Serious adverse events
|
Ibrutinib+BR |
Placebo+BR |
Crossover Ibrutinib |
Total subjects affected by serious adverse events
|
|
|
|
subjects affected / exposed
|
198 / 287 (68.99%) |
127 / 287 (44.25%) |
105 / 183 (57.38%) |
number of deaths (all causes)
|
74 |
107 |
57 |
number of deaths resulting from adverse events
|
|
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
|
Acute Lymphocytic Leukaemia
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Adenosquamous Cell Lung Cancer
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Anal Squamous Cell Carcinoma
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Basal Cell Carcinoma
|
|
|
|
subjects affected / exposed
|
5 / 287 (1.74%) |
1 / 287 (0.35%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
13 / 13 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bladder Cancer
|
|
|
|
subjects affected / exposed
|
2 / 287 (0.70%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bronchioloalveolar Carcinoma
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chronic Myelomonocytic Leukaemia
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Intestinal Adenocarcinoma
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intraductal Papilloma of Breast
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lipoma
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lung Adenocarcinoma
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
Malignant Melanoma
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Malignant Melanoma in Situ
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Maxillofacial Sinus Neoplasm
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to Central Nervous System
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
Metastatic Renal Cell Carcinoma
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Myelodysplastic Syndrome
|
|
|
|
subjects affected / exposed
|
2 / 287 (0.70%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 3 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 2 |
0 / 0 |
0 / 0 |
Myeloproliferative Neoplasm
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
Neuroendocrine Carcinoma
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Prostate Cancer
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
1 / 287 (0.35%) |
2 / 183 (1.09%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 1 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal Cancer
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal Cancer Stage I
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal Oncocytoma
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Squamous Cell Carcinoma
|
|
|
|
subjects affected / exposed
|
3 / 287 (1.05%) |
1 / 287 (0.35%) |
2 / 183 (1.09%) |
occurrences causally related to treatment / all
|
5 / 5 |
1 / 1 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Squamous Cell Carcinoma of Skin
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
2 / 287 (0.70%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Superficial Spreading Melanoma Stage Unspecified
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Transitional Cell Carcinoma
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vascular disorders
|
|
|
|
Aortic Aneurysm Rupture
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
Arterial Stenosis
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Deep Vein Thrombosis
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
3 / 287 (1.05%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
3 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haematoma
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypertension
|
|
|
|
subjects affected / exposed
|
2 / 287 (0.70%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypertensive Crisis
|
|
|
|
subjects affected / exposed
|
2 / 287 (0.70%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypotension
|
|
|
|
subjects affected / exposed
|
2 / 287 (0.70%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Jugular Vein Thrombosis
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lymphoedema
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral Arterial Occlusive Disease
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral Artery Occlusion
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral Artery Thrombosis
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral Ischaemia
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Thrombophlebitis
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Thrombosis
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vasculitis
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
General disorders and administration site conditions
|
|
|
|
Asthenia
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chest Pain
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chills
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Complication Associated with Device
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Condition Aggravated
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Death
|
|
|
|
subjects affected / exposed
|
2 / 287 (0.70%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
2 / 2 |
0 / 0 |
1 / 1 |
Disease Progression
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
2 / 287 (0.70%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
4 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 1 |
2 / 2 |
0 / 0 |
Fatigue
|
|
|
|
subjects affected / exposed
|
3 / 287 (1.05%) |
1 / 287 (0.35%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
2 / 3 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
General Physical Health Deterioration
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
Hernia
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Influenza Like Illness
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Infusion Site Extravasation
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Malaise
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
1 / 287 (0.35%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mucosal Inflammation
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Multiple Organ Dysfunction Syndrome
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
3 / 287 (1.05%) |
3 / 183 (1.64%) |
occurrences causally related to treatment / all
|
2 / 2 |
4 / 4 |
5 / 5 |
deaths causally related to treatment / all
|
1 / 1 |
3 / 3 |
3 / 3 |
Non-Cardiac Chest Pain
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oedema Peripheral
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumatosis
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pyrexia
|
|
|
|
subjects affected / exposed
|
11 / 287 (3.83%) |
7 / 287 (2.44%) |
4 / 183 (2.19%) |
occurrences causally related to treatment / all
|
13 / 13 |
11 / 11 |
3 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sudden Cardiac Death
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
Sudden Death
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
Systemic Inflammatory Response Syndrome
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
Immune system disorders
|
|
|
|
Anaphylactic Reaction
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Reproductive system and breast disorders
|
|
|
|
Benign Prostatic Hyperplasia
|
|
|
|
subjects affected / exposed
|
2 / 287 (0.70%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Fibrocystic Breast Disease
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Genital Rash
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pelvic Floor Muscle Weakness
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Penile Dysplasia
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Uterine Haemorrhage
|
|
|
|
subjects affected / exposed
|
2 / 287 (0.70%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Uterine Prolapse
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory, thoracic and mediastinal disorders
|
|
|
|
Acute Respiratory Failure
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
Chronic Obstructive Pulmonary Disease
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dyspnoea
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
3 / 287 (1.05%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
4 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dyspnoea Exertional
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemoptysis
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemothorax
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lung Infiltration
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
Pleural Effusion
|
|
|
|
subjects affected / exposed
|
3 / 287 (1.05%) |
2 / 287 (0.70%) |
2 / 183 (1.09%) |
occurrences causally related to treatment / all
|
4 / 5 |
1 / 2 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pleuritic Pain
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonitis
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
1 / 287 (0.35%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 1 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
Pneumothorax
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary Congestion
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary Mass
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary Sarcoidosis
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory Failure
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
3 / 183 (1.64%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
3 / 3 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
2 / 2 |
Respiratory Tract Oedema
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sleep Apnoea Syndrome
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Psychiatric disorders
|
|
|
|
Acute Stress Disorder
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Alcoholic Psychosis
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Completed Suicide
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
Confusional State
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Delirium
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mental Status Changes
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
3 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Investigations
|
|
|
|
Biopsy
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Blood Creatinine Increased
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Body Temperature Increased
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Neutrophil Count Decreased
|
|
|
|
subjects affected / exposed
|
2 / 287 (0.70%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Prostatic Specific Antigen Increased
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Weight Decreased
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Injury, poisoning and procedural complications
|
|
|
|
Abdominal Injury
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ankle Fracture
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Fall
|
|
|
|
subjects affected / exposed
|
2 / 287 (0.70%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Femoral Neck Fracture
|
|
|
|
subjects affected / exposed
|
2 / 287 (0.70%) |
0 / 287 (0.00%) |
2 / 183 (1.09%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Femur Fracture
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hip Fracture
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
1 / 287 (0.35%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Incision Site Haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Infusion Related Reaction
|
|
|
|
subjects affected / exposed
|
4 / 287 (1.39%) |
5 / 287 (1.74%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
4 / 4 |
5 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pelvic Fracture
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumoconiosis
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumothorax Traumatic
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Post Procedural Haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
2 / 183 (1.09%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
2 / 2 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
Post Procedural Swelling
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Subdural Haematoma
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Thoracic Vertebral Fracture
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac disorders
|
|
|
|
Acute Coronary Syndrome
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Acute Myocardial Infarction
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
3 / 287 (1.05%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
0 / 0 |
4 / 4 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
1 / 1 |
Angina Pectoris
|
|
|
|
subjects affected / exposed
|
4 / 287 (1.39%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
4 / 4 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Angina Unstable
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arrhythmia Supraventricular
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Atrial Fibrillation
|
|
|
|
subjects affected / exposed
|
16 / 287 (5.57%) |
2 / 287 (0.70%) |
6 / 183 (3.28%) |
occurrences causally related to treatment / all
|
16 / 19 |
2 / 2 |
6 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Atrial Flutter
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Atrioventricular Block
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac Arrest
|
|
|
|
subjects affected / exposed
|
2 / 287 (0.70%) |
0 / 287 (0.00%) |
3 / 183 (1.64%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
4 / 4 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
2 / 2 |
Cardiac Failure
|
|
|
|
subjects affected / exposed
|
3 / 287 (1.05%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
3 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
Cardio-Respiratory Arrest
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiopulmonary Failure
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
1 / 1 |
Cardiovascular Insufficiency
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
3 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
Carditis
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Coronary Artery Occlusion
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Myocardial Infarction
|
|
|
|
subjects affected / exposed
|
2 / 287 (0.70%) |
2 / 287 (0.70%) |
2 / 183 (1.09%) |
occurrences causally related to treatment / all
|
2 / 2 |
2 / 2 |
2 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
Myocarditis
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pericardial Effusion
|
|
|
|
subjects affected / exposed
|
2 / 287 (0.70%) |
1 / 287 (0.35%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
1 / 2 |
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sinus Node Dysfunction
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sinus Tachycardia
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tachycardia
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ventricular Fibrillation
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ventricular Flutter
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
Ventricular Tachycardia
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nervous system disorders
|
|
|
|
Carotid Sinus Syndrome
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral Disorder
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral Infarction
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral Ischaemia
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cerebrovascular Accident
|
|
|
|
subjects affected / exposed
|
3 / 287 (1.05%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
3 / 3 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cognitive Disorder
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Depressed Level of Consciousness
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Encephalopathy
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
0 / 287 (0.00%) |
2 / 183 (1.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
3 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
Facial Paresis
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhage Intracranial
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhagic Stroke
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Headache
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Loss of Consciousness
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Meningism
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral Sensory Neuropathy
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Post Herpetic Neuralgia
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Radiculopathy
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Syncope
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Transient Global Amnesia
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vascular Encephalopathy
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Blood and lymphatic system disorders
|
|
|
|
Anaemia
|
|
|
|
subjects affected / exposed
|
3 / 287 (1.05%) |
7 / 287 (2.44%) |
2 / 183 (1.09%) |
occurrences causally related to treatment / all
|
2 / 3 |
10 / 11 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Aplasia Pure Red Cell
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Aplastic Anaemia
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Autoimmune Haemolytic Anaemia
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
5 / 287 (1.74%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
4 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bone Marrow Failure
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cytopenia
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Febrile Neutropenia
|
|
|
|
subjects affected / exposed
|
30 / 287 (10.45%) |
22 / 287 (7.67%) |
2 / 183 (1.09%) |
occurrences causally related to treatment / all
|
22 / 33 |
20 / 28 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
Haemolytic Anaemia
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Immune Thrombocytopenic Purpura
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Neutropenia
|
|
|
|
subjects affected / exposed
|
7 / 287 (2.44%) |
6 / 287 (2.09%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
8 / 9 |
6 / 6 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pancytopenia
|
|
|
|
subjects affected / exposed
|
2 / 287 (0.70%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
4 / 4 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Thrombocytopenia
|
|
|
|
subjects affected / exposed
|
4 / 287 (1.39%) |
2 / 287 (0.70%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
2 / 4 |
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Eye disorders
|
|
|
|
Cataract
|
|
|
|
subjects affected / exposed
|
3 / 287 (1.05%) |
0 / 287 (0.00%) |
2 / 183 (1.09%) |
occurrences causally related to treatment / all
|
3 / 3 |
0 / 0 |
3 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Maculopathy
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Retinal Haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Scleral Disorder
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vitreous Adhesions
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vitreous Haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal disorders
|
|
|
|
Abdominal Hernia
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal Incarcerated Hernia
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal Pain
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
0 / 287 (0.00%) |
3 / 183 (1.64%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
3 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Anal Fistula
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ascites
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Colitis
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
2 / 287 (0.70%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Colitis Ischaemic
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Constipation
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diarrhoea
|
|
|
|
subjects affected / exposed
|
4 / 287 (1.39%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
3 / 5 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Duodenal Ulcer Haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dyspepsia
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dysphagia
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
2 / 287 (0.70%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Enterocolitis
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastric Haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastric Ulcer Perforation
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastritis
|
|
|
|
subjects affected / exposed
|
3 / 287 (1.05%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
3 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal Disorder
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal Haemorrhage
|
|
|
|
subjects affected / exposed
|
2 / 287 (0.70%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal Inflammation
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haematemesis
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haematochezia
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Inguinal Hernia
|
|
|
|
subjects affected / exposed
|
4 / 287 (1.39%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
5 / 5 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal Obstruction
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intra-Abdominal Haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
Large Intestine Perforation
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
Lower Gastrointestinal Haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mouth Ulceration
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nausea
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oesophageal Ulcer
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oesophagitis
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatitis
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatitis Acute
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Proctitis
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Small Intestinal Obstruction
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Stomatitis
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Volvulus
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vomiting
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
2 / 287 (0.70%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
0 / 1 |
2 / 2 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatobiliary disorders
|
|
|
|
Cholangitis
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cholecystitis
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
1 / 287 (0.35%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cholecystitis Acute
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cholecystitis Chronic
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cholelithiasis
|
|
|
|
subjects affected / exposed
|
2 / 287 (0.70%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
3 / 3 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cholestasis
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Gallbladder Obstruction
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic Cirrhosis
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
Hepatitis Toxic
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
2 / 287 (0.70%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatocellular Injury
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Hepatosplenomegaly
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Skin and subcutaneous tissue disorders
|
|
|
|
Acute Febrile Neutrophilic Dermatosis
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cellulitis
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Drug Eruption
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Excessive Granulation Tissue
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypersensitivity Vasculitis
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pemphigoid
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pemphigus
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rash
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
2 / 287 (0.70%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rash Erythematous
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rash Maculo-Papular
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Skin Necrosis
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urticaria
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal and urinary disorders
|
|
|
|
Acute Kidney Injury
|
|
|
|
subjects affected / exposed
|
2 / 287 (0.70%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Calculus Bladder
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dysuria
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haematuria
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
0 / 287 (0.00%) |
2 / 183 (1.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nephropathy
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nephropathy Toxic
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal Failure
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
2 / 183 (1.09%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal Impairment
|
|
|
|
subjects affected / exposed
|
2 / 287 (0.70%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ureteric Stenosis
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ureterolithiasis
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urge Incontinence
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urinary Incontinence
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urinary Retention
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Endocrine disorders
|
|
|
|
Addison's Disease
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Goitre
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal and connective tissue disorders
|
|
|
|
Arthralgia
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arthritis
|
|
|
|
subjects affected / exposed
|
2 / 287 (0.70%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
3 / 3 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Back Pain
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chondrocalcinosis Pyrophosphate
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Femoroacetabular Impingement
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Groin Pain
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lumbar Spinal Stenosis
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Muscle Haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Muscular Weakness
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal Pain
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Osteoarthritis
|
|
|
|
subjects affected / exposed
|
3 / 287 (1.05%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
3 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Osteonecrosis
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pain in Extremity
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Infections and infestations
|
|
|
|
Abscess Jaw
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Actinomycotic Pulmonary Infection
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Acute Sinusitis
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Appendicitis
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
2 / 183 (1.09%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arthritis Bacterial
|
|
|
|
subjects affected / exposed
|
2 / 287 (0.70%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ascariasis
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Atypical Pneumonia
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bacteraemia
|
|
|
|
subjects affected / exposed
|
2 / 287 (0.70%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Brain Abscess
|
|
|
|
subjects affected / exposed
|
2 / 287 (0.70%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Breast Abscess
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Breast Cellulitis
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bronchitis
|
|
|
|
subjects affected / exposed
|
8 / 287 (2.79%) |
5 / 287 (1.74%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
8 / 10 |
5 / 5 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bronchopulmonary Aspergillosis
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
1 / 287 (0.35%) |
2 / 183 (1.09%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 1 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
Campylobacter Infection
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cellulitis
|
|
|
|
subjects affected / exposed
|
4 / 287 (1.39%) |
2 / 287 (0.70%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
4 / 4 |
2 / 2 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cellulitis Staphylococcal
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Central Nervous System Infection
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chronic Sinusitis
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Clostridium Difficile Colitis
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Clostridium Difficile Infection
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
0 / 287 (0.00%) |
2 / 183 (1.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Conjunctivitis
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cystitis
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cytomegalovirus Colitis
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cytomegalovirus Infection
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Dacryocystitis
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dermo-Hypodermitis
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Disseminated Cryptococcosis
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Epstein-Barr Virus Infection
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Erysipelas
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
3 / 183 (1.64%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
3 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Escherichia Sepsis
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Escherichia Urinary Tract Infection
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Fungal Infection
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Gastroenteritis
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastroenteritis Viral
|
|
|
|
subjects affected / exposed
|
2 / 287 (0.70%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal Infection
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemophilus Infection
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatitis B Reactivation
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
Herpes Zoster
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
2 / 287 (0.70%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
1 / 1 |
2 / 2 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Infection
|
|
|
|
subjects affected / exposed
|
3 / 287 (1.05%) |
2 / 287 (0.70%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
3 / 3 |
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Infectious Pleural Effusion
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Influenza
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Laryngitis
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lower Respiratory Tract Infection
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
2 / 287 (0.70%) |
2 / 183 (1.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lung Infection
|
|
|
|
subjects affected / exposed
|
3 / 287 (1.05%) |
3 / 287 (1.05%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
3 / 3 |
3 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lymphadenitis Bacterial
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Muscle Abscess
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Neutropenic Sepsis
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nocardiosis
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oral Candidiasis
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
2 / 287 (0.70%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Osteomyelitis
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Otitis Media
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Periodontitis
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Periorbital Cellulitis
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peritonsillar Abscess
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pharyngeal Abscess
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pharyngitis
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pharyngitis Streptococcal
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumocystis Jirovecii Pneumonia
|
|
|
|
subjects affected / exposed
|
2 / 287 (0.70%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
3 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
Pneumonia
|
|
|
|
subjects affected / exposed
|
48 / 287 (16.72%) |
26 / 287 (9.06%) |
34 / 183 (18.58%) |
occurrences causally related to treatment / all
|
59 / 64 |
38 / 38 |
42 / 46 |
deaths causally related to treatment / all
|
1 / 1 |
3 / 3 |
4 / 4 |
Pneumonia Bacterial
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia Haemophilus
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia Pneumococcal
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia Streptococcal
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
2 / 183 (1.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Progressive Multifocal Leukoencephalopathy
|
|
|
|
subjects affected / exposed
|
2 / 287 (0.70%) |
0 / 287 (0.00%) |
2 / 183 (1.09%) |
occurrences causally related to treatment / all
|
4 / 4 |
0 / 0 |
4 / 4 |
deaths causally related to treatment / all
|
2 / 2 |
0 / 0 |
1 / 1 |
Pseudomembranous Colitis
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary Tuberculoma
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary Tuberculosis
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pyelonephritis
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rash Pustular
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory Syncytial Virus Infection
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory Tract Infection
|
|
|
|
subjects affected / exposed
|
5 / 287 (1.74%) |
2 / 287 (0.70%) |
5 / 183 (2.73%) |
occurrences causally related to treatment / all
|
6 / 6 |
2 / 2 |
5 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sepsis
|
|
|
|
subjects affected / exposed
|
8 / 287 (2.79%) |
4 / 287 (1.39%) |
4 / 183 (2.19%) |
occurrences causally related to treatment / all
|
9 / 9 |
5 / 7 |
6 / 6 |
deaths causally related to treatment / all
|
1 / 1 |
2 / 3 |
2 / 2 |
Septic Shock
|
|
|
|
subjects affected / exposed
|
6 / 287 (2.09%) |
2 / 287 (0.70%) |
5 / 183 (2.73%) |
occurrences causally related to treatment / all
|
9 / 9 |
1 / 3 |
7 / 7 |
deaths causally related to treatment / all
|
4 / 4 |
0 / 1 |
5 / 5 |
Sinusitis
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
2 / 287 (0.70%) |
2 / 183 (1.09%) |
occurrences causally related to treatment / all
|
1 / 1 |
2 / 2 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Skin Candida
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Skin Infection
|
|
|
|
subjects affected / exposed
|
2 / 287 (0.70%) |
1 / 287 (0.35%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
2 / 2 |
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Soft Tissue Infection
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Splenic Abscess
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Staphylococcal Infection
|
|
|
|
subjects affected / exposed
|
2 / 287 (0.70%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Staphylococcal Skin Infection
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Subcutaneous Abscess
|
|
|
|
subjects affected / exposed
|
3 / 287 (1.05%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
3 / 3 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tooth Abscess
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tuberculosis of Central Nervous System
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Upper Respiratory Tract Infection
|
|
|
|
subjects affected / exposed
|
3 / 287 (1.05%) |
3 / 287 (1.05%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
4 / 4 |
3 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urinary Tract Infection
|
|
|
|
subjects affected / exposed
|
6 / 287 (2.09%) |
1 / 287 (0.35%) |
2 / 183 (1.09%) |
occurrences causally related to treatment / all
|
5 / 6 |
1 / 1 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urosepsis
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Varicella
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Varicella Zoster Virus Infection
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Viral Infection
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
Metabolism and nutrition disorders
|
|
|
|
Decreased Appetite
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dehydration
|
|
|
|
subjects affected / exposed
|
2 / 287 (0.70%) |
1 / 287 (0.35%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
2 / 2 |
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diabetes Mellitus
|
|
|
|
subjects affected / exposed
|
1 / 287 (0.35%) |
0 / 287 (0.00%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypercalcaemia
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
0 / 287 (0.00%) |
1 / 183 (0.55%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hyperuricaemia
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hyponatraemia
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypophosphataemia
|
|
|
|
subjects affected / exposed
|
0 / 287 (0.00%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tumour Lysis Syndrome
|
|
|
|
subjects affected / exposed
|
6 / 287 (2.09%) |
1 / 287 (0.35%) |
0 / 183 (0.00%) |
occurrences causally related to treatment / all
|
4 / 6 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |