%) |
1 / 51 (1.96%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal failure
|
|
|
|
|
subjects affected / exposed
|
5 / 526 (0.95%) |
0 / 93 (0.00%) |
1 / 51 (1.96%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
renal failure acute
|
|
|
|
|
subjects affected / exposed
|
11 / 526 (2.09%) |
4 / 93 (4.30%) |
0 / 51 (0.00%) |
1 / 60 (1.67%) |
occurrences causally related to treatment / all
|
1 / 11 |
0 / 4 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ureteric obstruction
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
1 / 51 (1.96%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urethral obstruction
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urinary tract obstruction
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Endocrine disorders
|
|
|
|
|
Adrenal insufficiency
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypopituitarism
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal and connective tissue disorders
|
|
|
|
|
Arthralgia
|
|
|
|
|
subjects affected / exposed
|
0 / 526 (0.00%) |
0 / 93 (0.00%) |
1 / 51 (1.96%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Back pain
|
|
|
|
|
subjects affected / exposed
|
5 / 526 (0.95%) |
5 / 93 (5.38%) |
4 / 51 (7.84%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bone pain
|
|
|
|
|
subjects affected / exposed
|
0 / 526 (0.00%) |
6 / 93 (6.45%) |
1 / 51 (1.96%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 6 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Flank pain
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Groin pain
|
|
|
|
|
subjects affected / exposed
|
0 / 526 (0.00%) |
0 / 93 (0.00%) |
1 / 51 (1.96%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intervertebral disc protrusion
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Muscle haemorrhage
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Muscular weakness
|
|
|
|
|
subjects affected / exposed
|
3 / 526 (0.57%) |
1 / 93 (1.08%) |
1 / 51 (1.96%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
1 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal chest pain
|
|
|
|
|
subjects affected / exposed
|
0 / 526 (0.00%) |
0 / 93 (0.00%) |
1 / 51 (1.96%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Neck pain
|
|
|
|
|
subjects affected / exposed
|
0 / 526 (0.00%) |
0 / 93 (0.00%) |
1 / 51 (1.96%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Osteonecrosis of jaw
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
1 / 51 (1.96%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pain in extremity
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
2 / 93 (2.15%) |
1 / 51 (1.96%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pathological fracture
|
|
|
|
|
subjects affected / exposed
|
2 / 526 (0.38%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rhabdomyolysis
|
|
|
|
|
subjects affected / exposed
|
0 / 526 (0.00%) |
0 / 93 (0.00%) |
1 / 51 (1.96%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Malignant melanoma
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Infections and infestations
|
|
|
|
|
Abscess limb
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
1 / 93 (1.08%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bacterial sepsis
|
|
|
|
|
subjects affected / exposed
|
0 / 526 (0.00%) |
1 / 93 (1.08%) |
0 / 51 (0.00%) |
1 / 60 (1.67%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
Bronchitis
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
1 / 60 (1.67%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cellulitis
|
|
|
|
|
subjects affected / exposed
|
0 / 526 (0.00%) |
2 / 93 (2.15%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Clostridium difficile colitis
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Clostridium difficile infection
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cystitis
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Device related infection
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
1 / 93 (1.08%) |
1 / 51 (1.96%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic foot infection
|
|
|
|
|
subjects affected / exposed
|
0 / 526 (0.00%) |
1 / 93 (1.08%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diverticulitis
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Douglas' abscess
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Empyema
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Escherichia bacteraemia
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastroenteritis viral
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Herpes oesophagitis
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Klebsiella bacteraemia
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
lung infection
|
|
|
|
|
subjects affected / exposed
|
0 / 526 (0.00%) |
1 / 93 (1.08%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Osteomyelitis
|
|
|
|
|
subjects affected / exposed
|
0 / 526 (0.00%) |
1 / 93 (1.08%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Otitis media
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
1 / 93 (1.08%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pelvic abscess
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Perirectal abscess
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peritonitis
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia
|
|
|
|
|
subjects affected / exposed
|
16 / 526 (3.04%) |
3 / 93 (3.23%) |
1 / 51 (1.96%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 16 |
0 / 3 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
Pneumonia fungal
|
|
|
|
|
subjects affected / exposed
|
0 / 526 (0.00%) |
1 / 93 (1.08%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rectal abscess
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sepsis
|
|
|
|
|
subjects affected / exposed
|
5 / 526 (0.95%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
1 / 5 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Septic shock
|
|
|
|
|
subjects affected / exposed
|
2 / 526 (0.38%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
1 / 60 (1.67%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Staphylococcal infection
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Staphylococcal sepsis
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tooth infection
|
|
|
|
|
subjects affected / exposed
|
0 / 526 (0.00%) |
0 / 93 (0.00%) |
1 / 51 (1.96%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urinary tract infection
|
|
|
|
|
subjects affected / exposed
|
7 / 526 (1.33%) |
5 / 93 (5.38%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
1 / 7 |
0 / 5 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urosepsis
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
1 / 51 (1.96%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Wound infection
|
|
|
|
|
subjects affected / exposed
|
2 / 526 (0.38%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Wound sepsis
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metabolism and nutrition disorders
|
|
|
|
|
Decreased appetite
|
|
|
|
|
subjects affected / exposed
|
2 / 526 (0.38%) |
0 / 93 (0.00%) |
1 / 51 (1.96%) |
2 / 60 (3.33%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
1 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dehydration
|
|
|
|
|
subjects affected / exposed
|
17 / 526 (3.23%) |
6 / 93 (6.45%) |
2 / 51 (3.92%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
7 / 17 |
4 / 6 |
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic ketoacidosis
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Failure to thrive
|
|
|
|
|
subjects affected / exposed
|
3 / 526 (0.57%) |
2 / 93 (2.15%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
1 / 3 |
1 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gout
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypercalcaemia
|
|
|
|
|
subjects affected / exposed
|
2 / 526 (0.38%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyperglycaemia
|
|
|
|
|
subjects affected / exposed
|
1 / 526 (0.19%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyperkalaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 526 (0.00%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
1 / 60 (1.67%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypoglycaemia
|
|
|
|
|
subjects affected / exposed
|
5 / 526 (0.95%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypokalaemia
|
|
|
|
|
subjects affected / exposed
|
3 / 526 (0.57%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
0 / 60 (0.00%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyponatraemia
|
|
|
|
|
subjects affected / exposed
|
7 / 526 (1.33%) |
2 / 93 (2.15%) |
0 / 51 (0.00%) |
2 / 60 (3.33%) |
occurrences causally related to treatment / all
|
4 / 7 |
2 / 2 |
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Malnutrition
|
|
|
|
|
subjects affected / exposed
|
0 / 526 (0.00%) |
0 / 93 (0.00%) |
0 / 51 (0.00%) |
1 / 60 (1.67%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |