Serious adverse events
|
Imatinib 400mg daily |
Dasatinib 100mg daily |
Total subjects affected by serious adverse events
|
|
|
subjects affected / exposed
|
141 / 406 (34.73%) |
234 / 406 (57.64%) |
number of deaths (all causes)
|
34 |
31 |
number of deaths resulting from adverse events
|
20 |
18 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
ACUTE LYMPHOCYTIC LEUKAEMIA
|
|
|
subjects affected / exposed
|
2 / 406 (0.49%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
ACUTE MYELOID LEUKAEMIA
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
3 / 406 (0.74%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 3 |
ADENOCARCINOMA
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
B PRECURSOR TYPE ACUTE LEUKAEMIA
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
B-CELL LYMPHOMA
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
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
|
3 / 406 (0.74%) |
5 / 406 (1.23%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
BLADDER TRANSITIONAL CELL CARCINOMA
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
BLAST CELL CRISIS
|
|
|
subjects affected / exposed
|
2 / 406 (0.49%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
BLAST CRISIS IN MYELOGENOUS LEUKAEMIA
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
BREAST CANCER
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
2 / 406 (0.49%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
CHOLANGIOCARCINOMA
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
CHRONIC MYELOID LEUKAEMIA
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
COLON CANCER
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
DIFFUSE LARGE B-CELL LYMPHOMA
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ENDOMETRIAL CANCER
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ENDOMETRIAL CANCER METASTATIC
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
FOCAL NODULAR HYPERPLASIA
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
GASTRIC CANCER
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
INTRADUCTAL PROLIFERATIVE BREAST LESION
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
KERATOACANTHOMA
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
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
|
1 / 406 (0.25%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
LYMPHOMA
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
MALIGNANT NEOPLASM PROGRESSION
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
MENINGIOMA
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
MENINGIOMA MALIGNANT
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
METASTASES TO RECTUM
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
METASTASIS
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
MYELODYSPLASTIC SYNDROME
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PARATHYROID TUMOUR BENIGN
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PLASMA CELL MYELOMA
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
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
|
4 / 406 (0.99%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
RECTAL ADENOMA
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
RENAL CANCER
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
RENAL ONCOCYTOMA
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
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
|
2 / 406 (0.49%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 3 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SQUAMOUS CELL CARCINOMA OF LUNG
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
2 / 406 (0.49%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
TERATOMA
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
UTERINE LEIOMYOMA
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
2 / 406 (0.49%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular disorders
|
|
|
AORTIC ANEURYSM
|
|
|
subjects affected / exposed
|
2 / 406 (0.49%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
AORTIC STENOSIS
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ARTERIAL STENOSIS
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
DEEP VEIN THROMBOSIS
|
|
|
subjects affected / exposed
|
4 / 406 (0.99%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 4 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HAEMATOMA
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HAEMORRHAGE
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (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
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HYPOTENSION
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
INTERMITTENT CLAUDICATION
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
INTERNAL HAEMORRHAGE
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
LYMPHOEDEMA
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PERIPHERAL ARTERY OCCLUSION
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PERIPHERAL ISCHAEMIA
|
|
|
subjects affected / exposed
|
2 / 406 (0.49%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
THROMBOSIS
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
VASODILATATION
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Surgical and medical procedures
|
|
|
BREAST OPERATION
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CHOLECYSTECTOMY
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HERNIA REPAIR
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HIP ARTHROPLASTY
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
JOINT DEBRIDEMENT
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 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 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CATHETER SITE EXTRAVASATION
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CATHETER SITE HAEMORRHAGE
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CHEST PAIN
|
|
|
subjects affected / exposed
|
2 / 406 (0.49%) |
10 / 406 (2.46%) |
occurrences causally related to treatment / all
|
0 / 2 |
2 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
DISEASE PROGRESSION
|
|
|
subjects affected / exposed
|
3 / 406 (0.74%) |
2 / 406 (0.49%) |
occurrences causally related to treatment / all
|
1 / 3 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
GENERAL PHYSICAL HEALTH DETERIORATION
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
GENERALISED OEDEMA
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
INFLUENZA LIKE ILLNESS
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
3 / 406 (0.74%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
MUCOSAL ULCERATION
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
NON-CARDIAC CHEST PAIN
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
OEDEMA
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
OEDEMA PERIPHERAL
|
|
|
subjects affected / exposed
|
3 / 406 (0.74%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
3 / 3 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PAIN
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PERIPHERAL SWELLING
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
2 / 406 (0.49%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PYREXIA
|
|
|
subjects affected / exposed
|
3 / 406 (0.74%) |
12 / 406 (2.96%) |
occurrences causally related to treatment / all
|
1 / 3 |
6 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Immune system disorders
|
|
|
ANAPHYLACTIC REACTION
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
DRUG HYPERSENSITIVITY
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HYPERSENSITIVITY
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Reproductive system and breast disorders
|
|
|
DYSMENORRHOEA
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
MENORRHAGIA
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
OEDEMA GENITAL
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PRIAPISM
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
TESTICULAR SWELLING
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory, thoracic and mediastinal disorders
|
|
|
ASTHMA
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
4 / 406 (0.99%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
|
|
subjects affected / exposed
|
2 / 406 (0.49%) |
3 / 406 (0.74%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
COUGH
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
DYSPHONIA
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
DYSPNOEA
|
|
|
subjects affected / exposed
|
3 / 406 (0.74%) |
7 / 406 (1.72%) |
occurrences causally related to treatment / all
|
0 / 3 |
3 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
EMPHYSEMA
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
EPISTAXIS
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HAEMOPTYSIS
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HAEMOTHORAX
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HYPOXIA
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
OROPHARYNGEAL PAIN
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PLEURAL EFFUSION
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
56 / 406 (13.79%) |
occurrences causally related to treatment / all
|
0 / 1 |
61 / 65 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PLEURITIC PAIN
|
|
|
subjects affected / exposed
|
2 / 406 (0.49%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PNEUMONITIS
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PULMONARY ARTERIAL HYPERTENSION
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PULMONARY CONGESTION
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PULMONARY EMBOLISM
|
|
|
subjects affected / exposed
|
2 / 406 (0.49%) |
2 / 406 (0.49%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PULMONARY HYPERTENSION
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
4 / 406 (0.99%) |
occurrences causally related to treatment / all
|
0 / 0 |
4 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PULMONARY OEDEMA
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psychiatric disorders
|
|
|
CONFUSIONAL STATE
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
2 / 406 (0.49%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
DEPRESSION
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
MAJOR DEPRESSION
|
|
|
subjects affected / exposed
|
2 / 406 (0.49%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
MENTAL DISORDER
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PSYCHOTIC DISORDER
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SUICIDE ATTEMPT
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Investigations
|
|
|
ALANINE AMINOTRANSFERASE INCREASED
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
BLOOD CREATININE INCREASED
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
BLOOD UREA INCREASED
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ELECTROCARDIOGRAM QT PROLONGED
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ELECTROCARDIOGRAM ST-T SEGMENT ABNORMAL
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HAEMOGLOBIN DECREASED
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
LIVER FUNCTION TEST INCREASED
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Injury, poisoning and procedural complications
|
|
|
ACCIDENTAL OVERDOSE
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ANKLE FRACTURE
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CATARACT OPERATION COMPLICATION
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
FACIAL BONES FRACTURE
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
FALL
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
2 / 406 (0.49%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HUMERUS FRACTURE
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
INJURY
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
INTENTIONAL OVERDOSE
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
JOINT DISLOCATION
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
JOINT INJURY
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
LACERATION
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
LUMBAR VERTEBRAL FRACTURE
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
OPEN FRACTURE
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
POST PROCEDURAL COMPLICATION
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
POST PROCEDURAL HAEMORRHAGE
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
RIB FRACTURE
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SOFT TISSUE INJURY
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
STERNAL FRACTURE
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SUBARACHNOID HAEMORRHAGE
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
2 / 406 (0.49%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SUBDURAL HAEMORRHAGE
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
2 / 406 (0.49%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SYNOVIAL RUPTURE
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
TRANSFUSION REACTION
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
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
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Congenital, familial and genetic disorders
|
|
|
ATRIAL SEPTAL DEFECT
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ICHTHYOSIS
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac disorders
|
|
|
ACUTE CORONARY SYNDROME
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
2 / 406 (0.49%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
ACUTE MYOCARDIAL INFARCTION
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
3 / 406 (0.74%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
AGONAL RHYTHM
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
ANGINA PECTORIS
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
2 / 406 (0.49%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ARRHYTHMIA
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ATRIAL FIBRILLATION
|
|
|
subjects affected / exposed
|
7 / 406 (1.72%) |
3 / 406 (0.74%) |
occurrences causally related to treatment / all
|
0 / 9 |
1 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ATRIAL FLUTTER
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ATRIOVENTRICULAR BLOCK
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ATRIOVENTRICULAR BLOCK FIRST DEGREE
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
BRADYCARDIA
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CARDIAC ARREST
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
CARDIAC FAILURE
|
|
|
subjects affected / exposed
|
4 / 406 (0.99%) |
4 / 406 (0.99%) |
occurrences causally related to treatment / all
|
0 / 4 |
2 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
CARDIAC FAILURE CONGESTIVE
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
1 / 1 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CARDIAC TAMPONADE
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CARDIOMEGALY
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CORONARY ARTERY DISEASE
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CYANOSIS
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
LEFT VENTRICULAR FAILURE
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
MYOCARDIAL INFARCTION
|
|
|
subjects affected / exposed
|
2 / 406 (0.49%) |
2 / 406 (0.49%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
MYOCARDIAL ISCHAEMIA
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
3 / 406 (0.74%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PALPITATIONS
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
2 / 406 (0.49%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PERICARDIAL EFFUSION
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
5 / 406 (1.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
5 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PERICARDITIS
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SUPRAVENTRICULAR TACHYCARDIA
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nervous system disorders
|
|
|
AMNESIA
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
BALANCE DISORDER
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CENTRAL NERVOUS SYSTEM HAEMORRHAGE
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
CEREBELLAR HAEMORRHAGE
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CEREBRAL INFARCTION
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CEREBROVASCULAR ACCIDENT
|
|
|
subjects affected / exposed
|
2 / 406 (0.49%) |
3 / 406 (0.74%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
DIZZINESS
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
2 / 406 (0.49%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HEADACHE
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
2 / 406 (0.49%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ISCHAEMIC STROKE
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
LACUNAR INFARCTION
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (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 / 406 (0.25%) |
0 / 406 (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 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
NEUROPATHY PERIPHERAL
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
OPTIC NEURITIS
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PERIPHERAL SENSORY NEUROPATHY
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PRESYNCOPE
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SEIZURE
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SOMNOLENCE
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SPEECH DISORDER
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SYNCOPE
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
TRANSIENT ISCHAEMIC ATTACK
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood and lymphatic system disorders
|
|
|
ANAEMIA
|
|
|
subjects affected / exposed
|
2 / 406 (0.49%) |
4 / 406 (0.99%) |
occurrences causally related to treatment / all
|
2 / 2 |
2 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CYTOPENIA
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
LYMPHADENOPATHY
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
NEUTROPENIA
|
|
|
subjects affected / exposed
|
3 / 406 (0.74%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
3 / 3 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
THROMBOCYTOPENIA
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
THROMBOCYTOSIS
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ear and labyrinth disorders
|
|
|
MENIERE'S DISEASE
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
MIDDLE EAR EFFUSION
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
VERTIGO POSITIONAL
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eye disorders
|
|
|
CORNEAL PERFORATION
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
EYE OEDEMA
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
EYE SWELLING
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
MACULAR DEGENERATION
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PERIORBITAL OEDEMA
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
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 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
VITREOUS HAEMORRHAGE
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal disorders
|
|
|
ABDOMINAL HERNIA
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ABDOMINAL HERNIA OBSTRUCTIVE
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ABDOMINAL PAIN
|
|
|
subjects affected / exposed
|
2 / 406 (0.49%) |
6 / 406 (1.48%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ABDOMINAL PAIN LOWER
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ABDOMINAL PAIN UPPER
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ANAL FISSURE
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ASCITES
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
2 / 406 (0.49%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
BARRETT'S OESOPHAGUS
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
COLITIS
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
2 / 406 (0.49%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CONSTIPATION
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CROHN'S DISEASE
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
DIARRHOEA
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
9 / 406 (2.22%) |
occurrences causally related to treatment / all
|
0 / 1 |
4 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
DIVERTICULUM
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
DUODENAL STENOSIS
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
DYSPHAGIA
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ENTEROCUTANEOUS FISTULA
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
EPIGASTRIC DISCOMFORT
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
EROSIVE DUODENITIS
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
GASTRIC MUCOSAL LESION
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
GASTRIC ULCER
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
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 / 406 (0.00%) |
2 / 406 (0.49%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
GASTROINTESTINAL HAEMORRHAGE
|
|
|
subjects affected / exposed
|
2 / 406 (0.49%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
HAEMATEMESIS
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
INTESTINAL OBSTRUCTION
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
INTESTINAL PERFORATION
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
LARGE INTESTINAL OBSTRUCTION
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
LARGE INTESTINAL STENOSIS
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
LARGE INTESTINE PERFORATION
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
NAUSEA
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PANCREATITIS ACUTE
|
|
|
subjects affected / exposed
|
2 / 406 (0.49%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
RECTAL HAEMORRHAGE
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SMALL INTESTINAL OBSTRUCTION
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
VOMITING
|
|
|
subjects affected / exposed
|
2 / 406 (0.49%) |
5 / 406 (1.23%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatobiliary disorders
|
|
|
BILIARY COLIC
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (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 / 406 (0.25%) |
2 / 406 (0.49%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
GALLBLADDER PAIN
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HEPATIC CIRRHOSIS
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
2 / 406 (0.49%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Skin and subcutaneous tissue disorders
|
|
|
ANGIOEDEMA
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ERYTHEMA MULTIFORME
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HYPERSENSITIVITY VASCULITIS
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PERIVASCULAR DERMATITIS
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
RASH
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
RASH MACULAR
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SKIN REACTION
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SWELLING FACE
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
VASCULITIC RASH
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal and urinary disorders
|
|
|
ACUTE KIDNEY INJURY
|
|
|
subjects affected / exposed
|
2 / 406 (0.49%) |
4 / 406 (0.99%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HAEMATURIA
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
2 / 406 (0.49%) |
occurrences causally related to treatment / all
|
0 / 0 |
3 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
NEPHROLITHIASIS
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
NEPHROTIC SYNDROME
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
POLLAKIURIA
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
URETHRAL DISORDER
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
URETHRAL STENOSIS
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
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 / 406 (0.00%) |
2 / 406 (0.49%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endocrine disorders
|
|
|
HYPERTHYROIDISM
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
THYROID MASS
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal and connective tissue disorders
|
|
|
ARTHRALGIA
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
3 / 406 (0.74%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ARTHRITIS
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
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
|
1 / 406 (0.25%) |
4 / 406 (0.99%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
BONE EROSION
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
BONE INFARCTION
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
COSTOCHONDRITIS
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
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 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
FRACTURE NONUNION
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
GROIN PAIN
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HAEMARTHROSIS
|
|
|
subjects affected / exposed
|
2 / 406 (0.49%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
INTERVERTEBRAL DISC PROTRUSION
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
2 / 406 (0.49%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
MOBILITY DECREASED
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
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
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
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 / 406 (0.25%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
MYALGIA
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
2 / 406 (0.49%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
NECK PAIN
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
OSTEITIS DEFORMANS
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
OSTEOARTHRITIS
|
|
|
subjects affected / exposed
|
4 / 406 (0.99%) |
2 / 406 (0.49%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
OSTEONECROSIS
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PAIN IN EXTREMITY
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PERIARTHRITIS
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ROTATOR CUFF SYNDROME
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SPINAL OSTEOARTHRITIS
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SPINAL PAIN
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SYNOVITIS
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infections and infestations
|
|
|
ABSCESS LIMB
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ANAL ABSCESS
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
APPENDICITIS
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ARTHRITIS BACTERIAL
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
BACTERIAL DISEASE CARRIER
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
BACTERIAL INFECTION
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
BILIARY SEPSIS
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
BRONCHITIS
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CAMPYLOBACTER GASTROENTERITIS
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CELLULITIS
|
|
|
subjects affected / exposed
|
4 / 406 (0.99%) |
16 / 406 (3.94%) |
occurrences causally related to treatment / all
|
1 / 4 |
3 / 24 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CELLULITIS STREPTOCOCCAL
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CLOSTRIDIUM DIFFICILE INFECTION
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
COLONIC ABSCESS
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CYSTITIS
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
DERMATITIS INFECTED
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
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 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
DEVICE RELATED SEPSIS
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
DIVERTICULITIS
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
2 / 406 (0.49%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ENDOCARDITIS
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ERYSIPELAS
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
2 / 406 (0.49%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
FOLLICULITIS
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
FUNGAL INFECTION
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
GASTROENTERITIS
|
|
|
subjects affected / exposed
|
2 / 406 (0.49%) |
8 / 406 (1.97%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
GASTROENTERITIS ASTROVIRAL
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
GASTROENTERITIS NOROVIRUS
|
|
|
subjects affected / exposed
|
2 / 406 (0.49%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
GASTROENTERITIS VIRAL
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
4 / 406 (0.99%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
GASTROINTESTINAL INFECTION
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
H1N1 INFLUENZA
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
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 / 406 (0.49%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
INFECTION
|
|
|
subjects affected / exposed
|
2 / 406 (0.49%) |
4 / 406 (0.99%) |
occurrences causally related to treatment / all
|
0 / 2 |
2 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
INFLUENZA
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
4 / 406 (0.99%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
KIDNEY INFECTION
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
LOCALISED INFECTION
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
LOWER RESPIRATORY TRACT INFECTION
|
|
|
subjects affected / exposed
|
8 / 406 (1.97%) |
14 / 406 (3.45%) |
occurrences causally related to treatment / all
|
0 / 8 |
2 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
LUNG INFECTION
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
NEUTROPENIC SEPSIS
|
|
|
subjects affected / exposed
|
3 / 406 (0.74%) |
2 / 406 (0.49%) |
occurrences causally related to treatment / all
|
3 / 3 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ORCHITIS
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
OTITIS EXTERNA
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PAROTITIS
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PERINEAL INFECTION
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PERIORBITAL CELLULITIS
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
2 / 406 (0.49%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PNEUMOCYSTIS JIROVECII PNEUMONIA
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PNEUMONIA
|
|
|
subjects affected / exposed
|
8 / 406 (1.97%) |
15 / 406 (3.69%) |
occurrences causally related to treatment / all
|
0 / 8 |
1 / 15 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 1 |
PNEUMONIA PNEUMOCOCCAL
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
POST PROCEDURAL CELLULITIS
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
POSTOPERATIVE WOUND INFECTION
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PYELONEPHRITIS ACUTE
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
RESPIRATORY SYNCYTIAL VIRUS INFECTION
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
RESPIRATORY TRACT INFECTION VIRAL
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SCARLET FEVER
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SEPSIS
|
|
|
subjects affected / exposed
|
5 / 406 (1.23%) |
3 / 406 (0.74%) |
occurrences causally related to treatment / all
|
1 / 5 |
1 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
STITCH ABSCESS
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
STREPTOCOCCAL INFECTION
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SUBCUTANEOUS ABSCESS
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
TUBERCULOSIS
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
URINARY TRACT INFECTION
|
|
|
subjects affected / exposed
|
2 / 406 (0.49%) |
5 / 406 (1.23%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
UROSEPSIS
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
2 / 406 (0.49%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
VIRAL INFECTION
|
|
|
subjects affected / exposed
|
3 / 406 (0.74%) |
2 / 406 (0.49%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
VIRAL SEPSIS
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
VIRAL TONSILLITIS
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
WOUND INFECTION
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
2 / 406 (0.49%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolism and nutrition disorders
|
|
|
DEHYDRATION
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
3 / 406 (0.74%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
FLUID RETENTION
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
GOUT
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HYPERGLYCAEMIA
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
2 / 406 (0.49%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HYPERKALAEMIA
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HYPERNATRAEMIA
|
|
|
subjects affected / exposed
|
0 / 406 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HYPOGLYCAEMIA
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HYPOKALAEMIA
|
|
|
subjects affected / exposed
|
2 / 406 (0.49%) |
0 / 406 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HYPONATRAEMIA
|
|
|
subjects affected / exposed
|
1 / 406 (0.25%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |