Serious adverse events
|
Ld Cohort |
E-Ld Cohort |
Total subjects affected by serious adverse events
|
|
|
subjects affected / exposed
|
279 / 371 (75.20%) |
293 / 371 (78.98%) |
number of deaths (all causes)
|
232 |
240 |
number of deaths resulting from adverse events
|
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
Acute lymphocytic leukaemia
|
|
|
subjects affected / exposed
|
2 / 371 (0.54%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adenocarcinoma metastatic
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Adenocarcinoma pancreas
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Angiosarcoma
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Atypical fibroxanthoma
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Basal cell carcinoma
|
|
|
subjects affected / exposed
|
10 / 371 (2.70%) |
10 / 371 (2.70%) |
occurrences causally related to treatment / all
|
6 / 11 |
6 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Basosquamous carcinoma
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder neoplasm
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bowen's disease
|
|
|
subjects affected / exposed
|
2 / 371 (0.54%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholangiocarcinoma
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Colon cancer
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colon cancer metastatic
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
Hepatic cancer
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric cancer
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
Hepatocellular carcinoma
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intraductal proliferative breast lesion
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Keratoacanthoma
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laryngeal cancer
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lip squamous cell carcinoma
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laryngeal squamous cell carcinoma
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung adenocarcinoma
|
|
|
subjects affected / exposed
|
2 / 371 (0.54%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant melanoma
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Malignant melanoma in situ
|
|
|
subjects affected / exposed
|
2 / 371 (0.54%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant neoplasm progression
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Myelodysplastic syndrome
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nasal cavity cancer
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatic carcinoma
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Papilloma
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Plasma cell leukaemia
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Plasma cell myeloma
|
|
|
subjects affected / exposed
|
3 / 371 (0.81%) |
5 / 371 (1.35%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 3 |
Plasmacytoma
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostate cancer
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
5 / 371 (1.35%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal cancer
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectosigmoid cancer
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Refractory anaemia with ringed sideroblasts
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sebaceous carcinoma
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spindle cell sarcoma
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Squamous cell carcinoma
|
|
|
subjects affected / exposed
|
7 / 371 (1.89%) |
13 / 371 (3.50%) |
occurrences causally related to treatment / all
|
5 / 9 |
6 / 21 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Squamous cell carcinoma of skin
|
|
|
subjects affected / exposed
|
7 / 371 (1.89%) |
9 / 371 (2.43%) |
occurrences causally related to treatment / all
|
3 / 14 |
4 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Squamous cell carcinoma of head and neck
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transitional cell carcinoma
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
Squamous cell carcinoma of the oral cavity
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular disorders
|
|
|
Aortic aneurysm
|
|
|
subjects affected / exposed
|
2 / 371 (0.54%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Arteriosclerosis
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Circulatory collapse
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Deep vein thrombosis
|
|
|
subjects affected / exposed
|
10 / 371 (2.70%) |
9 / 371 (2.43%) |
occurrences causally related to treatment / all
|
8 / 10 |
7 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Embolism
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
3 / 371 (0.81%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Embolism venous
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematoma
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertension
|
|
|
subjects affected / exposed
|
2 / 371 (0.54%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypotension
|
|
|
subjects affected / exposed
|
2 / 371 (0.54%) |
7 / 371 (1.89%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 7 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Hypovolaemic shock
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Malignant hypertension
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Orthostatic hypotension
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery thrombosis
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral ischaemia
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Superficial vein thrombosis
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombophlebitis
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
2 / 371 (0.54%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombosis
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Venous thrombosis
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
General disorders and administration site conditions
|
|
|
Adverse drug reaction
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Asthenia
|
|
|
subjects affected / exposed
|
6 / 371 (1.62%) |
3 / 371 (0.81%) |
occurrences causally related to treatment / all
|
1 / 6 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chest pain
|
|
|
subjects affected / exposed
|
4 / 371 (1.08%) |
2 / 371 (0.54%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Complication associated with device
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Death
|
|
|
subjects affected / exposed
|
3 / 371 (0.81%) |
2 / 371 (0.54%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 2 |
Disease progression
|
|
|
subjects affected / exposed
|
5 / 371 (1.35%) |
8 / 371 (2.16%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 8 |
Fat necrosis
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
General physical health deterioration
|
|
|
subjects affected / exposed
|
5 / 371 (1.35%) |
3 / 371 (0.81%) |
occurrences causally related to treatment / all
|
1 / 5 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Fatigue
|
|
|
subjects affected / exposed
|
2 / 371 (0.54%) |
2 / 371 (0.54%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inflammation
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
2 / 371 (0.54%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malaise
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Multiple organ dysfunction syndrome
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Non-cardiac chest pain
|
|
|
subjects affected / exposed
|
3 / 371 (0.81%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oedema peripheral
|
|
|
subjects affected / exposed
|
4 / 371 (1.08%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
2 / 4 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oedema
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pain
|
|
|
subjects affected / exposed
|
3 / 371 (0.81%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Performance status decreased
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyrexia
|
|
|
subjects affected / exposed
|
7 / 371 (1.89%) |
19 / 371 (5.12%) |
occurrences causally related to treatment / all
|
1 / 7 |
11 / 21 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sudden cardiac death
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Sudden death
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
2 / 371 (0.54%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
Systemic inflammatory response syndrome
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Immune system disorders
|
|
|
Drug hypersensitivity
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypersensitivity
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
2 / 371 (0.54%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Reproductive system and breast disorders
|
|
|
Endometrial hyperplasia
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine prolapse
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory, thoracic and mediastinal disorders
|
|
|
Acute pulmonary oedema
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
2 / 371 (0.54%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Acute respiratory failure
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
3 / 371 (0.81%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Bronchiectasis
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 14 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchopneumopathy
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Bronchospasm
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic obstructive pulmonary disease
|
|
|
subjects affected / exposed
|
7 / 371 (1.89%) |
3 / 371 (0.81%) |
occurrences causally related to treatment / all
|
3 / 10 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cough
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dyspnoea
|
|
|
subjects affected / exposed
|
8 / 371 (2.16%) |
13 / 371 (3.50%) |
occurrences causally related to treatment / all
|
1 / 8 |
3 / 15 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Epistaxis
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoxia
|
|
|
subjects affected / exposed
|
2 / 371 (0.54%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Interstitial lung disease
|
|
|
subjects affected / exposed
|
3 / 371 (0.81%) |
3 / 371 (0.81%) |
occurrences causally related to treatment / all
|
0 / 3 |
2 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleural effusion
|
|
|
subjects affected / exposed
|
3 / 371 (0.81%) |
5 / 371 (1.35%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pleuritic pain
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonitis
|
|
|
subjects affected / exposed
|
4 / 371 (1.08%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumothorax
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary congestion
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary embolism
|
|
|
subjects affected / exposed
|
15 / 371 (4.04%) |
12 / 371 (3.23%) |
occurrences causally related to treatment / all
|
14 / 15 |
9 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary oedema
|
|
|
subjects affected / exposed
|
4 / 371 (1.08%) |
3 / 371 (0.81%) |
occurrences causally related to treatment / all
|
1 / 4 |
2 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Respiratory depression
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Respiratory disorder
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory distress
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
2 / 371 (0.54%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Respiratory failure
|
|
|
subjects affected / exposed
|
3 / 371 (0.81%) |
4 / 371 (1.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Restrictive pulmonary disease
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinus disorder
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vocal cord disorder
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psychiatric disorders
|
|
|
Anxiety
|
|
|
subjects affected / exposed
|
2 / 371 (0.54%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Completed suicide
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Confusional state
|
|
|
subjects affected / exposed
|
5 / 371 (1.35%) |
5 / 371 (1.35%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Delirium
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
2 / 371 (0.54%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Delusional disorder, unspecified type
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Depression
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
2 / 371 (0.54%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mental status changes
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psychotic disorder
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Product issues
|
|
|
Device dislocation
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
2 / 371 (0.54%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Investigations
|
|
|
Alanine aminotransferase increased
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
4 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aspartate aminotransferase increased
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
3 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacterial test positive
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood creatinine increased
|
|
|
subjects affected / exposed
|
2 / 371 (0.54%) |
2 / 371 (0.54%) |
occurrences causally related to treatment / all
|
1 / 2 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
C-reactive protein increased
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemoglobin decreased
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic enzyme increased
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Influenza A virus test positive
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Influenza B virus test positive
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Liver function test abnormal
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory syncytial virus test positive
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respirovirus test positive
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transaminases increased
|
|
|
subjects affected / exposed
|
2 / 371 (0.54%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Viral test positive
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Weight decreased
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Injury, poisoning and procedural complications
|
|
|
Accidental overdose
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Combined tibia-fibula fracture
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Comminuted fracture
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Extradural haematoma
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fall
|
|
|
subjects affected / exposed
|
3 / 371 (0.81%) |
3 / 371 (0.81%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Femoral neck fracture
|
|
|
subjects affected / exposed
|
2 / 371 (0.54%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Femur fracture
|
|
|
subjects affected / exposed
|
8 / 371 (2.16%) |
4 / 371 (1.08%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fibula fracture
|
|
|
subjects affected / exposed
|
2 / 371 (0.54%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fracture
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
3 / 371 (0.81%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Head injury
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hip fracture
|
|
|
subjects affected / exposed
|
4 / 371 (1.08%) |
5 / 371 (1.35%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Humerus fracture
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint injury
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infusion related reaction
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lumbar vertebral fracture
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Medication error
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pelvic fracture
|
|
|
subjects affected / exposed
|
2 / 371 (0.54%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Overdose
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
2 / 371 (0.54%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural complication
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Rib fracture
|
|
|
subjects affected / exposed
|
4 / 371 (1.08%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Shunt malfunction
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin laceration
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal compression fracture
|
|
|
subjects affected / exposed
|
4 / 371 (1.08%) |
2 / 371 (0.54%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal fracture
|
|
|
subjects affected / exposed
|
3 / 371 (0.81%) |
2 / 371 (0.54%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stress fracture
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subdural haematoma
|
|
|
subjects affected / exposed
|
2 / 371 (0.54%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Thoracic vertebral fracture
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tibia fracture
|
|
|
subjects affected / exposed
|
2 / 371 (0.54%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Traumatic fracture
|
|
|
subjects affected / exposed
|
2 / 371 (0.54%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wrist fracture
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Upper limb fracture
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Congenital, familial and genetic disorders
|
|
|
Corneal dystrophy
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac disorders
|
|
|
Acute coronary syndrome
|
|
|
subjects affected / exposed
|
2 / 371 (0.54%) |
2 / 371 (0.54%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute myocardial infarction
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
7 / 371 (1.89%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Angina pectoris
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
2 / 371 (0.54%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Angina unstable
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic valve calcification
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic valve incompetence
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Arrhythmia
|
|
|
subjects affected / exposed
|
2 / 371 (0.54%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
1 / 1 |
Atrial fibrillation
|
|
|
subjects affected / exposed
|
12 / 371 (3.23%) |
22 / 371 (5.93%) |
occurrences causally related to treatment / all
|
4 / 14 |
3 / 26 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 2 |
Atrial flutter
|
|
|
subjects affected / exposed
|
3 / 371 (0.81%) |
4 / 371 (1.08%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrial tachycardia
|
|
|
subjects affected / exposed
|
2 / 371 (0.54%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrial thrombosis
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrioventricular block
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bradycardia
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac arrest
|
|
|
subjects affected / exposed
|
6 / 371 (1.62%) |
7 / 371 (1.89%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 6 |
0 / 6 |
Cardiac failure
|
|
|
subjects affected / exposed
|
7 / 371 (1.89%) |
13 / 371 (3.50%) |
occurrences causally related to treatment / all
|
0 / 7 |
1 / 16 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 4 |
Cardiac failure acute
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cardiac failure chronic
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac failure congestive
|
|
|
subjects affected / exposed
|
4 / 371 (1.08%) |
4 / 371 (1.08%) |
occurrences causally related to treatment / all
|
2 / 4 |
2 / 6 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cardiac septal hypertrophy
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac ventricular thrombosis
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiogenic shock
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cardio-respiratory arrest
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Cardiomyopathy
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiopulmonary failure
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cardiovascular disorder
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
2 / 371 (0.54%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Congestive cardiomyopathy
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery disease
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
2 / 371 (0.54%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Left ventricular dysfunction
|
|
|
subjects affected / exposed
|
2 / 371 (0.54%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mitral valve incompetence
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
2 / 371 (0.54%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Myocardial infarction
|
|
|
subjects affected / exposed
|
5 / 371 (1.35%) |
6 / 371 (1.62%) |
occurrences causally related to treatment / all
|
1 / 5 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
Pericarditis
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myocardial ischaemia
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
2 / 371 (0.54%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prinzmetal angina
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinus arrest
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinus node dysfunction
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
3 / 371 (0.81%) |
occurrences causally related to treatment / all
|
0 / 1 |
2 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinus tachycardia
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Systolic dysfunction
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Supraventricular tachycardia
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tachycardia
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
3 / 371 (0.81%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Torsade de pointes
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular arrhythmia
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nervous system disorders
|
|
|
Ataxia
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid artery stenosis
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebellar haemorrhage
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral haemorrhage
|
|
|
subjects affected / exposed
|
3 / 371 (0.81%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Cerebral infarction
|
|
|
subjects affected / exposed
|
2 / 371 (0.54%) |
2 / 371 (0.54%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral ischaemia
|
|
|
subjects affected / exposed
|
2 / 371 (0.54%) |
3 / 371 (0.81%) |
occurrences causally related to treatment / all
|
0 / 2 |
2 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cerebrovascular accident
|
|
|
subjects affected / exposed
|
7 / 371 (1.89%) |
8 / 371 (2.16%) |
occurrences causally related to treatment / all
|
5 / 8 |
3 / 8 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Coma
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cognitive disorder
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dementia
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Depressed level of consciousness
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dizziness
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dizziness postural
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Encephalopathy
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dysarthria
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
2 / 371 (0.54%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Generalised tonic-clonic seizure
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Guillain-Barre syndrome
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhage intracranial
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhagic cerebral infarction
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhagic stroke
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Headache
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intracranial aneurysm
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intracranial haematoma
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic cerebral infarction
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic stroke
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
4 / 371 (1.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
2 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Lethargy
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Loss of consciousness
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Memory impairment
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolic encephalopathy
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Migraine
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myelopathy
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Normal pressure hydrocephalus
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Presyncope
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
2 / 371 (0.54%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sciatica
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal cord compression
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Somnolence
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subarachnoid haemorrhage
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
2 / 371 (0.54%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Syncope
|
|
|
subjects affected / exposed
|
5 / 371 (1.35%) |
7 / 371 (1.89%) |
occurrences causally related to treatment / all
|
0 / 5 |
2 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transient aphasia
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transient ischaemic attack
|
|
|
subjects affected / exposed
|
4 / 371 (1.08%) |
6 / 371 (1.62%) |
occurrences causally related to treatment / all
|
0 / 4 |
1 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood and lymphatic system disorders
|
|
|
Agranulocytosis
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaemia
|
|
|
subjects affected / exposed
|
12 / 371 (3.23%) |
12 / 371 (3.23%) |
occurrences causally related to treatment / all
|
4 / 17 |
5 / 16 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Febrile neutropenia
|
|
|
subjects affected / exposed
|
3 / 371 (0.81%) |
5 / 371 (1.35%) |
occurrences causally related to treatment / all
|
1 / 3 |
3 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemolysis
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemolytic anaemia
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neutropenia
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancytopenia
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
4 / 371 (1.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Plasmacytosis
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Thrombocytopenia
|
|
|
subjects affected / exposed
|
2 / 371 (0.54%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
2 / 2 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ear and labyrinth disorders
|
|
|
Sudden hearing loss
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertigo
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eye disorders
|
|
|
Blindness transient
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cataract
|
|
|
subjects affected / exposed
|
9 / 371 (2.43%) |
10 / 371 (2.70%) |
occurrences causally related to treatment / all
|
8 / 13 |
6 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cataract cortical
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epiretinal membrane
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Optic ischaemic neuropathy
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal detachment
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal disorders
|
|
|
Abdominal pain
|
|
|
subjects affected / exposed
|
2 / 371 (0.54%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
1 / 2 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal pain lower
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal pain upper
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anorectal varices haemorrhage
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colitis
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colitis ulcerative
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Constipation
|
|
|
subjects affected / exposed
|
2 / 371 (0.54%) |
3 / 371 (0.81%) |
occurrences causally related to treatment / all
|
1 / 2 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diaphragmatic hernia
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diarrhoea
|
|
|
subjects affected / exposed
|
10 / 371 (2.70%) |
9 / 371 (2.43%) |
occurrences causally related to treatment / all
|
3 / 11 |
2 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulum intestinal
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenal ulcer
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enteritis
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterovesical fistula
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Femoral hernia
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastritis
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
4 / 371 (1.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
2 / 371 (0.54%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hiatus hernia
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ileus
|
|
|
subjects affected / exposed
|
2 / 371 (0.54%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Incarcerated inguinal hernia
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incarcerated umbilical hernia
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inguinal hernia
|
|
|
subjects affected / exposed
|
2 / 371 (0.54%) |
3 / 371 (0.81%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inguinal hernia strangulated
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal infarction
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal obstruction
|
|
|
subjects affected / exposed
|
2 / 371 (0.54%) |
4 / 371 (1.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal perforation
|
|
|
subjects affected / exposed
|
2 / 371 (0.54%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestine polyp
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower gastrointestinal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Melaena
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nausea
|
|
|
subjects affected / exposed
|
3 / 371 (0.81%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
2 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Odynophagia
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal ulcer
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophagitis
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oroantral fistula
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatitis
|
|
|
subjects affected / exposed
|
3 / 371 (0.81%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatitis acute
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumatosis intestinalis
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal haemorrhage
|
|
|
subjects affected / exposed
|
2 / 371 (0.54%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small intestinal obstruction
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Umbilical hernia
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Varices oesophageal
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vomiting
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
3 / 371 (0.81%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatobiliary disorders
|
|
|
Bile duct stone
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Biliary obstruction
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
2 / 371 (0.54%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis acute
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
2 / 371 (0.54%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis chronic
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholelithiasis
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gallbladder rupture
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydrocholecystis
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Jaundice
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin and subcutaneous tissue disorders
|
|
|
Actinic keratosis
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Angioedema
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cold sweat
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cutaneous vasculitis
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dermatitis bullous
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dermatitis exfoliative generalised
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic foot
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Erythema
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Exfoliative rash
|
|
|
subjects affected / exposed
|
2 / 371 (0.54%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Purpura
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rash
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rash maculo-papular
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin ulcer
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stasis dermatitis
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subcutaneous emphysema
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stevens-Johnson syndrome
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal and urinary disorders
|
|
|
Acute kidney injury
|
|
|
subjects affected / exposed
|
20 / 371 (5.39%) |
20 / 371 (5.39%) |
occurrences causally related to treatment / all
|
4 / 21 |
4 / 20 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
Calculus urinary
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic kidney disease
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
2 / 371 (0.54%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
End stage renal disease
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myeloma cast nephropathy
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Haematuria
|
|
|
subjects affected / exposed
|
2 / 371 (0.54%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal failure
|
|
|
subjects affected / exposed
|
7 / 371 (1.89%) |
10 / 371 (2.70%) |
occurrences causally related to treatment / all
|
2 / 7 |
5 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephrolithiasis
|
|
|
subjects affected / exposed
|
2 / 371 (0.54%) |
2 / 371 (0.54%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal impairment
|
|
|
subjects affected / exposed
|
3 / 371 (0.81%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal injury
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal tubular necrosis
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary retention
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
2 / 371 (0.54%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary tract disorder
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endocrine disorders
|
|
|
Adrenal insufficiency
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal and connective tissue disorders
|
|
|
Arthralgia
|
|
|
subjects affected / exposed
|
2 / 371 (0.54%) |
2 / 371 (0.54%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthritis
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthritis reactive
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Back pain
|
|
|
subjects affected / exposed
|
9 / 371 (2.43%) |
11 / 371 (2.96%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bone pain
|
|
|
subjects affected / exposed
|
4 / 371 (1.08%) |
3 / 371 (0.81%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bursitis
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chondrocalcinosis
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chondrocalcinosis pyrophosphate
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral disc protrusion
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Flank pain
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscle contracture
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint hyperextension
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscular weakness
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal chest pain
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal disorder
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal pain
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteitis
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteoarthritis
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
3 / 371 (0.81%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteonecrosis
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
2 / 371 (0.54%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteonecrosis of jaw
|
|
|
subjects affected / exposed
|
2 / 371 (0.54%) |
3 / 371 (0.81%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pain in extremity
|
|
|
subjects affected / exposed
|
2 / 371 (0.54%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pathological fracture
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal pain
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
3 / 371 (0.81%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal stenosis
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infections and infestations
|
|
|
Abdominal abscess
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abscess limb
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abscess
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Appendicitis
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atypical pneumonia
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Bacteraemia
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacterial prostatitis
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Biliary sepsis
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchitis
|
|
|
subjects affected / exposed
|
6 / 371 (1.62%) |
18 / 371 (4.85%) |
occurrences causally related to treatment / all
|
1 / 6 |
6 / 20 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bursitis infective
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cellulitis
|
|
|
subjects affected / exposed
|
8 / 371 (2.16%) |
9 / 371 (2.43%) |
occurrences causally related to treatment / all
|
1 / 9 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cellulitis orbital
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Central nervous system infection
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clostridial sepsis
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clostridium colitis
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Clostridium difficile colitis
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
2 / 371 (0.54%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clostridium difficile infection
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
2 / 371 (0.54%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dacryocystitis
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device related infection
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulitis
|
|
|
subjects affected / exposed
|
3 / 371 (0.81%) |
5 / 371 (1.35%) |
occurrences causally related to treatment / all
|
0 / 3 |
4 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Erysipelas
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
2 / 371 (0.54%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Escherichia bacteraemia
|
|
|
subjects affected / exposed
|
2 / 371 (0.54%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Escherichia infection
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Escherichia urinary tract infection
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Febrile infection
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
2 / 371 (0.54%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis
|
|
|
subjects affected / exposed
|
2 / 371 (0.54%) |
8 / 371 (2.16%) |
occurrences causally related to treatment / all
|
0 / 2 |
2 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis clostridial
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis salmonella
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal infection
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis viral
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
H1N1 influenza
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis E
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Herpes zoster
|
|
|
subjects affected / exposed
|
2 / 371 (0.54%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Herpes zoster disseminated
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infected cyst
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infection
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
4 / 371 (1.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
2 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infectious pleural effusion
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Influenza
|
|
|
subjects affected / exposed
|
6 / 371 (1.62%) |
7 / 371 (1.89%) |
occurrences causally related to treatment / all
|
1 / 7 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral discitis
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestine infection
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Leishmaniasis
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Liver abscess
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Localised infection
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meningitis listeria
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Lower respiratory tract infection
|
|
|
subjects affected / exposed
|
8 / 371 (2.16%) |
9 / 371 (2.43%) |
occurrences causally related to treatment / all
|
4 / 8 |
1 / 10 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Metapneumovirus bronchiolitis
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metapneumovirus infection
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neutropenic sepsis
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Orchitis
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Perirectal abscess
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peritonitis
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Pharyngitis
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Plague
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleural infection
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pneumococcal sepsis
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumocystis jirovecii pneumonia
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
2 / 371 (0.54%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Pneumonia
|
|
|
subjects affected / exposed
|
48 / 371 (12.94%) |
60 / 371 (16.17%) |
occurrences causally related to treatment / all
|
11 / 58 |
21 / 80 |
deaths causally related to treatment / all
|
1 / 5 |
2 / 10 |
Pneumonia aspiration
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
5 / 371 (1.35%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Pneumonia bacterial
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia cytomegaloviral
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia fungal
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
2 / 371 (0.54%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia influenzal
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia legionella
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pneumonia staphylococcal
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
Pneumonia streptococcal
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia viral
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Progressive multifocal leukoencephalopathy
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
Pseudomembranous colitis
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyelonephritis
|
|
|
subjects affected / exposed
|
2 / 371 (0.54%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyoderma
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory syncytial virus infection
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory tract infection
|
|
|
subjects affected / exposed
|
3 / 371 (0.81%) |
8 / 371 (2.16%) |
occurrences causally related to treatment / all
|
2 / 5 |
2 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Sepsis
|
|
|
subjects affected / exposed
|
6 / 371 (1.62%) |
15 / 371 (4.04%) |
occurrences causally related to treatment / all
|
3 / 6 |
1 / 15 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 5 |
Septic shock
|
|
|
subjects affected / exposed
|
6 / 371 (1.62%) |
4 / 371 (1.08%) |
occurrences causally related to treatment / all
|
2 / 6 |
0 / 4 |
deaths causally related to treatment / all
|
2 / 5 |
0 / 4 |
Staphylococcal infection
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
2 / 371 (0.54%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Staphylococcal sepsis
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subcutaneous abscess
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Upper respiratory tract infection
|
|
|
subjects affected / exposed
|
4 / 371 (1.08%) |
5 / 371 (1.35%) |
occurrences causally related to treatment / all
|
1 / 4 |
1 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Urinary tract infection
|
|
|
subjects affected / exposed
|
11 / 371 (2.96%) |
15 / 371 (4.04%) |
occurrences causally related to treatment / all
|
3 / 13 |
2 / 19 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary tract infection bacterial
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary tract infection enterococcal
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urosepsis
|
|
|
subjects affected / exposed
|
5 / 371 (1.35%) |
5 / 371 (1.35%) |
occurrences causally related to treatment / all
|
2 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Varicella zoster virus infection
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular device infection
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Viral infection
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Whipple's disease
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Wound infection staphylococcal
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolism and nutrition disorders
|
|
|
Alcohol intolerance
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Decreased appetite
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dehydration
|
|
|
subjects affected / exposed
|
5 / 371 (1.35%) |
7 / 371 (1.89%) |
occurrences causally related to treatment / all
|
2 / 5 |
1 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic complication
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic ketoacidosis
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic metabolic decompensation
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Electrolyte imbalance
|
|
|
subjects affected / exposed
|
2 / 371 (0.54%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Failure to thrive
|
|
|
subjects affected / exposed
|
2 / 371 (0.54%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
1 / 2 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gout
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypercalcaemia
|
|
|
subjects affected / exposed
|
5 / 371 (1.35%) |
2 / 371 (0.54%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperglycaemia
|
|
|
subjects affected / exposed
|
2 / 371 (0.54%) |
3 / 371 (0.81%) |
occurrences causally related to treatment / all
|
2 / 2 |
3 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypervolaemia
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoalbuminaemia
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypocalcaemia
|
|
|
subjects affected / exposed
|
4 / 371 (1.08%) |
4 / 371 (1.08%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoglycaemia
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
5 / 371 (1.35%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypokalaemia
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
4 / 371 (1.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypomagnesaemia
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
4 / 371 (1.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyponatraemia
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
2 / 371 (0.54%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypophosphataemia
|
|
|
subjects affected / exposed
|
0 / 371 (0.00%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malnutrition
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
0 / 371 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tumour lysis syndrome
|
|
|
subjects affected / exposed
|
1 / 371 (0.27%) |
1 / 371 (0.27%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |