Serious adverse events
|
Palbociclib plus endocrine therapy |
Endocrine therapy |
Total subjects affected by serious adverse events
|
|
|
subjects affected / exposed
|
369 / 2841 (12.99%) |
229 / 2902 (7.89%) |
number of deaths (all causes)
|
100 |
76 |
number of deaths resulting from adverse events
|
14 |
10 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
Acute myeloid leukaemia
|
|
|
Additional description: Acute myeloid leukaemia
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute promyelocytic leukaemia
|
|
|
Additional description: Acute promyelocytic leukaemia
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adenocarcinoma pancreas
|
|
|
Additional description: Adenocarcinoma pancreas
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
B-cell small lymphocytic lymphoma
|
|
|
Additional description: B-cell small lymphocytic lymphoma
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Basal cell carcinoma
|
|
|
Additional description: Basal cell carcinoma
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign breast neoplasm
|
|
|
Additional description: Benign breast neoplasm
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder neoplasm
|
|
|
Additional description: Bladder neoplasm
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast cancer metastatic
|
|
|
Additional description: Breast cancer metastatic
|
|
|
subjects affected / exposed
|
2 / 2841 (0.07%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Breast cancer recurrent
|
|
|
Additional description: Breast cancer recurrent
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cervix carcinoma
|
|
|
Additional description: Cervix carcinoma
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervix carcinoma stage 0
|
|
|
Additional description: Cervix carcinoma stage 0
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colon cancer
|
|
|
Additional description: Colon cancer
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endometrial adenocarcinoma
|
|
|
Additional description: Endometrial adenocarcinoma
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intraductal papillary-mucinous carcinoma of pancreas
|
|
|
Additional description: Intraductal papillary-mucinous carcinoma of pancreas
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung neoplasm malignant
|
|
|
Additional description: Lung neoplasm malignant
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphoma
|
|
|
Additional description: Lymphoma
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphoplasmacytoid lymphoma/immunocytoma
|
|
|
Additional description: Lymphoplasmacytoid lymphoma/immunocytoma
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant melanoma
|
|
|
Additional description: Malignant melanoma
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant melanoma in situ
|
|
|
Additional description: Malignant melanoma in situ
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
2 / 2902 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastatic malignant melanoma
|
|
|
Additional description: Metastatic malignant melanoma
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ovarian adenoma
|
|
|
Additional description: Ovarian adenoma
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cell carcinoma
|
|
|
Additional description: Renal cell carcinoma
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Salivary gland adenoma
|
|
|
Additional description: Salivary gland adenoma
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Second primary malignancy
|
|
|
Additional description: Second primary malignancy
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Small cell carcinoma
|
|
|
Additional description: Small cell carcinoma
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Squamous cell carcinoma
|
|
|
Additional description: Squamous cell carcinoma
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Squamous cell carcinoma of the tongue
|
|
|
Additional description: Squamous cell carcinoma of the tongue
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thyroid adenoma
|
|
|
Additional description: Thyroid adenoma
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
2 / 2902 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine leiomyoma
|
|
|
Additional description: Uterine leiomyoma
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine leiomyosarcoma
|
|
|
Additional description: Uterine leiomyosarcoma
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uveal melanoma
|
|
|
Additional description: Uveal melanoma
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular disorders
|
|
|
Deep vein thrombosis
|
|
|
Additional description: Deep vein thrombosis
|
|
|
subjects affected / exposed
|
2 / 2841 (0.07%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Axillary vein thrombosis
|
|
|
Additional description: Axillary vein thrombosis
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Embolism
|
|
|
Additional description: Embolism
|
|
|
subjects affected / exposed
|
4 / 2841 (0.14%) |
2 / 2902 (0.07%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive crisis
|
|
|
Additional description: Hypertensive crisis
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
2 / 2902 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypotension
|
|
|
Additional description: Hypotension
|
|
|
subjects affected / exposed
|
2 / 2841 (0.07%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphoedema
|
|
|
Additional description: Lymphoedema
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral ischaemia
|
|
|
Additional description: Peripheral ischaemia
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
General disorders and administration site conditions
|
|
|
Capsular contracture associated with breast implant
|
|
|
Additional description: Capsular contracture associated with breast implant
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chest discomfort
|
|
|
Additional description: Chest discomfort
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chest pain
|
|
|
Additional description: Chest pain
|
|
|
subjects affected / exposed
|
3 / 2841 (0.11%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Death
|
|
|
Additional description: Death
|
|
|
subjects affected / exposed
|
2 / 2841 (0.07%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Disease progression
|
|
|
Additional description: Disease progression
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
2 / 2902 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
Disease recurrence
|
|
|
Additional description: Disease recurrence
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Dysplasia
|
|
|
Additional description: Dysplasia
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fatigue
|
|
|
Additional description: Fatigue
|
|
|
subjects affected / exposed
|
2 / 2841 (0.07%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypothermia
|
|
|
Additional description: Hypothermia
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Impaired healing
|
|
|
Additional description: Impaired healing
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Implant site fibrosis
|
|
|
Additional description: Implant site fibrosis
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Influenza like illness
|
|
|
Additional description: Influenza like illness
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infusion site extravasation
|
|
|
Additional description: Infusion site extravasation
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Non-cardiac chest pain
|
|
|
Additional description: Non-cardiac chest pain
|
|
|
subjects affected / exposed
|
4 / 2841 (0.14%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyrexia
|
|
|
Additional description: Pyrexia
|
|
|
subjects affected / exposed
|
3 / 2841 (0.11%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Immune system disorders
|
|
|
Anaphylactic reaction
|
|
|
Additional description: Anaphylactic reaction
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Reproductive system and breast disorders
|
|
|
Adnexa uteri cyst
|
|
|
Additional description: Adnexa uteri cyst
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast calcifications
|
|
|
Additional description: Breast calcifications
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast cyst
|
|
|
Additional description: Breast cyst
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast haematoma
|
|
|
Additional description: Breast haematoma
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast necrosis
|
|
|
Additional description: Breast necrosis
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
2 / 2902 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast swelling
|
|
|
Additional description: Breast swelling
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical cyst
|
|
|
Additional description: Cervical cyst
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endometrial disorder
|
|
|
Additional description: Endometrial disorder
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endometrial hyperplasia
|
|
|
Additional description: Endometrial hyperplasia
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
2 / 2902 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endometrial hypertrophy
|
|
|
Additional description: Endometrial hypertrophy
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endometrial thickening
|
|
|
Additional description: Endometrial thickening
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endometriosis
|
|
|
Additional description: Endometriosis
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ovarian cyst
|
|
|
Additional description: Ovarian cyst
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine polyp
|
|
|
Additional description: Uterine polyp
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine prolapse
|
|
|
Additional description: Uterine prolapse
|
|
|
subjects affected / exposed
|
2 / 2841 (0.07%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vaginal haematoma
|
|
|
Additional description: Vaginal haematoma
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vaginal prolapse
|
|
|
Additional description: Vaginal prolapse
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory, thoracic and mediastinal disorders
|
|
|
Acute respiratory distress syndrome
|
|
|
Additional description: Acute respiratory distress syndrome
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Asthma
|
|
|
Additional description: Asthma
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute respiratory failure
|
|
|
Additional description: Acute respiratory failure
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchospasm
|
|
|
Additional description: Bronchospasm
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Asthma-chronic obstructive pulmonary disease overlap syndrome
|
|
|
Additional description: Asthma-chronic obstructive pulmonary disease overlap syndrome
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dyspnoea
|
|
|
Additional description: Dyspnoea
|
|
|
subjects affected / exposed
|
2 / 2841 (0.07%) |
2 / 2902 (0.07%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic obstructive pulmonary disease
|
|
|
Additional description: Chronic obstructive pulmonary disease
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoxia
|
|
|
Additional description: Hypoxia
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laryngeal stenosis
|
|
|
Additional description: Laryngeal stenosis
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleurisy
|
|
|
Additional description: Pleurisy
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleural effusion
|
|
|
Additional description: Pleural effusion
|
|
|
subjects affected / exposed
|
2 / 2841 (0.07%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary embolism
|
|
|
Additional description: Pulmonary embolism
|
|
|
subjects affected / exposed
|
13 / 2841 (0.46%) |
5 / 2902 (0.17%) |
occurrences causally related to treatment / all
|
3 / 13 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonitis
|
|
|
Additional description: Pneumonitis
|
|
|
subjects affected / exposed
|
4 / 2841 (0.14%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
2 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary fibrosis
|
|
|
Additional description: Pulmonary fibrosis
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary haemorrhage
|
|
|
Additional description: Pulmonary haemorrhage
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary oedema
|
|
|
Additional description: Pulmonary oedema
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary sarcoidosis
|
|
|
Additional description: Pulmonary sarcoidosis
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory disorder
|
|
|
Additional description: Respiratory disorder
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory failure
|
|
|
Additional description: Respiratory failure
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vocal cord dysfunction
|
|
|
Additional description: Vocal cord dysfunction
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vocal cord polyp
|
|
|
Additional description: Vocal cord polyp
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psychiatric disorders
|
|
|
Alcohol use disorder
|
|
|
Additional description: Alcohol use disorder
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Alcohol abuse
|
|
|
Additional description: Alcohol abuse
|
|
|
subjects affected / exposed
|
2 / 2841 (0.07%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Alcohol withdrawal syndrome
|
|
|
Additional description: Alcohol withdrawal syndrome
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anxiety
|
|
|
Additional description: Anxiety
|
|
|
subjects affected / exposed
|
2 / 2841 (0.07%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Confusional state
|
|
|
Additional description: Confusional state
|
|
|
subjects affected / exposed
|
3 / 2841 (0.11%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Delusion
|
|
|
Additional description: Delusion
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Depression
|
|
|
Additional description: Depression
|
|
|
subjects affected / exposed
|
3 / 2841 (0.11%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Drug abuse
|
|
|
Additional description: Drug abuse
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mania
|
|
|
Additional description: Mania
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mental disorder
|
|
|
Additional description: Mental disorder
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mental status changes
|
|
|
Additional description: Mental status changes
|
|
|
subjects affected / exposed
|
2 / 2841 (0.07%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Panic attack
|
|
|
Additional description: Panic attack
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Paranoia
|
|
|
Additional description: Paranoia
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psychotic disorder
|
|
|
Additional description: Psychotic disorder
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Suicidal ideation
|
|
|
Additional description: Suicidal ideation
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Suicide attempt
|
|
|
Additional description: Suicide attempt
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
3 / 2902 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Product issues
|
|
|
Device breakage
|
|
|
Additional description: Device breakage
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device dislocation
|
|
|
Additional description: Device dislocation
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device leakage
|
|
|
Additional description: Device leakage
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Investigations
|
|
|
Alanine aminotransferase increased
|
|
|
Additional description: Alanine aminotransferase increased
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood bilirubin increased
|
|
|
Additional description: Blood bilirubin increased
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Liver function test increased
|
|
|
Additional description: Liver function test increased
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neutrophil count decreased
|
|
|
Additional description: Neutrophil count decreased
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Troponin increased
|
|
|
Additional description: Troponin increased
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
White blood cell count decreased
|
|
|
Additional description: White blood cell count decreased
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Injury, poisoning and procedural complications
|
|
|
Abdominal wound dehiscence
|
|
|
Additional description: Abdominal wound dehiscence
|
|
|
subjects affected / exposed
|
2 / 2841 (0.07%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Alcohol poisoning
|
|
|
Additional description: Alcohol poisoning
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Animal bite
|
|
|
Additional description: Animal bite
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ankle fracture
|
|
|
Additional description: Ankle fracture
|
|
|
subjects affected / exposed
|
3 / 2841 (0.11%) |
2 / 2902 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain contusion
|
|
|
Additional description: Brain contusion
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast procedural complication
|
|
|
Additional description: Breast procedural complication
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clavicle fracture
|
|
|
Additional description: Clavicle fracture
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
2 / 2902 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Concussion
|
|
|
Additional description: Concussion
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Craniocerebral injury
|
|
|
Additional description: Craniocerebral injury
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fall
|
|
|
Additional description: Fall
|
|
|
subjects affected / exposed
|
3 / 2841 (0.11%) |
3 / 2902 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Head injury
|
|
|
Additional description: Head injury
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hip fracture
|
|
|
Additional description: Hip fracture
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Humerus fracture
|
|
|
Additional description: Humerus fracture
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Limb injury
|
|
|
Additional description: Limb injury
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower limb fracture
|
|
|
Additional description: Lower limb fracture
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meniscus injury
|
|
|
Additional description: Meniscus injury
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
2 / 2902 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Open fracture
|
|
|
Additional description: Open fracture
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural haematoma
|
|
|
Additional description: Post procedural haematoma
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative wound complication
|
|
|
Additional description: Postoperative wound complication
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural complication
|
|
|
Additional description: Procedural complication
|
|
|
subjects affected / exposed
|
2 / 2841 (0.07%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radiation pneumonitis
|
|
|
Additional description: Radiation pneumonitis
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radius fracture
|
|
|
Additional description: Radius fracture
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rib fracture
|
|
|
Additional description: Rib fracture
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Seroma
|
|
|
Additional description: Seroma
|
|
|
subjects affected / exposed
|
3 / 2841 (0.11%) |
4 / 2902 (0.14%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin flap necrosis
|
|
|
Additional description: Skin flap necrosis
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal fracture
|
|
|
Additional description: Spinal fracture
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sternal fracture
|
|
|
Additional description: Sternal fracture
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subdural haematoma
|
|
|
Additional description: Subdural haematoma
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thermal burn
|
|
|
Additional description: Thermal burn
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thoracic vertebral fracture
|
|
|
Additional description: Thoracic vertebral fracture
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Upper limb fracture
|
|
|
Additional description: Upper limb fracture
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vaginal cuff dehiscence
|
|
|
Additional description: Vaginal cuff dehiscence
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular access site thrombosis
|
|
|
Additional description: Vascular access site thrombosis
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound complication
|
|
|
Additional description: Wound complication
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound dehiscence
|
|
|
Additional description: Wound dehiscence
|
|
|
subjects affected / exposed
|
9 / 2841 (0.32%) |
5 / 2902 (0.17%) |
occurrences causally related to treatment / all
|
1 / 9 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wrist fracture
|
|
|
Additional description: Wrist fracture
|
|
|
subjects affected / exposed
|
3 / 2841 (0.11%) |
2 / 2902 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Congenital, familial and genetic disorders
|
|
|
Atrial septal defect
|
|
|
Additional description: Atrial septal defect
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gene mutation
|
|
|
Additional description: Gene mutation
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac disorders
|
|
|
Acute coronary syndrome
|
|
|
Additional description: Acute coronary syndrome
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
2 / 2902 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute myocardial infarction
|
|
|
Additional description: Acute myocardial infarction
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Angina pectoris
|
|
|
Additional description: Angina pectoris
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriospasm coronary
|
|
|
Additional description: Arteriospasm coronary
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrial fibrillation
|
|
|
Additional description: Atrial fibrillation
|
|
|
subjects affected / exposed
|
2 / 2841 (0.07%) |
4 / 2902 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrioventricular block
|
|
|
Additional description: Atrioventricular block
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrioventricular block complete
|
|
|
Additional description: Atrioventricular block complete
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac arrest
|
|
|
Additional description: Cardiac arrest
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cardiac failure
|
|
|
Additional description: Cardiac failure
|
|
|
subjects affected / exposed
|
2 / 2841 (0.07%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac failure acute
|
|
|
Additional description: Cardiac failure acute
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac failure congestive
|
|
|
Additional description: Cardiac failure congestive
|
|
|
subjects affected / exposed
|
2 / 2841 (0.07%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cardiac ventricular thrombosis
|
|
|
Additional description: Cardiac ventricular thrombosis
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiomyopathy
|
|
|
Additional description: Cardiomyopathy
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery disease
|
|
|
Additional description: Coronary artery disease
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
2 / 2902 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Extrasystoles
|
|
|
Additional description: Extrasystoles
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Left ventricular failure
|
|
|
Additional description: Left ventricular failure
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myocardial ischaemia
|
|
|
Additional description: Myocardial ischaemia
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Palpitations
|
|
|
Additional description: Palpitations
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinus bradycardia
|
|
|
Additional description: Sinus bradycardia
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stress cardiomyopathy
|
|
|
Additional description: Stress cardiomyopathy
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Supraventricular tachycardia
|
|
|
Additional description: Supraventricular tachycardia
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nervous system disorders
|
|
|
Ageusia
|
|
|
Additional description: Ageusia
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aphasia
|
|
|
Additional description: Aphasia
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
2 / 2902 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carpal tunnel syndrome
|
|
|
Additional description: Carpal tunnel syndrome
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid artery stenosis
|
|
|
Additional description: Carotid artery stenosis
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral infarction
|
|
|
Additional description: Cerebral infarction
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral ischaemia
|
|
|
Additional description: Cerebral ischaemia
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dizziness
|
|
|
Additional description: Dizziness
|
|
|
subjects affected / exposed
|
2 / 2841 (0.07%) |
2 / 2902 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebrovascular accident
|
|
|
Additional description: Cerebrovascular accident
|
|
|
subjects affected / exposed
|
2 / 2841 (0.07%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Encephalopathy
|
|
|
Additional description: Encephalopathy
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Facial paralysis
|
|
|
Additional description: Facial paralysis
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epilepsy
|
|
|
Additional description: Epilepsy
|
|
|
subjects affected / exposed
|
2 / 2841 (0.07%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Headache
|
|
|
Additional description: Headache
|
|
|
subjects affected / exposed
|
3 / 2841 (0.11%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhage intracranial
|
|
|
Additional description: Haemorrhage intracranial
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
IIIrd nerve disorder
|
|
|
Additional description: IIIrd nerve disorder
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intercostal neuralgia
|
|
|
Additional description: Intercostal neuralgia
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic stroke
|
|
|
Additional description: Ischaemic stroke
|
|
|
subjects affected / exposed
|
2 / 2841 (0.07%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myasthenia gravis
|
|
|
Additional description: Myasthenia gravis
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Paraesthesia
|
|
|
Additional description: Paraesthesia
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Presyncope
|
|
|
Additional description: Presyncope
|
|
|
subjects affected / exposed
|
3 / 2841 (0.11%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ruptured cerebral aneurysm
|
|
|
Additional description: Ruptured cerebral aneurysm
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Subarachnoid haemorrhage
|
|
|
Additional description: Subarachnoid haemorrhage
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Syncope
|
|
|
Additional description: Syncope
|
|
|
subjects affected / exposed
|
2 / 2841 (0.07%) |
4 / 2902 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transient ischaemic attack
|
|
|
Additional description: Transient ischaemic attack
|
|
|
subjects affected / exposed
|
2 / 2841 (0.07%) |
3 / 2902 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
VIth nerve paralysis
|
|
|
Additional description: VIth nerve paralysis
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertigo CNS origin
|
|
|
Additional description: Vertigo CNS origin
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood and lymphatic system disorders
|
|
|
Anaemia
|
|
|
Additional description: Anaemia
|
|
|
subjects affected / exposed
|
3 / 2841 (0.11%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaemia macrocytic
|
|
|
Additional description: Anaemia macrocytic
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Febrile neutropenia
|
|
|
Additional description: Febrile neutropenia
|
|
|
subjects affected / exposed
|
13 / 2841 (0.46%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
13 / 13 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Leukocytosis
|
|
|
Additional description: Leukocytosis
|
|
|
subjects affected / exposed
|
2 / 2841 (0.07%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphadenitis
|
|
|
Additional description: Lymphadenitis
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neutropenia
|
|
|
Additional description: Neutropenia
|
|
|
subjects affected / exposed
|
4 / 2841 (0.14%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
5 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancytopenia
|
|
|
Additional description: Pancytopenia
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Splenic infarction
|
|
|
Additional description: Splenic infarction
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ear and labyrinth disorders
|
|
|
Deafness unilateral
|
|
|
Additional description: Deafness unilateral
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertigo
|
|
|
Additional description: Vertigo
|
|
|
subjects affected / exposed
|
2 / 2841 (0.07%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertigo positional
|
|
|
Additional description: Vertigo positional
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eye disorders
|
|
|
Cataract
|
|
|
Additional description: Cataract
|
|
|
subjects affected / exposed
|
2 / 2841 (0.07%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diplopia
|
|
|
Additional description: Diplopia
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eyelid function disorder
|
|
|
Additional description: Eyelid function disorder
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Maculopathy
|
|
|
Additional description: Maculopathy
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal disorders
|
|
|
Abdominal hernia
|
|
|
Additional description: Abdominal hernia
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal pain
|
|
|
Additional description: Abdominal pain
|
|
|
subjects affected / exposed
|
2 / 2841 (0.07%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal pain upper
|
|
|
Additional description: Abdominal pain upper
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colitis ischaemic
|
|
|
Additional description: Colitis ischaemic
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colitis
|
|
|
Additional description: Colitis
|
|
|
subjects affected / exposed
|
2 / 2841 (0.07%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diarrhoea
|
|
|
Additional description: Diarrhoea
|
|
|
subjects affected / exposed
|
2 / 2841 (0.07%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenal ulcer
|
|
|
Additional description: Duodenal ulcer
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenitis
|
|
|
Additional description: Duodenitis
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enteritis
|
|
|
Additional description: Enteritis
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrooesophageal reflux disease
|
|
|
Additional description: Gastrooesophageal reflux disease
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ileus
|
|
|
Additional description: Ileus
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal obstruction
|
|
|
Additional description: Intestinal obstruction
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
2 / 2902 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal perforation
|
|
|
Additional description: Intestinal perforation
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intussusception
|
|
|
Additional description: Intussusception
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestine perforation
|
|
|
Additional description: Large intestine perforation
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestine polyp
|
|
|
Additional description: Large intestine polyp
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nausea
|
|
|
Additional description: Nausea
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neutropenic colitis
|
|
|
Additional description: Neutropenic colitis
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oedematous pancreatitis
|
|
|
Additional description: Oedematous pancreatitis
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophagitis
|
|
|
Additional description: Oesophagitis
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatitis
|
|
|
Additional description: Pancreatitis
|
|
|
subjects affected / exposed
|
2 / 2841 (0.07%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peritoneal perforation
|
|
|
Additional description: Peritoneal perforation
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small intestinal obstruction
|
|
|
Additional description: Small intestinal obstruction
|
|
|
subjects affected / exposed
|
2 / 2841 (0.07%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Volvulus of small bowel
|
|
|
Additional description: Volvulus of small bowel
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vomiting
|
|
|
Additional description: Vomiting
|
|
|
subjects affected / exposed
|
2 / 2841 (0.07%) |
2 / 2902 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatobiliary disorders
|
|
|
Acute hepatic failure
|
|
|
Additional description: Acute hepatic failure
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Bile duct stone
|
|
|
Additional description: Bile duct stone
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholangitis
|
|
|
Additional description: Cholangitis
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis
|
|
|
Additional description: Cholecystitis
|
|
|
subjects affected / exposed
|
3 / 2841 (0.11%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis acute
|
|
|
Additional description: Cholecystitis acute
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholelithiasis
|
|
|
Additional description: Cholelithiasis
|
|
|
subjects affected / exposed
|
4 / 2841 (0.14%) |
2 / 2902 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Drug-induced liver injury
|
|
|
Additional description: Drug-induced liver injury
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic failure
|
|
|
Additional description: Hepatic failure
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Hepatitis acute
|
|
|
Additional description: Hepatitis acute
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin and subcutaneous tissue disorders
|
|
|
Keloid scar
|
|
|
Additional description: Keloid scar
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin necrosis
|
|
|
Additional description: Skin necrosis
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urticaria
|
|
|
Additional description: Urticaria
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal and urinary disorders
|
|
|
Acute kidney injury
|
|
|
Additional description: Acute kidney injury
|
|
|
subjects affected / exposed
|
4 / 2841 (0.14%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
1 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic kidney disease
|
|
|
Additional description: Chronic kidney disease
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephrolithiasis
|
|
|
Additional description: Nephrolithiasis
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
4 / 2902 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal colic
|
|
|
Additional description: Renal colic
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subcapsular renal haematoma
|
|
|
Additional description: Subcapsular renal haematoma
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ureteric obstruction
|
|
|
Additional description: Ureteric obstruction
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ureteric stenosis
|
|
|
Additional description: Ureteric stenosis
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ureterolithiasis
|
|
|
Additional description: Ureterolithiasis
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endocrine disorders
|
|
|
Goitre
|
|
|
Additional description: Goitre
|
|
|
subjects affected / exposed
|
3 / 2841 (0.11%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperparathyroidism
|
|
|
Additional description: Hyperparathyroidism
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypothyroidism
|
|
|
Additional description: Hypothyroidism
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal and connective tissue disorders
|
|
|
Arthralgia
|
|
|
Additional description: Arthralgia
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
4 / 2902 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthritis
|
|
|
Additional description: Arthritis
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
2 / 2902 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Back pain
|
|
|
Additional description: Back pain
|
|
|
subjects affected / exposed
|
2 / 2841 (0.07%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Flank pain
|
|
|
Additional description: Flank pain
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Foot deformity
|
|
|
Additional description: Foot deformity
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
2 / 2902 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemarthrosis
|
|
|
Additional description: Haemarthrosis
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral disc protrusion
|
|
|
Additional description: Intervertebral disc protrusion
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint range of motion decreased
|
|
|
Additional description: Joint range of motion decreased
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteoarthritis
|
|
|
Additional description: Osteoarthritis
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
3 / 2902 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pain in extremity
|
|
|
Additional description: Pain in extremity
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rotator cuff syndrome
|
|
|
Additional description: Rotator cuff syndrome
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Soft tissue necrosis
|
|
|
Additional description: Soft tissue necrosis
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal synovial cyst
|
|
|
Additional description: Spinal synovial cyst
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tendonitis
|
|
|
Additional description: Tendonitis
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infections and infestations
|
|
|
Anal abscess
|
|
|
Additional description: Anal abscess
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anorectal infection
|
|
|
Additional description: Anorectal infection
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Appendiceal abscess
|
|
|
Additional description: Appendiceal abscess
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Appendicitis
|
|
|
Additional description: Appendicitis
|
|
|
subjects affected / exposed
|
3 / 2841 (0.11%) |
5 / 2902 (0.17%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Appendicitis perforated
|
|
|
Additional description: Appendicitis perforated
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacterial infection
|
|
|
Additional description: Bacterial infection
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast abscess
|
|
|
Additional description: Breast abscess
|
|
|
subjects affected / exposed
|
2 / 2841 (0.07%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast cellulitis
|
|
|
Additional description: Breast cellulitis
|
|
|
subjects affected / exposed
|
16 / 2841 (0.56%) |
10 / 2902 (0.34%) |
occurrences causally related to treatment / all
|
7 / 17 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchitis
|
|
|
Additional description: Bronchitis
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
COVID-19 pneumonia
|
|
|
Additional description: COVID-19 pneumonia
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Campylobacter infection
|
|
|
Additional description: Campylobacter infection
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cellulitis
|
|
|
Additional description: Cellulitis
|
|
|
subjects affected / exposed
|
24 / 2841 (0.84%) |
9 / 2902 (0.31%) |
occurrences causally related to treatment / all
|
9 / 26 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cystitis
|
|
|
Additional description: Cystitis
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device related infection
|
|
|
Additional description: Device related infection
|
|
|
subjects affected / exposed
|
2 / 2841 (0.07%) |
4 / 2902 (0.14%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Disseminated varicella zoster virus infection
|
|
|
Additional description: Disseminated varicella zoster virus infection
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulitis
|
|
|
Additional description: Diverticulitis
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
3 / 2902 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Erysipelas
|
|
|
Additional description: Erysipelas
|
|
|
subjects affected / exposed
|
5 / 2841 (0.18%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
2 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Erysipelothrix sepsis
|
|
|
Additional description: Erysipelothrix sepsis
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Escherichia pyelonephritis
|
|
|
Additional description: Escherichia pyelonephritis
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Escherichia sepsis
|
|
|
Additional description: Escherichia sepsis
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis
|
|
|
Additional description: Gastroenteritis
|
|
|
subjects affected / exposed
|
4 / 2841 (0.14%) |
3 / 2902 (0.10%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis norovirus
|
|
|
Additional description: Gastroenteritis norovirus
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis viral
|
|
|
Additional description: Gastroenteritis viral
|
|
|
subjects affected / exposed
|
4 / 2841 (0.14%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Herpes zoster
|
|
|
Additional description: Herpes zoster
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infected seroma
|
|
|
Additional description: Infected seroma
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infection
|
|
|
Additional description: Infection
|
|
|
subjects affected / exposed
|
2 / 2841 (0.07%) |
3 / 2902 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Influenza
|
|
|
Additional description: Influenza
|
|
|
subjects affected / exposed
|
16 / 2841 (0.56%) |
2 / 2902 (0.07%) |
occurrences causally related to treatment / all
|
3 / 16 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laryngitis
|
|
|
Additional description: Laryngitis
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Listeria sepsis
|
|
|
Additional description: Listeria sepsis
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Localised infection
|
|
|
Additional description: Localised infection
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower respiratory tract infection
|
|
|
Additional description: Lower respiratory tract infection
|
|
|
subjects affected / exposed
|
2 / 2841 (0.07%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mastitis
|
|
|
Additional description: Mastitis
|
|
|
subjects affected / exposed
|
13 / 2841 (0.46%) |
10 / 2902 (0.34%) |
occurrences causally related to treatment / all
|
5 / 14 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Paronychia
|
|
|
Additional description: Paronychia
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pelvic inflammatory disease
|
|
|
Additional description: Pelvic inflammatory disease
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peritonitis
|
|
|
Additional description: Peritonitis
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia
|
|
|
Additional description: Pneumonia
|
|
|
subjects affected / exposed
|
16 / 2841 (0.56%) |
7 / 2902 (0.24%) |
occurrences causally related to treatment / all
|
10 / 18 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Postoperative wound infection
|
|
|
Additional description: Postoperative wound infection
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
2 / 2902 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyelonephritis
|
|
|
Additional description: Pyelonephritis
|
|
|
subjects affected / exposed
|
2 / 2841 (0.07%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyelonephritis acute
|
|
|
Additional description: Pyelonephritis acute
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory tract infection
|
|
|
Additional description: Respiratory tract infection
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sepsis
|
|
|
Additional description: Sepsis
|
|
|
subjects affected / exposed
|
8 / 2841 (0.28%) |
3 / 2902 (0.10%) |
occurrences causally related to treatment / all
|
4 / 9 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Septic shock
|
|
|
Additional description: Septic shock
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinusitis
|
|
|
Additional description: Sinusitis
|
|
|
subjects affected / exposed
|
2 / 2841 (0.07%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin infection
|
|
|
Additional description: Skin infection
|
|
|
subjects affected / exposed
|
8 / 2841 (0.28%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
3 / 8 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Soft tissue infection
|
|
|
Additional description: Soft tissue infection
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Staphylococcal bacteraemia
|
|
|
Additional description: Staphylococcal bacteraemia
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Staphylococcal infection
|
|
|
Additional description: Staphylococcal infection
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
2 / 2902 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Upper respiratory tract infection
|
|
|
Additional description: Upper respiratory tract infection
|
|
|
subjects affected / exposed
|
2 / 2841 (0.07%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary tract infection
|
|
|
Additional description: Urinary tract infection
|
|
|
subjects affected / exposed
|
8 / 2841 (0.28%) |
3 / 2902 (0.10%) |
occurrences causally related to treatment / all
|
2 / 8 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urosepsis
|
|
|
Additional description: Urosepsis
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular device infection
|
|
|
Additional description: Vascular device infection
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vestibular neuronitis
|
|
|
Additional description: Vestibular neuronitis
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Viral infection
|
|
|
Additional description: Viral infection
|
|
|
subjects affected / exposed
|
4 / 2841 (0.14%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Viral labyrinthitis
|
|
|
Additional description: Viral labyrinthitis
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Viral pericarditis
|
|
|
Additional description: Viral pericarditis
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vulvovaginal candidiasis
|
|
|
Additional description: Vulvovaginal candidiasis
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound abscess
|
|
|
Additional description: Wound abscess
|
|
|
subjects affected / exposed
|
2 / 2841 (0.07%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound infection
|
|
|
Additional description: Wound infection
|
|
|
subjects affected / exposed
|
3 / 2841 (0.11%) |
4 / 2902 (0.14%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolism and nutrition disorders
|
|
|
Dehydration
|
|
|
Additional description: Dehydration
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypercalcaemia
|
|
|
Additional description: Hypercalcaemia
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Hypoglycaemia
|
|
|
Additional description: Hypoglycaemia
|
|
|
subjects affected / exposed
|
1 / 2841 (0.04%) |
0 / 2902 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypokalaemia
|
|
|
Additional description: Hypokalaemia
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
1 / 2902 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyponatraemia
|
|
|
Additional description: Hyponatraemia
|
|
|
subjects affected / exposed
|
0 / 2841 (0.00%) |
2 / 2902 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |