Serious adverse events
|
Risankizumab 150mg |
Total subjects affected by serious adverse events
|
|
subjects affected / exposed
|
435 / 2170 (20.05%) |
number of deaths (all causes)
|
28 |
number of deaths resulting from adverse events
|
28 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
COLORECTAL ADENOCARCINOMA
|
|
subjects affected / exposed
|
2 / 2170 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
ANAL CANCER
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
BASAL CELL CARCINOMA
|
|
subjects affected / exposed
|
2 / 2170 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
BILE DUCT CANCER
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
BLADDER CANCER
|
|
subjects affected / exposed
|
2 / 2170 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
BLADDER TRANSITIONAL CELL CARCINOMA
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
BORDERLINE MUCINOUS TUMOUR OF OVARY
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
BRAIN NEOPLASM MALIGNANT
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
COLON CANCER STAGE 0
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
COLON CANCER METASTATIC
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
CLEAR CELL RENAL CELL CARCINOMA
|
|
subjects affected / exposed
|
2 / 2170 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
CHRONIC LYMPHOCYTIC LEUKAEMIA
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
CHROMOPHOBE RENAL CELL CARCINOMA
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
BREAST CANCER STAGE II
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
BREAST CANCER RECURRENT
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
BREAST CANCER
|
|
subjects affected / exposed
|
2 / 2170 (0.09%) |
occurrences causally related to treatment / all
|
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
ADENOCARCINOMA OF COLON
|
|
subjects affected / exposed
|
3 / 2170 (0.14%) |
occurrences causally related to treatment / all
|
2 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
INVASIVE LOBULAR BREAST CARCINOMA
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
LARYNGEAL CANCER STAGE II
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
LARYNGEAL SQUAMOUS CELL CARCINOMA
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
LIPOSARCOMA METASTATIC
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
LUNG ADENOCARCINOMA
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
LUNG CANCER METASTATIC
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
1 / 1 |
LUNG NEOPLASM MALIGNANT
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
COLORECTAL ADENOMA
|
|
subjects affected / exposed
|
3 / 2170 (0.14%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
COLORECTAL CANCER
|
|
subjects affected / exposed
|
2 / 2170 (0.09%) |
occurrences causally related to treatment / all
|
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
ENDOMETRIAL ADENOCARCINOMA
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
ENDOMETRIAL CANCER STAGE II
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
GASTRIC CANCER
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
GERM CELL CANCER METASTATIC
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
GLIOBLASTOMA
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
HAEMANGIOMA OF LIVER
|
|
subjects affected / exposed
|
2 / 2170 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
HEPATIC CANCER
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
INVASIVE BREAST CARCINOMA
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
INVASIVE DUCTAL BREAST CARCINOMA
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
MALIGNANT MELANOMA
|
|
subjects affected / exposed
|
2 / 2170 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
SARCOMA UTERUS
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
MENINGIOMA
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
METASTATIC SQUAMOUS CELL CARCINOMA
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
PANCREATIC CARCINOMA
|
|
subjects affected / exposed
|
3 / 2170 (0.14%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
PANCREATIC CARCINOMA STAGE IV
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
PAPILLARY THYROID CANCER
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
PENILE SQUAMOUS CELL CARCINOMA
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
PLASMA CELL MYELOMA
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
PROSTATE CANCER
|
|
subjects affected / exposed
|
3 / 2170 (0.14%) |
occurrences causally related to treatment / all
|
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
PROSTATE CANCER METASTATIC
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
PROSTATE CANCER STAGE IV
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
RECTAL ADENOCARCINOMA
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
RECTAL CANCER
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
RENAL CANCER
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
RENAL CELL CARCINOMA
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
MALIGNANT MELANOMA IN SITU
|
|
subjects affected / exposed
|
2 / 2170 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
UTERINE CANCER
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
TRANSITIONAL CELL CARCINOMA
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
SUPERFICIAL SPREADING MELANOMA STAGE I
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
SQUAMOUS CELL CARCINOMA OF THE TONGUE
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
SQUAMOUS CELL CARCINOMA OF THE ORAL CAVITY
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
SQUAMOUS CELL CARCINOMA OF SKIN
|
|
subjects affected / exposed
|
2 / 2170 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
SCHWANNOMA
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
UTERINE LEIOMYOMA
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
UTERINE MYOMA EXPULSION
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
TRIPLE NEGATIVE BREAST CANCER
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Vascular disorders
|
|
HYPERTENSIVE URGENCY
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
HYPERTENSION
|
|
subjects affected / exposed
|
2 / 2170 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
EMBOLISM ARTERIAL
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
AORTIC ANEURYSM
|
|
subjects affected / exposed
|
3 / 2170 (0.14%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
AORTIC STENOSIS
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
ARTERIOSCLEROSIS
|
|
subjects affected / exposed
|
2 / 2170 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
DEEP VEIN THROMBOSIS
|
|
subjects affected / exposed
|
2 / 2170 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
VARICOSE VEIN
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
PELVIC VENOUS THROMBOSIS
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
VASCULAR STENOSIS
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Surgical and medical procedures
|
|
ABDOMINOPLASTY
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
ABORTION INDUCED
|
|
subjects affected / exposed
|
4 / 2170 (0.18%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
Pregnancy, puerperium and perinatal conditions
|
|
ECLAMPSIA
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
ABORTION SPONTANEOUS
|
|
subjects affected / exposed
|
3 / 2170 (0.14%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
General disorders and administration site conditions
|
|
SURGICAL FAILURE
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
DEATH
|
|
subjects affected / exposed
|
6 / 2170 (0.28%) |
occurrences causally related to treatment / all
|
0 / 6 |
deaths causally related to treatment / all
|
0 / 6 |
MULTIPLE ORGAN DYSFUNCTION SYNDROME
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
NON-CARDIAC CHEST PAIN
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
OEDEMA PERIPHERAL
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
PAIN
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
SUDDEN CARDIAC DEATH
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
SUDDEN DEATH
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
VASCULAR STENT STENOSIS
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Immune system disorders
|
|
DRUG HYPERSENSITIVITY
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Social circumstances
|
|
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Reproductive system and breast disorders
|
|
BALANOPOSTHITIS
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
BENIGN PROSTATIC HYPERPLASIA
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
BREAST ENLARGEMENT
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
CYSTOCELE
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
ENDOMETRIAL DISORDER
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
ENDOMETRIOSIS
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
HEAVY MENSTRUAL BLEEDING
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
PROSTATITIS
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Respiratory, thoracic and mediastinal disorders
|
|
PNEUMOTHORAX
|
|
subjects affected / exposed
|
2 / 2170 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
ACUTE RESPIRATORY FAILURE
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
ASTHMA
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
|
subjects affected / exposed
|
3 / 2170 (0.14%) |
occurrences causally related to treatment / all
|
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
COUGH
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
DYSPNOEA EXERTIONAL
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
NASAL SEPTUM DEVIATION
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
PNEUMONITIS
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
RESPIRATORY DISTRESS
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
PULMONARY EMBOLISM
|
|
subjects affected / exposed
|
6 / 2170 (0.28%) |
occurrences causally related to treatment / all
|
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
RESPIRATORY FAILURE
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Psychiatric disorders
|
|
COMPLETED SUICIDE
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
CATATONIA
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
BIPOLAR DISORDER
|
|
subjects affected / exposed
|
2 / 2170 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
ANXIETY
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
ANOREXIA NERVOSA
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
ALCOHOL WITHDRAWAL SYNDROME
|
|
subjects affected / exposed
|
2 / 2170 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
ALCOHOL ABUSE
|
|
subjects affected / exposed
|
2 / 2170 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
CONFUSIONAL STATE
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
DEPRESSED MOOD
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
DEPRESSION
|
|
subjects affected / exposed
|
3 / 2170 (0.14%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
POST-TRAUMATIC AMNESTIC DISORDER
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
POST-TRAUMATIC STRESS DISORDER
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
SCHIZOPHRENIA
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
SOMATIC SYMPTOM DISORDER
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
SUICIDE ATTEMPT
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Hepatobiliary disorders
|
|
AUTOIMMUNE HEPATITIS
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
CHOLECYSTITIS
|
|
subjects affected / exposed
|
3 / 2170 (0.14%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
CHOLECYSTITIS ACUTE
|
|
subjects affected / exposed
|
4 / 2170 (0.18%) |
occurrences causally related to treatment / all
|
1 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
CHOLELITHIASIS
|
|
subjects affected / exposed
|
6 / 2170 (0.28%) |
occurrences causally related to treatment / all
|
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
CIRRHOSIS ALCOHOLIC
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
GALLBLADDER POLYP
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
HEPATIC CIRRHOSIS
|
|
subjects affected / exposed
|
4 / 2170 (0.18%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
HEPATITIS ALCOHOLIC
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
ALCOHOLIC LIVER DISEASE
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Investigations
|
|
BLOOD TRIGLYCERIDES INCREASED
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
HEPATIC ENZYME INCREASED
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Injury, poisoning and procedural complications
|
|
CARTILAGE INJURY
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
ACETABULUM FRACTURE
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
ALCOHOL POISONING
|
|
subjects affected / exposed
|
2 / 2170 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
ANKLE FRACTURE
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
COLON INJURY
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
LIMB INJURY
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
CONTUSION
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
CRANIOCEREBRAL INJURY
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
CRANIOFACIAL FRACTURE
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
FALL
|
|
subjects affected / exposed
|
3 / 2170 (0.14%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
FEMUR FRACTURE
|
|
subjects affected / exposed
|
2 / 2170 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
FIBULA FRACTURE
|
|
subjects affected / exposed
|
2 / 2170 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
HAND FRACTURE
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
HEAD INJURY
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
HIP FRACTURE
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
HUMERUS FRACTURE
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
INTENTIONAL OVERDOSE
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
JOINT DISLOCATION
|
|
subjects affected / exposed
|
2 / 2170 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
LIGAMENT INJURY
|
|
subjects affected / exposed
|
2 / 2170 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
LIGAMENT RUPTURE
|
|
subjects affected / exposed
|
2 / 2170 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
CONCUSSION
|
|
subjects affected / exposed
|
2 / 2170 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
LIMB TRAUMATIC AMPUTATION
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
LOWER LIMB FRACTURE
|
|
subjects affected / exposed
|
2 / 2170 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
LUMBAR VERTEBRAL FRACTURE
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
MENISCUS INJURY
|
|
subjects affected / exposed
|
2 / 2170 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
MULTIPLE INJURIES
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
NAIL INJURY
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
PATELLA FRACTURE
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
POST PROCEDURAL COMPLICATION
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
POST PROCEDURAL HAEMATOMA
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
POST PROCEDURAL SWELLING
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
RADIUS FRACTURE
|
|
subjects affected / exposed
|
3 / 2170 (0.14%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
RIB FRACTURE
|
|
subjects affected / exposed
|
2 / 2170 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
ROAD TRAFFIC ACCIDENT
|
|
subjects affected / exposed
|
2 / 2170 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
SKIN ABRASION
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
SPINAL COMPRESSION FRACTURE
|
|
subjects affected / exposed
|
2 / 2170 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
SUBDURAL HAEMATOMA
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
TENDON DISLOCATION
|
|
subjects affected / exposed
|
2 / 2170 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
TENDON INJURY
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
UPPER LIMB FRACTURE
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
ULNA FRACTURE
|
|
subjects affected / exposed
|
2 / 2170 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
TOXICITY TO VARIOUS AGENTS
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
TIBIA FRACTURE
|
|
subjects affected / exposed
|
2 / 2170 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
THERMAL BURN
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
TENDON RUPTURE
|
|
subjects affected / exposed
|
2 / 2170 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
WRIST FRACTURE
|
|
subjects affected / exposed
|
3 / 2170 (0.14%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Congenital, familial and genetic disorders
|
|
ATRIAL SEPTAL DEFECT
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
CONGENITAL CYSTIC KIDNEY DISEASE
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
HYPERTROPHIC CARDIOMYOPATHY
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Cardiac disorders
|
|
AORTIC VALVE INCOMPETENCE
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
ACUTE MYOCARDIAL INFARCTION
|
|
subjects affected / exposed
|
13 / 2170 (0.60%) |
occurrences causally related to treatment / all
|
2 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
ANGINA PECTORIS
|
|
subjects affected / exposed
|
2 / 2170 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
ANGINA UNSTABLE
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
ACUTE CORONARY SYNDROME
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
ARRHYTHMIA
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
CORONARY ARTERY OCCLUSION
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
ATRIAL FIBRILLATION
|
|
subjects affected / exposed
|
9 / 2170 (0.41%) |
occurrences causally related to treatment / all
|
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
ATRIAL FLUTTER
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
ATRIAL TACHYCARDIA
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
ATRIOVENTRICULAR BLOCK FIRST DEGREE
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
ATRIOVENTRICULAR BLOCK SECOND DEGREE
|
|
subjects affected / exposed
|
2 / 2170 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
BIFASCICULAR BLOCK
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
BRADYCARDIA
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
CARDIAC ARREST
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
CARDIAC FAILURE CONGESTIVE
|
|
subjects affected / exposed
|
5 / 2170 (0.23%) |
occurrences causally related to treatment / all
|
1 / 6 |
deaths causally related to treatment / all
|
1 / 1 |
CARDIAC VENTRICULAR THROMBOSIS
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
CARDIO-RESPIRATORY ARREST
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
CARDIOMYOPATHY
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
CARDIOVASCULAR DISORDER
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
CORONARY ARTERY DISEASE
|
|
subjects affected / exposed
|
9 / 2170 (0.41%) |
occurrences causally related to treatment / all
|
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
ARTERIOSCLEROSIS CORONARY ARTERY
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
DRESSLER'S SYNDROME
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
PERICARDIAL EFFUSION
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
PERICARDITIS
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
PRINZMETAL ANGINA
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
SINUS NODE DYSFUNCTION
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
SUPRAVENTRICULAR TACHYCARDIA
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
VENTRICULAR EXTRASYSTOLES
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
VENTRICULAR FIBRILLATION
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
MYOCARDIAL INFARCTION
|
|
subjects affected / exposed
|
9 / 2170 (0.41%) |
occurrences causally related to treatment / all
|
0 / 9 |
deaths causally related to treatment / all
|
0 / 2 |
Nervous system disorders
|
|
CEREBROVASCULAR ACCIDENT
|
|
subjects affected / exposed
|
3 / 2170 (0.14%) |
occurrences causally related to treatment / all
|
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
BELL'S PALSY
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
CAROTID ARTERY STENOSIS
|
|
subjects affected / exposed
|
4 / 2170 (0.18%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
CEREBRAL HAEMATOMA
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
CEREBRAL HAEMORRHAGE
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
CEREBRAL INFARCTION
|
|
subjects affected / exposed
|
5 / 2170 (0.23%) |
occurrences causally related to treatment / all
|
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
ISCHAEMIC STROKE
|
|
subjects affected / exposed
|
5 / 2170 (0.23%) |
occurrences causally related to treatment / all
|
1 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
HYPOAESTHESIA
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
HEMIPARESIS
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
HEADACHE
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
HAEMORRHAGIC STROKE
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
EPILEPSY
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
DIZZINESS
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
DEMENTIA
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
METABOLIC ENCEPHALOPATHY
|
|
subjects affected / exposed
|
2 / 2170 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
SEIZURE
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
RUPTURED CEREBRAL ANEURYSM
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
PROGRESSIVE SUPRANUCLEAR PALSY
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
PRESYNCOPE
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
PARTIAL SEIZURES
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
PARAESTHESIA
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
NEURALGIA
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
MULTIPLE SCLEROSIS
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
SENSORY DISTURBANCE
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
SUBARACHNOID HAEMORRHAGE
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
SYNCOPE
|
|
subjects affected / exposed
|
7 / 2170 (0.32%) |
occurrences causally related to treatment / all
|
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
THALAMIC INFARCTION
|
|
subjects affected / exposed
|
2 / 2170 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
TOXIC ENCEPHALOPATHY
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
TRANSIENT ISCHAEMIC ATTACK
|
|
subjects affected / exposed
|
5 / 2170 (0.23%) |
occurrences causally related to treatment / all
|
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
VERTEBROBASILAR INSUFFICIENCY
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
STATUS EPILEPTICUS
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Blood and lymphatic system disorders
|
|
ANAEMIA
|
|
subjects affected / exposed
|
3 / 2170 (0.14%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
FEBRILE NEUTROPENIA
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
HAEMOLYSIS
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
PANCYTOPENIA
|
|
subjects affected / exposed
|
2 / 2170 (0.09%) |
occurrences causally related to treatment / all
|
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Ear and labyrinth disorders
|
|
SUDDEN HEARING LOSS
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
VERTIGO
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
VERTIGO POSITIONAL
|
|
subjects affected / exposed
|
2 / 2170 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Eye disorders
|
|
BLINDNESS UNILATERAL
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
CATARACT
|
|
subjects affected / exposed
|
3 / 2170 (0.14%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
EPIRETINAL MEMBRANE
|
|
subjects affected / exposed
|
2 / 2170 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
MACULAR HOLE
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Gastrointestinal disorders
|
|
GASTRIC ULCER
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
ABDOMINAL HERNIA
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
ABDOMINAL INCARCERATED HERNIA
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
ASCITES
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
CHRONIC GASTRITIS
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
COLITIS ISCHAEMIC
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
DUODENAL ULCER
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
DYSPEPSIA
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
GASTRIC ULCER HAEMORRHAGE
|
|
subjects affected / exposed
|
3 / 2170 (0.14%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
PANCREATITIS
|
|
subjects affected / exposed
|
2 / 2170 (0.09%) |
occurrences causally related to treatment / all
|
1 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
GASTRITIS EROSIVE
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
GASTROOESOPHAGEAL REFLUX DISEASE
|
|
subjects affected / exposed
|
3 / 2170 (0.14%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
HAEMATEMESIS
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
HAEMATOCHEZIA
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
HAEMORRHOIDS
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
INCARCERATED INGUINAL HERNIA
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
INCARCERATED UMBILICAL HERNIA
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
INGUINAL HERNIA
|
|
subjects affected / exposed
|
2 / 2170 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
INTESTINAL ISCHAEMIA
|
|
subjects affected / exposed
|
2 / 2170 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
INTESTINAL OBSTRUCTION
|
|
subjects affected / exposed
|
2 / 2170 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
LARGE INTESTINE PERFORATION
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
LARGE INTESTINE POLYP
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
OESOPHAGEAL STENOSIS
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
OESOPHAGITIS
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
GASTRITIS
|
|
subjects affected / exposed
|
3 / 2170 (0.14%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
PANCREATITIS ACUTE
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
RECTAL STENOSIS
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
RETROPERITONEAL MASS
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
SMALL INTESTINAL OBSTRUCTION
|
|
subjects affected / exposed
|
2 / 2170 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
TOOTH DISORDER
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
UMBILICAL HERNIA
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
UPPER GASTROINTESTINAL HAEMORRHAGE
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
VOMITING
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
RECTAL HAEMORRHAGE
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Skin and subcutaneous tissue disorders
|
|
ANGIOEDEMA
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
ECZEMA
|
|
subjects affected / exposed
|
2 / 2170 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
LICHEN PLANUS
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
PRECANCEROUS SKIN LESION
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
STEVENS-JOHNSON SYNDROME
|
|
subjects affected / exposed
|
2 / 2170 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Renal and urinary disorders
|
|
PYELOCALIECTASIS
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
RENAL ARTERY STENOSIS
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
RENAL COLIC
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
ACUTE KIDNEY INJURY
|
|
subjects affected / exposed
|
2 / 2170 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
CALCULUS URINARY
|
|
subjects affected / exposed
|
2 / 2170 (0.09%) |
occurrences causally related to treatment / all
|
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
CYSTITIS INTERSTITIAL
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
HYDRONEPHROSIS
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
NEPHROLITHIASIS
|
|
subjects affected / exposed
|
8 / 2170 (0.37%) |
occurrences causally related to treatment / all
|
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
PELVI-URETERIC OBSTRUCTION
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
RENAL CYST
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Endocrine disorders
|
|
GOITRE
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
GRAVES' DISEASE
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
THYROTOXIC CRISIS
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
HYPERTHYROIDISM
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Musculoskeletal and connective tissue disorders
|
|
BACK PAIN
|
|
subjects affected / exposed
|
2 / 2170 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
ARTHRALGIA
|
|
subjects affected / exposed
|
2 / 2170 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
PAIN IN EXTREMITY
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
OSTEONECROSIS
|
|
subjects affected / exposed
|
2 / 2170 (0.09%) |
occurrences causally related to treatment / all
|
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
OSTEOARTHRITIS
|
|
subjects affected / exposed
|
17 / 2170 (0.78%) |
occurrences causally related to treatment / all
|
0 / 20 |
deaths causally related to treatment / all
|
0 / 0 |
LUMBAR SPINAL STENOSIS
|
|
subjects affected / exposed
|
2 / 2170 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
LOOSE BODY IN JOINT
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
INTERVERTEBRAL DISC PROTRUSION
|
|
subjects affected / exposed
|
6 / 2170 (0.28%) |
occurrences causally related to treatment / all
|
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
FOOT DEFORMITY
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
CERVICAL SPINAL STENOSIS
|
|
subjects affected / exposed
|
2 / 2170 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
PSORIATIC ARTHROPATHY
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
TENDINOUS CONTRACTURE
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
SYSTEMIC LUPUS ERYTHEMATOSUS
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
SYNOVITIS
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
SYNOVIAL CYST
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
SPONDYLOLISTHESIS
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
SPINAL STENOSIS
|
|
subjects affected / exposed
|
4 / 2170 (0.18%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
SPINAL LIGAMENT OSSIFICATION
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
ROTATOR CUFF SYNDROME
|
|
subjects affected / exposed
|
3 / 2170 (0.14%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
TENOSYNOVITIS
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Infections and infestations
|
|
BRONCHIOLITIS
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
ABSCESS JAW
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
ABSCESS LIMB
|
|
subjects affected / exposed
|
2 / 2170 (0.09%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
APPENDICITIS
|
|
subjects affected / exposed
|
6 / 2170 (0.28%) |
occurrences causally related to treatment / all
|
2 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
ARTHRITIS BACTERIAL
|
|
subjects affected / exposed
|
3 / 2170 (0.14%) |
occurrences causally related to treatment / all
|
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
BURSITIS INFECTIVE
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
INTERVERTEBRAL DISCITIS
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
CELLULITIS OF MALE EXTERNAL GENITAL ORGAN
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
CHRONIC TONSILLITIS
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
CLOSTRIDIUM DIFFICILE COLITIS
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
COVID-19
|
|
subjects affected / exposed
|
13 / 2170 (0.60%) |
occurrences causally related to treatment / all
|
3 / 14 |
deaths causally related to treatment / all
|
1 / 5 |
COVID-19 PNEUMONIA
|
|
subjects affected / exposed
|
7 / 2170 (0.32%) |
occurrences causally related to treatment / all
|
1 / 7 |
deaths causally related to treatment / all
|
0 / 2 |
DIVERTICULITIS
|
|
subjects affected / exposed
|
6 / 2170 (0.28%) |
occurrences causally related to treatment / all
|
1 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
EPIDIDYMITIS
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
ERYSIPELAS
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
ESCHERICHIA URINARY TRACT INFECTION
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
FALLOPIAN TUBE ABSCESS
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
FOURNIER'S GANGRENE
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
GAS GANGRENE
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
GASTROENTERITIS
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
HERPES ZOSTER
|
|
subjects affected / exposed
|
2 / 2170 (0.09%) |
occurrences causally related to treatment / all
|
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
INFECTIVE GLOSSITIS
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
CELLULITIS
|
|
subjects affected / exposed
|
5 / 2170 (0.23%) |
occurrences causally related to treatment / all
|
3 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
LARGE INTESTINE INFECTION
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
PSOAS ABSCESS
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
MENINGITIS
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
NEUROSYPHILIS
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
ORCHITIS
|
|
subjects affected / exposed
|
2 / 2170 (0.09%) |
occurrences causally related to treatment / all
|
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
OSTEOMYELITIS
|
|
subjects affected / exposed
|
4 / 2170 (0.18%) |
occurrences causally related to treatment / all
|
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
PERICORONITIS
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
PERIRECTAL ABSCESS
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
PERITONITIS
|
|
subjects affected / exposed
|
2 / 2170 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
PERITONSILLAR ABSCESS
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
PNEUMONIA
|
|
subjects affected / exposed
|
7 / 2170 (0.32%) |
occurrences causally related to treatment / all
|
3 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
PNEUMONIA ASPIRATION
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
PNEUMONIA BACTERIAL
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
PNEUMONIA VIRAL
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
POST PROCEDURAL INFECTION
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
POSTOPERATIVE ABSCESS
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
PSEUDOMONAL SEPSIS
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
MEDIASTINAL ABSCESS
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
PYELONEPHRITIS
|
|
subjects affected / exposed
|
3 / 2170 (0.14%) |
occurrences causally related to treatment / all
|
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
RENAL ABSCESS
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
SCROTAL ABSCESS
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
SEPSIS
|
|
subjects affected / exposed
|
6 / 2170 (0.28%) |
occurrences causally related to treatment / all
|
1 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
SEPTIC SHOCK
|
|
subjects affected / exposed
|
2 / 2170 (0.09%) |
occurrences causally related to treatment / all
|
1 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
STAPHYLOCOCCAL INFECTION
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
SUBCUTANEOUS ABSCESS
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
TONSILLITIS
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
URINARY TRACT INFECTION
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
UROSEPSIS
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
VESTIBULAR NEURONITIS
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
PYELONEPHRITIS ACUTE
|
|
subjects affected / exposed
|
2 / 2170 (0.09%) |
occurrences causally related to treatment / all
|
2 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Metabolism and nutrition disorders
|
|
DEHYDRATION
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
DIABETES MELLITUS
|
|
subjects affected / exposed
|
3 / 2170 (0.14%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
DIABETIC KETOACIDOSIS
|
|
subjects affected / exposed
|
2 / 2170 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
ELECTROLYTE IMBALANCE
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
HYPERGLYCAEMIA
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
HYPOKALAEMIA
|
|
subjects affected / exposed
|
1 / 2170 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
OBESITY
|
|
subjects affected / exposed
|
4 / 2170 (0.18%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |