Serious adverse events
|
SOC-controlled Period: SOC |
SOC-controlled Period: Evolocumab + SOC |
All-IP Period: SOC / Evolocumab |
All-IP Period: Evolocumab + SoC / Evolocumab |
All-IP Period: Total |
Total subjects affected by serious adverse events
|
|
|
|
|
|
subjects affected / exposed
|
30 / 442 (6.79%) |
72 / 882 (8.16%) |
78 / 398 (19.60%) |
181 / 822 (22.02%) |
259 / 1220 (21.23%) |
number of deaths (all causes)
|
2 |
1 |
3 |
13 |
16 |
number of deaths resulting from adverse events
|
|
|
|
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
|
|
|
Acute leukaemia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Adenocarcinoma gastric
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
1 / 398 (0.25%) |
0 / 822 (0.00%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Adenocarcinoma of colon
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Adenoma benign
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Anal squamous cell carcinoma
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
B-cell lymphoma
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
2 / 398 (0.50%) |
1 / 822 (0.12%) |
3 / 1220 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Benign neoplasm of bladder
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bladder cancer
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
1 / 398 (0.25%) |
0 / 822 (0.00%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bladder neoplasm
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bladder transitional cell carcinoma
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Breast cancer
|
|
|
|
|
|
subjects affected / exposed
|
1 / 442 (0.23%) |
0 / 882 (0.00%) |
1 / 398 (0.25%) |
5 / 822 (0.61%) |
6 / 1220 (0.49%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 5 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cholangiocarcinoma
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chronic lymphocytic leukaemia
|
|
|
|
|
|
subjects affected / exposed
|
1 / 442 (0.23%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
0 / 822 (0.00%) |
0 / 1220 (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 |
Colon adenoma
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
1 / 398 (0.25%) |
0 / 822 (0.00%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
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
|
1 / 442 (0.23%) |
0 / 882 (0.00%) |
2 / 398 (0.50%) |
1 / 822 (0.12%) |
3 / 1220 (0.25%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diffuse large B-cell lymphoma
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
1 / 398 (0.25%) |
0 / 822 (0.00%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastric cancer
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
1 / 882 (0.11%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hairy cell leukaemia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic cancer metastatic
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
Intraductal papilloma of breast
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
1 / 882 (0.11%) |
0 / 398 (0.00%) |
0 / 822 (0.00%) |
0 / 1220 (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 |
Intraductal proliferative breast lesion
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
1 / 882 (0.11%) |
0 / 398 (0.00%) |
0 / 822 (0.00%) |
0 / 1220 (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 |
Kaposi's sarcoma
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
1 / 398 (0.25%) |
0 / 822 (0.00%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lung adenocarcinoma
|
|
|
|
|
|
subjects affected / exposed
|
1 / 442 (0.23%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
2 / 822 (0.24%) |
2 / 1220 (0.16%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
Lung neoplasm malignant
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
1 / 882 (0.11%) |
0 / 398 (0.00%) |
2 / 822 (0.24%) |
2 / 1220 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lymphoma
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Mantle cell lymphoma stage IV
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Meningioma
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to lung
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to lymph nodes
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
2 / 822 (0.24%) |
2 / 1220 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Myxoid liposarcoma
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Oesophageal carcinoma
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatic carcinoma
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
2 / 822 (0.24%) |
2 / 1220 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
2 / 2 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
1 / 1 |
Papillary thyroid cancer
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Prostate cancer
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
1 / 882 (0.11%) |
2 / 398 (0.50%) |
4 / 822 (0.49%) |
6 / 1220 (0.49%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
1 / 2 |
2 / 5 |
3 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rectal adenoma
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rectal cancer
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
1 / 398 (0.25%) |
1 / 822 (0.12%) |
2 / 1220 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Small cell lung cancer
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
1 / 398 (0.25%) |
0 / 822 (0.00%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Small cell lung cancer metastatic
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
1 / 398 (0.25%) |
0 / 822 (0.00%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Squamous cell carcinoma
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
1 / 882 (0.11%) |
0 / 398 (0.00%) |
0 / 822 (0.00%) |
0 / 1220 (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 lung
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Thyroid adenoma
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
1 / 882 (0.11%) |
0 / 398 (0.00%) |
0 / 822 (0.00%) |
0 / 1220 (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 |
Uterine cancer
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
1 / 882 (0.11%) |
1 / 398 (0.25%) |
0 / 822 (0.00%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Uterine leiomyoma
|
|
|
|
|
|
subjects affected / exposed
|
1 / 442 (0.23%) |
0 / 882 (0.00%) |
1 / 398 (0.25%) |
0 / 822 (0.00%) |
1 / 1220 (0.08%) |
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 |
Vascular disorders
|
|
|
|
|
|
Accelerated hypertension
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
1 / 882 (0.11%) |
0 / 398 (0.00%) |
0 / 822 (0.00%) |
0 / 1220 (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 |
Aortic aneurysm
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
1 / 398 (0.25%) |
0 / 822 (0.00%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Aortic stenosis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
1 / 882 (0.11%) |
1 / 398 (0.25%) |
0 / 822 (0.00%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Deep vein thrombosis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
2 / 822 (0.24%) |
2 / 1220 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 3 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypertension
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypertensive crisis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral arterial occlusive disease
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral ischaemia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral vascular disorder
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Surgical and medical procedures
|
|
|
|
|
|
Cholecystectomy
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Knee arthroplasty
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Medical device removal
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
1 / 398 (0.25%) |
0 / 822 (0.00%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pregnancy, puerperium and perinatal conditions
|
|
|
|
|
|
Abortion spontaneous
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
1 / 882 (0.11%) |
0 / 398 (0.00%) |
0 / 822 (0.00%) |
0 / 1220 (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 |
Ectopic pregnancy
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
1 / 882 (0.11%) |
0 / 398 (0.00%) |
0 / 822 (0.00%) |
0 / 1220 (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
|
|
|
|
|
|
Chest discomfort
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
1 / 882 (0.11%) |
0 / 398 (0.00%) |
0 / 822 (0.00%) |
0 / 1220 (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 |
Chest pain
|
|
|
|
|
|
subjects affected / exposed
|
1 / 442 (0.23%) |
4 / 882 (0.45%) |
1 / 398 (0.25%) |
6 / 822 (0.73%) |
7 / 1220 (0.57%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
0 / 1 |
0 / 6 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Fatigue
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypothermia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
1 / 398 (0.25%) |
0 / 822 (0.00%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Mass
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nodule
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
1 / 398 (0.25%) |
0 / 822 (0.00%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Non-cardiac chest pain
|
|
|
|
|
|
subjects affected / exposed
|
1 / 442 (0.23%) |
4 / 882 (0.45%) |
0 / 398 (0.00%) |
7 / 822 (0.85%) |
7 / 1220 (0.57%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 0 |
0 / 8 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Organ failure
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pain
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Immune system disorders
|
|
|
|
|
|
Contrast media allergy
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
1 / 882 (0.11%) |
0 / 398 (0.00%) |
0 / 822 (0.00%) |
0 / 1220 (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 |
Drug hypersensitivity
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Reproductive system and breast disorders
|
|
|
|
|
|
Benign prostatic hyperplasia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
2 / 882 (0.23%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cystocele
|
|
|
|
|
|
subjects affected / exposed
|
1 / 442 (0.23%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
0 / 822 (0.00%) |
0 / 1220 (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
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Postmenopausal haemorrhage
|
|
|
|
|
|
subjects affected / exposed
|
1 / 442 (0.23%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
0 / 822 (0.00%) |
0 / 1220 (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 |
Prostatitis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Uterine prolapse
|
|
|
|
|
|
subjects affected / exposed
|
1 / 442 (0.23%) |
0 / 882 (0.00%) |
1 / 398 (0.25%) |
0 / 822 (0.00%) |
1 / 1220 (0.08%) |
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 |
Respiratory, thoracic and mediastinal disorders
|
|
|
|
|
|
Asthma
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
1 / 398 (0.25%) |
1 / 822 (0.12%) |
2 / 1220 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chronic obstructive pulmonary disease
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
1 / 882 (0.11%) |
0 / 398 (0.00%) |
4 / 822 (0.49%) |
4 / 1220 (0.33%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 6 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dyspnoea
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
2 / 398 (0.50%) |
2 / 822 (0.24%) |
4 / 1220 (0.33%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dyspnoea exertional
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Epistaxis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemoptysis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Interstitial lung disease
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
1 / 398 (0.25%) |
1 / 822 (0.12%) |
2 / 1220 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Laryngeal polyp
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pharyngeal oedema
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pleurisy
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
1 / 882 (0.11%) |
0 / 398 (0.00%) |
0 / 822 (0.00%) |
0 / 1220 (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 embolism
|
|
|
|
|
|
subjects affected / exposed
|
2 / 442 (0.45%) |
1 / 882 (0.11%) |
1 / 398 (0.25%) |
4 / 822 (0.49%) |
5 / 1220 (0.41%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 1 |
1 / 5 |
1 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary granuloma
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary oedema
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
1 / 882 (0.11%) |
0 / 398 (0.00%) |
0 / 822 (0.00%) |
0 / 1220 (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 failure
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sinus polyp
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vocal cord polyp
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
1 / 398 (0.25%) |
0 / 822 (0.00%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Psychiatric disorders
|
|
|
|
|
|
Alcohol abuse
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
1 / 398 (0.25%) |
0 / 822 (0.00%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Alcohol withdrawal syndrome
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
1 / 882 (0.11%) |
0 / 398 (0.00%) |
0 / 822 (0.00%) |
0 / 1220 (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 |
Anxiety
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
1 / 882 (0.11%) |
0 / 398 (0.00%) |
0 / 822 (0.00%) |
0 / 1220 (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 |
Confusional state
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Delirium
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Depression
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
1 / 882 (0.11%) |
1 / 398 (0.25%) |
1 / 822 (0.12%) |
2 / 1220 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hallucination
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Mental status changes
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Psychotic disorder
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Suicidal ideation
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Investigations
|
|
|
|
|
|
Electrocardiogram ST segment abnormal
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
1 / 882 (0.11%) |
0 / 398 (0.00%) |
0 / 822 (0.00%) |
0 / 1220 (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 |
HIV test positive
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Heart rate increased
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
1 / 398 (0.25%) |
0 / 822 (0.00%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic enzyme increased
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
1 / 398 (0.25%) |
1 / 822 (0.12%) |
2 / 1220 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
1 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Platelet count decreased
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Weight decreased
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Injury, poisoning and procedural complications
|
|
|
|
|
|
Anaesthetic complication
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ankle fracture
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
2 / 822 (0.24%) |
2 / 1220 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac contusion
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
1 / 398 (0.25%) |
0 / 822 (0.00%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Clavicle fracture
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
1 / 398 (0.25%) |
0 / 822 (0.00%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Concussion
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
1 / 882 (0.11%) |
1 / 398 (0.25%) |
0 / 822 (0.00%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Contusion
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
1 / 882 (0.11%) |
0 / 398 (0.00%) |
0 / 822 (0.00%) |
0 / 1220 (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 |
Fall
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
1 / 398 (0.25%) |
0 / 822 (0.00%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Femur fracture
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
2 / 398 (0.50%) |
2 / 822 (0.24%) |
4 / 1220 (0.33%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Foot fracture
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
2 / 398 (0.50%) |
0 / 822 (0.00%) |
2 / 1220 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hip fracture
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intervertebral disc injury
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Joint dislocation
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
1 / 882 (0.11%) |
0 / 398 (0.00%) |
0 / 822 (0.00%) |
0 / 1220 (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 |
Laceration
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
1 / 398 (0.25%) |
0 / 822 (0.00%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lower limb fracture
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
2 / 882 (0.23%) |
0 / 398 (0.00%) |
0 / 822 (0.00%) |
0 / 1220 (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 |
Lumbar vertebral fracture
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
1 / 882 (0.11%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Meniscus injury
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Multiple fractures
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Muscle rupture
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
1 / 882 (0.11%) |
0 / 398 (0.00%) |
0 / 822 (0.00%) |
0 / 1220 (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 |
Pelvic fracture
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
1 / 882 (0.11%) |
0 / 398 (0.00%) |
0 / 822 (0.00%) |
0 / 1220 (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 |
Post procedural haematoma
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural haematuria
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural haemorrhage
|
|
|
|
|
|
subjects affected / exposed
|
1 / 442 (0.23%) |
0 / 882 (0.00%) |
1 / 398 (0.25%) |
1 / 822 (0.12%) |
2 / 1220 (0.16%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Procedural complication
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Procedural nausea
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Procedural pain
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Procedural vomiting
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pubis fracture
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
1 / 882 (0.11%) |
0 / 398 (0.00%) |
0 / 822 (0.00%) |
0 / 1220 (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 contusion
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
1 / 398 (0.25%) |
0 / 822 (0.00%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rib fracture
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
2 / 398 (0.50%) |
1 / 822 (0.12%) |
3 / 1220 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Scapula fracture
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
1 / 882 (0.11%) |
0 / 398 (0.00%) |
0 / 822 (0.00%) |
0 / 1220 (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 |
Spinal compression fracture
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Subdural haematoma
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
1 / 398 (0.25%) |
0 / 822 (0.00%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tendon injury
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tendon rupture
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
1 / 882 (0.11%) |
0 / 398 (0.00%) |
0 / 822 (0.00%) |
0 / 1220 (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 |
Tibia fracture
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
1 / 398 (0.25%) |
0 / 822 (0.00%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Toxicity to various agents
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Traumatic intracranial haemorrhage
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ulna fracture
|
|
|
|
|
|
subjects affected / exposed
|
1 / 442 (0.23%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
0 / 822 (0.00%) |
0 / 1220 (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 |
Upper limb fracture
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
1 / 398 (0.25%) |
0 / 822 (0.00%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urinary retention postoperative
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Wound
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
1 / 398 (0.25%) |
0 / 822 (0.00%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Wound dehiscence
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
1 / 398 (0.25%) |
0 / 822 (0.00%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Wrist fracture
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
1 / 398 (0.25%) |
3 / 822 (0.36%) |
4 / 1220 (0.33%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac disorders
|
|
|
|
|
|
Acute coronary syndrome
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Angina pectoris
|
|
|
|
|
|
subjects affected / exposed
|
2 / 442 (0.45%) |
4 / 882 (0.45%) |
1 / 398 (0.25%) |
9 / 822 (1.09%) |
10 / 1220 (0.82%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 1 |
0 / 9 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Angina unstable
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
1 / 882 (0.11%) |
1 / 398 (0.25%) |
1 / 822 (0.12%) |
2 / 1220 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Aortic valve disease
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
2 / 822 (0.24%) |
2 / 1220 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Aortic valve disease mixed
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Aortic valve incompetence
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Aortic valve sclerosis
|
|
|
|
|
|
subjects affected / exposed
|
1 / 442 (0.23%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
0 / 822 (0.00%) |
0 / 1220 (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 |
Aortic valve stenosis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arteriosclerosis coronary artery
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Atrial fibrillation
|
|
|
|
|
|
subjects affected / exposed
|
1 / 442 (0.23%) |
1 / 882 (0.11%) |
2 / 398 (0.50%) |
7 / 822 (0.85%) |
9 / 1220 (0.74%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
1 / 9 |
1 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Atrial flutter
|
|
|
|
|
|
subjects affected / exposed
|
1 / 442 (0.23%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Atrial thrombosis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bradycardia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac arrest
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
1 / 398 (0.25%) |
1 / 822 (0.12%) |
2 / 1220 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Cardiac failure
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
2 / 822 (0.24%) |
2 / 1220 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac failure congestive
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
1 / 398 (0.25%) |
1 / 822 (0.12%) |
2 / 1220 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiogenic shock
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiopulmonary failure
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
1 / 398 (0.25%) |
0 / 822 (0.00%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Coronary artery disease
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
1 / 882 (0.11%) |
2 / 398 (0.50%) |
4 / 822 (0.49%) |
6 / 1220 (0.49%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
0 / 4 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Coronary artery embolism
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
1 / 398 (0.25%) |
0 / 822 (0.00%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Coronary artery occlusion
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
1 / 882 (0.11%) |
0 / 398 (0.00%) |
0 / 822 (0.00%) |
0 / 1220 (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 |
Coronary artery stenosis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
1 / 882 (0.11%) |
1 / 398 (0.25%) |
2 / 822 (0.24%) |
3 / 1220 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Mitral valve disease
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Mitral valve disease mixed
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Mitral valve incompetence
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
2 / 822 (0.24%) |
2 / 1220 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Myocardial ischaemia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nodal rhythm
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
1 / 882 (0.11%) |
0 / 398 (0.00%) |
0 / 822 (0.00%) |
0 / 1220 (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 |
Pericarditis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Supraventricular tachycardia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ventricular extrasystoles
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ventricular tachycardia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nervous system disorders
|
|
|
|
|
|
Ataxia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Brain stem haemorrhage
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Carotid artery stenosis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
1 / 882 (0.11%) |
0 / 398 (0.00%) |
0 / 822 (0.00%) |
0 / 1220 (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 |
Cerebral thrombosis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
1 / 398 (0.25%) |
0 / 822 (0.00%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cerebrovascular accident
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
1 / 398 (0.25%) |
0 / 822 (0.00%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cervical radiculopathy
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
1 / 398 (0.25%) |
0 / 822 (0.00%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dizziness
|
|
|
|
|
|
subjects affected / exposed
|
1 / 442 (0.23%) |
0 / 882 (0.00%) |
2 / 398 (0.50%) |
0 / 822 (0.00%) |
2 / 1220 (0.16%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dizziness postural
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Encephalopathy
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
1 / 398 (0.25%) |
0 / 822 (0.00%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Facial paralysis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Generalised tonic-clonic seizure
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Guillain-Barre syndrome
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
1 / 398 (0.25%) |
0 / 822 (0.00%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhage intracranial
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
1 / 398 (0.25%) |
0 / 822 (0.00%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Headache
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
1 / 398 (0.25%) |
0 / 822 (0.00%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lumbar radiculopathy
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
1 / 398 (0.25%) |
0 / 822 (0.00%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Migraine
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
1 / 882 (0.11%) |
0 / 398 (0.00%) |
0 / 822 (0.00%) |
0 / 1220 (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 |
Motor neurone disease
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Myelopathy
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Presyncope
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
2 / 882 (0.23%) |
0 / 398 (0.00%) |
0 / 822 (0.00%) |
0 / 1220 (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 |
Sciatica
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spinal claudication
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Syncope
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
2 / 882 (0.23%) |
0 / 398 (0.00%) |
4 / 822 (0.49%) |
4 / 1220 (0.33%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tension headache
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
1 / 398 (0.25%) |
0 / 822 (0.00%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Transient ischaemic attack
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tremor
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Trigeminal neuralgia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vertebrobasilar insufficiency
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
1 / 398 (0.25%) |
0 / 822 (0.00%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
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
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Febrile neutropenia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Iron deficiency anaemia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ear and labyrinth disorders
|
|
|
|
|
|
Sudden hearing loss
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
1 / 882 (0.11%) |
0 / 398 (0.00%) |
0 / 822 (0.00%) |
0 / 1220 (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 |
Vertigo positional
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
1 / 882 (0.11%) |
0 / 398 (0.00%) |
0 / 822 (0.00%) |
0 / 1220 (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
|
|
|
|
|
|
Cataract
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
2 / 398 (0.50%) |
2 / 822 (0.24%) |
4 / 1220 (0.33%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 3 |
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cataract cortical
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
1 / 882 (0.11%) |
0 / 398 (0.00%) |
0 / 822 (0.00%) |
0 / 1220 (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 |
Corneal defect
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Eyelid ptosis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Keratitis
|
|
|
|
|
|
subjects affected / exposed
|
1 / 442 (0.23%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
0 / 822 (0.00%) |
0 / 1220 (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 |
Gastrointestinal disorders
|
|
|
|
|
|
Abdominal discomfort
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
1 / 882 (0.11%) |
0 / 398 (0.00%) |
0 / 822 (0.00%) |
0 / 1220 (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 |
Abdominal pain
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
2 / 822 (0.24%) |
2 / 1220 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal pain upper
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Anal fistula
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Brunner's gland hyperplasia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Colitis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Constipation
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
1 / 882 (0.11%) |
0 / 398 (0.00%) |
0 / 822 (0.00%) |
0 / 1220 (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
|
|
|
|
|
|
subjects affected / exposed
|
1 / 442 (0.23%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dysphagia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Faecaloma
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
1 / 882 (0.11%) |
0 / 398 (0.00%) |
0 / 822 (0.00%) |
0 / 1220 (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 |
Faeces discoloured
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
1 / 882 (0.11%) |
0 / 398 (0.00%) |
0 / 822 (0.00%) |
0 / 1220 (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 |
Gastritis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
1 / 882 (0.11%) |
0 / 398 (0.00%) |
0 / 822 (0.00%) |
0 / 1220 (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 |
Gastrooesophageal reflux disease
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
2 / 822 (0.24%) |
2 / 1220 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhoidal haemorrhage
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
1 / 882 (0.11%) |
0 / 398 (0.00%) |
0 / 822 (0.00%) |
0 / 1220 (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 |
Haemorrhoids
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hiatus hernia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
2 / 822 (0.24%) |
2 / 1220 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ileus paralytic
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Impaired gastric emptying
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
1 / 882 (0.11%) |
1 / 398 (0.25%) |
0 / 822 (0.00%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Inguinal hernia
|
|
|
|
|
|
subjects affected / exposed
|
1 / 442 (0.23%) |
0 / 882 (0.00%) |
2 / 398 (0.50%) |
0 / 822 (0.00%) |
2 / 1220 (0.16%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal ischaemia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal obstruction
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
1 / 882 (0.11%) |
0 / 398 (0.00%) |
0 / 822 (0.00%) |
0 / 1220 (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 |
Large intestine polyp
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
1 / 398 (0.25%) |
2 / 822 (0.24%) |
3 / 1220 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
0 / 2 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lumbar hernia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nausea
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
1 / 398 (0.25%) |
0 / 822 (0.00%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Obstructive pancreatitis
|
|
|
|
|
|
subjects affected / exposed
|
1 / 442 (0.23%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
0 / 822 (0.00%) |
0 / 1220 (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 |
Oesophageal spasm
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
1 / 882 (0.11%) |
0 / 398 (0.00%) |
0 / 822 (0.00%) |
0 / 1220 (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
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
1 / 882 (0.11%) |
0 / 398 (0.00%) |
2 / 822 (0.24%) |
2 / 1220 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Retroperitoneal haematoma
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Splenic artery aneurysm
|
|
|
|
|
|
subjects affected / exposed
|
1 / 442 (0.23%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
0 / 822 (0.00%) |
0 / 1220 (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 |
Tooth impacted
|
|
|
|
|
|
subjects affected / exposed
|
1 / 442 (0.23%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
0 / 822 (0.00%) |
0 / 1220 (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
|
|
|
|
|
|
Autoimmune hepatitis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Biliary dyskinesia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
1 / 398 (0.25%) |
0 / 822 (0.00%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cholecystitis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
2 / 398 (0.50%) |
1 / 822 (0.12%) |
3 / 1220 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 2 |
0 / 1 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cholecystitis acute
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
4 / 822 (0.49%) |
4 / 1220 (0.33%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cholelithiasis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
1 / 398 (0.25%) |
4 / 822 (0.49%) |
5 / 1220 (0.41%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 5 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Drug-induced liver injury
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic function abnormal
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
1 / 398 (0.25%) |
1 / 822 (0.12%) |
2 / 1220 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
0 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatotoxicity
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
1 / 882 (0.11%) |
0 / 398 (0.00%) |
0 / 822 (0.00%) |
0 / 1220 (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 |
Jaundice
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Skin and subcutaneous tissue disorders
|
|
|
|
|
|
Urticaria
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal and urinary disorders
|
|
|
|
|
|
Acute kidney injury
|
|
|
|
|
|
subjects affected / exposed
|
1 / 442 (0.23%) |
1 / 882 (0.11%) |
0 / 398 (0.00%) |
2 / 822 (0.24%) |
2 / 1220 (0.16%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bladder prolapse
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Calculus bladder
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chronic kidney disease
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hydronephrosis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
2 / 822 (0.24%) |
2 / 1220 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nephrolithiasis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
1 / 882 (0.11%) |
1 / 398 (0.25%) |
3 / 822 (0.36%) |
4 / 1220 (0.33%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal artery stenosis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
1 / 398 (0.25%) |
0 / 822 (0.00%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal colic
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal failure
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ureterolithiasis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urinary incontinence
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
1 / 882 (0.11%) |
0 / 398 (0.00%) |
0 / 822 (0.00%) |
0 / 1220 (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 disorders
|
|
|
|
|
|
Thyroid mass
|
|
|
|
|
|
subjects affected / exposed
|
1 / 442 (0.23%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
0 / 822 (0.00%) |
0 / 1220 (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 |
Thyroiditis acute
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal and connective tissue disorders
|
|
|
|
|
|
Arthralgia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
1 / 882 (0.11%) |
0 / 398 (0.00%) |
3 / 822 (0.36%) |
3 / 1220 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arthritis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
1 / 398 (0.25%) |
1 / 822 (0.12%) |
2 / 1220 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Back pain
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
1 / 398 (0.25%) |
3 / 822 (0.36%) |
4 / 1220 (0.33%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bursitis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
1 / 882 (0.11%) |
1 / 398 (0.25%) |
1 / 822 (0.12%) |
2 / 1220 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chondrocalcinosis pyrophosphate
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
1 / 398 (0.25%) |
0 / 822 (0.00%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chondropathy
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Costochondritis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
1 / 882 (0.11%) |
2 / 398 (0.50%) |
1 / 822 (0.12%) |
3 / 1220 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dupuytren's contracture
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
1 / 398 (0.25%) |
0 / 822 (0.00%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Foot deformity
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intervertebral disc disorder
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
1 / 882 (0.11%) |
0 / 398 (0.00%) |
0 / 822 (0.00%) |
0 / 1220 (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 |
Intervertebral disc protrusion
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lumbar spinal stenosis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
2 / 398 (0.50%) |
0 / 822 (0.00%) |
2 / 1220 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Muscular weakness
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
1 / 398 (0.25%) |
0 / 822 (0.00%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal chest pain
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
1 / 882 (0.11%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal pain
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
1 / 882 (0.11%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Myalgia
|
|
|
|
|
|
subjects affected / exposed
|
1 / 442 (0.23%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
0 / 822 (0.00%) |
0 / 1220 (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 |
Osteoarthritis
|
|
|
|
|
|
subjects affected / exposed
|
1 / 442 (0.23%) |
3 / 882 (0.34%) |
5 / 398 (1.26%) |
9 / 822 (1.09%) |
14 / 1220 (1.15%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 5 |
0 / 11 |
0 / 16 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Osteoporosis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pain in extremity
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
1 / 398 (0.25%) |
1 / 822 (0.12%) |
2 / 1220 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rhabdomyolysis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rotator cuff syndrome
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spinal column stenosis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
1 / 398 (0.25%) |
3 / 822 (0.36%) |
4 / 1220 (0.33%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spinal osteoarthritis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
1 / 882 (0.11%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spinal pain
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Synovial cyst
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
1 / 398 (0.25%) |
0 / 822 (0.00%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tendonitis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Infections and infestations
|
|
|
|
|
|
Abscess limb
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
1 / 398 (0.25%) |
0 / 822 (0.00%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Anal abscess
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Appendiceal abscess
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Appendicitis
|
|
|
|
|
|
subjects affected / exposed
|
1 / 442 (0.23%) |
5 / 882 (0.57%) |
2 / 398 (0.50%) |
3 / 822 (0.36%) |
5 / 1220 (0.41%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
0 / 2 |
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arthritis bacterial
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arthritis infective
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bacterial pyelonephritis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
1 / 398 (0.25%) |
0 / 822 (0.00%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bronchitis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
2 / 398 (0.50%) |
2 / 822 (0.24%) |
4 / 1220 (0.33%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bursitis infective
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
2 / 822 (0.24%) |
2 / 1220 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cellulitis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
1 / 882 (0.11%) |
0 / 398 (0.00%) |
2 / 822 (0.24%) |
2 / 1220 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cellulitis staphylococcal
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chronic sinusitis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
1 / 882 (0.11%) |
1 / 398 (0.25%) |
0 / 822 (0.00%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Clostridial infection
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Clostridium difficile colitis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cystitis
|
|
|
|
|
|
subjects affected / exposed
|
1 / 442 (0.23%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diverticulitis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
1 / 398 (0.25%) |
1 / 822 (0.12%) |
2 / 1220 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Endocarditis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Erysipelas
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Escherichia sepsis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastroenteritis
|
|
|
|
|
|
subjects affected / exposed
|
1 / 442 (0.23%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
2 / 822 (0.24%) |
2 / 1220 (0.16%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastroenteritis bacterial
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Groin abscess
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
1 / 398 (0.25%) |
0 / 822 (0.00%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Herpes zoster
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Infective spondylitis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Joint abscess
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Meningitis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ophthalmic herpes simplex
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Osteomyelitis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
3 / 882 (0.34%) |
2 / 398 (0.50%) |
4 / 822 (0.49%) |
6 / 1220 (0.49%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 2 |
0 / 6 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia bacterial
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Postoperative wound infection
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pyelonephritis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
1 / 882 (0.11%) |
1 / 398 (0.25%) |
3 / 822 (0.36%) |
4 / 1220 (0.33%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory tract infection
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
1 / 882 (0.11%) |
0 / 398 (0.00%) |
0 / 822 (0.00%) |
0 / 1220 (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 |
Rocky mountain spotted fever
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sepsis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
1 / 882 (0.11%) |
0 / 398 (0.00%) |
0 / 822 (0.00%) |
0 / 1220 (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 |
Skin infection
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Streptococcal sepsis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Subcutaneous abscess
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Upper respiratory tract infection
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urinary tract infection
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
4 / 822 (0.49%) |
4 / 1220 (0.33%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metabolism and nutrition disorders
|
|
|
|
|
|
Dehydration
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diabetes mellitus
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
3 / 882 (0.34%) |
2 / 398 (0.50%) |
0 / 822 (0.00%) |
2 / 1220 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 3 |
0 / 3 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic ketoacidosis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Fluid retention
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyperglycaemia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypoglycaemia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
1 / 398 (0.25%) |
0 / 822 (0.00%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyponatraemia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
1 / 882 (0.11%) |
0 / 398 (0.00%) |
0 / 822 (0.00%) |
0 / 1220 (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 |
Malnutrition
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Type 2 diabetes mellitus
|
|
|
|
|
|
subjects affected / exposed
|
0 / 442 (0.00%) |
0 / 882 (0.00%) |
0 / 398 (0.00%) |
1 / 822 (0.12%) |
1 / 1220 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |