Serious adverse events
|
Valsartan |
LCZ696 |
All patients |
Total subjects affected by serious adverse events
|
|
|
|
subjects affected / exposed
|
1416 / 2402 (58.95%) |
1424 / 2419 (58.87%) |
2840 / 4821 (58.91%) |
number of deaths (all causes)
|
357 |
347 |
704 |
number of deaths resulting from adverse events
|
5 |
5 |
10 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
|
Acute lymphocytic leukaemia
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
Acute myeloid leukaemia
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
0 / 2419 (0.00%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Acute promyelocytic leukaemia
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Adenocarcinoma
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
0 / 2419 (0.00%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 3 |
Adenocarcinoma gastric
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
3 / 2419 (0.12%) |
4 / 4821 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
Adenocarcinoma of colon
|
|
|
|
subjects affected / exposed
|
4 / 2402 (0.17%) |
3 / 2419 (0.12%) |
7 / 4821 (0.15%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Anal cancer stage 0
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
B-cell lymphoma
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
2 / 2419 (0.08%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Basal cell carcinoma
|
|
|
|
subjects affected / exposed
|
11 / 2402 (0.46%) |
11 / 2419 (0.45%) |
22 / 4821 (0.46%) |
occurrences causally related to treatment / all
|
0 / 12 |
1 / 14 |
1 / 26 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Benign gastrointestinal neoplasm
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Benign lung neoplasm
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Benign pancreatic neoplasm
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Bile duct cancer
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
1 / 2419 (0.04%) |
4 / 4821 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 3 |
Bladder cancer
|
|
|
|
subjects affected / exposed
|
5 / 2402 (0.21%) |
2 / 2419 (0.08%) |
7 / 4821 (0.15%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 2 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
Bladder neoplasm
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
2 / 2419 (0.08%) |
4 / 4821 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bladder transitional cell carcinoma
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bone cancer
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Bowen's disease
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Brain neoplasm
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
Brain neoplasm malignant
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Breast angiosarcoma
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Breast cancer
|
|
|
|
subjects affected / exposed
|
8 / 2402 (0.33%) |
6 / 2419 (0.25%) |
14 / 4821 (0.29%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 6 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
Breast neoplasm
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bronchial carcinoma
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
4 / 2419 (0.17%) |
5 / 4821 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
Carcinoma in situ of skin
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Central nervous system lymphoma
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Cholangiocarcinoma
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
Chronic lymphocytic leukaemia
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chronic myeloid leukaemia
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Clear cell renal cell carcinoma
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Colon adenoma
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
0 / 2419 (0.00%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Colon cancer
|
|
|
|
subjects affected / exposed
|
4 / 2402 (0.17%) |
5 / 2419 (0.21%) |
9 / 4821 (0.19%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 5 |
1 / 9 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
Colon cancer metastatic
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Colon neoplasm
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Colorectal cancer
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Diffuse large B-cell lymphoma
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Endometrial adenocarcinoma
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
2 / 2419 (0.08%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Endometrial cancer
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
2 / 2419 (0.08%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Fibroma
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gallbladder cancer
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Gallbladder neoplasm
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastric cancer
|
|
|
|
subjects affected / exposed
|
4 / 2402 (0.17%) |
3 / 2419 (0.12%) |
7 / 4821 (0.15%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 5 |
Gastric neoplasm
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
0 / 2419 (0.00%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal carcinoma
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal neoplasm
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal stromal tumour
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Gastrointestinal tract adenoma
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Glioblastoma
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemangioma of liver
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic cancer
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
2 / 2419 (0.08%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 3 |
Hepatic cancer metastatic
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Hepatic neoplasm
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Hepatocellular carcinoma
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
5 / 2419 (0.21%) |
7 / 4821 (0.15%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 3 |
Hormone-refractory prostate cancer
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal adenocarcinoma
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Invasive breast carcinoma
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
2 / 2419 (0.08%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Invasive lobular breast carcinoma
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Invasive papillary breast carcinoma
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Kaposi's sarcoma
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Laryngeal cancer
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Laryngeal squamous cell carcinoma
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Leiomyoma
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lip and/or oral cavity cancer
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lip squamous cell carcinoma
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lipoma
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
3 / 2419 (0.12%) |
5 / 4821 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lung adenocarcinoma
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
1 / 2419 (0.04%) |
4 / 4821 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lung cancer metastatic
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Lung carcinoma cell type unspecified stage II
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lung neoplasm
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Lung neoplasm malignant
|
|
|
|
subjects affected / exposed
|
10 / 2402 (0.42%) |
8 / 2419 (0.33%) |
18 / 4821 (0.37%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 8 |
0 / 18 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 4 |
0 / 7 |
Lymphoma
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
1 / 2419 (0.04%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lymphoproliferative disorder
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Malignant mediastinal neoplasm
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Malignant melanoma
|
|
|
|
subjects affected / exposed
|
6 / 2402 (0.25%) |
7 / 2419 (0.29%) |
13 / 4821 (0.27%) |
occurrences causally related to treatment / all
|
1 / 6 |
0 / 7 |
1 / 13 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Malignant neoplasm of unknown primary site
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Malignant pleural effusion
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Mantle cell lymphoma
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mediastinum neoplasm
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Meningioma
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mesothelioma
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Metastases to bone
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
2 / 2419 (0.08%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Metastases to central nervous system
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Metastases to liver
|
|
|
|
subjects affected / exposed
|
4 / 2402 (0.17%) |
3 / 2419 (0.12%) |
7 / 4821 (0.15%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 3 |
Metastases to lung
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
2 / 2419 (0.08%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
Metastases to lymph nodes
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Metastasis
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Metastatic carcinoma of the bladder
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metastatic lymphoma
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Metastatic malignant melanoma
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Metastatic squamous cell carcinoma
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
2 / 2419 (0.08%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Monoclonal gammopathy
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
1 / 2419 (0.04%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 1 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Myelodysplastic syndrome
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Myeloid leukaemia
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Myeloproliferative neoplasm
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Neoplasm malignant
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
1 / 2419 (0.04%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Neoplasm skin
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
0 / 2419 (0.00%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Non-Hodgkin's lymphoma
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Non-small cell lung cancer
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Oesophageal adenocarcinoma
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oesophageal carcinoma
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oncologic complication
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Oral haemangioma
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oropharyngeal cancer
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Oropharyngeal squamous cell carcinoma
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Ovarian cancer
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Ovarian epithelial cancer
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatic carcinoma
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
4 / 2419 (0.17%) |
6 / 4821 (0.12%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 5 |
Pancreatic neoplasm
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
2 / 2419 (0.08%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Papillary thyroid cancer
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
2 / 2419 (0.08%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Papilloma
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Parathyroid tumour benign
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Penile cancer
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Plasma cell myeloma
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
0 / 2419 (0.00%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 0 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Prostate cancer
|
|
|
|
subjects affected / exposed
|
8 / 2402 (0.33%) |
7 / 2419 (0.29%) |
15 / 4821 (0.31%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 7 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Prostate cancer metastatic
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
2 / 2419 (0.08%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Prostatic adenoma
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rectal adenocarcinoma
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
2 / 2419 (0.08%) |
5 / 4821 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rectal cancer
|
|
|
|
subjects affected / exposed
|
4 / 2402 (0.17%) |
6 / 2419 (0.25%) |
10 / 4821 (0.21%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 6 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
Rectal cancer metastatic
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Rectal cancer recurrent
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rectal neoplasm
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal cancer
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal cell carcinoma
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
2 / 2419 (0.08%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal neoplasm
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
2 / 2419 (0.08%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sarcoma uterus
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Schwannoma
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Seborrhoeic keratosis
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Skin cancer
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
2 / 2419 (0.08%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Skin neoplasm bleeding
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Small cell lung cancer
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
2 / 2419 (0.08%) |
4 / 4821 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 3 |
Squamous cell carcinoma
|
|
|
|
subjects affected / exposed
|
8 / 2402 (0.33%) |
6 / 2419 (0.25%) |
14 / 4821 (0.29%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 7 |
0 / 17 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Squamous cell carcinoma of lung
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
4 / 2419 (0.17%) |
5 / 4821 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 4 |
1 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Transitional cell carcinoma
|
|
|
|
subjects affected / exposed
|
4 / 2402 (0.17%) |
0 / 2419 (0.00%) |
4 / 4821 (0.08%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Transitional cell carcinoma recurrent
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tumour compression
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tumour embolism
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tumour haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Ureteral neoplasm
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ureteric cancer
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Uterine cancer
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Uterine leiomyoma
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vaginal adenocarcinoma
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vaginal cancer
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Waldenstrom's macroglobulinaemia
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
0 / 2419 (0.00%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vascular disorders
|
|
|
|
Accelerated hypertension
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
0 / 2419 (0.00%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Angiopathy
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Aortic aneurysm
|
|
|
|
subjects affected / exposed
|
8 / 2402 (0.33%) |
2 / 2419 (0.08%) |
10 / 4821 (0.21%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 2 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Aortic aneurysm rupture
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
2 / 2419 (0.08%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 3 |
Aortic dissection
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Aortic rupture
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Aortic stenosis
|
|
|
|
subjects affected / exposed
|
12 / 2402 (0.50%) |
13 / 2419 (0.54%) |
25 / 4821 (0.52%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 13 |
0 / 25 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Aortic thrombosis
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arterial occlusive disease
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
2 / 2419 (0.08%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arteriosclerosis
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bleeding varicose vein
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Blood pressure fluctuation
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
0 / 2419 (0.00%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Circulatory collapse
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
3 / 2419 (0.12%) |
5 / 4821 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 3 |
1 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Deep vein thrombosis
|
|
|
|
subjects affected / exposed
|
7 / 2402 (0.29%) |
4 / 2419 (0.17%) |
11 / 4821 (0.23%) |
occurrences causally related to treatment / all
|
1 / 8 |
0 / 4 |
1 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dry gangrene
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Essential hypertension
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Extremity necrosis
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
2 / 2419 (0.08%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haematoma
|
|
|
|
subjects affected / exposed
|
8 / 2402 (0.33%) |
7 / 2419 (0.29%) |
15 / 4821 (0.31%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 7 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
2 / 2419 (0.08%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhagic infarction
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypertension
|
|
|
|
subjects affected / exposed
|
25 / 2402 (1.04%) |
16 / 2419 (0.66%) |
41 / 4821 (0.85%) |
occurrences causally related to treatment / all
|
0 / 30 |
0 / 16 |
0 / 46 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypertensive crisis
|
|
|
|
subjects affected / exposed
|
8 / 2402 (0.33%) |
4 / 2419 (0.17%) |
12 / 4821 (0.25%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 6 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypertensive emergency
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
1 / 2419 (0.04%) |
4 / 4821 (0.08%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Hypertensive urgency
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
6 / 2419 (0.25%) |
7 / 4821 (0.15%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 6 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypotension
|
|
|
|
subjects affected / exposed
|
47 / 2402 (1.96%) |
52 / 2419 (2.15%) |
99 / 4821 (2.05%) |
occurrences causally related to treatment / all
|
22 / 52 |
24 / 60 |
46 / 112 |
deaths causally related to treatment / all
|
0 / 1 |
1 / 3 |
1 / 4 |
Hypovolaemic shock
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
1 / 2419 (0.04%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Iliac artery embolism
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intermittent claudication
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
2 / 2419 (0.08%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ischaemia
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Jugular vein thrombosis
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Leriche syndrome
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lymphoedema
|
|
|
|
subjects affected / exposed
|
4 / 2402 (0.17%) |
0 / 2419 (0.00%) |
4 / 4821 (0.08%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Orthostatic hypertension
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Orthostatic hypotension
|
|
|
|
subjects affected / exposed
|
9 / 2402 (0.37%) |
5 / 2419 (0.21%) |
14 / 4821 (0.29%) |
occurrences causally related to treatment / all
|
3 / 9 |
1 / 5 |
4 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral arterial occlusive disease
|
|
|
|
subjects affected / exposed
|
7 / 2402 (0.29%) |
18 / 2419 (0.74%) |
25 / 4821 (0.52%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 19 |
0 / 28 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral artery aneurysm
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral artery occlusion
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
2 / 2419 (0.08%) |
4 / 4821 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral artery stenosis
|
|
|
|
subjects affected / exposed
|
4 / 2402 (0.17%) |
3 / 2419 (0.12%) |
7 / 4821 (0.15%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral artery thrombosis
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
2 / 2419 (0.08%) |
4 / 4821 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral coldness
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral embolism
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
3 / 2419 (0.12%) |
6 / 4821 (0.12%) |
occurrences causally related to treatment / all
|
0 / 3 |
1 / 3 |
1 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral ischaemia
|
|
|
|
subjects affected / exposed
|
7 / 2402 (0.29%) |
8 / 2419 (0.33%) |
15 / 4821 (0.31%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 9 |
0 / 17 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
Peripheral vascular disorder
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
5 / 2419 (0.21%) |
7 / 4821 (0.15%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 7 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral venous disease
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
2 / 2419 (0.08%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Phlebitis
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Post thrombotic syndrome
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Shock
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Shock haemorrhagic
|
|
|
|
subjects affected / exposed
|
5 / 2402 (0.21%) |
2 / 2419 (0.08%) |
7 / 4821 (0.15%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
Subclavian artery stenosis
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Subclavian artery thrombosis
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Temporal arteritis
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Thrombosis
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Varicose ulceration
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
0 / 2419 (0.00%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Venous thrombosis
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
General disorders and administration site conditions
|
|
|
|
Adverse drug reaction
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Asthenia
|
|
|
|
subjects affected / exposed
|
21 / 2402 (0.87%) |
12 / 2419 (0.50%) |
33 / 4821 (0.68%) |
occurrences causally related to treatment / all
|
3 / 23 |
0 / 12 |
3 / 35 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Cardiac death
|
|
|
|
subjects affected / exposed
|
6 / 2402 (0.25%) |
3 / 2419 (0.12%) |
9 / 4821 (0.19%) |
occurrences causally related to treatment / all
|
1 / 6 |
0 / 3 |
1 / 9 |
deaths causally related to treatment / all
|
1 / 6 |
0 / 3 |
1 / 9 |
Catheter site haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chest discomfort
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
4 / 2419 (0.17%) |
5 / 4821 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 8 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chest pain
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
2 / 2419 (0.08%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Concomitant disease progression
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Condition aggravated
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Death
|
|
|
|
subjects affected / exposed
|
23 / 2402 (0.96%) |
34 / 2419 (1.41%) |
57 / 4821 (1.18%) |
occurrences causally related to treatment / all
|
0 / 23 |
0 / 34 |
0 / 57 |
deaths causally related to treatment / all
|
0 / 23 |
0 / 34 |
0 / 57 |
Disuse syndrome
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Euthanasia
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
Fatigue
|
|
|
|
subjects affected / exposed
|
4 / 2402 (0.17%) |
4 / 2419 (0.17%) |
8 / 4821 (0.17%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 8 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gait disturbance
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
3 / 2419 (0.12%) |
6 / 4821 (0.12%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
General physical health deterioration
|
|
|
|
subjects affected / exposed
|
5 / 2402 (0.21%) |
9 / 2419 (0.37%) |
14 / 4821 (0.29%) |
occurrences causally related to treatment / all
|
0 / 6 |
1 / 9 |
1 / 15 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 3 |
0 / 6 |
Hyperthermia
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ill-defined disorder
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Impaired healing
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
3 / 2419 (0.12%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Impaired self-care
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Implant site haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Incarcerated hernia
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
2 / 2419 (0.08%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Influenza like illness
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lithiasis
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Malaise
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
2 / 2419 (0.08%) |
4 / 4821 (0.08%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 2 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mass
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
1 / 2419 (0.04%) |
4 / 4821 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Medical device discomfort
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Multiple organ dysfunction syndrome
|
|
|
|
subjects affected / exposed
|
7 / 2402 (0.29%) |
10 / 2419 (0.41%) |
17 / 4821 (0.35%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 10 |
0 / 17 |
deaths causally related to treatment / all
|
0 / 7 |
0 / 9 |
0 / 16 |
Necrosis
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
2 / 2419 (0.08%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Non-cardiac chest pain
|
|
|
|
subjects affected / exposed
|
37 / 2402 (1.54%) |
42 / 2419 (1.74%) |
79 / 4821 (1.64%) |
occurrences causally related to treatment / all
|
0 / 51 |
0 / 51 |
0 / 102 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oedema
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
2 / 2419 (0.08%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oedema peripheral
|
|
|
|
subjects affected / exposed
|
12 / 2402 (0.50%) |
6 / 2419 (0.25%) |
18 / 4821 (0.37%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 6 |
0 / 18 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pain
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
1 / 2419 (0.04%) |
4 / 4821 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Peripheral swelling
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
1 / 2419 (0.04%) |
4 / 4821 (0.08%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pyrexia
|
|
|
|
subjects affected / exposed
|
13 / 2402 (0.54%) |
8 / 2419 (0.33%) |
21 / 4821 (0.44%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 10 |
0 / 24 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Stenosis
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sudden cardiac death
|
|
|
|
subjects affected / exposed
|
16 / 2402 (0.67%) |
15 / 2419 (0.62%) |
31 / 4821 (0.64%) |
occurrences causally related to treatment / all
|
1 / 16 |
0 / 15 |
1 / 31 |
deaths causally related to treatment / all
|
1 / 16 |
0 / 15 |
1 / 31 |
Sudden death
|
|
|
|
subjects affected / exposed
|
22 / 2402 (0.92%) |
21 / 2419 (0.87%) |
43 / 4821 (0.89%) |
occurrences causally related to treatment / all
|
1 / 22 |
0 / 21 |
1 / 43 |
deaths causally related to treatment / all
|
1 / 22 |
0 / 21 |
1 / 43 |
Surgical failure
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Swelling
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Systemic inflammatory response syndrome
|
|
|
|
subjects affected / exposed
|
5 / 2402 (0.21%) |
1 / 2419 (0.04%) |
6 / 4821 (0.12%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Treatment noncompliance
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ulcer haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Unevaluable event
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
0 / 2419 (0.00%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vascular stent stenosis
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
1 / 2419 (0.04%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Immune system disorders
|
|
|
|
Anaphylactic reaction
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Anaphylactic shock
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Drug hypersensitivity
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Food allergy
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sarcoidosis
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Social circumstances
|
|
|
|
Immobile
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Living in residential institution
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Reproductive system and breast disorders
|
|
|
|
Adenomyosis
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Benign prostatic hyperplasia
|
|
|
|
subjects affected / exposed
|
5 / 2402 (0.21%) |
8 / 2419 (0.33%) |
13 / 4821 (0.27%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 8 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Breast calcifications
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Breast cyst
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Breast mass
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cervical dysplasia
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cervical polyp
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Endometrial hyperplasia
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Endometrial thickening
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Erectile dysfunction
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metrorrhagia
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ovarian cyst
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
2 / 2419 (0.08%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Postmenopausal haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Prostatic haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Prostatic obstruction
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Prostatitis
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Scrotal inflammation
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Spermatocele
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Uterine polyp
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Uterine prolapse
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
2 / 2419 (0.08%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vaginal haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
2 / 2419 (0.08%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vaginal prolapse
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory, thoracic and mediastinal disorders
|
|
|
|
Acute pulmonary oedema
|
|
|
|
subjects affected / exposed
|
14 / 2402 (0.58%) |
12 / 2419 (0.50%) |
26 / 4821 (0.54%) |
occurrences causally related to treatment / all
|
0 / 15 |
0 / 13 |
0 / 28 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 4 |
Acute respiratory distress syndrome
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Acute respiratory failure
|
|
|
|
subjects affected / exposed
|
24 / 2402 (1.00%) |
20 / 2419 (0.83%) |
44 / 4821 (0.91%) |
occurrences causally related to treatment / all
|
0 / 28 |
0 / 22 |
0 / 50 |
deaths causally related to treatment / all
|
0 / 9 |
0 / 7 |
0 / 16 |
Aspiration
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
1 / 2419 (0.04%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
Asthma
|
|
|
|
subjects affected / exposed
|
10 / 2402 (0.42%) |
9 / 2419 (0.37%) |
19 / 4821 (0.39%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 10 |
0 / 24 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Atelectasis
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bronchial hyperreactivity
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
2 / 2419 (0.08%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Bronchial obstruction
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bronchiectasis
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Bronchitis chronic
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
0 / 2419 (0.00%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bronchospasm
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
2 / 2419 (0.08%) |
4 / 4821 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Chronic obstructive pulmonary disease
|
|
|
|
subjects affected / exposed
|
67 / 2402 (2.79%) |
42 / 2419 (1.74%) |
109 / 4821 (2.26%) |
occurrences causally related to treatment / all
|
1 / 92 |
0 / 65 |
1 / 157 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 1 |
0 / 5 |
Chronic respiratory failure
|
|
|
|
subjects affected / exposed
|
4 / 2402 (0.17%) |
3 / 2419 (0.12%) |
7 / 4821 (0.15%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
Cough
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
3 / 2419 (0.12%) |
6 / 4821 (0.12%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Dyspnoea
|
|
|
|
subjects affected / exposed
|
64 / 2402 (2.66%) |
42 / 2419 (1.74%) |
106 / 4821 (2.20%) |
occurrences causally related to treatment / all
|
2 / 75 |
0 / 50 |
2 / 125 |
deaths causally related to treatment / all
|
0 / 6 |
0 / 1 |
0 / 7 |
Dyspnoea at rest
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
0 / 2419 (0.00%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dyspnoea exertional
|
|
|
|
subjects affected / exposed
|
5 / 2402 (0.21%) |
4 / 2419 (0.17%) |
9 / 4821 (0.19%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Emphysema
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Epistaxis
|
|
|
|
subjects affected / exposed
|
4 / 2402 (0.17%) |
4 / 2419 (0.17%) |
8 / 4821 (0.17%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemoptysis
|
|
|
|
subjects affected / exposed
|
5 / 2402 (0.21%) |
2 / 2419 (0.08%) |
7 / 4821 (0.15%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Haemothorax
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
0 / 2419 (0.00%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hydrothorax
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypercapnia
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
2 / 2419 (0.08%) |
4 / 4821 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
Hypoventilation
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypoxia
|
|
|
|
subjects affected / exposed
|
6 / 2402 (0.25%) |
2 / 2419 (0.08%) |
8 / 4821 (0.17%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 2 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
Interstitial lung disease
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
4 / 2419 (0.17%) |
7 / 4821 (0.15%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
Laryngeal haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Laryngeal oedema
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Laryngospasm
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lung disorder
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
1 / 2419 (0.04%) |
4 / 4821 (0.08%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mediastinal mass
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nasal septum deviation
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Obstructive airways disorder
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
0 / 2419 (0.00%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Organising pneumonia
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Orthopnoea
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
1 / 2419 (0.04%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pharyngeal haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pickwickian syndrome
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pleural effusion
|
|
|
|
subjects affected / exposed
|
15 / 2402 (0.62%) |
17 / 2419 (0.70%) |
32 / 4821 (0.66%) |
occurrences causally related to treatment / all
|
0 / 17 |
0 / 23 |
0 / 40 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Pleurisy
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Pneumonia aspiration
|
|
|
|
subjects affected / exposed
|
11 / 2402 (0.46%) |
7 / 2419 (0.29%) |
18 / 4821 (0.37%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 8 |
0 / 19 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 4 |
Pneumonitis
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
2 / 2419 (0.08%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumothorax
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
4 / 2419 (0.17%) |
5 / 4821 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Presbyphonia
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary alveolar haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary arterial hypertension
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary congestion
|
|
|
|
subjects affected / exposed
|
5 / 2402 (0.21%) |
0 / 2419 (0.00%) |
5 / 4821 (0.10%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 0 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary embolism
|
|
|
|
subjects affected / exposed
|
17 / 2402 (0.71%) |
16 / 2419 (0.66%) |
33 / 4821 (0.68%) |
occurrences causally related to treatment / all
|
0 / 17 |
0 / 17 |
0 / 34 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 4 |
0 / 8 |
Pulmonary eosinophilia
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary fibrosis
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
3 / 2419 (0.12%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
Pulmonary hypertension
|
|
|
|
subjects affected / exposed
|
9 / 2402 (0.37%) |
4 / 2419 (0.17%) |
13 / 4821 (0.27%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 5 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Pulmonary mass
|
|
|
|
subjects affected / exposed
|
4 / 2402 (0.17%) |
3 / 2419 (0.12%) |
7 / 4821 (0.15%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary oedema
|
|
|
|
subjects affected / exposed
|
16 / 2402 (0.67%) |
7 / 2419 (0.29%) |
23 / 4821 (0.48%) |
occurrences causally related to treatment / all
|
0 / 17 |
0 / 7 |
0 / 24 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 3 |
Respiratory acidosis
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory arrest
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
1 / 2419 (0.04%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 3 |
Respiratory depression
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory distress
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
1 / 2419 (0.04%) |
4 / 4821 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
Respiratory failure
|
|
|
|
subjects affected / exposed
|
32 / 2402 (1.33%) |
29 / 2419 (1.20%) |
61 / 4821 (1.27%) |
occurrences causally related to treatment / all
|
0 / 39 |
0 / 32 |
0 / 71 |
deaths causally related to treatment / all
|
0 / 13 |
0 / 13 |
0 / 26 |
Respiratory tract congestion
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sleep apnoea syndrome
|
|
|
|
subjects affected / exposed
|
5 / 2402 (0.21%) |
4 / 2419 (0.17%) |
9 / 4821 (0.19%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Status asthmaticus
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tracheal stenosis
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vocal cord polyp
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Wheezing
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Psychiatric disorders
|
|
|
|
Acute stress disorder
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Adjustment disorder
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Adjustment disorder with mixed anxiety and depressed mood
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Agitation
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
1 / 1 |
Alcoholism
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Anxiety
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
2 / 2419 (0.08%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 2 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
1 / 1 |
Anxiety disorder
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Behaviour disorder
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Completed suicide
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
4 / 2419 (0.17%) |
6 / 4821 (0.12%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 6 |
Confusional state
|
|
|
|
subjects affected / exposed
|
7 / 2402 (0.29%) |
6 / 2419 (0.25%) |
13 / 4821 (0.27%) |
occurrences causally related to treatment / all
|
1 / 7 |
2 / 8 |
3 / 15 |
deaths causally related to treatment / all
|
0 / 1 |
1 / 1 |
1 / 2 |
Delirium
|
|
|
|
subjects affected / exposed
|
11 / 2402 (0.46%) |
7 / 2419 (0.29%) |
18 / 4821 (0.37%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 8 |
0 / 19 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Delirium febrile
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Delusion
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Depressed mood
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Depression
|
|
|
|
subjects affected / exposed
|
7 / 2402 (0.29%) |
6 / 2419 (0.25%) |
13 / 4821 (0.27%) |
occurrences causally related to treatment / all
|
1 / 11 |
0 / 7 |
1 / 18 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Disorientation
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
1 / 1 |
Hallucination
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
2 / 2419 (0.08%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Major depression
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
1 / 2419 (0.04%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mental disorder
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mental disorder due to a general medical condition
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mental status changes
|
|
|
|
subjects affected / exposed
|
5 / 2402 (0.21%) |
3 / 2419 (0.12%) |
8 / 4821 (0.17%) |
occurrences causally related to treatment / all
|
1 / 8 |
0 / 3 |
1 / 11 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Organic brain syndrome
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Paranoia
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Personality disorder
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Somatic symptom disorder
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Suicidal ideation
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Suicide attempt
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
2 / 2419 (0.08%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Product issues
|
|
|
|
Device battery issue
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
1 / 2419 (0.04%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Device breakage
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Device damage
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Device defective
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
0 / 2419 (0.00%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Device dislocation
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
2 / 2419 (0.08%) |
4 / 4821 (0.08%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 3 |
1 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Device failure
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Device leakage
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Device loosening
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Device malfunction
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Device occlusion
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lead dislodgement
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatobiliary disorders
|
|
|
|
Bile duct obstruction
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
2 / 2419 (0.08%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bile duct stenosis
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bile duct stone
|
|
|
|
subjects affected / exposed
|
4 / 2402 (0.17%) |
5 / 2419 (0.21%) |
9 / 4821 (0.19%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 6 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Biliary colic
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
2 / 2419 (0.08%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Biliary dyskinesia
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cholangitis
|
|
|
|
subjects affected / exposed
|
4 / 2402 (0.17%) |
4 / 2419 (0.17%) |
8 / 4821 (0.17%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cholangitis acute
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Cholecystitis
|
|
|
|
subjects affected / exposed
|
11 / 2402 (0.46%) |
14 / 2419 (0.58%) |
25 / 4821 (0.52%) |
occurrences causally related to treatment / all
|
1 / 11 |
0 / 15 |
1 / 26 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cholecystitis acute
|
|
|
|
subjects affected / exposed
|
9 / 2402 (0.37%) |
8 / 2419 (0.33%) |
17 / 4821 (0.35%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 8 |
0 / 18 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Cholecystitis chronic
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
5 / 2419 (0.21%) |
7 / 4821 (0.15%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cholelithiasis
|
|
|
|
subjects affected / exposed
|
19 / 2402 (0.79%) |
17 / 2419 (0.70%) |
36 / 4821 (0.75%) |
occurrences causally related to treatment / all
|
2 / 19 |
0 / 19 |
2 / 38 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Cholelithiasis migration
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cholestasis
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chronic hepatic failure
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cirrhosis alcoholic
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cryptogenic cirrhosis
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gallbladder disorder
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Gallbladder rupture
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
2 / 2419 (0.08%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemobilia
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic cirrhosis
|
|
|
|
subjects affected / exposed
|
6 / 2402 (0.25%) |
4 / 2419 (0.17%) |
10 / 4821 (0.21%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 4 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
Hepatic cyst
|
|
|
|
subjects affected / exposed
|
6 / 2402 (0.25%) |
5 / 2419 (0.21%) |
11 / 4821 (0.23%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 5 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic failure
|
|
|
|
subjects affected / exposed
|
4 / 2402 (0.17%) |
3 / 2419 (0.12%) |
7 / 4821 (0.15%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 3 |
Hepatic function abnormal
|
|
|
|
subjects affected / exposed
|
5 / 2402 (0.21%) |
5 / 2419 (0.21%) |
10 / 4821 (0.21%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Hepatic lesion
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic mass
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic steatosis
|
|
|
|
subjects affected / exposed
|
10 / 2402 (0.42%) |
10 / 2419 (0.41%) |
20 / 4821 (0.41%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 10 |
0 / 20 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatitis
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatitis acute
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
0 / 2419 (0.00%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatobiliary disease
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatocellular injury
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
1 / 2419 (0.04%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatomegaly
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
0 / 2419 (0.00%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Hepatorenal syndrome
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
1 / 2419 (0.04%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
Hepatosplenomegaly
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Jaundice
|
|
|
|
subjects affected / exposed
|
5 / 2402 (0.21%) |
8 / 2419 (0.33%) |
13 / 4821 (0.27%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 8 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Jaundice cholestatic
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Liver disorder
|
|
|
|
subjects affected / exposed
|
4 / 2402 (0.17%) |
1 / 2419 (0.04%) |
5 / 4821 (0.10%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Liver injury
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nonalcoholic fatty liver disease
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
1 / 2419 (0.04%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Portal hypertension
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
1 / 2419 (0.04%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 1 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Portal vein thrombosis
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Primary biliary cholangitis
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Steatohepatitis
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Investigations
|
|
|
|
Alanine aminotransferase increased
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
2 / 2419 (0.08%) |
4 / 4821 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Anticoagulation drug level above therapeutic
|
|
|
|
subjects affected / exposed
|
4 / 2402 (0.17%) |
2 / 2419 (0.08%) |
6 / 4821 (0.12%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Aspartate aminotransferase increased
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
4 / 2419 (0.17%) |
6 / 4821 (0.12%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 4 |
1 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bleeding time abnormal
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Blood alkaline phosphatase increased
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Blood bilirubin increased
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Blood creatine phosphokinase increased
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Blood creatinine increased
|
|
|
|
subjects affected / exposed
|
4 / 2402 (0.17%) |
1 / 2419 (0.04%) |
5 / 4821 (0.10%) |
occurrences causally related to treatment / all
|
3 / 4 |
0 / 1 |
3 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Blood glucose abnormal
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Blood glucose decreased
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Blood glucose fluctuation
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
2 / 2419 (0.08%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Blood glucose increased
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
1 / 2419 (0.04%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Blood osmolarity decreased
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Blood pressure decreased
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Blood pressure increased
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
2 / 2419 (0.08%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Blood sodium decreased
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Blood urea increased
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Brain natriuretic peptide increased
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac output decreased
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Coagulation time prolonged
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Electrocardiogram QT prolonged
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Electrocardiogram repolarisation abnormality
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
General physical condition abnormal
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Glomerular filtration rate decreased
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
0 / 2419 (0.00%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
2 / 3 |
0 / 0 |
2 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemoglobin decreased
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
0 / 2419 (0.00%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Heart rate decreased
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Heart rate irregular
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic enzyme increased
|
|
|
|
subjects affected / exposed
|
6 / 2402 (0.25%) |
7 / 2419 (0.29%) |
13 / 4821 (0.27%) |
occurrences causally related to treatment / all
|
0 / 7 |
1 / 7 |
1 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Inflammatory marker increased
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
0 / 2419 (0.00%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Influenza virus test positive
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
International normalised ratio increased
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
3 / 2419 (0.12%) |
5 / 4821 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Lipase increased
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Myocardial necrosis marker increased
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Platelet count decreased
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Precancerous cells present
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Prostatic specific antigen increased
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulse absent
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory rate increased
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Transaminases increased
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
1 / 2419 (0.04%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Troponin I increased
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Troponin T increased
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Troponin increased
|
|
|
|
subjects affected / exposed
|
4 / 2402 (0.17%) |
0 / 2419 (0.00%) |
4 / 4821 (0.08%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 0 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urine output decreased
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ventilation/perfusion scan abnormal
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Visual field tests abnormal
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Weight decreased
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
0 / 2419 (0.00%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Injury, poisoning and procedural complications
|
|
|
|
Abdominal injury
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Accident
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Accidental overdose
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
2 / 2419 (0.08%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Acetabulum fracture
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Alcohol poisoning
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
0 / 2419 (0.00%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Anaemia postoperative
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Anastomotic leak
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
0 / 2419 (0.00%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Anastomotic ulcer
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
2 / 2419 (0.08%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Animal bite
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ankle fracture
|
|
|
|
subjects affected / exposed
|
4 / 2402 (0.17%) |
7 / 2419 (0.29%) |
11 / 4821 (0.23%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 7 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arterial bypass occlusion
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arteriovenous fistula thrombosis
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Avulsion fracture
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bone contusion
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Brain herniation
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Carbon monoxide poisoning
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac function disturbance postoperative
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Cervical vertebral fracture
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chest injury
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Clavicle fracture
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Comminuted fracture
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Complications of transplanted kidney
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Concussion
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Contusion
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
4 / 2419 (0.17%) |
7 / 4821 (0.15%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Coronary bypass stenosis
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Craniocerebral injury
|
|
|
|
subjects affected / exposed
|
4 / 2402 (0.17%) |
3 / 2419 (0.12%) |
7 / 4821 (0.15%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
Cystitis radiation
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Extra dose administered
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Extradural haematoma
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Eye injury
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Facial bones fracture
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Fall
|
|
|
|
subjects affected / exposed
|
26 / 2402 (1.08%) |
33 / 2419 (1.36%) |
59 / 4821 (1.22%) |
occurrences causally related to treatment / all
|
2 / 29 |
3 / 37 |
5 / 66 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 3 |
Femoral neck fracture
|
|
|
|
subjects affected / exposed
|
8 / 2402 (0.33%) |
5 / 2419 (0.21%) |
13 / 4821 (0.27%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 5 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
Femur fracture
|
|
|
|
subjects affected / exposed
|
20 / 2402 (0.83%) |
11 / 2419 (0.45%) |
31 / 4821 (0.64%) |
occurrences causally related to treatment / all
|
0 / 21 |
0 / 11 |
0 / 32 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Foot fracture
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Fracture
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Fractured coccyx
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal stoma complication
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hand fracture
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
2 / 2419 (0.08%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Head injury
|
|
|
|
subjects affected / exposed
|
6 / 2402 (0.25%) |
5 / 2419 (0.21%) |
11 / 4821 (0.23%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 5 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Hip fracture
|
|
|
|
subjects affected / exposed
|
14 / 2402 (0.58%) |
13 / 2419 (0.54%) |
27 / 4821 (0.56%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 14 |
0 / 28 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Humerus fracture
|
|
|
|
subjects affected / exposed
|
7 / 2402 (0.29%) |
5 / 2419 (0.21%) |
12 / 4821 (0.25%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 5 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypobarism
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Incision site haematoma
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Incisional hernia
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
1 / 2419 (0.04%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Injury
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Joint dislocation
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
2 / 2419 (0.08%) |
5 / 4821 (0.10%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ligament injury
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ligament sprain
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Limb crushing injury
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Limb injury
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
4 / 2419 (0.17%) |
5 / 4821 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 7 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lower limb fracture
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
2 / 2419 (0.08%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lumbar vertebral fracture
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
3 / 2419 (0.12%) |
5 / 4821 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Meniscus injury
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Multiple injuries
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Muscle strain
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
0 / 2419 (0.00%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nerve root injury cervical
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Overdose
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
4 / 2419 (0.17%) |
6 / 4821 (0.12%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Patella fracture
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pelvic fracture
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
1 / 2419 (0.04%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Periprosthetic fracture
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
0 / 2419 (0.00%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural complication
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural haematoma
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
2 / 2419 (0.08%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural myocardial infarction
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Post-traumatic pain
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Postoperative hypotension
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Postoperative respiratory failure
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Postoperative wound complication
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Procedural pneumothorax
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Procedural vomiting
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pubis fracture
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Radiation proctitis
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Radius fracture
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
7 / 2419 (0.29%) |
8 / 4821 (0.17%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 8 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory fume inhalation disorder
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Rib fracture
|
|
|
|
subjects affected / exposed
|
6 / 2402 (0.25%) |
11 / 2419 (0.45%) |
17 / 4821 (0.35%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 11 |
0 / 17 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Road traffic accident
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Scapula fracture
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sedation complication
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Skin abrasion
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
0 / 2419 (0.00%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Skin laceration
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
6 / 2419 (0.25%) |
8 / 4821 (0.17%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 6 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Spinal compression fracture
|
|
|
|
subjects affected / exposed
|
8 / 2402 (0.33%) |
3 / 2419 (0.12%) |
11 / 4821 (0.23%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 3 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Spinal fracture
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
6 / 2419 (0.25%) |
8 / 4821 (0.17%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 6 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Splenic rupture
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Stomal hernia
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Subdural haematoma
|
|
|
|
subjects affected / exposed
|
8 / 2402 (0.33%) |
7 / 2419 (0.29%) |
15 / 4821 (0.31%) |
occurrences causally related to treatment / all
|
0 / 8 |
1 / 10 |
1 / 18 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 4 |
Subdural haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tendon rupture
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Thoracic vertebral fracture
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
2 / 2419 (0.08%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tibia fracture
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
2 / 2419 (0.08%) |
4 / 4821 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Toxicity to various agents
|
|
|
|
subjects affected / exposed
|
8 / 2402 (0.33%) |
2 / 2419 (0.08%) |
10 / 4821 (0.21%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 2 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Traumatic haematoma
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
2 / 2419 (0.08%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Traumatic haemothorax
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Traumatic intracranial haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Traumatic liver injury
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ulna fracture
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Upper limb fracture
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
2 / 2419 (0.08%) |
4 / 4821 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Vascular graft occlusion
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
2 / 2419 (0.08%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vascular pseudoaneurysm
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
1 / 2419 (0.04%) |
4 / 4821 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vascular pseudoaneurysm ruptured
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Wound
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Wound complication
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Congenital, familial and genetic disorders
|
|
|
|
Atrial septal defect
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Congenital coronary artery malformation
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Congenital megaureter
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal arteriovenous malformation
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
2 / 2419 (0.08%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
LUMBAR syndrome
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Phimosis
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vertebral artery hypoplasia
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac disorders
|
|
|
|
Acute coronary syndrome
|
|
|
|
subjects affected / exposed
|
13 / 2402 (0.54%) |
11 / 2419 (0.45%) |
24 / 4821 (0.50%) |
occurrences causally related to treatment / all
|
0 / 15 |
1 / 11 |
1 / 26 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
Acute left ventricular failure
|
|
|
|
subjects affected / exposed
|
15 / 2402 (0.62%) |
14 / 2419 (0.58%) |
29 / 4821 (0.60%) |
occurrences causally related to treatment / all
|
0 / 19 |
0 / 22 |
0 / 41 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 3 |
Acute myocardial infarction
|
|
|
|
subjects affected / exposed
|
54 / 2402 (2.25%) |
60 / 2419 (2.48%) |
114 / 4821 (2.36%) |
occurrences causally related to treatment / all
|
0 / 61 |
0 / 69 |
0 / 130 |
deaths causally related to treatment / all
|
0 / 9 |
0 / 8 |
0 / 17 |
Adams-Stokes syndrome
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Angina pectoris
|
|
|
|
subjects affected / exposed
|
50 / 2402 (2.08%) |
42 / 2419 (1.74%) |
92 / 4821 (1.91%) |
occurrences causally related to treatment / all
|
1 / 57 |
1 / 49 |
2 / 106 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 4 |
Angina unstable
|
|
|
|
subjects affected / exposed
|
43 / 2402 (1.79%) |
50 / 2419 (2.07%) |
93 / 4821 (1.93%) |
occurrences causally related to treatment / all
|
0 / 52 |
0 / 61 |
0 / 113 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Aortic valve disease
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Aortic valve incompetence
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
2 / 2419 (0.08%) |
4 / 4821 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Aortic valve stenosis
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
4 / 2419 (0.17%) |
7 / 4821 (0.15%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arrhythmia
|
|
|
|
subjects affected / exposed
|
4 / 2402 (0.17%) |
4 / 2419 (0.17%) |
8 / 4821 (0.17%) |
occurrences causally related to treatment / all
|
0 / 4 |
1 / 4 |
1 / 8 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Arrhythmia supraventricular
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arteriosclerosis coronary artery
|
|
|
|
subjects affected / exposed
|
4 / 2402 (0.17%) |
4 / 2419 (0.17%) |
8 / 4821 (0.17%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 6 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Atrial fibrillation
|
|
|
|
subjects affected / exposed
|
145 / 2402 (6.04%) |
162 / 2419 (6.70%) |
307 / 4821 (6.37%) |
occurrences causally related to treatment / all
|
4 / 196 |
8 / 220 |
12 / 416 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 3 |
Atrial flutter
|
|
|
|
subjects affected / exposed
|
23 / 2402 (0.96%) |
31 / 2419 (1.28%) |
54 / 4821 (1.12%) |
occurrences causally related to treatment / all
|
1 / 27 |
2 / 38 |
3 / 65 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Atrial tachycardia
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
7 / 2419 (0.29%) |
9 / 4821 (0.19%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 9 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Atrial thrombosis
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Atrioventricular block
|
|
|
|
subjects affected / exposed
|
4 / 2402 (0.17%) |
6 / 2419 (0.25%) |
10 / 4821 (0.21%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 6 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Atrioventricular block complete
|
|
|
|
subjects affected / exposed
|
11 / 2402 (0.46%) |
8 / 2419 (0.33%) |
19 / 4821 (0.39%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 8 |
0 / 19 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Atrioventricular block first degree
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Atrioventricular block second degree
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
4 / 2419 (0.17%) |
7 / 4821 (0.15%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bradyarrhythmia
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
3 / 2419 (0.12%) |
6 / 4821 (0.12%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Bradycardia
|
|
|
|
subjects affected / exposed
|
24 / 2402 (1.00%) |
27 / 2419 (1.12%) |
51 / 4821 (1.06%) |
occurrences causally related to treatment / all
|
1 / 26 |
0 / 27 |
1 / 53 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Bundle branch block left
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac amyloidosis
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Cardiac arrest
|
|
|
|
subjects affected / exposed
|
30 / 2402 (1.25%) |
17 / 2419 (0.70%) |
47 / 4821 (0.97%) |
occurrences causally related to treatment / all
|
0 / 30 |
1 / 17 |
1 / 47 |
deaths causally related to treatment / all
|
0 / 21 |
1 / 13 |
1 / 34 |
Cardiac asthma
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Cardiac discomfort
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac failure
|
|
|
|
subjects affected / exposed
|
380 / 2402 (15.82%) |
340 / 2419 (14.06%) |
720 / 4821 (14.93%) |
occurrences causally related to treatment / all
|
15 / 652 |
5 / 529 |
20 / 1181 |
deaths causally related to treatment / all
|
1 / 49 |
0 / 41 |
1 / 90 |
Cardiac failure acute
|
|
|
|
subjects affected / exposed
|
77 / 2402 (3.21%) |
85 / 2419 (3.51%) |
162 / 4821 (3.36%) |
occurrences causally related to treatment / all
|
1 / 109 |
1 / 113 |
2 / 222 |
deaths causally related to treatment / all
|
0 / 7 |
0 / 10 |
0 / 17 |
Cardiac failure chronic
|
|
|
|
subjects affected / exposed
|
30 / 2402 (1.25%) |
26 / 2419 (1.07%) |
56 / 4821 (1.16%) |
occurrences causally related to treatment / all
|
1 / 47 |
4 / 38 |
5 / 85 |
deaths causally related to treatment / all
|
0 / 4 |
1 / 5 |
1 / 9 |
Cardiac failure congestive
|
|
|
|
subjects affected / exposed
|
83 / 2402 (3.46%) |
86 / 2419 (3.56%) |
169 / 4821 (3.51%) |
occurrences causally related to treatment / all
|
0 / 155 |
5 / 146 |
5 / 301 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 13 |
0 / 18 |
Cardiac fibrillation
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac flutter
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac tamponade
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
2 / 2419 (0.08%) |
4 / 4821 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac valve disease
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac ventricular disorder
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardio-respiratory arrest
|
|
|
|
subjects affected / exposed
|
13 / 2402 (0.54%) |
15 / 2419 (0.62%) |
28 / 4821 (0.58%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 15 |
0 / 28 |
deaths causally related to treatment / all
|
0 / 11 |
0 / 12 |
0 / 23 |
Cardiogenic shock
|
|
|
|
subjects affected / exposed
|
6 / 2402 (0.25%) |
12 / 2419 (0.50%) |
18 / 4821 (0.37%) |
occurrences causally related to treatment / all
|
0 / 6 |
1 / 12 |
1 / 18 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 6 |
0 / 10 |
Cardiomegaly
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiomyopathy
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
0 / 2419 (0.00%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Cardiopulmonary failure
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
4 / 2419 (0.17%) |
5 / 4821 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 5 |
Cardiorenal syndrome
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
2 / 2419 (0.08%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiovascular disorder
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Cardiovascular insufficiency
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
1 / 2419 (0.04%) |
4 / 4821 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 3 |
Chronic left ventricular failure
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
3 / 2419 (0.12%) |
4 / 4821 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Congestive cardiomyopathy
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
2 / 2419 (0.08%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cor pulmonale
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Coronary artery disease
|
|
|
|
subjects affected / exposed
|
27 / 2402 (1.12%) |
24 / 2419 (0.99%) |
51 / 4821 (1.06%) |
occurrences causally related to treatment / all
|
0 / 30 |
1 / 25 |
1 / 55 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
Coronary artery occlusion
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Coronary artery stenosis
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
5 / 2419 (0.21%) |
7 / 4821 (0.15%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypertensive heart disease
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
1 / 2419 (0.04%) |
4 / 4821 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Intracardiac mass
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ischaemic cardiomyopathy
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
4 / 2419 (0.17%) |
5 / 4821 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Left ventricular dysfunction
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
0 / 2419 (0.00%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Left ventricular failure
|
|
|
|
subjects affected / exposed
|
5 / 2402 (0.21%) |
6 / 2419 (0.25%) |
11 / 4821 (0.23%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 7 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Microvascular coronary artery disease
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mitral valve calcification
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mitral valve incompetence
|
|
|
|
subjects affected / exposed
|
8 / 2402 (0.33%) |
7 / 2419 (0.29%) |
15 / 4821 (0.31%) |
occurrences causally related to treatment / all
|
0 / 10 |
1 / 7 |
1 / 17 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Mitral valve prolapse
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
2 / 2419 (0.08%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Myocardial infarction
|
|
|
|
subjects affected / exposed
|
35 / 2402 (1.46%) |
32 / 2419 (1.32%) |
67 / 4821 (1.39%) |
occurrences causally related to treatment / all
|
1 / 38 |
1 / 36 |
2 / 74 |
deaths causally related to treatment / all
|
1 / 13 |
0 / 11 |
1 / 24 |
Myocardial ischaemia
|
|
|
|
subjects affected / exposed
|
11 / 2402 (0.46%) |
7 / 2419 (0.29%) |
18 / 4821 (0.37%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 7 |
0 / 18 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
Myocardial rupture
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Myocarditis
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
2 / 2419 (0.08%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
Nodal rhythm
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
0 / 2419 (0.00%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Palpitations
|
|
|
|
subjects affected / exposed
|
4 / 2402 (0.17%) |
3 / 2419 (0.12%) |
7 / 4821 (0.15%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 6 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pericardial effusion
|
|
|
|
subjects affected / exposed
|
4 / 2402 (0.17%) |
3 / 2419 (0.12%) |
7 / 4821 (0.15%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pericarditis
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
1 / 2419 (0.04%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pericarditis constrictive
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulseless electrical activity
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
3 / 2419 (0.12%) |
4 / 4821 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
Right ventricular dysfunction
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Right ventricular failure
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
0 / 2419 (0.00%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sinoatrial block
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sinus arrest
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sinus bradycardia
|
|
|
|
subjects affected / exposed
|
8 / 2402 (0.33%) |
1 / 2419 (0.04%) |
9 / 4821 (0.19%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 1 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sinus node dysfunction
|
|
|
|
subjects affected / exposed
|
12 / 2402 (0.50%) |
18 / 2419 (0.74%) |
30 / 4821 (0.62%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 18 |
0 / 30 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sinus tachycardia
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
0 / 2419 (0.00%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Stress cardiomyopathy
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Supraventricular extrasystoles
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Supraventricular tachycardia
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
6 / 2419 (0.25%) |
9 / 4821 (0.19%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 11 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Systolic dysfunction
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tachyarrhythmia
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
3 / 2419 (0.12%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tachycardia
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
3 / 2419 (0.12%) |
4 / 4821 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Torsade de pointes
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tricuspid valve incompetence
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
0 / 2419 (0.00%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Trifascicular block
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ventricular arrhythmia
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ventricular dyssynchrony
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ventricular extrasystoles
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
2 / 2419 (0.08%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ventricular fibrillation
|
|
|
|
subjects affected / exposed
|
5 / 2402 (0.21%) |
4 / 2419 (0.17%) |
9 / 4821 (0.19%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 4 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 3 |
Ventricular tachycardia
|
|
|
|
subjects affected / exposed
|
4 / 2402 (0.17%) |
9 / 2419 (0.37%) |
13 / 4821 (0.27%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 9 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Nervous system disorders
|
|
|
|
Altered state of consciousness
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Amyotrophic lateral sclerosis
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Aphasia
|
|
|
|
subjects affected / exposed
|
4 / 2402 (0.17%) |
1 / 2419 (0.04%) |
5 / 4821 (0.10%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ataxia
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Brain hypoxia
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Brain injury
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
Brain oedema
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
2 / 2419 (0.08%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Brain stem stroke
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Carotid artery aneurysm
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
0 / 2419 (0.00%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Carotid artery disease
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Carotid artery stenosis
|
|
|
|
subjects affected / exposed
|
7 / 2402 (0.29%) |
9 / 2419 (0.37%) |
16 / 4821 (0.33%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 10 |
0 / 18 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Carpal tunnel syndrome
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Central nervous system lesion
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cerebellar haematoma
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Cerebellar infarction
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
0 / 2419 (0.00%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cerebellar ischaemia
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral arteriosclerosis
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral artery embolism
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral cyst
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Cerebral haemorrhage
|
|
|
|
subjects affected / exposed
|
6 / 2402 (0.25%) |
5 / 2419 (0.21%) |
11 / 4821 (0.23%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 5 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 5 |
Cerebral infarction
|
|
|
|
subjects affected / exposed
|
18 / 2402 (0.75%) |
17 / 2419 (0.70%) |
35 / 4821 (0.73%) |
occurrences causally related to treatment / all
|
0 / 20 |
1 / 20 |
1 / 40 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
Cerebral ischaemia
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
3 / 2419 (0.12%) |
6 / 4821 (0.12%) |
occurrences causally related to treatment / all
|
0 / 3 |
2 / 3 |
2 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral thrombosis
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cerebrospinal fluid leakage
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cerebrovascular accident
|
|
|
|
subjects affected / exposed
|
42 / 2402 (1.75%) |
39 / 2419 (1.61%) |
81 / 4821 (1.68%) |
occurrences causally related to treatment / all
|
0 / 48 |
2 / 46 |
2 / 94 |
deaths causally related to treatment / all
|
0 / 8 |
1 / 10 |
1 / 18 |
Cerebrovascular disorder
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cerebrovascular insufficiency
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
2 / 2419 (0.08%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cervical radiculopathy
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cervicobrachial syndrome
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cognitive disorder
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
7 / 2419 (0.29%) |
9 / 4821 (0.19%) |
occurrences causally related to treatment / all
|
0 / 2 |
2 / 7 |
2 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Coma
|
|
|
|
subjects affected / exposed
|
4 / 2402 (0.17%) |
1 / 2419 (0.04%) |
5 / 4821 (0.10%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 3 |
Dementia
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
2 / 2419 (0.08%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Dementia Alzheimer's type
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Dementia with Lewy bodies
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Depressed level of consciousness
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic ketoacidotic hyperglycaemic coma
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic neuropathy
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
2 / 2419 (0.08%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dizziness
|
|
|
|
subjects affected / exposed
|
11 / 2402 (0.46%) |
17 / 2419 (0.70%) |
28 / 4821 (0.58%) |
occurrences causally related to treatment / all
|
2 / 11 |
4 / 19 |
6 / 30 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dysarthria
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Embolic stroke
|
|
|
|
subjects affected / exposed
|
4 / 2402 (0.17%) |
5 / 2419 (0.21%) |
9 / 4821 (0.19%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Encephalopathy
|
|
|
|
subjects affected / exposed
|
6 / 2402 (0.25%) |
1 / 2419 (0.04%) |
7 / 4821 (0.15%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 2 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Epilepsy
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
0 / 2419 (0.00%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Facial paralysis
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
2 / 2419 (0.08%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Generalised tonic-clonic seizure
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Guillain-Barre syndrome
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhage intracranial
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Haemorrhagic cerebral infarction
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
2 / 2419 (0.08%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Haemorrhagic stroke
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
3 / 2419 (0.12%) |
6 / 4821 (0.12%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 3 |
Haemorrhagic transformation stroke
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Headache
|
|
|
|
subjects affected / exposed
|
10 / 2402 (0.42%) |
3 / 2419 (0.12%) |
13 / 4821 (0.27%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 3 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Hemiparesis
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hemiplegia
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Hepatic encephalopathy
|
|
|
|
subjects affected / exposed
|
5 / 2402 (0.21%) |
1 / 2419 (0.04%) |
6 / 4821 (0.12%) |
occurrences causally related to treatment / all
|
1 / 8 |
0 / 1 |
1 / 9 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
Hydrocephalus
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypoaesthesia
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
3 / 2419 (0.12%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypoglycaemic coma
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypoxic-ischaemic encephalopathy
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
IIIrd nerve paralysis
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intracranial aneurysm
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
2 / 2419 (0.08%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intracranial haematoma
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intracranial pressure increased
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ischaemic cerebral infarction
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Ischaemic stroke
|
|
|
|
subjects affected / exposed
|
29 / 2402 (1.21%) |
32 / 2419 (1.32%) |
61 / 4821 (1.27%) |
occurrences causally related to treatment / all
|
0 / 29 |
0 / 36 |
0 / 65 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 4 |
0 / 9 |
Lacunar infarction
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
4 / 2419 (0.17%) |
6 / 4821 (0.12%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lacunar stroke
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lethargy
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
2 / 2419 (0.08%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Loss of consciousness
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
3 / 2419 (0.12%) |
6 / 4821 (0.12%) |
occurrences causally related to treatment / all
|
0 / 3 |
1 / 3 |
1 / 6 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Lumbar radiculopathy
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
1 / 2419 (0.04%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lumbosacral radiculopathy
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metabolic encephalopathy
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
6 / 2419 (0.25%) |
9 / 4821 (0.19%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 6 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Migraine
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mixed dementia
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Motor dysfunction
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Movement disorder
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Multiple system atrophy
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Myasthenia gravis
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Myasthenic syndrome
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Myelopathy
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
2 / 2419 (0.08%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Myoclonus
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nervous system disorder
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Neuralgia
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
2 / 2419 (0.08%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Neuropathy peripheral
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Normal pressure hydrocephalus
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Parkinson's disease
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
2 / 2419 (0.08%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Parkinsonism
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
0 / 2419 (0.00%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral sensorimotor neuropathy
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Polyneuropathy
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Post herpetic neuralgia
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Post stroke epilepsy
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Posterior reversible encephalopathy syndrome
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Presyncope
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
3 / 2419 (0.12%) |
6 / 4821 (0.12%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pseudoradicular syndrome
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Radiculopathy
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
2 / 2419 (0.08%) |
4 / 4821 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Resting tremor
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sciatica
|
|
|
|
subjects affected / exposed
|
4 / 2402 (0.17%) |
4 / 2419 (0.17%) |
8 / 4821 (0.17%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Seizure
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
6 / 2419 (0.25%) |
8 / 4821 (0.17%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 6 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sensory disturbance
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
2 / 2419 (0.08%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Somnolence
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
0 / 2419 (0.00%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Speech disorder
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Spinal cord compression
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Spinal cord disorder
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Spondylitic myelopathy
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
2 / 2419 (0.08%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Status epilepticus
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
0 / 2419 (0.00%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Stroke in evolution
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Subarachnoid haemorrhage
|
|
|
|
subjects affected / exposed
|
4 / 2402 (0.17%) |
3 / 2419 (0.12%) |
7 / 4821 (0.15%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 3 |
Syncope
|
|
|
|
subjects affected / exposed
|
57 / 2402 (2.37%) |
41 / 2419 (1.69%) |
98 / 4821 (2.03%) |
occurrences causally related to treatment / all
|
9 / 67 |
12 / 44 |
21 / 111 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Thalamus haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Thrombotic cerebral infarction
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Thrombotic stroke
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Toxic encephalopathy
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Transient ischaemic attack
|
|
|
|
subjects affected / exposed
|
26 / 2402 (1.08%) |
34 / 2419 (1.41%) |
60 / 4821 (1.24%) |
occurrences causally related to treatment / all
|
1 / 26 |
2 / 37 |
3 / 63 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 2 |
1 / 2 |
Tremor
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Trigeminal neuralgia
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Unresponsive to stimuli
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Uraemic encephalopathy
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
VIth nerve paresis
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vascular dementia
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
2 / 2419 (0.08%) |
4 / 4821 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vascular parkinsonism
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vertebrobasilar insufficiency
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
4 / 2419 (0.17%) |
6 / 4821 (0.12%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vertigo CNS origin
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Blood and lymphatic system disorders
|
|
|
|
Acquired haemophilia
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Anaemia
|
|
|
|
subjects affected / exposed
|
67 / 2402 (2.79%) |
68 / 2419 (2.81%) |
135 / 4821 (2.80%) |
occurrences causally related to treatment / all
|
1 / 77 |
1 / 83 |
2 / 160 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
Anaemia macrocytic
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
2 / 2419 (0.08%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Anaemia megaloblastic
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Anaemia vitamin B12 deficiency
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
2 / 2419 (0.08%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Autoimmune haemolytic anaemia
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Blood loss anaemia
|
|
|
|
subjects affected / exposed
|
7 / 2402 (0.29%) |
2 / 2419 (0.08%) |
9 / 4821 (0.19%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 2 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Coagulopathy
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
1 / 2419 (0.04%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Disseminated intravascular coagulation
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Hypercoagulation
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypersplenism
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Immune thrombocytopenic purpura
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Iron deficiency anaemia
|
|
|
|
subjects affected / exposed
|
6 / 2402 (0.25%) |
5 / 2419 (0.21%) |
11 / 4821 (0.23%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 5 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Leukocytosis
|
|
|
|
subjects affected / exposed
|
6 / 2402 (0.25%) |
1 / 2419 (0.04%) |
7 / 4821 (0.15%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 1 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Leukopenia
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
2 / 2419 (0.08%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lymphadenitis
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lymphadenopathy
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
0 / 2419 (0.00%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lymphadenopathy mediastinal
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Microcytic anaemia
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
3 / 2419 (0.12%) |
4 / 4821 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nephrogenic anaemia
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Neutropenia
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
2 / 2419 (0.08%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Normochromic normocytic anaemia
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pancytopenia
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
1 / 2419 (0.04%) |
4 / 4821 (0.08%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Splenic infarction
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Splenitis
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Thrombocytopenia
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
6 / 2419 (0.25%) |
7 / 4821 (0.15%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 6 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Thrombocytosis
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ear and labyrinth disorders
|
|
|
|
Deafness unilateral
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sudden hearing loss
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tinnitus
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vertigo
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
6 / 2419 (0.25%) |
9 / 4821 (0.19%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 6 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vertigo positional
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
5 / 2419 (0.21%) |
6 / 4821 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 6 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vestibular ischaemia
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Eye disorders
|
|
|
|
Amaurosis fugax
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Blindness unilateral
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cataract
|
|
|
|
subjects affected / exposed
|
12 / 2402 (0.50%) |
14 / 2419 (0.58%) |
26 / 4821 (0.54%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 14 |
0 / 28 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cataract diabetic
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Conjunctival haemorrhage
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
1 / 2419 (0.04%) |
4 / 4821 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Entropion
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Eye pain
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Glaucoma
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
2 / 2419 (0.08%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 7 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Macular degeneration
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Macular fibrosis
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Maculopathy
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Narrow anterior chamber angle
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Neovascular age-related macular degeneration
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pterygium
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Retinal detachment
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
1 / 2419 (0.04%) |
4 / 4821 (0.08%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 1 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Retinal haemorrhage
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
1 / 2419 (0.04%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Retinal vein occlusion
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vision blurred
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Visual acuity reduced
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vitreous haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal disorders
|
|
|
|
Abdominal distension
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal hernia
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
3 / 2419 (0.12%) |
4 / 4821 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal pain
|
|
|
|
subjects affected / exposed
|
8 / 2402 (0.33%) |
6 / 2419 (0.25%) |
14 / 4821 (0.29%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 6 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal pain lower
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
1 / 2419 (0.04%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal pain upper
|
|
|
|
subjects affected / exposed
|
4 / 2402 (0.17%) |
3 / 2419 (0.12%) |
7 / 4821 (0.15%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Abdominal wall haematoma
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
2 / 2419 (0.08%) |
4 / 4821 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Anal fissure
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Anal fistula
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
1 / 2419 (0.04%) |
4 / 4821 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Anal haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Anal incontinence
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Appendiceal mucocoele
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ascites
|
|
|
|
subjects affected / exposed
|
9 / 2402 (0.37%) |
8 / 2419 (0.33%) |
17 / 4821 (0.35%) |
occurrences causally related to treatment / all
|
1 / 12 |
0 / 13 |
1 / 25 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Chronic gastritis
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
2 / 2419 (0.08%) |
5 / 4821 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Colitis
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
5 / 2419 (0.21%) |
8 / 4821 (0.17%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Colitis ischaemic
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
1 / 2419 (0.04%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
Colitis microscopic
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
2 / 2419 (0.08%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Colitis ulcerative
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
3 / 2419 (0.12%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Constipation
|
|
|
|
subjects affected / exposed
|
6 / 2402 (0.25%) |
2 / 2419 (0.08%) |
8 / 4821 (0.17%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 2 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Crohn's disease
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dental caries
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic gastroenteropathy
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diaphragmatic hernia
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diarrhoea
|
|
|
|
subjects affected / exposed
|
14 / 2402 (0.58%) |
13 / 2419 (0.54%) |
27 / 4821 (0.56%) |
occurrences causally related to treatment / all
|
0 / 15 |
0 / 13 |
0 / 28 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dieulafoy's vascular malformation
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
0 / 2419 (0.00%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Diverticular perforation
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
1 / 2419 (0.04%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Diverticulum
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diverticulum intestinal
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diverticulum intestinal haemorrhagic
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Duodenal polyp
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Duodenal ulcer
|
|
|
|
subjects affected / exposed
|
4 / 2402 (0.17%) |
3 / 2419 (0.12%) |
7 / 4821 (0.15%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Duodenal ulcer haemorrhage
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
1 / 2419 (0.04%) |
4 / 4821 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Duodenitis
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dyspepsia
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
3 / 2419 (0.12%) |
5 / 4821 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dysphagia
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
2 / 2419 (0.08%) |
5 / 4821 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Enteritis
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
3 / 2419 (0.12%) |
4 / 4821 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Erosive oesophagitis
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Faecaloma
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Faeces discoloured
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
0 / 2419 (0.00%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Femoral hernia
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastric disorder
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastric haemorrhage
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
1 / 2419 (0.04%) |
4 / 4821 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastric polyps
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastric ulcer
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
8 / 2419 (0.33%) |
11 / 4821 (0.23%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 8 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastric ulcer haemorrhage
|
|
|
|
subjects affected / exposed
|
4 / 2402 (0.17%) |
2 / 2419 (0.08%) |
6 / 4821 (0.12%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastritis
|
|
|
|
subjects affected / exposed
|
7 / 2402 (0.29%) |
3 / 2419 (0.12%) |
10 / 4821 (0.21%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 4 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastritis erosive
|
|
|
|
subjects affected / exposed
|
7 / 2402 (0.29%) |
1 / 2419 (0.04%) |
8 / 4821 (0.17%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 1 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastritis haemorrhagic
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
0 / 2419 (0.00%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal haemorrhage
|
|
|
|
subjects affected / exposed
|
32 / 2402 (1.33%) |
29 / 2419 (1.20%) |
61 / 4821 (1.27%) |
occurrences causally related to treatment / all
|
1 / 36 |
0 / 31 |
1 / 67 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 4 |
Gastrointestinal perforation
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Gastrointestinal polyp haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal ulcer
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal ulcer haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal wall thickening
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrooesophageal reflux disease
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
4 / 2419 (0.17%) |
7 / 4821 (0.15%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haematemesis
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
2 / 2419 (0.08%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Haematochezia
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
4 / 2419 (0.17%) |
7 / 4821 (0.15%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhagic erosive gastritis
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhoidal haemorrhage
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
0 / 2419 (0.00%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhoids
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
5 / 2419 (0.21%) |
8 / 4821 (0.17%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hiatus hernia
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ileus
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
2 / 2419 (0.08%) |
5 / 4821 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
Ileus paralytic
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Impaired gastric emptying
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
0 / 2419 (0.00%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Incarcerated inguinal hernia
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Incarcerated umbilical hernia
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Inguinal hernia
|
|
|
|
subjects affected / exposed
|
13 / 2402 (0.54%) |
10 / 2419 (0.41%) |
23 / 4821 (0.48%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 10 |
0 / 24 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Inguinal hernia, obstructive
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal haemorrhage
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
1 / 2419 (0.04%) |
4 / 4821 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal infarction
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Intestinal ischaemia
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
3 / 2419 (0.12%) |
6 / 4821 (0.12%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 3 |
Intestinal obstruction
|
|
|
|
subjects affected / exposed
|
5 / 2402 (0.21%) |
5 / 2419 (0.21%) |
10 / 4821 (0.21%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Intestinal perforation
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Intestinal polyp
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal strangulation
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intra-abdominal haematoma
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intra-abdominal haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Irritable bowel syndrome
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Large intestinal obstruction
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Large intestine perforation
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
1 / 2419 (0.04%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Large intestine polyp
|
|
|
|
subjects affected / exposed
|
4 / 2402 (0.17%) |
5 / 2419 (0.21%) |
9 / 4821 (0.19%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lower gastrointestinal haemorrhage
|
|
|
|
subjects affected / exposed
|
6 / 2402 (0.25%) |
1 / 2419 (0.04%) |
7 / 4821 (0.15%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 1 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mallory-Weiss syndrome
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Melaena
|
|
|
|
subjects affected / exposed
|
6 / 2402 (0.25%) |
7 / 2419 (0.29%) |
13 / 4821 (0.27%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 8 |
0 / 16 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Mouth haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nausea
|
|
|
|
subjects affected / exposed
|
5 / 2402 (0.21%) |
12 / 2419 (0.50%) |
17 / 4821 (0.35%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 15 |
0 / 21 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Obstructive pancreatitis
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
2 / 2419 (0.08%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oesophageal haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oesophageal perforation
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Oesophageal ulcer
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatitis
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
2 / 2419 (0.08%) |
5 / 4821 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatitis acute
|
|
|
|
subjects affected / exposed
|
9 / 2402 (0.37%) |
5 / 2419 (0.21%) |
14 / 4821 (0.29%) |
occurrences causally related to treatment / all
|
1 / 10 |
0 / 6 |
1 / 16 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
1 / 1 |
Pancreatitis chronic
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatitis necrotising
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatitis relapsing
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peptic ulcer haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peritoneal haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Portal hypertensive gastropathy
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Proctitis
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rectal haemorrhage
|
|
|
|
subjects affected / exposed
|
4 / 2402 (0.17%) |
9 / 2419 (0.37%) |
13 / 4821 (0.27%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 11 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rectal polyp
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rectal prolapse
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Retroperitoneal haematoma
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
2 / 2419 (0.08%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Salivary gland calculus
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Small intestinal haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Small intestinal obstruction
|
|
|
|
subjects affected / exposed
|
5 / 2402 (0.21%) |
7 / 2419 (0.29%) |
12 / 4821 (0.25%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 7 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Subileus
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Toothache
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Umbilical hernia
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
2 / 2419 (0.08%) |
4 / 4821 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Upper gastrointestinal haemorrhage
|
|
|
|
subjects affected / exposed
|
11 / 2402 (0.46%) |
7 / 2419 (0.29%) |
18 / 4821 (0.37%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 8 |
0 / 19 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
Varices oesophageal
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
3 / 2419 (0.12%) |
5 / 4821 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vomiting
|
|
|
|
subjects affected / exposed
|
11 / 2402 (0.46%) |
9 / 2419 (0.37%) |
20 / 4821 (0.41%) |
occurrences causally related to treatment / all
|
1 / 12 |
0 / 9 |
1 / 21 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Skin and subcutaneous tissue disorders
|
|
|
|
Angioedema
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
5 / 2419 (0.21%) |
6 / 4821 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
4 / 5 |
4 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Blister
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Butterfly rash
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Decubitus ulcer
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
3 / 2419 (0.12%) |
4 / 4821 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Dermatitis
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dermatitis exfoliative generalised
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic foot
|
|
|
|
subjects affected / exposed
|
5 / 2402 (0.21%) |
2 / 2419 (0.08%) |
7 / 4821 (0.15%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 2 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic wound
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Eczema
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
2 / 2419 (0.08%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Eczema asteatotic
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Erythema
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhage subcutaneous
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hyperhidrosis
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intertrigo
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ischaemic skin ulcer
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Neurodermatitis
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
2 / 2419 (0.08%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Purpura
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rash
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rash maculo-papular
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rash pruritic
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rhinophyma
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Skin lesion
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Skin ulcer
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
5 / 2419 (0.21%) |
8 / 4821 (0.17%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Subcutaneous emphysema
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Urticaria
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vasculitic ulcer
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal and urinary disorders
|
|
|
|
Acute kidney injury
|
|
|
|
subjects affected / exposed
|
110 / 2402 (4.58%) |
90 / 2419 (3.72%) |
200 / 4821 (4.15%) |
occurrences causally related to treatment / all
|
47 / 142 |
29 / 110 |
76 / 252 |
deaths causally related to treatment / all
|
2 / 12 |
2 / 9 |
4 / 21 |
Anuria
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
2 / 2419 (0.08%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Azotaemia
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
3 / 2419 (0.12%) |
6 / 4821 (0.12%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Bladder diverticulum
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bladder neck obstruction
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bladder prolapse
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Calculus bladder
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Calculus urethral
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Calculus urinary
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chronic kidney disease
|
|
|
|
subjects affected / exposed
|
14 / 2402 (0.58%) |
13 / 2419 (0.54%) |
27 / 4821 (0.56%) |
occurrences causally related to treatment / all
|
5 / 16 |
3 / 13 |
8 / 29 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dysuria
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
0 / 2419 (0.00%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
End stage renal disease
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
3 / 2419 (0.12%) |
6 / 4821 (0.12%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
Glomerulonephritis
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Glomerulonephropathy
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haematuria
|
|
|
|
subjects affected / exposed
|
8 / 2402 (0.33%) |
5 / 2419 (0.21%) |
13 / 4821 (0.27%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 5 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhage urinary tract
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hydronephrosis
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
2 / 2419 (0.08%) |
5 / 4821 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nephrolithiasis
|
|
|
|
subjects affected / exposed
|
5 / 2402 (0.21%) |
3 / 2419 (0.12%) |
8 / 4821 (0.17%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nephropathy toxic
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
0 / 2419 (0.00%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Nephrotic syndrome
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oliguria
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Prerenal failure
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
1 / 2419 (0.04%) |
4 / 4821 (0.08%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 1 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Proteinuria
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal artery stenosis
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal colic
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal cyst
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
0 / 2419 (0.00%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal disorder
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal failure
|
|
|
|
subjects affected / exposed
|
29 / 2402 (1.21%) |
31 / 2419 (1.28%) |
60 / 4821 (1.24%) |
occurrences causally related to treatment / all
|
5 / 33 |
10 / 36 |
15 / 69 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 5 |
0 / 10 |
Renal impairment
|
|
|
|
subjects affected / exposed
|
48 / 2402 (2.00%) |
24 / 2419 (0.99%) |
72 / 4821 (1.49%) |
occurrences causally related to treatment / all
|
17 / 53 |
11 / 25 |
28 / 78 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
Renal infarct
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
3 / 2419 (0.12%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
Renal injury
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
0 / 2419 (0.00%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal mass
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal pain
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal tubular necrosis
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
0 / 2419 (0.00%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal vein stenosis
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ureteric obstruction
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Ureterolithiasis
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urethral stenosis
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urinary incontinence
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
1 / 2419 (0.04%) |
4 / 4821 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urinary retention
|
|
|
|
subjects affected / exposed
|
8 / 2402 (0.33%) |
8 / 2419 (0.33%) |
16 / 4821 (0.33%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 9 |
0 / 17 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urinary tract obstruction
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
2 / 2419 (0.08%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Endocrine disorders
|
|
|
|
Goitre
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
0 / 2419 (0.00%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypercorticoidism
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hyperparathyroidism
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hyperthyroidism
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypothyroidism
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
3 / 2419 (0.12%) |
6 / 4821 (0.12%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Inappropriate antidiuretic hormone secretion
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Parathyroid hyperplasia
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal and connective tissue disorders
|
|
|
|
Acquired claw toe
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arthralgia
|
|
|
|
subjects affected / exposed
|
7 / 2402 (0.29%) |
4 / 2419 (0.17%) |
11 / 4821 (0.23%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 4 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arthritis
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
5 / 2419 (0.21%) |
8 / 4821 (0.17%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Back pain
|
|
|
|
subjects affected / exposed
|
11 / 2402 (0.46%) |
11 / 2419 (0.45%) |
22 / 4821 (0.46%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 12 |
0 / 24 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bursitis
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
CREST syndrome
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chest wall haematoma
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chondrocalcinosis
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Costochondritis
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dactylitis
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dupuytren's contracture
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Exostosis
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Fibromyalgia
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Flank pain
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
3 / 2419 (0.12%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Foot deformity
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
3 / 2419 (0.12%) |
4 / 4821 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gouty arthritis
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
3 / 2419 (0.12%) |
4 / 4821 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemarthrosis
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
1 / 2419 (0.04%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intervertebral disc degeneration
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
0 / 2419 (0.00%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intervertebral disc disorder
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
0 / 2419 (0.00%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intervertebral disc protrusion
|
|
|
|
subjects affected / exposed
|
5 / 2402 (0.21%) |
9 / 2419 (0.37%) |
14 / 4821 (0.29%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 11 |
0 / 16 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Joint effusion
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Kyphosis
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lumbar spinal stenosis
|
|
|
|
subjects affected / exposed
|
5 / 2402 (0.21%) |
4 / 2419 (0.17%) |
9 / 4821 (0.19%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 4 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mobility decreased
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Muscle spasms
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Muscular weakness
|
|
|
|
subjects affected / exposed
|
4 / 2402 (0.17%) |
3 / 2419 (0.12%) |
7 / 4821 (0.15%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal chest pain
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
0 / 2419 (0.00%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal pain
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
2 / 2419 (0.08%) |
4 / 4821 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Myalgia
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Myositis
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Myositis ossificans
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Neck pain
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
2 / 2419 (0.08%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Osteitis
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Osteitis deformans
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Osteoarthritis
|
|
|
|
subjects affected / exposed
|
28 / 2402 (1.17%) |
31 / 2419 (1.28%) |
59 / 4821 (1.22%) |
occurrences causally related to treatment / all
|
0 / 31 |
0 / 39 |
0 / 70 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Osteochondrosis
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Osteonecrosis
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Osteoporosis
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pain in extremity
|
|
|
|
subjects affected / exposed
|
6 / 2402 (0.25%) |
2 / 2419 (0.08%) |
8 / 4821 (0.17%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 3 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pathological fracture
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Periarthritis
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Periostitis
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Polymyalgia rheumatica
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pseudarthrosis
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rheumatoid arthritis
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
0 / 2419 (0.00%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rotator cuff syndrome
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
6 / 2419 (0.25%) |
9 / 4821 (0.19%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 6 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Scleroderma
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Spinal osteoarthritis
|
|
|
|
subjects affected / exposed
|
4 / 2402 (0.17%) |
6 / 2419 (0.25%) |
10 / 4821 (0.21%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 6 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Spinal pain
|
|
|
|
subjects affected / exposed
|
6 / 2402 (0.25%) |
3 / 2419 (0.12%) |
9 / 4821 (0.19%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 3 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Spinal stenosis
|
|
|
|
subjects affected / exposed
|
6 / 2402 (0.25%) |
5 / 2419 (0.21%) |
11 / 4821 (0.23%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 7 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Spondylolisthesis
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Synovial cyst
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
2 / 2419 (0.08%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tenosynovitis
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Infections and infestations
|
|
|
|
Abdominal sepsis
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal wall abscess
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Abscess jaw
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Abscess limb
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
2 / 2419 (0.08%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Abscess neck
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Abscess oral
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Acinetobacter bacteraemia
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Acute endocarditis
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Amoebiasis
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Anal abscess
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
0 / 2419 (0.00%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Appendicitis
|
|
|
|
subjects affected / exposed
|
4 / 2402 (0.17%) |
2 / 2419 (0.08%) |
6 / 4821 (0.12%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Arthritis bacterial
|
|
|
|
subjects affected / exposed
|
6 / 2402 (0.25%) |
3 / 2419 (0.12%) |
9 / 4821 (0.19%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 5 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arthritis infective
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Aspergillus infection
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Bacteraemia
|
|
|
|
subjects affected / exposed
|
7 / 2402 (0.29%) |
6 / 2419 (0.25%) |
13 / 4821 (0.27%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 7 |
0 / 16 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
Bacterial disease carrier
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bacterial infection
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bacterial rhinitis
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bacterial sepsis
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
0 / 2419 (0.00%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Beta haemolytic streptococcal infection
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
0 / 2419 (0.00%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Biliary sepsis
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Biliary tract infection
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bone abscess
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bronchiolitis
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bronchitis
|
|
|
|
subjects affected / exposed
|
41 / 2402 (1.71%) |
32 / 2419 (1.32%) |
73 / 4821 (1.51%) |
occurrences causally related to treatment / all
|
0 / 50 |
0 / 39 |
0 / 89 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
Bronchitis viral
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
0 / 2419 (0.00%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Campylobacter infection
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cellulitis
|
|
|
|
subjects affected / exposed
|
25 / 2402 (1.04%) |
30 / 2419 (1.24%) |
55 / 4821 (1.14%) |
occurrences causally related to treatment / all
|
0 / 35 |
0 / 38 |
0 / 73 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Chest wall abscess
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cholangitis infective
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
2 / 2419 (0.08%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Chronic sinusitis
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Clostridium colitis
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Clostridium difficile colitis
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
6 / 2419 (0.25%) |
9 / 4821 (0.19%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 7 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Clostridium difficile infection
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
3 / 2419 (0.12%) |
5 / 4821 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Colonic abscess
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
1 / 2419 (0.04%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Complicated appendicitis
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cystitis
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
2 / 2419 (0.08%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cystitis bacterial
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cystitis escherichia
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cytomegalovirus infection
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dengue fever
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Device related infection
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
2 / 2419 (0.08%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic foot infection
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
1 / 2419 (0.04%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic gangrene
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diarrhoea infectious
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diverticulitis
|
|
|
|
subjects affected / exposed
|
9 / 2402 (0.37%) |
3 / 2419 (0.12%) |
12 / 4821 (0.25%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 3 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Eczema infected
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Embolic pneumonia
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Endocarditis
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
2 / 2419 (0.08%) |
5 / 4821 (0.10%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 3 |
Enteritis infectious
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Enterococcal bacteraemia
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Enterococcal sepsis
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Epididymitis
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Epiglottitis
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Erysipelas
|
|
|
|
subjects affected / exposed
|
7 / 2402 (0.29%) |
11 / 2419 (0.45%) |
18 / 4821 (0.37%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 15 |
0 / 23 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Escherichia bacteraemia
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
0 / 2419 (0.00%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Escherichia sepsis
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Escherichia urinary tract infection
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
2 / 2419 (0.08%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gangrene
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
3 / 2419 (0.12%) |
6 / 4821 (0.12%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Gastroenteritis
|
|
|
|
subjects affected / exposed
|
16 / 2402 (0.67%) |
21 / 2419 (0.87%) |
37 / 4821 (0.77%) |
occurrences causally related to treatment / all
|
0 / 16 |
0 / 21 |
0 / 37 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Gastroenteritis bacterial
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
0 / 2419 (0.00%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastroenteritis clostridial
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastroenteritis norovirus
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
0 / 2419 (0.00%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastroenteritis salmonella
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastroenteritis viral
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
2 / 2419 (0.08%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal viral infection
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Genital herpes zoster
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haematoma infection
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Helicobacter infection
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatitis E
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Herpes zoster
|
|
|
|
subjects affected / exposed
|
4 / 2402 (0.17%) |
2 / 2419 (0.08%) |
6 / 4821 (0.12%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hordeolum
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Human anaplasmosis
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Infected skin ulcer
|
|
|
|
subjects affected / exposed
|
4 / 2402 (0.17%) |
2 / 2419 (0.08%) |
6 / 4821 (0.12%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Infection
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
1 / 2419 (0.04%) |
4 / 4821 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Infectious pleural effusion
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Infective exacerbation of bronchiectasis
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
1 / 2419 (0.04%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Infective exacerbation of chronic obstructive airways disease
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
2 / 2419 (0.08%) |
5 / 4821 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Influenza
|
|
|
|
subjects affected / exposed
|
11 / 2402 (0.46%) |
16 / 2419 (0.66%) |
27 / 4821 (0.56%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 16 |
0 / 27 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 3 |
Intervertebral discitis
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
1 / 2419 (0.04%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal sepsis
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intracranial infection
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Klebsiella sepsis
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
2 / 2419 (0.08%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Labyrinthitis
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Laryngitis
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Liver abscess
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
0 / 2419 (0.00%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Localised infection
|
|
|
|
subjects affected / exposed
|
5 / 2402 (0.21%) |
4 / 2419 (0.17%) |
9 / 4821 (0.19%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 4 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Lower respiratory tract infection
|
|
|
|
subjects affected / exposed
|
12 / 2402 (0.50%) |
11 / 2419 (0.45%) |
23 / 4821 (0.48%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 11 |
0 / 25 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Lower respiratory tract infection viral
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lung abscess
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lung infection
|
|
|
|
subjects affected / exposed
|
11 / 2402 (0.46%) |
12 / 2419 (0.50%) |
23 / 4821 (0.48%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 13 |
0 / 25 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Lymphangitis
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mediastinitis
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
0 / 2419 (0.00%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Medical device site infection
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Meningitis enterococcal
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nasopharyngitis
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Necrotising fasciitis
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nosocomial infection
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oesophageal candidiasis
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ophthalmic herpes zoster
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oral candidiasis
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oral herpes
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
2 / 2419 (0.08%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Orchitis
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Osteomyelitis
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
7 / 2419 (0.29%) |
10 / 4821 (0.21%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 9 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Otitis media
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pelvic abscess
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Periodontitis
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peritonitis
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
0 / 2419 (0.00%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peritonitis bacterial
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pharyngitis
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumococcal sepsis
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
3 / 2419 (0.12%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Pneumonia
|
|
|
|
subjects affected / exposed
|
178 / 2402 (7.41%) |
162 / 2419 (6.70%) |
340 / 4821 (7.05%) |
occurrences causally related to treatment / all
|
0 / 212 |
0 / 197 |
0 / 409 |
deaths causally related to treatment / all
|
0 / 24 |
0 / 23 |
0 / 47 |
Pneumonia bacterial
|
|
|
|
subjects affected / exposed
|
5 / 2402 (0.21%) |
4 / 2419 (0.17%) |
9 / 4821 (0.19%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia influenzal
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Pneumonia mycoplasmal
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia pneumococcal
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia respiratory syncytial viral
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia streptococcal
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia viral
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
2 / 2419 (0.08%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural infection
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Postoperative wound infection
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
3 / 2419 (0.12%) |
6 / 4821 (0.12%) |
occurrences causally related to treatment / all
|
0 / 3 |
1 / 3 |
1 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pseudomembranous colitis
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
1 / 2419 (0.04%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary sepsis
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary tuberculosis
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Pyelonephritis
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
3 / 2419 (0.12%) |
6 / 4821 (0.12%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pyelonephritis acute
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
4 / 2419 (0.17%) |
7 / 4821 (0.15%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pyelonephritis chronic
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rectal abscess
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal abscess
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory moniliasis
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory syncytial virus bronchitis
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory syncytial virus infection
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
1 / 2419 (0.04%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory tract infection
|
|
|
|
subjects affected / exposed
|
21 / 2402 (0.87%) |
19 / 2419 (0.79%) |
40 / 4821 (0.83%) |
occurrences causally related to treatment / all
|
0 / 25 |
0 / 21 |
0 / 46 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 3 |
Respiratory tract infection bacterial
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory tract infection viral
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
1 / 2419 (0.04%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Salmonellosis
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sepsis
|
|
|
|
subjects affected / exposed
|
37 / 2402 (1.54%) |
34 / 2419 (1.41%) |
71 / 4821 (1.47%) |
occurrences causally related to treatment / all
|
1 / 44 |
0 / 41 |
1 / 85 |
deaths causally related to treatment / all
|
0 / 9 |
0 / 12 |
0 / 21 |
Septic encephalopathy
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Septic necrosis
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Septic shock
|
|
|
|
subjects affected / exposed
|
16 / 2402 (0.67%) |
21 / 2419 (0.87%) |
37 / 4821 (0.77%) |
occurrences causally related to treatment / all
|
0 / 17 |
0 / 23 |
0 / 40 |
deaths causally related to treatment / all
|
0 / 10 |
0 / 10 |
0 / 20 |
Severe acute respiratory syndrome
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Shunt infection
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Skin bacterial infection
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Skin infection
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Soft tissue infection
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Staphylococcal bacteraemia
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
0 / 2419 (0.00%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Staphylococcal infection
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Staphylococcal sepsis
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Streptococcal bacteraemia
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Streptococcal sepsis
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
0 / 2419 (0.00%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Syphilis
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tooth abscess
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tracheobronchitis
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
2 / 2419 (0.08%) |
4 / 4821 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tuberculosis
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Tuberculous pleurisy
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tubo-ovarian abscess
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Upper respiratory tract infection
|
|
|
|
subjects affected / exposed
|
6 / 2402 (0.25%) |
5 / 2419 (0.21%) |
11 / 4821 (0.23%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 5 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urethritis
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urinary tract infection
|
|
|
|
subjects affected / exposed
|
68 / 2402 (2.83%) |
54 / 2419 (2.23%) |
122 / 4821 (2.53%) |
occurrences causally related to treatment / all
|
0 / 76 |
0 / 68 |
0 / 144 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
Urosepsis
|
|
|
|
subjects affected / exposed
|
14 / 2402 (0.58%) |
11 / 2419 (0.45%) |
25 / 4821 (0.52%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 12 |
0 / 26 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 4 |
Vestibular neuronitis
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
2 / 2419 (0.08%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Viral infection
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Viral upper respiratory tract infection
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
2 / 2419 (0.08%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Wound abscess
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Wound infection
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
2 / 2419 (0.08%) |
5 / 4821 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metabolism and nutrition disorders
|
|
|
|
Cachexia
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
2 / 2419 (0.08%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 3 |
Cardiometabolic syndrome
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Decreased appetite
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Dehydration
|
|
|
|
subjects affected / exposed
|
26 / 2402 (1.08%) |
18 / 2419 (0.74%) |
44 / 4821 (0.91%) |
occurrences causally related to treatment / all
|
1 / 30 |
1 / 18 |
2 / 48 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 3 |
Diabetes mellitus
|
|
|
|
subjects affected / exposed
|
8 / 2402 (0.33%) |
9 / 2419 (0.37%) |
17 / 4821 (0.35%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 9 |
0 / 18 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Diabetes mellitus inadequate control
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
4 / 2419 (0.17%) |
7 / 4821 (0.15%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic complication
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Diabetic ketoacidosis
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic metabolic decompensation
|
|
|
|
subjects affected / exposed
|
9 / 2402 (0.37%) |
3 / 2419 (0.12%) |
12 / 4821 (0.25%) |
occurrences causally related to treatment / all
|
1 / 11 |
0 / 3 |
1 / 14 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
1 / 1 |
Electrolyte imbalance
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
0 / 2419 (0.00%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Failure to thrive
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
2 / 2419 (0.08%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Fluid overload
|
|
|
|
subjects affected / exposed
|
8 / 2402 (0.33%) |
8 / 2419 (0.33%) |
16 / 4821 (0.33%) |
occurrences causally related to treatment / all
|
1 / 8 |
1 / 11 |
2 / 19 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Fluid retention
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Folate deficiency
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gout
|
|
|
|
subjects affected / exposed
|
11 / 2402 (0.46%) |
5 / 2419 (0.21%) |
16 / 4821 (0.33%) |
occurrences causally related to treatment / all
|
1 / 11 |
0 / 5 |
1 / 16 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Haemochromatosis
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hyperammonaemia
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypercalcaemia
|
|
|
|
subjects affected / exposed
|
2 / 2402 (0.08%) |
2 / 2419 (0.08%) |
4 / 4821 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Hypercholesterolaemia
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
0 / 2419 (0.00%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hyperglycaemia
|
|
|
|
subjects affected / exposed
|
16 / 2402 (0.67%) |
10 / 2419 (0.41%) |
26 / 4821 (0.54%) |
occurrences causally related to treatment / all
|
0 / 18 |
0 / 15 |
0 / 33 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
Hyperglycaemic hyperosmolar nonketotic syndrome
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
2 / 2419 (0.08%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hyperkalaemia
|
|
|
|
subjects affected / exposed
|
42 / 2402 (1.75%) |
19 / 2419 (0.79%) |
61 / 4821 (1.27%) |
occurrences causally related to treatment / all
|
28 / 51 |
6 / 21 |
34 / 72 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 3 |
Hypernatraemia
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
3 / 2419 (0.12%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hyperuricaemia
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypoalbuminaemia
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypocalcaemia
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypoglycaemia
|
|
|
|
subjects affected / exposed
|
6 / 2402 (0.25%) |
20 / 2419 (0.83%) |
26 / 4821 (0.54%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 20 |
0 / 26 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Hypokalaemia
|
|
|
|
subjects affected / exposed
|
14 / 2402 (0.58%) |
8 / 2419 (0.33%) |
22 / 4821 (0.46%) |
occurrences causally related to treatment / all
|
1 / 15 |
0 / 9 |
1 / 24 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Hypomagnesaemia
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
2 / 2419 (0.08%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hyponatraemia
|
|
|
|
subjects affected / exposed
|
17 / 2402 (0.71%) |
17 / 2419 (0.70%) |
34 / 4821 (0.71%) |
occurrences causally related to treatment / all
|
1 / 21 |
1 / 19 |
2 / 40 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypoosmolar state
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypophosphataemia
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypovolaemia
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
4 / 2419 (0.17%) |
5 / 4821 (0.10%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 5 |
2 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Iron deficiency
|
|
|
|
subjects affected / exposed
|
4 / 2402 (0.17%) |
0 / 2419 (0.00%) |
4 / 4821 (0.08%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Ketoacidosis
|
|
|
|
subjects affected / exposed
|
0 / 2402 (0.00%) |
1 / 2419 (0.04%) |
1 / 4821 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lactic acidosis
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Malnutrition
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
0 / 2419 (0.00%) |
3 / 4821 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Marasmus
|
|
|
|
subjects affected / exposed
|
1 / 2402 (0.04%) |
1 / 2419 (0.04%) |
2 / 4821 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
Metabolic acidosis
|
|
|
|
subjects affected / exposed
|
3 / 2402 (0.12%) |
3 / 2419 (0.12%) |
6 / 4821 (0.12%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Type 2 diabetes mellitus
|
|
|
|
subjects affected / exposed
|
8 / 2402 (0.33%) |
5 / 2419 (0.21%) |
13 / 4821 (0.27%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 5 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |