Serious adverse events
|
Tolvaptan (From 156-13-210: Tolvaptan) |
Tolvaptan (From 156-13-210: Placebo) |
Tolvaptan (From 156-08-271: Tolvaptan) |
Tolvaptan (From Other: Tolvaptan) |
Tolvaptan (From Other: Placebo) |
Total subjects affected by serious adverse events
|
|
|
|
|
|
subjects affected / exposed
|
87 / 505 (17.23%) |
96 / 569 (16.87%) |
103 / 717 (14.37%) |
1 / 6 (16.67%) |
2 / 3 (66.67%) |
number of deaths (all causes)
|
1 |
5 |
3 |
0 |
0 |
number of deaths resulting from adverse events
|
1 |
5 |
3 |
0 |
0 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
|
|
|
Metastatic Squamous Cell Carcinoma
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Squamous Cell Carcinoma of Head and Neck
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Squamous Cell Carcinoma
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal Neoplasm
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rectal Cancer
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
0 / 569 (0.00%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Prostate Cancer
|
|
|
|
|
|
subjects affected / exposed [1]
|
1 / 272 (0.37%) |
1 / 280 (0.36%) |
0 / 375 (0.00%) |
0 / 1 (0.00%) |
0 / 1 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Papillary Thyroid Cancer
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ovarian Theca Cell Tumour
|
|
|
|
|
|
subjects affected / exposed [2]
|
0 / 234 (0.00%) |
1 / 290 (0.34%) |
0 / 343 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to Meninges
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Carcinoid Tumour
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to Adrenals
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
0 / 569 (0.00%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to Liver
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Basal Cell Carcinoma
|
|
|
|
|
|
subjects affected / exposed
|
2 / 505 (0.40%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bone Cancer Metastatic
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
0 / 569 (0.00%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
B-Cell Small Lymphocytic Lymphoma
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
0 / 569 (0.00%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
1 / 3 (33.33%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Colon Cancer
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intraductal Proliferative Breast Lesion
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
0 / 569 (0.00%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Malignant Melanoma
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bronchial Carcinoma
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
0 / 569 (0.00%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Breast Cancer
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vascular disorders
|
|
|
|
|
|
Thrombophlebitis Superficial
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Shock
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral Ischaemia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypotension
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
2 / 569 (0.35%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypertensive Crisis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
1 / 6 (16.67%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Deep Vein Thrombosis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhage
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arteritis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Aortic Dissection
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Aneurysm
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
0 / 569 (0.00%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypertension
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
0 / 569 (0.00%) |
3 / 717 (0.42%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Aortic Aneurysm
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
General disorders and administration site conditions
|
|
|
|
|
|
Pyrexia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Thirst
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Oedema Peripheral
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
0 / 569 (0.00%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chest Pain
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Fatigue
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
0 / 569 (0.00%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Death
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Non-Cardiac Chest Pain
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
2 / 569 (0.35%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Asthenia
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
0 / 569 (0.00%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chest Discomfort
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Immune system disorders
|
|
|
|
|
|
Drug Hypersensitivity
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
0 / 569 (0.00%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Reproductive system and breast disorders
|
|
|
|
|
|
Rectocele
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Prostatitis
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
0 / 569 (0.00%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Menorrhagia
|
|
|
|
|
|
subjects affected / exposed [3]
|
1 / 234 (0.43%) |
0 / 290 (0.00%) |
0 / 343 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Breast Enlargement
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
0 / 569 (0.00%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metrorrhagia
|
|
|
|
|
|
subjects affected / exposed [4]
|
0 / 234 (0.00%) |
1 / 290 (0.34%) |
0 / 343 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory, thoracic and mediastinal disorders
|
|
|
|
|
|
Sinus Polyp
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory Failure
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pleuritic Pain
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary Toxicity
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary Embolism
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
0 / 569 (0.00%) |
2 / 717 (0.28%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumothorax
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pleural Effusion
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Asthma
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Epistaxis
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemothorax
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Acute Respiratory Distress Syndrome
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Acute Respiratory Failure
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Acute Pulmonary Oedema
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chronic Obstructive Pulmonary Disease
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cough
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bronchospasm
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Psychiatric disorders
|
|
|
|
|
|
Depression
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Panic Attack
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
0 / 569 (0.00%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Suicidal Ideation
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
0 / 569 (0.00%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Investigations
|
|
|
|
|
|
Weight Decreased
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
0 / 569 (0.00%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tumour Marker Increased
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
0 / 569 (0.00%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Liver Function Test Increased
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
3 / 569 (0.53%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 3 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
International Normalised Ratio Fluctuation
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic Enzyme Increased
|
|
|
|
|
|
subjects affected / exposed
|
2 / 505 (0.40%) |
3 / 569 (0.53%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
2 / 3 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Glomerular Filtration Rate Decreased
|
|
|
|
|
|
subjects affected / exposed
|
2 / 505 (0.40%) |
3 / 569 (0.53%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Transaminases Increased
|
|
|
|
|
|
subjects affected / exposed
|
2 / 505 (0.40%) |
0 / 569 (0.00%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
C-Reactive Protein Increased
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gamma-Glutamyltransferase Increased
|
|
|
|
|
|
subjects affected / exposed
|
2 / 505 (0.40%) |
2 / 569 (0.35%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
1 / 2 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Alanine Aminotransferase Increased
|
|
|
|
|
|
subjects affected / exposed
|
3 / 505 (0.59%) |
5 / 569 (0.88%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
3 / 3 |
4 / 5 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Aspartate Aminotransferase Increased
|
|
|
|
|
|
subjects affected / exposed
|
2 / 505 (0.40%) |
1 / 569 (0.18%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
1 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Alanine Aminotransferase Abnormal
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Blood Creatinine Increased
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
5 / 569 (0.88%) |
3 / 717 (0.42%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
2 / 5 |
1 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Blood Glucose Increased
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Blood Alkaline Phosphatase Increased
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Blood Urine Present
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
0 / 569 (0.00%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Injury, poisoning and procedural complications
|
|
|
|
|
|
Radius Fracture
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
0 / 569 (0.00%) |
2 / 717 (0.28%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tibia Fracture
|
|
|
|
|
|
subjects affected / exposed
|
2 / 505 (0.40%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tendon Rupture
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
0 / 569 (0.00%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Subdural Haematoma
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Subarachnoid Haemorrhage
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Spinal Fracture
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Perirenal Haematoma
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Traumatic Haemothorax
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Injury
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Incisional Hernia
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
0 / 569 (0.00%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Humerus Fracture
|
|
|
|
|
|
subjects affected / exposed
|
2 / 505 (0.40%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Fibula Fracture
|
|
|
|
|
|
subjects affected / exposed
|
2 / 505 (0.40%) |
0 / 569 (0.00%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Brain Contusion
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arteriovenous Fistula Site Haematoma
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ankle Fracture
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
1 / 3 (33.33%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Anastomotic Complication
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Meniscus Injury
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Accidental Overdose
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
0 / 569 (0.00%) |
2 / 717 (0.28%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Congenital, familial and genetic disorders
|
|
|
|
|
|
Polycystic Liver Disease
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urachal Abnormality
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
0 / 569 (0.00%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac disorders
|
|
|
|
|
|
Ventricular Tachycardia
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
0 / 569 (0.00%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pericarditis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pericardial Effusion
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Myocardial Infarction
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Mitral Valve Prolapse
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
0 / 569 (0.00%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Left Ventricular Dysfunction
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Coronary Artery Stenosis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Coronary Artery Disease
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
0 / 569 (0.00%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiogenic Shock
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac Failure
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac Arrest
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Atrial Fibrillation
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
0 / 569 (0.00%) |
3 / 717 (0.42%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Aortic Valve Incompetence
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Angina Unstable
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Angina Pectoris
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
2 / 569 (0.35%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Acute Myocardial Infarction
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Acute Left Ventricular Failure
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
0 / 569 (0.00%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Acute Coronary Syndrome
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nervous system disorders
|
|
|
|
|
|
Paraesthesia
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tremor
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
0 / 569 (0.00%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Transient Ischaemic Attack
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Syncope
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
2 / 569 (0.35%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sciatica
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
0 / 569 (0.00%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ruptured Cerebral Aneurysm
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Presyncope
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
0 / 569 (0.00%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vith Nerve Paralysis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Headache
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intracranial Aneurysm
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
0 / 569 (0.00%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Basilar Artery Aneurysm
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cerebellar Ischaemia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ischaemic Stroke
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cerebrovascular Accident
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Encephalopathy
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral Ischaemia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Epilepsy
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Blood and lymphatic system disorders
|
|
|
|
|
|
Anaemia
|
|
|
|
|
|
subjects affected / exposed
|
2 / 505 (0.40%) |
1 / 569 (0.18%) |
2 / 717 (0.28%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhagic Anaemia
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Leukocytosis
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
0 / 569 (0.00%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pancytopenia
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
0 / 569 (0.00%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ear and labyrinth disorders
|
|
|
|
|
|
Deafness
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Eye disorders
|
|
|
|
|
|
Retinal Detachment
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
0 / 569 (0.00%) |
2 / 717 (0.28%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Borderline Glaucoma
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
0 / 569 (0.00%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diplopia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Endocrine Ophthalmopathy
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal disorders
|
|
|
|
|
|
Gastrointestinal Disorder
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
0 / 569 (0.00%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vomiting
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Upper Gastrointestinal Haemorrhage
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
0 / 569 (0.00%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Umbilical Hernia
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
0 / 569 (0.00%) |
3 / 717 (0.42%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Small Intestinal Obstruction
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatitis Acute
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatitis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nausea
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lower Gastrointestinal Haemorrhage
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal Obstruction
|
|
|
|
|
|
subjects affected / exposed
|
2 / 505 (0.40%) |
0 / 569 (0.00%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Inguinal Hernia, Obstructive
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Inguinal Hernia
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
1 / 569 (0.18%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Incarcerated Umbilical Hernia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ileus
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
0 / 569 (0.00%) |
3 / 717 (0.42%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Colitis Ischaemic
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
0 / 569 (0.00%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrooesophageal Reflux Disease
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastritis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastric Ulcer Haemorrhage
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Duodenal Perforation
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diverticulum
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diarrhoea
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
3 / 569 (0.53%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 3 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Constipation
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
0 / 569 (0.00%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haematemesis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Colitis
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
0 / 569 (0.00%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ascites
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal Pain Upper
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
1 / 569 (0.18%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal Pain Lower
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal Pain
|
|
|
|
|
|
subjects affected / exposed
|
3 / 505 (0.59%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal Hernia
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
0 / 569 (0.00%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatobiliary disorders
|
|
|
|
|
|
Bile Duct Stone
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
0 / 569 (0.00%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cholecystitis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cholelithiasis
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
0 / 569 (0.00%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic Cyst
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic Pain
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ischaemic Hepatitis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Skin and subcutaneous tissue disorders
|
|
|
|
|
|
Angioedema
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rash Vesicular
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Skin Laxity
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
0 / 569 (0.00%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Skin Lesion
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal and urinary disorders
|
|
|
|
|
|
Renal Pain
|
|
|
|
|
|
subjects affected / exposed
|
2 / 505 (0.40%) |
5 / 569 (0.88%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 7 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal Impairment
|
|
|
|
|
|
subjects affected / exposed
|
6 / 505 (1.19%) |
2 / 569 (0.35%) |
3 / 717 (0.42%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
3 / 6 |
0 / 2 |
1 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal Haemorrhage
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal Failure
|
|
|
|
|
|
subjects affected / exposed
|
2 / 505 (0.40%) |
1 / 569 (0.18%) |
2 / 717 (0.28%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal Cyst Haemorrhage
|
|
|
|
|
|
subjects affected / exposed
|
3 / 505 (0.59%) |
4 / 569 (0.70%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 6 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal Cyst
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal Colic
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal Cyst Ruptured
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
1 / 569 (0.18%) |
2 / 717 (0.28%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pollakiuria
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nephropathy
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Acute Kidney Injury
|
|
|
|
|
|
subjects affected / exposed
|
5 / 505 (0.99%) |
8 / 569 (1.41%) |
7 / 717 (0.98%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
1 / 5 |
3 / 9 |
3 / 7 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nephrolithiasis
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
1 / 569 (0.18%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Kidney Enlargement
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haematuria
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
2 / 569 (0.35%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 2 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
End Stage Renal Disease
|
|
|
|
|
|
subjects affected / exposed
|
3 / 505 (0.59%) |
0 / 569 (0.00%) |
8 / 717 (1.12%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 8 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chronic Kidney Disease
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Polyuria
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal and connective tissue disorders
|
|
|
|
|
|
Spinal Osteoarthritis
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
0 / 569 (0.00%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arthritis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Foot Deformity
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
0 / 569 (0.00%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arthralgia
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
0 / 569 (0.00%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pain In Extremity
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Infections and infestations
|
|
|
|
|
|
Pulmonary Tuberculosis
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
0 / 569 (0.00%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pyelonephritis
|
|
|
|
|
|
subjects affected / exposed
|
3 / 505 (0.59%) |
1 / 569 (0.18%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Postoperative Wound Infection
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal Abscess
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
0 / 569 (0.00%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal Cyst Infection
|
|
|
|
|
|
subjects affected / exposed
|
5 / 505 (0.99%) |
8 / 569 (1.41%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
1 / 7 |
0 / 10 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Salmonellosis
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
0 / 569 (0.00%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sepsis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
2 / 569 (0.35%) |
2 / 717 (0.28%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urinary Tract Infection
|
|
|
|
|
|
subjects affected / exposed
|
3 / 505 (0.59%) |
2 / 569 (0.35%) |
5 / 717 (0.70%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 5 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sinusitis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Staphylococcal Infection
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Superinfection
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tonsillitis
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
0 / 569 (0.00%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urosepsis
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
1 / 569 (0.18%) |
2 / 717 (0.28%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Viral Infection
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia Staphylococcal
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Septic Shock
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia
|
|
|
|
|
|
subjects affected / exposed
|
4 / 505 (0.79%) |
5 / 569 (0.88%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal Wall Abscess
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ophthalmic Herpes Zoster
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Appendicitis
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
0 / 569 (0.00%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Appendicitis Perforated
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cat Scratch Disease
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cellulitis
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Clostridium Difficile Infection
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
0 / 569 (0.00%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peritonitis Bacterial
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diarrhoea Infectious
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diverticulitis
|
|
|
|
|
|
subjects affected / exposed
|
2 / 505 (0.40%) |
1 / 569 (0.18%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cytomegalovirus
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Escherichia Bacteraemia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Escherichia Urinary Tract Infection
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastroenteritis
|
|
|
|
|
|
subjects affected / exposed
|
2 / 505 (0.40%) |
3 / 569 (0.53%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic Cyst Infection
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Herpes Zoster
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
0 / 569 (0.00%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Herpes Zoster Oticus
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Infected Cyst
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Infection
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Endocarditis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metabolism and nutrition disorders
|
|
|
|
|
|
Dehydration
|
|
|
|
|
|
subjects affected / exposed
|
2 / 505 (0.40%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diabetes Mellitus
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyperkalaemia
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypernatraemia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypoglycaemia
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
0 / 569 (0.00%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypokalaemia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyponatraemia
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
2 / 569 (0.35%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 2 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypophosphataemia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metabolic Acidosis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 505 (0.00%) |
1 / 569 (0.18%) |
0 / 717 (0.00%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Obesity
|
|
|
|
|
|
subjects affected / exposed
|
1 / 505 (0.20%) |
0 / 569 (0.00%) |
1 / 717 (0.14%) |
0 / 6 (0.00%) |
0 / 3 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |