Serious adverse events
|
Low Risk Placebo |
High Risk Placebo |
High Risk Pioglitazone |
Total subjects affected by serious adverse events
|
|
|
|
subjects affected / exposed
|
81 / 427 (18.97%) |
404 / 1507 (26.81%) |
358 / 1531 (23.38%) |
number of deaths (all causes)
|
2 |
21 |
7 |
number of deaths resulting from adverse events
|
|
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
|
Prostate cancer
|
|
|
|
subjects affected / exposed
|
1 / 427 (0.23%) |
8 / 1507 (0.53%) |
5 / 1531 (0.33%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 8 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Breast cancer
|
|
|
|
subjects affected / exposed
|
2 / 427 (0.47%) |
2 / 1507 (0.13%) |
4 / 1531 (0.26%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatic carcinoma
|
|
|
|
Additional description: One treatment-emergent death occurred during treatment with placebo (in low-risk group) and was not related. Two treatment-emergent deaths occurred during treatment with placebo (in high-risk group) and were not related.
|
|
|
|
subjects affected / exposed
|
1 / 427 (0.23%) |
3 / 1507 (0.20%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
Malignant melanoma
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
4 / 1531 (0.26%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bladder cancer
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
2 / 1531 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bladder transitional cell carcinoma
|
|
|
|
subjects affected / exposed
|
1 / 427 (0.23%) |
1 / 1507 (0.07%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diffuse large B-cell lymphoma
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
3 / 1531 (0.20%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Invasive ductal breast carcinoma
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
2 / 1531 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lung neoplasm malignant
|
|
|
|
subjects affected / exposed
|
1 / 427 (0.23%) |
2 / 1507 (0.13%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Adenocarcinoma of colon
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Adenocarcinoma pancreas
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
2 / 1531 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Endometrial cancer
|
|
|
|
subjects affected / exposed
|
2 / 427 (0.47%) |
0 / 1507 (0.00%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lung adenocarcinoma
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lymphoma
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
2 / 1507 (0.13%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Malignant melanoma in situ
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
2 / 1531 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Non-small cell lung cancer
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Parathyroid tumour benign
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
1 / 1531 (0.07%) |
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 adenocarcinoma
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Squamous cell carcinoma of lung
|
|
|
|
Additional description: One treatment-emergent death occurred during treatment with pioglitazone (in high-risk group) and was not related.
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Anal squamous cell carcinoma
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Basal cell carcinoma
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Benign neoplasm of thyroid gland
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Benign renal neoplasm
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bladder cancer stage 0, with cancer in situ
|
|
|
|
subjects affected / exposed
|
1 / 427 (0.23%) |
0 / 1507 (0.00%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Brain neoplasm
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Breast cancer in situ
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac myxoma
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cholangiocarcinoma
|
|
|
|
Additional description: One treatment-emergent death occurred during treatment with pioglitazone (in high-risk group) and was not related.
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Choroid plexus papilloma
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Colon cancer
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Colon cancer stage II
|
|
|
|
subjects affected / exposed
|
1 / 427 (0.23%) |
0 / 1507 (0.00%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Endometrial adenocarcinoma
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Follicular thyroid cancer
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal carcinoma
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Glioma
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intracranial meningioma malignant
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Invasive papillary breast carcinoma
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Large intestine benign neoplasm
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Laryngeal squamous cell carcinoma
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lung adenocarcinoma stage II
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lung cancer metastatic
|
|
|
|
Additional description: One treatment-emergent death occurred during treatment with placebo (in high-risk group) and was not related.
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Lung carcinoma cell type unspecified stage IV
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mantle cell lymphoma recurrent
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metastatic malignant melanoma
|
|
|
|
subjects affected / exposed
|
1 / 427 (0.23%) |
0 / 1507 (0.00%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mucinous breast carcinoma
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Myelodysplastic syndrome
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Non-Hodgkin's lymphoma
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Non-small cell lung cancer stage IIIB
|
|
|
|
subjects affected / exposed
|
1 / 427 (0.23%) |
0 / 1507 (0.00%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oesophageal adenocarcinoma
|
|
|
|
Additional description: One treatment-emergent death occurred during treatment with placebo (in high-risk group) and was not related.
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Oesophageal carcinoma
|
|
|
|
Additional description: One treatment-emergent death occurred during treatment with placebo (in high-risk group) and was related.
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Oesophageal squamous cell carcinoma
|
|
|
|
subjects affected / exposed
|
1 / 427 (0.23%) |
0 / 1507 (0.00%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ovarian adenoma
|
|
|
|
subjects affected / exposed
|
1 / 427 (0.23%) |
0 / 1507 (0.00%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Papillary cystadenoma lymphomatosum
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Penile squamous cell carcinoma
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pituitary tumour benign
|
|
|
|
subjects affected / exposed
|
1 / 427 (0.23%) |
0 / 1507 (0.00%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Plasma cell myeloma
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Plasmacytoma
|
|
|
|
Additional description: One treatment-emergent death occurred during treatment with pioglitazone (in high-risk group) and was not related.
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Polycythaemia vera
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rectal cancer
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal cancer
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Schwannoma
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Spinal cord neoplasm
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Squamous cell carcinoma of skin
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Squamous cell carcinoma of the tongue
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tongue neoplasm malignant stage unspecified
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tonsil cancer
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Uterine cancer
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Uterine leiomyoma
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vascular disorders
|
|
|
|
Deep vein thrombosis
|
|
|
|
subjects affected / exposed
|
1 / 427 (0.23%) |
3 / 1507 (0.20%) |
2 / 1531 (0.13%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypotension
|
|
|
|
Additional description: One treatment-emergent death occurred during treatment with placebo (in low-risk group) and was not related.
|
|
|
|
subjects affected / exposed
|
1 / 427 (0.23%) |
4 / 1507 (0.27%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Aortic stenosis
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
3 / 1507 (0.20%) |
2 / 1531 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Aortic aneurysm
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
2 / 1507 (0.13%) |
2 / 1531 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypertension
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral artery occlusion
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral artery stenosis
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
2 / 1507 (0.13%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral vascular disorder
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Varicose vein
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
2 / 1507 (0.13%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arteriosclerosis
|
|
|
|
subjects affected / exposed
|
1 / 427 (0.23%) |
0 / 1507 (0.00%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haematoma
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypertensive crisis
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Orthostatic hypotension
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Superior mesenteric artery syndrome
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Superior vena cava syndrome
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Surgical and medical procedures
|
|
|
|
Shoulder arthroplasty
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
General disorders and administration site conditions
|
|
|
|
Non-cardiac chest pain
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
5 / 1507 (0.33%) |
8 / 1531 (0.52%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 5 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Asthenia
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
2 / 1531 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chest pain
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
2 / 1507 (0.13%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hernia
|
|
|
|
subjects affected / exposed
|
1 / 427 (0.23%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pyrexia
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Adverse drug reaction
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Death
|
|
|
|
Additional description: One treatment-emergent death occurred during treatment with placebo (in high-risk group) and was not related.
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Fatigue
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ill-defined disorder
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Systemic inflammatory response syndrome
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Unevaluable event
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Immune system disorders
|
|
|
|
Anaphylactic reaction
|
|
|
|
subjects affected / exposed
|
1 / 427 (0.23%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Drug hypersensitivity
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sarcoidosis
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Reproductive system and breast disorders
|
|
|
|
Benign prostatic hyperplasia
|
|
|
|
subjects affected / exposed
|
2 / 427 (0.47%) |
4 / 1507 (0.27%) |
2 / 1531 (0.13%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Prostatitis
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Prostatomegaly
|
|
|
|
subjects affected / exposed
|
1 / 427 (0.23%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vaginal prolapse
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Acquired hydrocele
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Prostatic haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Uterine prolapse
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Uterovaginal prolapse
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vaginal haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory, thoracic and mediastinal disorders
|
|
|
|
Pulmonary embolism
|
|
|
|
subjects affected / exposed
|
1 / 427 (0.23%) |
9 / 1507 (0.60%) |
11 / 1531 (0.72%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 9 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary hypertension
|
|
|
|
subjects affected / exposed
|
2 / 427 (0.47%) |
6 / 1507 (0.40%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 6 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chronic obstructive pulmonary disease
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
4 / 1507 (0.27%) |
3 / 1531 (0.20%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 6 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dyspnoea
|
|
|
|
subjects affected / exposed
|
1 / 427 (0.23%) |
2 / 1507 (0.13%) |
3 / 1531 (0.20%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary fibrosis
|
|
|
|
Additional description: One treatment-emergent death occurred during treatment with placebo (in high-risk group) and was not related.
|
|
|
|
subjects affected / exposed
|
1 / 427 (0.23%) |
1 / 1507 (0.07%) |
4 / 1531 (0.26%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Asthma
|
|
|
|
subjects affected / exposed
|
1 / 427 (0.23%) |
3 / 1507 (0.20%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumothorax
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
3 / 1507 (0.20%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory failure
|
|
|
|
Additional description: One treatment-emergent death occurred during treatment with pioglitazone (in high-risk group) and was not related.
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
2 / 1507 (0.13%) |
2 / 1531 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Acute respiratory failure
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
2 / 1507 (0.13%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bronchiectasis
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cough
|
|
|
|
Additional description: One treatment-emergent death occurred during treatment with pioglitazone (in high-risk group) and was not related.
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Interstitial lung disease
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pleural effusion
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
1 / 1531 (0.07%) |
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 oedema
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Idiopathic pulmonary fibrosis
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lung disorder
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary granuloma
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Psychiatric disorders
|
|
|
|
Mental status changes
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
2 / 1507 (0.13%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Alcohol abuse
|
|
|
|
subjects affected / exposed
|
1 / 427 (0.23%) |
0 / 1507 (0.00%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Alcohol withdrawal syndrome
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Confusional state
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Delirium
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Panic attack
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Suicidal ideation
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Product issues
|
|
|
|
Device dislocation
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatobiliary disorders
|
|
|
|
Cholecystitis
|
|
|
|
subjects affected / exposed
|
1 / 427 (0.23%) |
3 / 1507 (0.20%) |
6 / 1531 (0.39%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cholecystitis acute
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
3 / 1507 (0.20%) |
3 / 1531 (0.20%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cholelithiasis
|
|
|
|
subjects affected / exposed
|
2 / 427 (0.47%) |
2 / 1507 (0.13%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bile duct stone
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
1 / 1531 (0.07%) |
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
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cholecystitis chronic
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Drug-induced liver injury
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Jaundice
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Primary biliary cholangitis
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Investigations
|
|
|
|
Blood magnesium decreased
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
2 / 1507 (0.13%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Blood pressure increased
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Electrocardiogram QT prolonged
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Blood parathyroid hormone increased
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Heart rate irregular
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic enzyme increased
|
|
|
|
subjects affected / exposed
|
1 / 427 (0.23%) |
0 / 1507 (0.00%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Platelet count decreased
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Injury, poisoning and procedural complications
|
|
|
|
Fall
|
|
|
|
subjects affected / exposed
|
1 / 427 (0.23%) |
7 / 1507 (0.46%) |
3 / 1531 (0.20%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 8 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hip fracture
|
|
|
|
subjects affected / exposed
|
2 / 427 (0.47%) |
7 / 1507 (0.46%) |
2 / 1531 (0.13%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 8 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rib fracture
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
4 / 1507 (0.27%) |
3 / 1531 (0.20%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Femur fracture
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
3 / 1507 (0.20%) |
3 / 1531 (0.20%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Subarachnoid haemorrhage
|
|
|
|
Additional description: Two treatment-emergent deaths occurred during treatment with placebo (in high-risk group) and were not related.
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
4 / 1507 (0.27%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
Upper limb fracture
|
|
|
|
subjects affected / exposed
|
1 / 427 (0.23%) |
3 / 1507 (0.20%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ankle fracture
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
2 / 1507 (0.13%) |
2 / 1531 (0.13%) |
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
|
0 / 427 (0.00%) |
3 / 1507 (0.20%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Laceration
|
|
|
|
subjects affected / exposed
|
1 / 427 (0.23%) |
0 / 1507 (0.00%) |
2 / 1531 (0.13%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lower limb fracture
|
|
|
|
subjects affected / exposed
|
1 / 427 (0.23%) |
1 / 1507 (0.07%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Meniscus injury
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
3 / 1531 (0.20%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Radius fracture
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
2 / 1507 (0.13%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Road traffic accident
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
3 / 1531 (0.20%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Spinal fracture
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
2 / 1507 (0.13%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Facial bones fracture
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Femoral neck fracture
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Humerus fracture
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
1 / 1531 (0.07%) |
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
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
2 / 1531 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Joint dislocation
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
2 / 1531 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pelvic fracture
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Periprosthetic osteolysis
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
1 / 1531 (0.07%) |
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 procedural haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
2 / 1507 (0.13%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pubis fracture
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
2 / 1531 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Traumatic intracranial haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
1 / 1531 (0.07%) |
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 retention postoperative
|
|
|
|
subjects affected / exposed
|
1 / 427 (0.23%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Wrist fracture
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
2 / 1531 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Accidental overdose
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Avulsion fracture
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cataract operation complication
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cervical vertebral fracture
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Clavicle fracture
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Concussion
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Contusion
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Craniocerebral injury
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Extradural haematoma
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Fibula fracture
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Flatback syndrome
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Foot fracture
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Fracture displacement
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Fractured ischium
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Fractured sacrum
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hand fracture
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ligament rupture
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ligament sprain
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Periprosthetic fracture
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural complication
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural haematoma
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Postoperative ileus
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Postoperative respiratory failure
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Procedural intestinal perforation
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Procedural pain
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Procedural vomiting
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Spinal compression fracture
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sternal fracture
|
|
|
|
subjects affected / exposed
|
1 / 427 (0.23%) |
0 / 1507 (0.00%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Stress fracture
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Subdural haemorrhage
|
|
|
|
Additional description: One treatment-emergent death occurred in participant who also suffered from cerebrovascular accident during treatment with placebo (in high-risk group) and was not related.
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Tendon injury
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tendon rupture
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ulna fracture
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Wound secretion
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Congenital, familial and genetic disorders
|
|
|
|
Congenital cerebrovascular anomaly
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac disorders
|
|
|
|
Atrial fibrillation
|
|
|
|
subjects affected / exposed
|
5 / 427 (1.17%) |
15 / 1507 (1.00%) |
16 / 1531 (1.05%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 20 |
0 / 20 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Angina pectoris
|
|
|
|
subjects affected / exposed
|
3 / 427 (0.70%) |
10 / 1507 (0.66%) |
6 / 1531 (0.39%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 10 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Coronary artery disease
|
|
|
|
subjects affected / exposed
|
2 / 427 (0.47%) |
7 / 1507 (0.46%) |
7 / 1531 (0.46%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 7 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Myocardial infarction
|
|
|
|
Additional description: Four treatment-emergent deaths occurred during treatment with placebo (in high-risk group) and were not related.
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
13 / 1507 (0.86%) |
3 / 1531 (0.20%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 13 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 0 |
Cardiac failure congestive
|
|
|
|
Additional description: Two treatment-emergent deaths occurred during treatment with placebo (in high-risk group) and were not related.
|
|
|
|
subjects affected / exposed
|
1 / 427 (0.23%) |
8 / 1507 (0.53%) |
6 / 1531 (0.39%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 11 |
1 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
Acute myocardial infarction
|
|
|
|
Additional description: One treatment-emergent death occurred during treatment with pioglitazone (in high-risk group) and was not related.
|
|
|
|
subjects affected / exposed
|
1 / 427 (0.23%) |
5 / 1507 (0.33%) |
3 / 1531 (0.20%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Sinus node dysfunction
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
2 / 1507 (0.13%) |
5 / 1531 (0.33%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bradycardia
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
4 / 1507 (0.27%) |
2 / 1531 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mitral valve incompetence
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
5 / 1531 (0.33%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac arrest
|
|
|
|
Additional description: Two treatment-emergent deaths occurred during treatment with placebo (in high-risk group) and were not related.
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
3 / 1507 (0.20%) |
2 / 1531 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
Ventricular tachycardia
|
|
|
|
subjects affected / exposed
|
1 / 427 (0.23%) |
3 / 1507 (0.20%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Acute coronary syndrome
|
|
|
|
subjects affected / exposed
|
1 / 427 (0.23%) |
1 / 1507 (0.07%) |
2 / 1531 (0.13%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Coronary artery stenosis
|
|
|
|
subjects affected / exposed
|
1 / 427 (0.23%) |
2 / 1507 (0.13%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Angina unstable
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
3 / 1507 (0.20%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arrhythmia
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
2 / 1507 (0.13%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Atrial flutter
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
2 / 1507 (0.13%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Myocardial ischaemia
|
|
|
|
Additional description: One treatment-emergent death occurred during treatment with pioglitazone (in high-risk group) and was not related.
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
2 / 1507 (0.13%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Aortic valve stenosis
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
2 / 1531 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Atrioventricular block complete
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Coronary artery occlusion
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Extrasystoles
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
1 / 1531 (0.07%) |
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
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
1 / 1531 (0.07%) |
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 fibrillation
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
2 / 1531 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arteriosclerosis coronary artery
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arteriospasm coronary
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Atrial septal defect acquired
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bradyarrhythmia
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac failure chronic
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac tamponade
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mitral valve disease
|
|
|
|
subjects affected / exposed
|
1 / 427 (0.23%) |
0 / 1507 (0.00%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Palpitations
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Stress cardiomyopathy
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tricuspid valve incompetence
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ventricular extrasystoles
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nervous system disorders
|
|
|
|
Syncope
|
|
|
|
subjects affected / exposed
|
2 / 427 (0.47%) |
13 / 1507 (0.86%) |
14 / 1531 (0.91%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 13 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Transient ischaemic attack
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
11 / 1507 (0.73%) |
10 / 1531 (0.65%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 11 |
1 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cerebrovascular accident
|
|
|
|
Additional description: One treatment-emergent death occurred in participant who also suffered from subdural haemorrhage during treatment with placebo (in high-risk group) and was not related.
|
|
|
|
subjects affected / exposed
|
1 / 427 (0.23%) |
10 / 1507 (0.66%) |
6 / 1531 (0.39%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 10 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Presyncope
|
|
|
|
subjects affected / exposed
|
1 / 427 (0.23%) |
4 / 1507 (0.27%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Carotid artery stenosis
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
2 / 1507 (0.13%) |
3 / 1531 (0.20%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dizziness
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
3 / 1507 (0.20%) |
2 / 1531 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ischaemic stroke
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
3 / 1531 (0.20%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral haemorrhage
|
|
|
|
Additional description: One treatment-emergent death occurred during treatment with placebo (in high-risk group) and was not related.
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
3 / 1507 (0.20%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Seizure
|
|
|
|
subjects affected / exposed
|
1 / 427 (0.23%) |
1 / 1507 (0.07%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Generalised tonic-clonic seizure
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intracranial aneurysm
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
2 / 1531 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Somnolence
|
|
|
|
subjects affected / exposed
|
1 / 427 (0.23%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Transient global amnesia
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
2 / 1507 (0.13%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Amnesia
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Aphasia
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Carpal tunnel syndrome
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral infarction
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dizziness postural
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Encephalopathy
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Facial neuralgia
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Facial paralysis
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhage intracranial
|
|
|
|
Additional description: One treatment-emergent death occurred during treatment with placebo (in high-risk group) and was not related.
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Haemorrhagic stroke
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
IIIrd nerve paralysis
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lacunar infarction
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lacunar stroke
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metabolic encephalopathy
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nerve compression
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Paraplegia
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Parkinson's disease
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sciatica
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Spinal cord compression
|
|
|
|
subjects affected / exposed
|
1 / 427 (0.23%) |
0 / 1507 (0.00%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Temporal lobe epilepsy
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Blood and lymphatic system disorders
|
|
|
|
Anaemia
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
3 / 1507 (0.20%) |
2 / 1531 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemolytic anaemia
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhagic anaemia
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ear and labyrinth disorders
|
|
|
|
Vertigo
|
|
|
|
subjects affected / exposed
|
1 / 427 (0.23%) |
1 / 1507 (0.07%) |
3 / 1531 (0.20%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vertigo positional
|
|
|
|
subjects affected / exposed
|
1 / 427 (0.23%) |
3 / 1507 (0.20%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Eye disorders
|
|
|
|
Macular fibrosis
|
|
|
|
subjects affected / exposed
|
2 / 427 (0.47%) |
0 / 1507 (0.00%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cataract
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dacryostenosis acquired
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Macular oedema
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Neovascular age-related macular degeneration
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal disorders
|
|
|
|
Small intestinal obstruction
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
8 / 1507 (0.53%) |
5 / 1531 (0.33%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 8 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal pain
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
2 / 1507 (0.13%) |
5 / 1531 (0.33%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Inguinal hernia
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
2 / 1507 (0.13%) |
4 / 1531 (0.26%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal obstruction
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
3 / 1507 (0.20%) |
3 / 1531 (0.20%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rectal haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
3 / 1507 (0.20%) |
2 / 1531 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Colitis
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
2 / 1531 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diverticulum intestinal haemorrhagic
|
|
|
|
subjects affected / exposed
|
1 / 427 (0.23%) |
1 / 1507 (0.07%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
2 / 1531 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hiatus hernia
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
2 / 1507 (0.13%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatitis
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
2 / 1531 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Constipation
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
2 / 1507 (0.13%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diarrhoea
|
|
|
|
subjects affected / exposed
|
1 / 427 (0.23%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diverticular perforation
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
2 / 1531 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diverticulum
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
2 / 1531 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrooesophageal reflux disease
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
2 / 1531 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Irritable bowel syndrome
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
1 / 1531 (0.07%) |
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 pancreatitis
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Umbilical hernia
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
2 / 1531 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Upper gastrointestinal haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
2 / 1507 (0.13%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vomiting
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
1 / 1531 (0.07%) |
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 adhesions
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal pain lower
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Colitis ischaemic
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Duodenal stenosis
|
|
|
|
subjects affected / exposed
|
1 / 427 (0.23%) |
0 / 1507 (0.00%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dyspepsia
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Functional gastrointestinal disorder
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gallstone ileus
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastric ulcer haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhoids
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ileus
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Impaired gastric emptying
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Incarcerated inguinal hernia
|
|
|
|
subjects affected / exposed
|
1 / 427 (0.23%) |
0 / 1507 (0.00%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal pseudo-obstruction
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Large intestine polyp
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nausea
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oesophageal spasm
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatitis acute
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Volvulus
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Skin and subcutaneous tissue disorders
|
|
|
|
Angioedema
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Precancerous skin lesion
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal and urinary disorders
|
|
|
|
Acute kidney injury
|
|
|
|
subjects affected / exposed
|
3 / 427 (0.70%) |
5 / 1507 (0.33%) |
7 / 1531 (0.46%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urinary retention
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
2 / 1507 (0.13%) |
2 / 1531 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haematuria
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
2 / 1531 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nephrolithiasis
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
2 / 1531 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urinary tract obstruction
|
|
|
|
subjects affected / exposed
|
1 / 427 (0.23%) |
1 / 1507 (0.07%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal failure
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
1 / 1531 (0.07%) |
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
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Calculus bladder
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chronic kidney disease
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic nephropathy
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lower urinary tract symptoms
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urethral obstruction
|
|
|
|
subjects affected / exposed
|
1 / 427 (0.23%) |
0 / 1507 (0.00%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urethral stenosis
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urinoma
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Endocrine disorders
|
|
|
|
Thyroid mass
|
|
|
|
subjects affected / exposed
|
1 / 427 (0.23%) |
0 / 1507 (0.00%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal and connective tissue disorders
|
|
|
|
Osteoarthritis
|
|
|
|
subjects affected / exposed
|
4 / 427 (0.94%) |
22 / 1507 (1.46%) |
23 / 1531 (1.50%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 24 |
0 / 26 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arthralgia
|
|
|
|
subjects affected / exposed
|
3 / 427 (0.70%) |
13 / 1507 (0.86%) |
10 / 1531 (0.65%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 14 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arthritis
|
|
|
|
subjects affected / exposed
|
1 / 427 (0.23%) |
6 / 1507 (0.40%) |
8 / 1531 (0.52%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 6 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Back pain
|
|
|
|
subjects affected / exposed
|
2 / 427 (0.47%) |
4 / 1507 (0.27%) |
5 / 1531 (0.33%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rotator cuff syndrome
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
2 / 1507 (0.13%) |
4 / 1531 (0.26%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intervertebral disc degeneration
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
2 / 1507 (0.13%) |
3 / 1531 (0.20%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal chest pain
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
2 / 1507 (0.13%) |
2 / 1531 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal pain
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
2 / 1507 (0.13%) |
2 / 1531 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Spinal column stenosis
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
3 / 1531 (0.20%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lumbar spinal stenosis
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
2 / 1507 (0.13%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Muscular weakness
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
2 / 1531 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arthropathy
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
2 / 1531 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bursitis
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
2 / 1531 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cervical spinal stenosis
|
|
|
|
subjects affected / exposed
|
1 / 427 (0.23%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intervertebral disc protrusion
|
|
|
|
subjects affected / exposed
|
1 / 427 (0.23%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pain in extremity
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dupuytren's contracture
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Foot deformity
|
|
|
|
subjects affected / exposed
|
1 / 427 (0.23%) |
0 / 1507 (0.00%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Fracture pain
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Joint instability
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Joint range of motion decreased
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Muscle haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal discomfort
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Myosclerosis
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Osteonecrosis
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pain in jaw
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Polymyalgia rheumatica
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sacroiliitis
|
|
|
|
subjects affected / exposed
|
1 / 427 (0.23%) |
0 / 1507 (0.00%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Scoliosis
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Seronegative arthritis
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Spinal osteoarthritis
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Spondylolisthesis
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Synovial cyst
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tendon disorder
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vertebral foraminal stenosis
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vertebral osteophyte
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Infections and infestations
|
|
|
|
Pneumonia
|
|
|
|
Additional description: One treatment-emergent death occurred during treatment with placebo (in high-risk group) and was not related.
|
|
|
|
subjects affected / exposed
|
3 / 427 (0.70%) |
12 / 1507 (0.80%) |
15 / 1531 (0.98%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 13 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Diverticulitis
|
|
|
|
subjects affected / exposed
|
3 / 427 (0.70%) |
7 / 1507 (0.46%) |
4 / 1531 (0.26%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 7 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cellulitis
|
|
|
|
subjects affected / exposed
|
1 / 427 (0.23%) |
3 / 1507 (0.20%) |
8 / 1531 (0.52%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sepsis
|
|
|
|
subjects affected / exposed
|
1 / 427 (0.23%) |
5 / 1507 (0.33%) |
6 / 1531 (0.39%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urosepsis
|
|
|
|
subjects affected / exposed
|
2 / 427 (0.47%) |
4 / 1507 (0.27%) |
4 / 1531 (0.26%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urinary tract infection
|
|
|
|
subjects affected / exposed
|
1 / 427 (0.23%) |
5 / 1507 (0.33%) |
3 / 1531 (0.20%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Appendicitis
|
|
|
|
subjects affected / exposed
|
2 / 427 (0.47%) |
1 / 1507 (0.07%) |
4 / 1531 (0.26%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastroenteritis
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
3 / 1507 (0.20%) |
4 / 1531 (0.26%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lower respiratory tract infection
|
|
|
|
subjects affected / exposed
|
1 / 427 (0.23%) |
2 / 1507 (0.13%) |
3 / 1531 (0.20%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Influenza
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
4 / 1507 (0.27%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Clostridium difficile colitis
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
2 / 1531 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pyelonephritis
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
2 / 1507 (0.13%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Wound infection
|
|
|
|
subjects affected / exposed
|
1 / 427 (0.23%) |
2 / 1507 (0.13%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Abscess limb
|
|
|
|
subjects affected / exposed
|
1 / 427 (0.23%) |
0 / 1507 (0.00%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Anal abscess
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bronchiolitis
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bronchitis
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Clostridium difficile infection
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Coccidioidomycosis
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Colonic abscess
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Device related infection
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Escherichia sepsis
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Escherichia urinary tract infection
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastroenteritis viral
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Infected skin ulcer
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Infective exacerbation of bronchiectasis
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Klebsiella sepsis
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Labyrinthitis
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Localised infection
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Meningoencephalitis herpetic
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Osteomyelitis
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumocystis jirovecii pneumonia
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia bacterial
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia klebsiella
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural cellulitis
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Postoperative wound infection
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory syncytial virus bronchitis
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory tract infection
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Septic shock
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sinusitis
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Staphylococcal sepsis
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metabolism and nutrition disorders
|
|
|
|
Dehydration
|
|
|
|
subjects affected / exposed
|
1 / 427 (0.23%) |
3 / 1507 (0.20%) |
3 / 1531 (0.20%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hyponatraemia
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
2 / 1507 (0.13%) |
3 / 1531 (0.20%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral salt-wasting syndrome
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
0 / 1507 (0.00%) |
1 / 1531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypokalaemia
|
|
|
|
subjects affected / exposed
|
0 / 427 (0.00%) |
1 / 1507 (0.07%) |
0 / 1531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |