Serious adverse events
|
Pirfenidone |
Total subjects affected by serious adverse events
|
|
subjects affected / exposed
|
571 / 1058 (53.97%) |
number of deaths (all causes)
|
231 |
number of deaths resulting from adverse events
|
13 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
Adenocarcinoma pancreas
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Benign ovarian tumour
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Bladder cancer
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Bladder cancer recurrent
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Breast cancer
|
|
subjects affected / exposed
|
2 / 1058 (0.19%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Breast cancer in situ
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Breast cancer metastatic
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Bronchial carcinoma
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Burkitt's lymphoma
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Chronic lymphocytic leukaemia
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Colon cancer
|
|
subjects affected / exposed
|
3 / 1058 (0.28%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Colon cancer metastatic
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Gastric adenoma
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Gastrointestinal carcinoma
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Hepatic neoplasm
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Hepatic neoplasm malignant
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Intestinal adenocarcinoma
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Large cell carcinoma of the respiratory tract stage unspecified
|
|
subjects affected / exposed
|
2 / 1058 (0.19%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
Lung adenocarcinoma
|
|
subjects affected / exposed
|
2 / 1058 (0.19%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Lung adenocarcinoma Stage IV
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Lung cancer metastatic
|
|
subjects affected / exposed
|
6 / 1058 (0.57%) |
occurrences causally related to treatment / all
|
0 / 6 |
deaths causally related to treatment / all
|
0 / 3 |
Lung neoplasm malignant
|
|
subjects affected / exposed
|
8 / 1058 (0.76%) |
occurrences causally related to treatment / all
|
1 / 8 |
deaths causally related to treatment / all
|
1 / 3 |
Lung squamous cell carcinoma stage unspecified
|
|
subjects affected / exposed
|
8 / 1058 (0.76%) |
occurrences causally related to treatment / all
|
1 / 9 |
deaths causally related to treatment / all
|
0 / 1 |
Lymphoma
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Malignant melanoma Stage I
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Malignant pleural effusion
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Metastases to bone
|
|
subjects affected / exposed
|
2 / 1058 (0.19%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Metastases to liver
|
|
subjects affected / exposed
|
3 / 1058 (0.28%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Non-small cell lung cancer
|
|
subjects affected / exposed
|
5 / 1058 (0.47%) |
occurrences causally related to treatment / all
|
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
Non-small cell lung cancer metastatic
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Non-small cell lung cancer Stage IV
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Oesophageal adenocarcinoma metastatic
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Oesophageal cancer metastatic
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Ovarian cancer
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Ovarian cancer recurrent
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Pancreatic carcinoma metastatic
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Prostate cancer
|
|
subjects affected / exposed
|
3 / 1058 (0.28%) |
occurrences causally related to treatment / all
|
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Prostate cancer metastatic
|
|
subjects affected / exposed
|
3 / 1058 (0.28%) |
occurrences causally related to treatment / all
|
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Renal cancer
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Sarcoma
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Small cell carcinoma
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Small cell lung cancer stage unspecified
|
|
subjects affected / exposed
|
4 / 1058 (0.38%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
Squamous cell carcinoma
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Vascular disorders
|
|
Air embolism
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Aortic aneurysm
|
|
subjects affected / exposed
|
4 / 1058 (0.38%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
Aortic stenosis
|
|
subjects affected / exposed
|
2 / 1058 (0.19%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Arterial occlusive disease
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Deep vein thrombosis
|
|
subjects affected / exposed
|
7 / 1058 (0.66%) |
occurrences causally related to treatment / all
|
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
Arteriosclerosis
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Hypertension
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Embolism venous
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Hypertensive crisis
|
|
subjects affected / exposed
|
2 / 1058 (0.19%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Hypotension
|
|
subjects affected / exposed
|
7 / 1058 (0.66%) |
occurrences causally related to treatment / all
|
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
Orthostatic hypotension
|
|
subjects affected / exposed
|
3 / 1058 (0.28%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Peripheral vascular disorder
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Shock
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Vasculitis necrotising
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
General disorders and administration site conditions
|
|
Asthenia
|
|
subjects affected / exposed
|
2 / 1058 (0.19%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Chest pain
|
|
subjects affected / exposed
|
15 / 1058 (1.42%) |
occurrences causally related to treatment / all
|
0 / 16 |
deaths causally related to treatment / all
|
0 / 0 |
Death
|
|
subjects affected / exposed
|
2 / 1058 (0.19%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
Hypothermia
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Multi-organ failure
|
|
subjects affected / exposed
|
3 / 1058 (0.28%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Non-cardiac chest pain
|
|
subjects affected / exposed
|
6 / 1058 (0.57%) |
occurrences causally related to treatment / all
|
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
Oedema peripheral
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Pyrexia
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Sudden death
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Systemic inflammatory response syndrome
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Immune system disorders
|
|
Anaphylactic reaction
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Anti-neutrophil cytoplasmic antibody positive vasculitis
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Polyarteritis nodosa
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Reproductive system and breast disorders
|
|
Benign prostatic hyperplasia
|
|
subjects affected / exposed
|
2 / 1058 (0.19%) |
occurrences causally related to treatment / all
|
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Endometriosis
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Endosalpingiosis
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Female genital tract fistula
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Pelvic floor muscle weakness
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Prostatitis
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Respiratory, thoracic and mediastinal disorders
|
|
Acute pulmonary oedema
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Acute respiratory distress syndrome
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Acute respiratory failure
|
|
subjects affected / exposed
|
30 / 1058 (2.84%) |
occurrences causally related to treatment / all
|
5 / 30 |
deaths causally related to treatment / all
|
2 / 11 |
Bronchospasm
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Alveolitis
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Chronic obstructive pulmonary disease
|
|
subjects affected / exposed
|
2 / 1058 (0.19%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Cough
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Dyspnoea
|
|
subjects affected / exposed
|
8 / 1058 (0.76%) |
occurrences causally related to treatment / all
|
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
Haemoptysis
|
|
subjects affected / exposed
|
3 / 1058 (0.28%) |
occurrences causally related to treatment / all
|
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Haemothorax
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Hypoxia
|
|
subjects affected / exposed
|
17 / 1058 (1.61%) |
occurrences causally related to treatment / all
|
1 / 18 |
deaths causally related to treatment / all
|
1 / 4 |
Idiopathic pulmonary fibrosis
|
|
subjects affected / exposed
|
230 / 1058 (21.74%) |
occurrences causally related to treatment / all
|
9 / 276 |
deaths causally related to treatment / all
|
2 / 133 |
Increased bronchial secretion
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Interstitial lung disease
|
|
subjects affected / exposed
|
4 / 1058 (0.38%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
Lung disorder
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Nasal discomfort
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Pleural effusion
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Pleurisy
|
|
subjects affected / exposed
|
2 / 1058 (0.19%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Pneumomediastinum
|
|
subjects affected / exposed
|
2 / 1058 (0.19%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Pneumonia aspiration
|
|
subjects affected / exposed
|
8 / 1058 (0.76%) |
occurrences causally related to treatment / all
|
1 / 8 |
deaths causally related to treatment / all
|
0 / 1 |
Pneumonitis
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Pneumothorax
|
|
subjects affected / exposed
|
8 / 1058 (0.76%) |
occurrences causally related to treatment / all
|
2 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
Pneumothorax spontaneous tension
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Pulmonary arterial hypertension
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Pulmonary embolism
|
|
subjects affected / exposed
|
19 / 1058 (1.80%) |
occurrences causally related to treatment / all
|
3 / 20 |
deaths causally related to treatment / all
|
0 / 0 |
Pulmonary cavitation
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Pulmonary haemorrhage
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Pulmonary hypertension
|
|
subjects affected / exposed
|
11 / 1058 (1.04%) |
occurrences causally related to treatment / all
|
0 / 11 |
deaths causally related to treatment / all
|
0 / 2 |
Pulmonary mass
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Respiratory failure
|
|
subjects affected / exposed
|
29 / 1058 (2.74%) |
occurrences causally related to treatment / all
|
4 / 29 |
deaths causally related to treatment / all
|
1 / 18 |
Sleep apnoea syndrome
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Psychiatric disorders
|
|
Anxiety
|
|
subjects affected / exposed
|
2 / 1058 (0.19%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Confusional state
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Depression
|
|
subjects affected / exposed
|
2 / 1058 (0.19%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Major depression
|
|
subjects affected / exposed
|
2 / 1058 (0.19%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Psychotic disorder
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Investigations
|
|
Hepatic enzyme increased
|
|
subjects affected / exposed
|
2 / 1058 (0.19%) |
occurrences causally related to treatment / all
|
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Mycobacteria blood test positive
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Panel-reactive antibody increased
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Pulmonary arterial pressure increased
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Troponin increased
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Tumour marker increased
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Injury, poisoning and procedural complications
|
|
Ankle fracture
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Burns second degree
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Cervical vertebral fracture
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Device lead damage
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Drug toxicity
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Extradural haematoma
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Facial bones fracture
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Failure of implant
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Fall
|
|
subjects affected / exposed
|
5 / 1058 (0.47%) |
occurrences causally related to treatment / all
|
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
Femur fracture
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Fractured coccyx
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Head injury
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Hip fracture
|
|
subjects affected / exposed
|
4 / 1058 (0.38%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
Humerus fracture
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Incisional hernia, obstructive
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Injury
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Joint dislocation
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Lower limb fracture
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Lumbar vertebral fracture
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Patella fracture
|
|
subjects affected / exposed
|
2 / 1058 (0.19%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Post procedural complication
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Post procedural haemorrhage
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Radiation pneumonitis
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Renal haematoma
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Renal injury
|
|
subjects affected / exposed
|
2 / 1058 (0.19%) |
occurrences causally related to treatment / all
|
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Rib fracture
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Road traffic accident
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Skeletal injury
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Skin laceration
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Spinal compression fracture
|
|
subjects affected / exposed
|
3 / 1058 (0.28%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
Spinal cord injury
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Sternal fracture
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Struck by lightning
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Subdural haematoma
|
|
subjects affected / exposed
|
2 / 1058 (0.19%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Tendon rupture
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Ulna fracture
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Upper limb fracture
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Congenital, familial and genetic disorders
|
|
Gastrointestinal arteriovenous malformation
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Cardiac disorders
|
|
Acute coronary syndrome
|
|
subjects affected / exposed
|
7 / 1058 (0.66%) |
occurrences causally related to treatment / all
|
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
Acute myocardial infarction
|
|
subjects affected / exposed
|
12 / 1058 (1.13%) |
occurrences causally related to treatment / all
|
0 / 12 |
deaths causally related to treatment / all
|
0 / 1 |
Acute right ventricular failure
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Angina pectoris
|
|
subjects affected / exposed
|
6 / 1058 (0.57%) |
occurrences causally related to treatment / all
|
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
Angina unstable
|
|
subjects affected / exposed
|
4 / 1058 (0.38%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
Aortic valve stenosis
|
|
subjects affected / exposed
|
2 / 1058 (0.19%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Arrhythmia
|
|
subjects affected / exposed
|
3 / 1058 (0.28%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 3 |
Arteriosclerosis coronary artery
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Atrial fibrillation
|
|
subjects affected / exposed
|
26 / 1058 (2.46%) |
occurrences causally related to treatment / all
|
1 / 32 |
deaths causally related to treatment / all
|
0 / 1 |
Atrial flutter
|
|
subjects affected / exposed
|
3 / 1058 (0.28%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
Atrial tachycardia
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Atrioventricular block complete
|
|
subjects affected / exposed
|
3 / 1058 (0.28%) |
occurrences causally related to treatment / all
|
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Atrioventricular block second degree
|
|
subjects affected / exposed
|
4 / 1058 (0.38%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
Bradycardia
|
|
subjects affected / exposed
|
5 / 1058 (0.47%) |
occurrences causally related to treatment / all
|
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
Cardiac arrest
|
|
subjects affected / exposed
|
9 / 1058 (0.85%) |
occurrences causally related to treatment / all
|
0 / 9 |
deaths causally related to treatment / all
|
0 / 6 |
Cardiac failure
|
|
subjects affected / exposed
|
5 / 1058 (0.47%) |
occurrences causally related to treatment / all
|
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
Cardiac failure acute
|
|
subjects affected / exposed
|
2 / 1058 (0.19%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Cardiac failure congestive
|
|
subjects affected / exposed
|
12 / 1058 (1.13%) |
occurrences causally related to treatment / all
|
1 / 19 |
deaths causally related to treatment / all
|
1 / 2 |
Cardiomyopathy
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Cor pulmonale
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Coronary artery disease
|
|
subjects affected / exposed
|
20 / 1058 (1.89%) |
occurrences causally related to treatment / all
|
0 / 20 |
deaths causally related to treatment / all
|
0 / 0 |
Coronary artery dissection
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Coronary artery occlusion
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Heart valve incompetence
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Ischaemic cardiomyopathy
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Left ventricular dysfunction
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Left ventricular failure
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Myocardial infarction
|
|
subjects affected / exposed
|
7 / 1058 (0.66%) |
occurrences causally related to treatment / all
|
1 / 7 |
deaths causally related to treatment / all
|
1 / 3 |
Myocardial ischaemia
|
|
subjects affected / exposed
|
2 / 1058 (0.19%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
Palpitations
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Pericardial effusion
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Right ventricular dysfunction
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Right ventricular failure
|
|
subjects affected / exposed
|
4 / 1058 (0.38%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
Sick sinus syndrome
|
|
subjects affected / exposed
|
2 / 1058 (0.19%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Sinus bradycardia
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Supraventricular tachycardia
|
|
subjects affected / exposed
|
3 / 1058 (0.28%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Tachycardia
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Ventricular extrasystoles
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Ventricular tachycardia
|
|
subjects affected / exposed
|
2 / 1058 (0.19%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Nervous system disorders
|
|
Anoxic encephalopathy
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Brain stem infarction
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Carotid artery stenosis
|
|
subjects affected / exposed
|
2 / 1058 (0.19%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Central nervous system lesion
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Cerebral haematoma
|
|
subjects affected / exposed
|
2 / 1058 (0.19%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Cerebral infarction
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Cerebral ischaemia
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Cerebral thrombosis
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Cerebrovascular accident
|
|
subjects affected / exposed
|
14 / 1058 (1.32%) |
occurrences causally related to treatment / all
|
3 / 16 |
deaths causally related to treatment / all
|
1 / 4 |
Chronic inflammatory demyelinating polyradiculoneuropathy
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Convulsion
|
|
subjects affected / exposed
|
3 / 1058 (0.28%) |
occurrences causally related to treatment / all
|
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Demyelinating polyneuropathy
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Dizziness
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Embolic stroke
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Hemiparesis
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Hypoaesthesia
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Ischaemic stroke
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Mononeuropathy multiplex
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Neuropathy peripheral
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Paraparesis
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Spinal cord compression
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Syncope
|
|
subjects affected / exposed
|
20 / 1058 (1.89%) |
occurrences causally related to treatment / all
|
2 / 26 |
deaths causally related to treatment / all
|
0 / 0 |
Syncope vasovagal
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Tension headache
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Thalamic infarction
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Transient ischaemic attack
|
|
subjects affected / exposed
|
8 / 1058 (0.76%) |
occurrences causally related to treatment / all
|
1 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
Blood and lymphatic system disorders
|
|
Anaemia
|
|
subjects affected / exposed
|
5 / 1058 (0.47%) |
occurrences causally related to treatment / all
|
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
Coagulopathy
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Haemorrhagic anaemia
|
|
subjects affected / exposed
|
3 / 1058 (0.28%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Iron deficiency anaemia
|
|
subjects affected / exposed
|
2 / 1058 (0.19%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Leukopenia
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Pancytopenia
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Thrombocytopenia
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Ear and labyrinth disorders
|
|
Vertigo
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Vertigo positional
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Eye disorders
|
|
Eye disorder
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Retinal detachment
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Gastrointestinal disorders
|
|
Abdominal adhesions
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Colitis ischaemic
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Colonic fistula
|
|
subjects affected / exposed
|
2 / 1058 (0.19%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Colonic polyp
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Constipation
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Diverticulum
|
|
subjects affected / exposed
|
2 / 1058 (0.19%) |
occurrences causally related to treatment / all
|
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Diverticulum intestinal haemorrhagic
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Enteritis
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Gastric ulcer
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Gastritis
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Gastrointestinal haemorrhage
|
|
subjects affected / exposed
|
5 / 1058 (0.47%) |
occurrences causally related to treatment / all
|
1 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
Gastrointestinal necrosis
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Gastrooesophageal reflux disease
|
|
subjects affected / exposed
|
3 / 1058 (0.28%) |
occurrences causally related to treatment / all
|
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Haematochezia
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Haemorrhoidal haemorrhage
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Haemorrhoids
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Hiatus hernia
|
|
subjects affected / exposed
|
3 / 1058 (0.28%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Ileus
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Inguinal hernia
|
|
subjects affected / exposed
|
2 / 1058 (0.19%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Inguinal hernia strangulated
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Intestinal obstruction
|
|
subjects affected / exposed
|
3 / 1058 (0.28%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Intra-abdominal haematoma
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Jejunal perforation
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Lower gastrointestinal haemorrhage
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Mesenteric vein thrombosis
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Nausea
|
|
subjects affected / exposed
|
2 / 1058 (0.19%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Obstruction gastric
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Oesophageal perforation
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Pancreatitis
|
|
subjects affected / exposed
|
2 / 1058 (0.19%) |
occurrences causally related to treatment / all
|
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Pancreatitis acute
|
|
subjects affected / exposed
|
2 / 1058 (0.19%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Peritonitis
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Small intestinal obstruction
|
|
subjects affected / exposed
|
3 / 1058 (0.28%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
Rectal polyp
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Small intestinal perforation
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Umbilical hernia, obstructive
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Upper gastrointestinal haemorrhage
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Vomiting
|
|
subjects affected / exposed
|
2 / 1058 (0.19%) |
occurrences causally related to treatment / all
|
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Hepatobiliary disorders
|
|
Bile duct stone
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Bile duct obstruction
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Bile duct stenosis
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Biliary dyskinesia
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Cholangitis
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Cholecystitis
|
|
subjects affected / exposed
|
3 / 1058 (0.28%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Cholecystitis acute
|
|
subjects affected / exposed
|
4 / 1058 (0.38%) |
occurrences causally related to treatment / all
|
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
Cholecystitis chronic
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Cholelithiasis
|
|
subjects affected / exposed
|
2 / 1058 (0.19%) |
occurrences causally related to treatment / all
|
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Skin and subcutaneous tissue disorders
|
|
Eczema
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Hypoaesthesia facial
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Photosensitivity reaction
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Urticaria
|
|
subjects affected / exposed
|
2 / 1058 (0.19%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Renal and urinary disorders
|
|
Calculus ureteric
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Calculus urinary
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Glomerulonephritis rapidly progressive
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Haematuria
|
|
subjects affected / exposed
|
3 / 1058 (0.28%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Nephrolithiasis
|
|
subjects affected / exposed
|
6 / 1058 (0.57%) |
occurrences causally related to treatment / all
|
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
Renal cyst
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Renal failure
|
|
subjects affected / exposed
|
4 / 1058 (0.38%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
Renal failure acute
|
|
subjects affected / exposed
|
3 / 1058 (0.28%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
Urinary retention
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Endocrine disorders
|
|
Adrenal mass
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Musculoskeletal and connective tissue disorders
|
|
Back pain
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Costochondritis
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Intervertebral disc degeneration
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Intervertebral disc disorder
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Intervertebral disc protrusion
|
|
subjects affected / exposed
|
2 / 1058 (0.19%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Lumbar spinal stenosis
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Muscle spasms
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Muscular weakness
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Musculoskeletal pain
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Neck pain
|
|
subjects affected / exposed
|
2 / 1058 (0.19%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Osteoarthritis
|
|
subjects affected / exposed
|
7 / 1058 (0.66%) |
occurrences causally related to treatment / all
|
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
Osteoporosis
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Polymyalgia rheumatica
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Spinal column stenosis
|
|
subjects affected / exposed
|
2 / 1058 (0.19%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Infections and infestations
|
|
Abdominal abscess
|
|
subjects affected / exposed
|
2 / 1058 (0.19%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Abscess intestinal
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Acute sinusitis
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Appendicitis
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Bacteraemia
|
|
subjects affected / exposed
|
2 / 1058 (0.19%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Bacterial abscess central nervous system
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Bartonellosis
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Bronchiectasis
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Bronchitis
|
|
subjects affected / exposed
|
32 / 1058 (3.02%) |
occurrences causally related to treatment / all
|
0 / 38 |
deaths causally related to treatment / all
|
0 / 0 |
Bronchitis viral
|
|
subjects affected / exposed
|
2 / 1058 (0.19%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Bronchopneumonia
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Bronchopulmonary aspergillosis
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Bursitis infective
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Campylobacter intestinal infection
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Candidiasis
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Cellulitis
|
|
subjects affected / exposed
|
3 / 1058 (0.28%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Cellulitis staphylococcal
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Clostridial infection
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Diverticulitis
|
|
subjects affected / exposed
|
4 / 1058 (0.38%) |
occurrences causally related to treatment / all
|
2 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
Endocarditis
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Endocarditis enterococcal
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Enterococcal bacteraemia
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Enterocolitis infectious
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Escherichia sepsis
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Fungal oesophagitis
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Gastroenteritis
|
|
subjects affected / exposed
|
3 / 1058 (0.28%) |
occurrences causally related to treatment / all
|
2 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Herpes zoster
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Herpes zoster oticus
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Influenza
|
|
subjects affected / exposed
|
7 / 1058 (0.66%) |
occurrences causally related to treatment / all
|
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
Liver abscess
|
|
subjects affected / exposed
|
2 / 1058 (0.19%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Lobar pneumonia
|
|
subjects affected / exposed
|
4 / 1058 (0.38%) |
occurrences causally related to treatment / all
|
1 / 5 |
deaths causally related to treatment / all
|
1 / 1 |
Lower respiratory tract infection
|
|
subjects affected / exposed
|
4 / 1058 (0.38%) |
occurrences causally related to treatment / all
|
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
Lower respiratory tract infection bacterial
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Lung infection
|
|
subjects affected / exposed
|
2 / 1058 (0.19%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
Lung infection pseudomonal
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Pneumocystis jiroveci pneumonia
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
1 / 1 |
Pneumonia
|
|
subjects affected / exposed
|
90 / 1058 (8.51%) |
occurrences causally related to treatment / all
|
7 / 104 |
deaths causally related to treatment / all
|
1 / 10 |
Pneumonia bacterial
|
|
subjects affected / exposed
|
2 / 1058 (0.19%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Pneumonia herpes viral
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Pneumonia influenzal
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Pneumonia pneumococcal
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Pneumonia respiratory syncytial viral
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Pneumonia staphylococcal
|
|
subjects affected / exposed
|
4 / 1058 (0.38%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
Pneumonia streptococcal
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Pneumonia viral
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Postoperative abscess
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Postoperative wound infection
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Pseudomembranous colitis
|
|
subjects affected / exposed
|
2 / 1058 (0.19%) |
occurrences causally related to treatment / all
|
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Respiratory tract infection
|
|
subjects affected / exposed
|
3 / 1058 (0.28%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
Sepsis
|
|
subjects affected / exposed
|
3 / 1058 (0.28%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
Septic shock
|
|
subjects affected / exposed
|
3 / 1058 (0.28%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Sinusitis
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Staphylococcal infection
|
|
subjects affected / exposed
|
2 / 1058 (0.19%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Upper respiratory tract infection
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Urinary tract infection
|
|
subjects affected / exposed
|
8 / 1058 (0.76%) |
occurrences causally related to treatment / all
|
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
Viral infection
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Metabolism and nutrition disorders
|
|
Cachexia
|
|
subjects affected / exposed
|
2 / 1058 (0.19%) |
occurrences causally related to treatment / all
|
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Dehydration
|
|
subjects affected / exposed
|
6 / 1058 (0.57%) |
occurrences causally related to treatment / all
|
1 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
Diabetes mellitus inadequate control
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Hypochloraemia
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Hypokalaemia
|
|
subjects affected / exposed
|
2 / 1058 (0.19%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Hyponatraemia
|
|
subjects affected / exposed
|
4 / 1058 (0.38%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
Hypovolaemia
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Metabolic acidosis
|
|
subjects affected / exposed
|
1 / 1058 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |