Serious adverse events
|
Cohort A |
Cohort C |
Cohort B |
Cohort A1 |
Total subjects affected by serious adverse events
|
|
|
|
|
subjects affected / exposed
|
264 / 391 (67.52%) |
42 / 57 (73.68%) |
282 / 395 (71.39%) |
149 / 198 (75.25%) |
number of deaths (all causes)
|
294 |
32 |
334 |
166 |
number of deaths resulting from adverse events
|
101 |
15 |
159 |
85 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
|
|
Malignant neoplasm progression
|
|
|
|
|
subjects affected / exposed
|
81 / 391 (20.72%) |
6 / 57 (10.53%) |
144 / 395 (36.46%) |
64 / 198 (32.32%) |
occurrences causally related to treatment / all
|
0 / 82 |
0 / 6 |
0 / 151 |
0 / 68 |
deaths causally related to treatment / all
|
0 / 73 |
0 / 4 |
0 / 134 |
0 / 63 |
Lymphangiosis carcinomatosa
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Colon neoplasm
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cancer pain
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bladder neoplasm
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
2 / 395 (0.51%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bladder cancer
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tumour pain
|
|
|
|
|
subjects affected / exposed
|
2 / 391 (0.51%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tumour obstruction
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tumour compression
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Transitional cell carcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
2 / 395 (0.51%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory tract neoplasm
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pericardial effusion malignant
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Neuroma
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to central nervous system
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
2 / 395 (0.51%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to bone
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Malignant pleural effusion
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Vascular disorders
|
|
|
|
|
Brachiocephalic vein thrombosis
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral arterial occlusive disease
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral ischaemia
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Subclavian vein thrombosis
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Superior vena cava syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
1 / 57 (1.75%) |
1 / 395 (0.25%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Thrombosis
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
2 / 395 (0.51%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Infarction
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypotension
|
|
|
|
|
subjects affected / exposed
|
3 / 391 (0.77%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Exsanguination
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
1 / 57 (1.75%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Embolism
|
|
|
|
|
subjects affected / exposed
|
2 / 391 (0.51%) |
0 / 57 (0.00%) |
2 / 395 (0.51%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Deep vein thrombosis
|
|
|
|
|
subjects affected / exposed
|
3 / 391 (0.77%) |
0 / 57 (0.00%) |
2 / 395 (0.51%) |
2 / 198 (1.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vena cava thrombosis
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
General disorders and administration site conditions
|
|
|
|
|
Disease progression
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Death
|
|
|
|
|
subjects affected / exposed
|
2 / 391 (0.51%) |
0 / 57 (0.00%) |
2 / 395 (0.51%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
0 / 0 |
Chills
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chest pain
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Asthenia
|
|
|
|
|
subjects affected / exposed
|
4 / 391 (1.02%) |
1 / 57 (1.75%) |
2 / 395 (0.51%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 1 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Fatigue
|
|
|
|
|
subjects affected / exposed
|
2 / 391 (0.51%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Multiple organ dysfunction syndrome
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
2 / 198 (1.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
Non-cardiac chest pain
|
|
|
|
|
subjects affected / exposed
|
2 / 391 (0.51%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Oedema peripheral
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pain
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
4 / 395 (1.01%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Sudden death
|
|
|
|
|
subjects affected / exposed
|
6 / 391 (1.53%) |
2 / 57 (3.51%) |
4 / 395 (1.01%) |
4 / 198 (2.02%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 2 |
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 6 |
0 / 2 |
0 / 4 |
0 / 4 |
Pyrexia
|
|
|
|
|
subjects affected / exposed
|
5 / 391 (1.28%) |
0 / 57 (0.00%) |
7 / 395 (1.77%) |
8 / 198 (4.04%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
2 / 8 |
5 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Mucosal inflammation
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyperthermia
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
General physical health deterioration
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
3 / 395 (0.76%) |
3 / 198 (1.52%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
Performance status decreased
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
3 / 395 (0.76%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Ulcer
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Immune system disorders
|
|
|
|
|
Hypersensitivity
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Contrast media allergy
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Anaphylactic reaction
|
|
|
|
|
subjects affected / exposed
|
2 / 391 (0.51%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Reproductive system and breast disorders
|
|
|
|
|
Breast inflammation
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pelvic pain
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Breast pain
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory, thoracic and mediastinal disorders
|
|
|
|
|
Chronic obstructive pulmonary disease
|
|
|
|
|
subjects affected / exposed
|
6 / 391 (1.53%) |
1 / 57 (1.75%) |
7 / 395 (1.77%) |
3 / 198 (1.52%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 2 |
1 / 9 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
Bronchostenosis
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bronchospasm
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bronchial obstruction
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
2 / 395 (0.51%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Atelectasis
|
|
|
|
|
subjects affected / exposed
|
2 / 391 (0.51%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diaphragmatic paralysis
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Alveolitis
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Acute respiratory failure
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
2 / 57 (3.51%) |
1 / 395 (0.25%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Asthma
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Immune-mediated lung disease
|
|
|
|
|
subjects affected / exposed
|
2 / 391 (0.51%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypoxia
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
1 / 57 (1.75%) |
2 / 395 (0.51%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypersensitivity pneumonitis
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemoptysis
|
|
|
|
|
subjects affected / exposed
|
5 / 391 (1.28%) |
1 / 57 (1.75%) |
5 / 395 (1.27%) |
2 / 198 (1.01%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 0 |
Dyspnoea
|
|
|
|
|
subjects affected / exposed
|
14 / 391 (3.58%) |
2 / 57 (3.51%) |
22 / 395 (5.57%) |
9 / 198 (4.55%) |
occurrences causally related to treatment / all
|
1 / 14 |
0 / 2 |
0 / 22 |
1 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 3 |
Interstitial lung disease
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
Pulmonary embolism
|
|
|
|
|
subjects affected / exposed
|
2 / 391 (0.51%) |
1 / 57 (1.75%) |
4 / 395 (1.01%) |
6 / 198 (3.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 4 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 1 |
Pneumothorax
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
1 / 57 (1.75%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonitis
|
|
|
|
|
subjects affected / exposed
|
23 / 391 (5.88%) |
3 / 57 (5.26%) |
17 / 395 (4.30%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
22 / 24 |
3 / 3 |
18 / 18 |
1 / 1 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
2 / 2 |
0 / 0 |
Pleural effusion
|
|
|
|
|
subjects affected / exposed
|
8 / 391 (2.05%) |
0 / 57 (0.00%) |
4 / 395 (1.01%) |
4 / 198 (2.02%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 0 |
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Lung disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Pulmonary haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
2 / 395 (0.51%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 1 |
Pulmonary oedema
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory failure
|
|
|
|
|
subjects affected / exposed
|
9 / 391 (2.30%) |
2 / 57 (3.51%) |
2 / 395 (0.51%) |
2 / 198 (1.01%) |
occurrences causally related to treatment / all
|
2 / 9 |
0 / 2 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 0 |
0 / 1 |
Respiratory distress
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Psychiatric disorders
|
|
|
|
|
Agitation
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Confusional state
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
2 / 395 (0.51%) |
2 / 198 (1.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Delirium
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Disorientation
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Mental status changes
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
1 / 57 (1.75%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Schizophrenia
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Product issues
|
|
|
|
|
Device loosening
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
1 / 57 (1.75%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Device dislocation
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Investigations
|
|
|
|
|
Oxygen saturation decreased
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Neutrophil count decreased
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Liver function test increased
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
1 / 57 (1.75%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 1 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lipase increased
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
International normalised ratio increased
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Amylase increased
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
General physical condition abnormal
|
|
|
|
|
subjects affected / exposed
|
2 / 391 (0.51%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
2 / 198 (1.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
C-reactive protein increased
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Blood gases abnormal
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Blood creatinine increased
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Influenza B virus test positive
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Weight decreased
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Troponin increased
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Transaminases increased
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Platelet count decreased
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Injury, poisoning and procedural complications
|
|
|
|
|
Infusion related reaction
|
|
|
|
|
subjects affected / exposed
|
4 / 391 (1.02%) |
0 / 57 (0.00%) |
2 / 395 (0.51%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
4 / 4 |
0 / 0 |
2 / 2 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Incision site impaired healing
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Femur fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Fall
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
1 / 57 (1.75%) |
1 / 395 (0.25%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Anastomotic stenosis
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Upper limb fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spinal fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spinal compression fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Road traffic accident
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rib fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
1 / 57 (1.75%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Recall phenomenon
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural complication
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Poisoning
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Overdose
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
2 / 395 (0.51%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lumbar vertebral fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lower limb fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Wound evisceration
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac disorders
|
|
|
|
|
Atrial flutter
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
2 / 57 (3.51%) |
0 / 395 (0.00%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Acute myocardial infarction
|
|
|
|
|
subjects affected / exposed
|
2 / 391 (0.51%) |
0 / 57 (0.00%) |
3 / 395 (0.76%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
1 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Angina unstable
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arrhythmia
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Arteriosclerosis coronary artery
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Atrial fibrillation
|
|
|
|
|
subjects affected / exposed
|
7 / 391 (1.79%) |
2 / 57 (3.51%) |
2 / 395 (0.51%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
1 / 7 |
0 / 2 |
1 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Acute coronary syndrome
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac tamponade
|
|
|
|
|
subjects affected / exposed
|
2 / 391 (0.51%) |
1 / 57 (1.75%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac failure congestive
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
1 / 57 (1.75%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac failure
|
|
|
|
|
subjects affected / exposed
|
2 / 391 (0.51%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
Cardiac arrest
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Cardio-respiratory arrest
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
Pericardial effusion
|
|
|
|
|
subjects affected / exposed
|
6 / 391 (1.53%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
2 / 198 (1.01%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Myocarditis
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
Myocardial infarction
|
|
|
|
|
subjects affected / exposed
|
3 / 391 (0.77%) |
2 / 57 (3.51%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
Intracardiac thrombus
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiopulmonary failure
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiogenic shock
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Pericarditis
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sinus tachycardia
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Supraventricular tachycardia
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nervous system disorders
|
|
|
|
|
Aphasia
|
|
|
|
|
subjects affected / exposed
|
2 / 391 (0.51%) |
1 / 57 (1.75%) |
3 / 395 (0.76%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Balance disorder
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Central nervous system lesion
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Burning sensation
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Brain oedema
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral ischaemia
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Encephalopathy
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
2 / 57 (3.51%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
2 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Encephalitis autoimmune
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Embolic stroke
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dizziness
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cluster headache
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cerebrovascular accident
|
|
|
|
|
subjects affected / exposed
|
3 / 391 (0.77%) |
1 / 57 (1.75%) |
1 / 395 (0.25%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
Epilepsy
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Febrile convulsion
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Loss of consciousness
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ischaemic cerebral infarction
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intracranial pressure increased
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Immune-mediated encephalitis
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hemiparesis
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hemianopia homonymous
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Headache
|
|
|
|
|
subjects affected / exposed
|
2 / 391 (0.51%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
3 / 198 (1.52%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhage intracranial
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Guillain-Barre syndrome
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Monoparesis
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Optic neuritis
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Paraesthesia
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Paresis
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral motor neuropathy
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Somnolence
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Seizure
|
|
|
|
|
subjects affected / exposed
|
2 / 391 (0.51%) |
1 / 57 (1.75%) |
1 / 395 (0.25%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Neurological decompensation
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Myasthenic syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
Motor dysfunction
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pyramidal tract syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spinal cord compression
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Status epilepticus
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Syncope
|
|
|
|
|
subjects affected / exposed
|
2 / 391 (0.51%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Transient aphasia
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Transient ischaemic attack
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vasogenic cerebral oedema
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vertebrobasilar insufficiency
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Blood and lymphatic system disorders
|
|
|
|
|
Anaemia
|
|
|
|
|
subjects affected / exposed
|
2 / 391 (0.51%) |
2 / 57 (3.51%) |
4 / 395 (1.01%) |
2 / 198 (1.01%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 2 |
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
Autoimmune anaemia
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Leukocytosis
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
1 / 57 (1.75%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Thrombocytopenia
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
2 / 395 (0.51%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Febrile neutropenia
|
|
|
|
|
subjects affected / exposed
|
4 / 391 (1.02%) |
0 / 57 (0.00%) |
3 / 395 (0.76%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Immune thrombocytopenia
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ear and labyrinth disorders
|
|
|
|
|
Vertigo
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
2 / 395 (0.51%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Eye disorders
|
|
|
|
|
Ophthalmoplegia
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal disorders
|
|
|
|
|
Chronic gastritis
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Barrett's oesophagus
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Autoimmune colitis
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ascites
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal pain upper
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal pain
|
|
|
|
|
subjects affected / exposed
|
2 / 391 (0.51%) |
1 / 57 (1.75%) |
2 / 395 (0.51%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Gastritis
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
1 / 57 (1.75%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastric ulcer
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastric perforation
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
1 / 57 (1.75%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Enterocolitis
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
1 / 57 (1.75%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Enteritis
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dysphagia
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
2 / 395 (0.51%) |
3 / 198 (1.52%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diverticular perforation
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
Diarrhoea
|
|
|
|
|
subjects affected / exposed
|
7 / 391 (1.79%) |
1 / 57 (1.75%) |
11 / 395 (2.78%) |
4 / 198 (2.02%) |
occurrences causally related to treatment / all
|
6 / 8 |
1 / 1 |
10 / 11 |
3 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diaphragmatic hernia
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
1 / 57 (1.75%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Constipation
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal necrosis
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
1 / 57 (1.75%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Colitis
|
|
|
|
|
subjects affected / exposed
|
5 / 391 (1.28%) |
0 / 57 (0.00%) |
6 / 395 (1.52%) |
3 / 198 (1.52%) |
occurrences causally related to treatment / all
|
5 / 5 |
0 / 0 |
7 / 7 |
3 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal obstruction
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Immune-mediated enterocolitis
|
|
|
|
|
subjects affected / exposed
|
3 / 391 (0.77%) |
0 / 57 (0.00%) |
5 / 395 (1.27%) |
4 / 198 (2.02%) |
occurrences causally related to treatment / all
|
6 / 6 |
0 / 0 |
7 / 7 |
4 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haematochezia
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal toxicity
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal perforation
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
1 / 57 (1.75%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatitis
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Oesophagitis
|
|
|
|
|
subjects affected / exposed
|
2 / 391 (0.51%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
3 / 4 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Nausea
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
3 / 198 (1.52%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
2 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Mouth ulceration
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lower gastrointestinal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
1 / 57 (1.75%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Large intestine perforation
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rectal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Small intestinal obstruction
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
1 / 57 (1.75%) |
0 / 395 (0.00%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vomiting
|
|
|
|
|
subjects affected / exposed
|
3 / 391 (0.77%) |
1 / 57 (1.75%) |
2 / 395 (0.51%) |
3 / 198 (1.52%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 1 |
1 / 2 |
2 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Upper gastrointestinal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Subileus
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
Stomatitis
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Hepatobiliary disorders
|
|
|
|
|
Hepatic failure
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic function abnormal
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic haematoma
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Autoimmune hepatitis
|
|
|
|
|
subjects affected / exposed
|
2 / 391 (0.51%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Bile duct stenosis
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Biliary cirrhosis
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Cholangitis
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cholecystitis
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
2 / 395 (0.51%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cholecystitis acute
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Drug-induced liver injury
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
1 / 57 (1.75%) |
0 / 395 (0.00%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 1 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
Liver injury
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypertransaminasaemia
|
|
|
|
|
subjects affected / exposed
|
2 / 391 (0.51%) |
1 / 57 (1.75%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatotoxicity
|
|
|
|
|
subjects affected / exposed
|
4 / 391 (1.02%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
4 / 4 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
Hepatitis toxic
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatitis
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
2 / 198 (1.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
1 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Liver disorder
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Skin and subcutaneous tissue disorders
|
|
|
|
|
Toxic skin eruption
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Skin necrosis
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Skin lesion
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rash maculo-papular
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rash
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
2 / 395 (0.51%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
2 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pustular psoriasis
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Eosinophilic cellulitis
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dermatitis acneiform
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal and urinary disorders
|
|
|
|
|
Chronic kidney disease
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Acute kidney injury
|
|
|
|
|
subjects affected / exposed
|
4 / 391 (1.02%) |
0 / 57 (0.00%) |
8 / 395 (2.03%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
2 / 4 |
0 / 0 |
3 / 9 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 2 |
0 / 0 |
Urinary tract obstruction
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal failure
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Immune-mediated nephritis
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hydronephrosis
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haematuria
|
|
|
|
|
subjects affected / exposed
|
3 / 391 (0.77%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cystitis haemorrhagic
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Endocrine disorders
|
|
|
|
|
Hypophysitis
|
|
|
|
|
subjects affected / exposed
|
3 / 391 (0.77%) |
1 / 57 (1.75%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
3 / 3 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypopituitarism
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Euthyroid sick syndrome
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Autoimmune thyroiditis
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Adrenocorticotropic hormone deficiency
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
2 / 198 (1.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Adrenal insufficiency
|
|
|
|
|
subjects affected / exposed
|
6 / 391 (1.53%) |
1 / 57 (1.75%) |
4 / 395 (1.01%) |
2 / 198 (1.01%) |
occurrences causally related to treatment / all
|
5 / 6 |
1 / 1 |
4 / 4 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
Hyperthyroidism
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
3 / 395 (0.76%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
3 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
Thyroiditis
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypothyroidism
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Inappropriate antidiuretic hormone secretion
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lymphocytic hypophysitis
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
Musculoskeletal and connective tissue disorders
|
|
|
|
|
Arthralgia
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
2 / 395 (0.51%) |
5 / 198 (2.53%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
1 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Arthritis
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
1 / 57 (1.75%) |
2 / 395 (0.51%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Back pain
|
|
|
|
|
subjects affected / exposed
|
3 / 391 (0.77%) |
0 / 57 (0.00%) |
2 / 395 (0.51%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bone pain
|
|
|
|
|
subjects affected / exposed
|
2 / 391 (0.51%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Flank pain
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Intervertebral disc degeneration
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Muscular weakness
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Osteonecrosis of jaw
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Myalgia
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Neck pain
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Osteoarthritis
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Osteolysis
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal chest pain
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rhabdomyolysis
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Spinal pain
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pain in extremity
|
|
|
|
|
subjects affected / exposed
|
2 / 391 (0.51%) |
0 / 57 (0.00%) |
2 / 395 (0.51%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pathological fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
1 / 57 (1.75%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Polymyositis
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
Infections and infestations
|
|
|
|
|
Abscess
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Appendicitis
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Clostridium difficile colitis
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
1 / 57 (1.75%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cholecystitis infective
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cellulitis
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bronchopulmonary aspergillosis
|
|
|
|
|
subjects affected / exposed
|
2 / 391 (0.51%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bronchitis bacterial
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bronchitis
|
|
|
|
|
subjects affected / exposed
|
2 / 391 (0.51%) |
0 / 57 (0.00%) |
7 / 395 (1.77%) |
3 / 198 (1.52%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 7 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bacterial infection
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
2 / 198 (1.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bacteraemia
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Atypical pneumonia
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arthritis bacterial
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Clostridium difficile infection
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Colonic abscess
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
Gastroenteritis
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Fungal oesophagitis
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Escherichia urinary tract infection
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Erysipelas
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cystitis
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Diverticulitis intestinal perforated
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diverticulitis
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diarrhoea infectious
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Device related infection
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Encephalitis
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
4 / 198 (2.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
4 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
Orchitis
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Oral candidiasis
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Lung abscess
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
1 / 57 (1.75%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lower respiratory tract infection
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Liver abscess
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Influenza
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
2 / 198 (1.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Infective spondylitis
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Infective exacerbation of chronic obstructive airways disease
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Infectious pleural effusion
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peritonitis
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
Infection
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumococcal sepsis
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumocystis jirovecii pneumonia
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia
|
|
|
|
|
subjects affected / exposed
|
21 / 391 (5.37%) |
2 / 57 (3.51%) |
26 / 395 (6.58%) |
6 / 198 (3.03%) |
occurrences causally related to treatment / all
|
1 / 26 |
0 / 2 |
3 / 27 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 1 |
0 / 0 |
Pneumonia aspiration
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
1 / 57 (1.75%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia bacterial
|
|
|
|
|
subjects affected / exposed
|
2 / 391 (0.51%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural infection
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Pyelonephritis acute
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory tract infection
|
|
|
|
|
subjects affected / exposed
|
7 / 391 (1.79%) |
0 / 57 (0.00%) |
3 / 395 (0.76%) |
4 / 198 (2.02%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 0 |
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 1 |
0 / 1 |
Sepsis
|
|
|
|
|
subjects affected / exposed
|
7 / 391 (1.79%) |
2 / 57 (3.51%) |
5 / 395 (1.27%) |
4 / 198 (2.02%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 2 |
2 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 1 |
1 / 2 |
0 / 4 |
Septic shock
|
|
|
|
|
subjects affected / exposed
|
5 / 391 (1.28%) |
0 / 57 (0.00%) |
2 / 395 (0.51%) |
2 / 198 (1.01%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 2 |
Skin infection
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Staphylococcal infection
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urosepsis
|
|
|
|
|
subjects affected / exposed
|
2 / 391 (0.51%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Urinary tract infection
|
|
|
|
|
subjects affected / exposed
|
2 / 391 (0.51%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Upper respiratory tract infection
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Staphylococcal sepsis
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Viral infection
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metabolism and nutrition disorders
|
|
|
|
|
Hypercalcaemia
|
|
|
|
|
subjects affected / exposed
|
3 / 391 (0.77%) |
0 / 57 (0.00%) |
2 / 395 (0.51%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Failure to thrive
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
1 / 57 (1.75%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic ketoacidosis
|
|
|
|
|
subjects affected / exposed
|
2 / 391 (0.51%) |
1 / 57 (1.75%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
2 / 3 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diabetes mellitus
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
2 / 395 (0.51%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dehydration
|
|
|
|
|
subjects affected / exposed
|
2 / 391 (0.51%) |
2 / 57 (3.51%) |
2 / 395 (0.51%) |
2 / 198 (1.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 2 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Decreased appetite
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Acidosis
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyperglycaemia
|
|
|
|
|
subjects affected / exposed
|
4 / 391 (1.02%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
3 / 198 (1.52%) |
occurrences causally related to treatment / all
|
2 / 4 |
0 / 0 |
0 / 1 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypoglycaemia
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypokalaemia
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
3 / 198 (1.52%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyponatraemia
|
|
|
|
|
subjects affected / exposed
|
4 / 391 (1.02%) |
2 / 57 (3.51%) |
3 / 395 (0.76%) |
2 / 198 (1.01%) |
occurrences causally related to treatment / all
|
2 / 4 |
0 / 3 |
1 / 3 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypophagia
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Steroid diabetes
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tumour lysis syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
1 / 395 (0.25%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Type 1 diabetes mellitus
|
|
|
|
|
subjects affected / exposed
|
1 / 391 (0.26%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
0 / 198 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Type 2 diabetes mellitus
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypocalcaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 391 (0.00%) |
0 / 57 (0.00%) |
0 / 395 (0.00%) |
1 / 198 (0.51%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |