Serious adverse events
|
Osimertinib |
Total subjects affected by serious adverse events
|
|
subjects affected / exposed
|
657 / 3014 (21.80%) |
number of deaths (all causes)
|
1361 |
number of deaths resulting from adverse events
|
19 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
Colon cancer
|
|
subjects affected / exposed
|
2 / 3014 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Acute myeloid leukaemia
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Malignant pleural effusion
|
|
subjects affected / exposed
|
2 / 3014 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Acute promyelocytic leukaemia
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Benign breast neoplasm
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Bladder cancer recurrent
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Bladder neoplasm
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Bladder transitional cell carcinoma
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Breast cancer female
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Glioblastoma
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Metastases to bone
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Metastases to central nervous system
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Laryngeal cancer
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Myelodysplastic syndrome
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Metastases to meninges
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Oesophageal carcinoma
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Transitional cell carcinoma
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Uterine leiomyoma
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Ovarian cancer metastatic
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Vascular disorders
|
|
Deep vein thrombosis
|
|
subjects affected / exposed
|
17 / 3014 (0.56%) |
occurrences causally related to treatment / all
|
2 / 18 |
deaths causally related to treatment / all
|
0 / 0 |
Embolism
|
|
subjects affected / exposed
|
2 / 3014 (0.07%) |
occurrences causally related to treatment / all
|
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Hypotension
|
|
subjects affected / exposed
|
2 / 3014 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Thrombosis
|
|
subjects affected / exposed
|
2 / 3014 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Venous thrombosis limb
|
|
subjects affected / exposed
|
2 / 3014 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Hypertension
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Superior vena cava occlusion
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Superior vena cava syndrome
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Vena cava thrombosis
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Venous thrombosis
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Pregnancy, puerperium and perinatal conditions
|
|
Unintended pregnancy
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
General disorders and administration site conditions
|
|
Death
|
|
subjects affected / exposed
|
34 / 3014 (1.13%) |
occurrences causally related to treatment / all
|
1 / 34 |
deaths causally related to treatment / all
|
1 / 34 |
Asthenia
|
|
subjects affected / exposed
|
4 / 3014 (0.13%) |
occurrences causally related to treatment / all
|
2 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
Pyrexia
|
|
subjects affected / exposed
|
12 / 3014 (0.40%) |
occurrences causally related to treatment / all
|
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
Gait disturbance
|
|
subjects affected / exposed
|
2 / 3014 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Malaise
|
|
subjects affected / exposed
|
3 / 3014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Sudden death
|
|
subjects affected / exposed
|
4 / 3014 (0.13%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 4 |
Multiple organ dysfunction syndrome
|
|
subjects affected / exposed
|
2 / 3014 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
Chest discomfort
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Condition aggravated
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Cyst
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Fatigue
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Granuloma
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Sudden cardiac death
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Reproductive system and breast disorders
|
|
Benign prostatic hyperplasia
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Endometrial hyperplasia
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Ovarian cyst
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Pelvic pain
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Prostatic obstruction
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Vaginal haemorrhage
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Respiratory, thoracic and mediastinal disorders
|
|
Pulmonary embolism
|
|
subjects affected / exposed
|
49 / 3014 (1.63%) |
occurrences causally related to treatment / all
|
5 / 49 |
deaths causally related to treatment / all
|
3 / 13 |
Pleural effusion
|
|
subjects affected / exposed
|
20 / 3014 (0.66%) |
occurrences causally related to treatment / all
|
1 / 25 |
deaths causally related to treatment / all
|
0 / 0 |
Dyspnoea
|
|
subjects affected / exposed
|
15 / 3014 (0.50%) |
occurrences causally related to treatment / all
|
2 / 15 |
deaths causally related to treatment / all
|
0 / 1 |
Respiratory failure
|
|
subjects affected / exposed
|
11 / 3014 (0.36%) |
occurrences causally related to treatment / all
|
2 / 11 |
deaths causally related to treatment / all
|
2 / 9 |
Interstitial lung disease
|
|
subjects affected / exposed
|
9 / 3014 (0.30%) |
occurrences causally related to treatment / all
|
7 / 9 |
deaths causally related to treatment / all
|
3 / 4 |
Pneumonitis
|
|
subjects affected / exposed
|
9 / 3014 (0.30%) |
occurrences causally related to treatment / all
|
6 / 9 |
deaths causally related to treatment / all
|
0 / 1 |
Asphyxia
|
|
subjects affected / exposed
|
4 / 3014 (0.13%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 3 |
Pneumothorax
|
|
subjects affected / exposed
|
5 / 3014 (0.17%) |
occurrences causally related to treatment / all
|
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
Haemoptysis
|
|
subjects affected / exposed
|
4 / 3014 (0.13%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
Pneumonia aspiration
|
|
subjects affected / exposed
|
4 / 3014 (0.13%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
Bronchitis chronic
|
|
subjects affected / exposed
|
3 / 3014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Cough
|
|
subjects affected / exposed
|
3 / 3014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Acute respiratory failure
|
|
subjects affected / exposed
|
2 / 3014 (0.07%) |
occurrences causally related to treatment / all
|
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Bronchial haemorrhage
|
|
subjects affected / exposed
|
2 / 3014 (0.07%) |
occurrences causally related to treatment / all
|
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Acute interstitial pneumonitis
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
1 / 1 |
Asthma
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Bronchiectasis
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Chronic obstructive pulmonary disease
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Emphysema
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Laryngeal oedema
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Pleuritic pain
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Pulmonary artery thrombosis
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Pulmonary toxicity
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Respiratory arrest
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Psychiatric disorders
|
|
Completed suicide
|
|
subjects affected / exposed
|
2 / 3014 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
Delirium
|
|
subjects affected / exposed
|
2 / 3014 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Depression
|
|
subjects affected / exposed
|
2 / 3014 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Breath holding
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Product issues
|
|
Device dislocation
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Investigations
|
|
Electrocardiogram QT prolonged
|
|
subjects affected / exposed
|
5 / 3014 (0.17%) |
occurrences causally related to treatment / all
|
3 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
Alanine aminotransferase increased
|
|
subjects affected / exposed
|
3 / 3014 (0.10%) |
occurrences causally related to treatment / all
|
2 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Neutrophil count decreased
|
|
subjects affected / exposed
|
3 / 3014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Amylase increased
|
|
subjects affected / exposed
|
2 / 3014 (0.07%) |
occurrences causally related to treatment / all
|
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Blood creatinine increased
|
|
subjects affected / exposed
|
2 / 3014 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
Aspartate aminotransferase increased
|
|
subjects affected / exposed
|
2 / 3014 (0.07%) |
occurrences causally related to treatment / all
|
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Platelet count decreased
|
|
subjects affected / exposed
|
2 / 3014 (0.07%) |
occurrences causally related to treatment / all
|
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Eastern Cooperative Oncology Group performance status worsened
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Influenza A virus test
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Lipase increased
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Troponin increased
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Injury, poisoning and procedural complications
|
|
Femur fracture
|
|
subjects affected / exposed
|
8 / 3014 (0.27%) |
occurrences causally related to treatment / all
|
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
Spinal compression fracture
|
|
subjects affected / exposed
|
3 / 3014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Lumbar vertebral fracture
|
|
subjects affected / exposed
|
3 / 3014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Spinal fracture
|
|
subjects affected / exposed
|
3 / 3014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Head injury
|
|
subjects affected / exposed
|
2 / 3014 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Traumatic fracture
|
|
subjects affected / exposed
|
3 / 3014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Hip fracture
|
|
subjects affected / exposed
|
2 / 3014 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Humerus fracture
|
|
subjects affected / exposed
|
2 / 3014 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Multiple injuries
|
|
subjects affected / exposed
|
2 / 3014 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Subdural haematoma
|
|
subjects affected / exposed
|
2 / 3014 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Thoracic vertebral fracture
|
|
subjects affected / exposed
|
2 / 3014 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Ankle fracture
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Brain herniation
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Compression fracture
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Fall
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Foot fracture
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Femoral neck fracture
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Foreign body in respiratory tract
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Pelvic fracture
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Post procedural haemorrhage
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Radius fracture
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Radiation pneumonitis
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Rib fracture
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Subdural haemorrhage
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Tibia fracture
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Traumatic intracranial haemorrhage
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Ulna fracture
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Ulnar nerve injury
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Wrist fracture
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Cardiac disorders
|
|
Cardiac failure
|
|
subjects affected / exposed
|
9 / 3014 (0.30%) |
occurrences causally related to treatment / all
|
1 / 10 |
deaths causally related to treatment / all
|
1 / 3 |
Cardiac arrest
|
|
subjects affected / exposed
|
6 / 3014 (0.20%) |
occurrences causally related to treatment / all
|
0 / 6 |
deaths causally related to treatment / all
|
0 / 5 |
Myocardial infarction
|
|
subjects affected / exposed
|
4 / 3014 (0.13%) |
occurrences causally related to treatment / all
|
1 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
Cardiac failure congestive
|
|
subjects affected / exposed
|
3 / 3014 (0.10%) |
occurrences causally related to treatment / all
|
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Angina pectoris
|
|
subjects affected / exposed
|
2 / 3014 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Atrial fibrillation
|
|
subjects affected / exposed
|
2 / 3014 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Cardiac failure acute
|
|
subjects affected / exposed
|
2 / 3014 (0.07%) |
occurrences causally related to treatment / all
|
1 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
Cardiomyopathy
|
|
subjects affected / exposed
|
2 / 3014 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Palpitations
|
|
subjects affected / exposed
|
2 / 3014 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Pericardial effusion
|
|
subjects affected / exposed
|
2 / 3014 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Supraventricular tachycardia
|
|
subjects affected / exposed
|
2 / 3014 (0.07%) |
occurrences causally related to treatment / all
|
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Acute myocardial infarction
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Arrhythmia
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Cardiac disorder
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Cardiac dysfunction
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Cardiopulmonary failure
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Cardiotoxicity
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Congestive cardiomyopathy
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Hypertensive heart disease
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Coronary artery disease
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Myocardial ischaemia
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Sinus tachycardia
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Ventricular fibrillation
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Nervous system disorders
|
|
Cerebral infarction
|
|
subjects affected / exposed
|
22 / 3014 (0.73%) |
occurrences causally related to treatment / all
|
5 / 22 |
deaths causally related to treatment / all
|
2 / 11 |
Headache
|
|
subjects affected / exposed
|
6 / 3014 (0.20%) |
occurrences causally related to treatment / all
|
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
Cerebral haemorrhage
|
|
subjects affected / exposed
|
5 / 3014 (0.17%) |
occurrences causally related to treatment / all
|
1 / 5 |
deaths causally related to treatment / all
|
0 / 2 |
Epilepsy
|
|
subjects affected / exposed
|
4 / 3014 (0.13%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
Transient ischaemic attack
|
|
subjects affected / exposed
|
5 / 3014 (0.17%) |
occurrences causally related to treatment / all
|
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
Cerebrovascular accident
|
|
subjects affected / exposed
|
4 / 3014 (0.13%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
Lacunar infarction
|
|
subjects affected / exposed
|
3 / 3014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Cognitive disorder
|
|
subjects affected / exposed
|
3 / 3014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Dizziness
|
|
subjects affected / exposed
|
2 / 3014 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Generalised tonic-clonic seizure
|
|
subjects affected / exposed
|
2 / 3014 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Haemorrhage intracranial
|
|
subjects affected / exposed
|
2 / 3014 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Haemorrhagic stroke
|
|
subjects affected / exposed
|
2 / 3014 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
Apraxia
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Basal ganglia infarction
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Brain oedema
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Cerebellar infarction
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Cerebellar ischaemia
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Cerebral ischaemia
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Coma
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Dysarthria
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Facial paralysis
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Hemiparesis
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Nervous system disorder
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Polyneuropathy
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Presyncope
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Psychomotor hyperactivity
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Psychomotor skills impaired
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Seizure
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Somnolence
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Spinal cord compression
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Syncope
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Thrombotic stroke
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Tremor
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Vascular headache
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Blood and lymphatic system disorders
|
|
Anaemia
|
|
subjects affected / exposed
|
4 / 3014 (0.13%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
Myelosuppression
|
|
subjects affected / exposed
|
4 / 3014 (0.13%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
Thrombocytopenia
|
|
subjects affected / exposed
|
4 / 3014 (0.13%) |
occurrences causally related to treatment / all
|
3 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
Anaemia of chronic disease
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Blood disorder
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Bone marrow disorder
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Ear and labyrinth disorders
|
|
Middle ear inflammation
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Vertigo
|
|
subjects affected / exposed
|
4 / 3014 (0.13%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
Vertigo positional
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Eye disorders
|
|
Cataract
|
|
subjects affected / exposed
|
3 / 3014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Dacryostenosis acquired
|
|
subjects affected / exposed
|
2 / 3014 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Glaucoma
|
|
subjects affected / exposed
|
2 / 3014 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Gastrointestinal disorders
|
|
Vomiting
|
|
subjects affected / exposed
|
13 / 3014 (0.43%) |
occurrences causally related to treatment / all
|
0 / 16 |
deaths causally related to treatment / all
|
0 / 0 |
Diarrhoea
|
|
subjects affected / exposed
|
12 / 3014 (0.40%) |
occurrences causally related to treatment / all
|
6 / 12 |
deaths causally related to treatment / all
|
1 / 1 |
Nausea
|
|
subjects affected / exposed
|
6 / 3014 (0.20%) |
occurrences causally related to treatment / all
|
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
Abdominal pain
|
|
subjects affected / exposed
|
7 / 3014 (0.23%) |
occurrences causally related to treatment / all
|
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
Constipation
|
|
subjects affected / exposed
|
4 / 3014 (0.13%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
Enteritis
|
|
subjects affected / exposed
|
4 / 3014 (0.13%) |
occurrences causally related to treatment / all
|
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
Ascites
|
|
subjects affected / exposed
|
3 / 3014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Chronic gastritis
|
|
subjects affected / exposed
|
3 / 3014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Dysphagia
|
|
subjects affected / exposed
|
3 / 3014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Gastritis
|
|
subjects affected / exposed
|
3 / 3014 (0.10%) |
occurrences causally related to treatment / all
|
2 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
Intestinal obstruction
|
|
subjects affected / exposed
|
3 / 3014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
Pancreatitis acute
|
|
subjects affected / exposed
|
3 / 3014 (0.10%) |
occurrences causally related to treatment / all
|
1 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
Upper gastrointestinal haemorrhage
|
|
subjects affected / exposed
|
3 / 3014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Colitis
|
|
subjects affected / exposed
|
2 / 3014 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Duodenal ulcer haemorrhage
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Pancreatitis
|
|
subjects affected / exposed
|
2 / 3014 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Diverticulum intestinal haemorrhagic
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Enterocolitis
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Gastrointestinal disorder
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Gastric perforation
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Gastrointestinal haemorrhage
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Gastrointestinal perforation
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Gingival ulceration
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Haemorrhoids
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Haematochezia
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Haematemesis
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Ischaemic enteritis
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Large intestinal obstruction
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Ileus
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Oesophagitis
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Large intestine perforation
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Obstructive pancreatitis
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Peptic ulcer
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Peptic ulcer haemorrhage
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Rectal haemorrhage
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Stomatitis
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Hepatobiliary disorders
|
|
Cholecystitis acute
|
|
subjects affected / exposed
|
5 / 3014 (0.17%) |
occurrences causally related to treatment / all
|
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
Hepatic function abnormal
|
|
subjects affected / exposed
|
3 / 3014 (0.10%) |
occurrences causally related to treatment / all
|
3 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Drug-induced liver injury
|
|
subjects affected / exposed
|
3 / 3014 (0.10%) |
occurrences causally related to treatment / all
|
3 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Biliary colic
|
|
subjects affected / exposed
|
2 / 3014 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Jaundice cholestatic
|
|
subjects affected / exposed
|
2 / 3014 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Cholecystitis
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Cholelithiasis
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Hepatotoxicity
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Hypertransaminasaemia
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Liver injury
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Skin and subcutaneous tissue disorders
|
|
Cutaneous lupus erythematosus
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Dermatitis allergic
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Diabetic foot
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Erythema multiforme
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Rash
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Rash papular
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Renal and urinary disorders
|
|
Acute kidney injury
|
|
subjects affected / exposed
|
5 / 3014 (0.17%) |
occurrences causally related to treatment / all
|
1 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
Renal failure
|
|
subjects affected / exposed
|
4 / 3014 (0.13%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 2 |
Haematuria
|
|
subjects affected / exposed
|
3 / 3014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Hydronephrosis
|
|
subjects affected / exposed
|
2 / 3014 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Calculus urinary
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Nephrolithiasis
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Nephrotic syndrome
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Renal impairment
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Renal injury
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Endocrine disorders
|
|
Inappropriate antidiuretic hormone secretion
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Musculoskeletal and connective tissue disorders
|
|
Back pain
|
|
subjects affected / exposed
|
7 / 3014 (0.23%) |
occurrences causally related to treatment / all
|
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
Pathological fracture
|
|
subjects affected / exposed
|
6 / 3014 (0.20%) |
occurrences causally related to treatment / all
|
0 / 6 |
deaths causally related to treatment / all
|
0 / 1 |
Arthralgia
|
|
subjects affected / exposed
|
2 / 3014 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Intervertebral disc protrusion
|
|
subjects affected / exposed
|
2 / 3014 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Osteoporotic fracture
|
|
subjects affected / exposed
|
2 / 3014 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Bone pain
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Fracture pain
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Malignant psoas syndrome
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Myopathy
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Myositis
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Osteoporosis
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Pain in extremity
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Rotator cuff syndrome
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Synovitis
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Spondylolisthesis
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Vertebral lesion
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Infections and infestations
|
|
Pneumonia
|
|
subjects affected / exposed
|
74 / 3014 (2.46%) |
occurrences causally related to treatment / all
|
7 / 79 |
deaths causally related to treatment / all
|
4 / 20 |
Upper respiratory tract infection
|
|
subjects affected / exposed
|
10 / 3014 (0.33%) |
occurrences causally related to treatment / all
|
0 / 10 |
deaths causally related to treatment / all
|
0 / 1 |
Urinary tract infection
|
|
subjects affected / exposed
|
10 / 3014 (0.33%) |
occurrences causally related to treatment / all
|
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
Bronchitis
|
|
subjects affected / exposed
|
6 / 3014 (0.20%) |
occurrences causally related to treatment / all
|
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
Respiratory tract infection
|
|
subjects affected / exposed
|
7 / 3014 (0.23%) |
occurrences causally related to treatment / all
|
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
Gastroenteritis
|
|
subjects affected / exposed
|
6 / 3014 (0.20%) |
occurrences causally related to treatment / all
|
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
Herpes zoster
|
|
subjects affected / exposed
|
5 / 3014 (0.17%) |
occurrences causally related to treatment / all
|
1 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
Cellulitis
|
|
subjects affected / exposed
|
3 / 3014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
Osteomyelitis
|
|
subjects affected / exposed
|
3 / 3014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Urosepsis
|
|
subjects affected / exposed
|
3 / 3014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 2 |
Device related infection
|
|
subjects affected / exposed
|
2 / 3014 (0.07%) |
occurrences causally related to treatment / all
|
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
Pulmonary sepsis
|
|
subjects affected / exposed
|
2 / 3014 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
Empyema
|
|
subjects affected / exposed
|
2 / 3014 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Appendicitis
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Abdominal abscess
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Bacteraemia
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Complicated appendicitis
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Diarrhoea infectious
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Diverticulitis
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Enterocolitis infectious
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Haemorrhagic fever
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Enterobacter pneumonia
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Infection
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Infectious pleural effusion
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Infective spondylitis
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Influenza
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Labyrinthitis
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Laryngitis
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Localised infection
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Lower respiratory tract infection
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Lower respiratory tract infection bacterial
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Lymphangitis
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Meningitis aseptic
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Mucosal infection
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Nasal abscess
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Otitis media acute
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Peripheral nerve infection
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Pneumocystis jirovecii pneumonia
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Pneumonia fungal
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Postoperative wound infection
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Scrub typhus
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Respiratory tract infection bacterial
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Septic shock
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Sinusitis
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Soft tissue infection
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Upper respiratory tract infection bacterial
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Urinary tract infection bacterial
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Wound infection
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Viral upper respiratory tract infection
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Sepsis
|
|
subjects affected / exposed
|
5 / 3014 (0.17%) |
occurrences causally related to treatment / all
|
0 / 5 |
deaths causally related to treatment / all
|
0 / 2 |
Metabolism and nutrition disorders
|
|
Hyponatraemia
|
|
subjects affected / exposed
|
8 / 3014 (0.27%) |
occurrences causally related to treatment / all
|
2 / 11 |
deaths causally related to treatment / all
|
0 / 1 |
Decreased appetite
|
|
subjects affected / exposed
|
5 / 3014 (0.17%) |
occurrences causally related to treatment / all
|
4 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
Hyperuricaemia
|
|
subjects affected / exposed
|
4 / 3014 (0.13%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
Hyperkalaemia
|
|
subjects affected / exposed
|
3 / 3014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Malnutrition
|
|
subjects affected / exposed
|
3 / 3014 (0.10%) |
occurrences causally related to treatment / all
|
1 / 3 |
deaths causally related to treatment / all
|
1 / 2 |
Cachexia
|
|
subjects affected / exposed
|
2 / 3014 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
Hyperglycaemia
|
|
subjects affected / exposed
|
2 / 3014 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Hypoglycaemia
|
|
subjects affected / exposed
|
2 / 3014 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Diabetes mellitus inadequate control
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Diabetic ketoacidosis
|
|
subjects affected / exposed
|
1 / 3014 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |