Non-serious adverse events
|
Ramucirumab 8 mg/kg I.V. infusion every 2 weeks |
Placebo 8 mg/kg I.V. infusion every 2 weeks |
Total subjects affected by non serious adverse events
|
|
|
subjects affected / exposed
|
265 / 277 (95.67%) |
257 / 276 (93.12%) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
cancer pain
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
3 / 276 (1.09%) |
occurrences all number
|
1 |
3 |
haemangioma
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
haemangioma of skin
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
2 |
0 |
keratoacanthoma
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
malignant neoplasm progression
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
5 / 277 (1.81%) |
3 / 276 (1.09%) |
occurrences all number
|
6 |
3 |
melanocytic naevus
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
metastases to lung
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
2 |
0 |
metastatic pain
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
2 / 276 (0.72%) |
occurrences all number
|
0 |
2 |
pyogenic granuloma
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
0 / 276 (0.00%) |
occurrences all number
|
2 |
0 |
skin papilloma
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
squamous cell carcinoma
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
tongue neoplasm malignant stage unspecified
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
2 |
tumour pain
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
4 / 277 (1.44%) |
4 / 276 (1.45%) |
occurrences all number
|
4 |
5 |
tumour thrombosis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
Vascular disorders
|
|
|
deep vein thrombosis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
1 / 276 (0.36%) |
occurrences all number
|
1 |
1 |
embolism
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
extravasation blood
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
1 / 276 (0.36%) |
occurrences all number
|
1 |
1 |
femoral artery occlusion
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
flushing
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
3 / 277 (1.08%) |
0 / 276 (0.00%) |
occurrences all number
|
3 |
0 |
haematoma
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
7 / 277 (2.53%) |
2 / 276 (0.72%) |
occurrences all number
|
7 |
2 |
haemorrhage
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
hot flush
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
2 / 276 (0.72%) |
occurrences all number
|
0 |
2 |
hypertension
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
55 / 277 (19.86%) |
20 / 276 (7.25%) |
occurrences all number
|
104 |
43 |
hypotension
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
4 / 277 (1.44%) |
4 / 276 (1.45%) |
occurrences all number
|
5 |
4 |
intermittent claudication
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
lymphostasis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
orthostatic hypotension
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
peripheral coldness
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
periphlebitis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
thrombophlebitis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
0 / 276 (0.00%) |
occurrences all number
|
3 |
0 |
vein disorder
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
venous insufficiency
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
2 / 276 (0.72%) |
occurrences all number
|
1 |
3 |
venous lake
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
0 / 276 (0.00%) |
occurrences all number
|
2 |
0 |
General disorders and administration site conditions
|
|
|
application site pain
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
asthenia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
50 / 277 (18.05%) |
36 / 276 (13.04%) |
occurrences all number
|
80 |
63 |
axillary pain
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
catheter site pain
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
0 / 276 (0.00%) |
occurrences all number
|
2 |
0 |
chest discomfort
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
3 / 276 (1.09%) |
occurrences all number
|
2 |
4 |
chest pain
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
3 / 277 (1.08%) |
8 / 276 (2.90%) |
occurrences all number
|
4 |
10 |
chills
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
11 / 277 (3.97%) |
6 / 276 (2.17%) |
occurrences all number
|
15 |
15 |
crepitations
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
0 / 276 (0.00%) |
occurrences all number
|
2 |
0 |
drug intolerance
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
drug withdrawal syndrome
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
effusion
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
face oedema
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
8 / 277 (2.89%) |
1 / 276 (0.36%) |
occurrences all number
|
9 |
1 |
fatigue
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
66 / 277 (23.83%) |
60 / 276 (21.74%) |
occurrences all number
|
97 |
99 |
feeling cold
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
1 / 276 (0.36%) |
occurrences all number
|
1 |
1 |
gait disturbance
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
1 / 276 (0.36%) |
occurrences all number
|
2 |
1 |
general physical health deterioration
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
2 / 276 (0.72%) |
occurrences all number
|
2 |
2 |
generalised oedema
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
4 |
0 |
hernia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
1 / 276 (0.36%) |
occurrences all number
|
1 |
1 |
hyperthermia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
3 / 277 (1.08%) |
0 / 276 (0.00%) |
occurrences all number
|
9 |
0 |
influenza like illness
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
6 / 277 (2.17%) |
11 / 276 (3.99%) |
occurrences all number
|
9 |
25 |
infusion site pruritus
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
infusion site swelling
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
injection site reaction
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
injection site pruritus
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
local swelling
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
3 / 277 (1.08%) |
1 / 276 (0.36%) |
occurrences all number
|
4 |
2 |
localised oedema
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
0 / 276 (0.00%) |
occurrences all number
|
3 |
0 |
malaise
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
5 / 277 (1.81%) |
10 / 276 (3.62%) |
occurrences all number
|
6 |
11 |
medical device complication
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
mucosal dryness
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
1 / 276 (0.36%) |
occurrences all number
|
1 |
1 |
mucosal inflammation
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
6 / 277 (2.17%) |
3 / 276 (1.09%) |
occurrences all number
|
10 |
5 |
non-cardiac chest pain
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
3 / 277 (1.08%) |
7 / 276 (2.54%) |
occurrences all number
|
3 |
7 |
oedema
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
3 / 276 (1.09%) |
occurrences all number
|
3 |
6 |
oedema peripheral
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
100 / 277 (36.10%) |
50 / 276 (18.12%) |
occurrences all number
|
151 |
58 |
pain
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
4 / 277 (1.44%) |
5 / 276 (1.81%) |
occurrences all number
|
4 |
5 |
pyrexia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
42 / 277 (15.16%) |
25 / 276 (9.06%) |
occurrences all number
|
59 |
32 |
suprapubic pain
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
systemic inflammatory response syndrome
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
thirst
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
0 / 276 (0.00%) |
occurrences all number
|
2 |
0 |
ulcer
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
xerosis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
1 / 276 (0.36%) |
occurrences all number
|
1 |
1 |
Immune system disorders
|
|
|
cytokine release syndrome
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
3 / 277 (1.08%) |
0 / 276 (0.00%) |
occurrences all number
|
4 |
0 |
hypersensitivity
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
4 / 277 (1.44%) |
1 / 276 (0.36%) |
occurrences all number
|
4 |
1 |
seasonal allergy
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
Reproductive system and breast disorders
|
|
|
balanitis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed [1]
|
1 / 230 (0.43%) |
0 / 236 (0.00%) |
occurrences all number
|
1 |
0 |
benign prostatic hyperplasia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed [2]
|
1 / 230 (0.43%) |
1 / 236 (0.42%) |
occurrences all number
|
1 |
1 |
breast pain
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
4 / 277 (1.44%) |
1 / 276 (0.36%) |
occurrences all number
|
5 |
1 |
genital rash
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
gynaecomastia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed [3]
|
5 / 230 (2.17%) |
0 / 236 (0.00%) |
occurrences all number
|
6 |
0 |
pelvic pain
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
pruritus genital
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
2 |
0 |
rectocele
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed [4]
|
1 / 47 (2.13%) |
0 / 40 (0.00%) |
occurrences all number
|
1 |
0 |
scrotal swelling
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed [5]
|
0 / 230 (0.00%) |
1 / 236 (0.42%) |
occurrences all number
|
0 |
1 |
sexual dysfunction
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
Respiratory, thoracic and mediastinal disorders
|
|
|
asthma
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
atelectasis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
1 / 276 (0.36%) |
occurrences all number
|
2 |
1 |
bronchial obstruction
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
chronic obstructive pulmonary disease
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
cough
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
41 / 277 (14.80%) |
25 / 276 (9.06%) |
occurrences all number
|
54 |
29 |
diaphragmalgia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
dysphonia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
9 / 277 (3.25%) |
1 / 276 (0.36%) |
occurrences all number
|
9 |
2 |
dyspnoea
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
26 / 277 (9.39%) |
26 / 276 (9.42%) |
occurrences all number
|
33 |
33 |
dyspnoea exertional
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
3 / 277 (1.08%) |
3 / 276 (1.09%) |
occurrences all number
|
5 |
3 |
epistaxis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
38 / 277 (13.72%) |
17 / 276 (6.16%) |
occurrences all number
|
48 |
22 |
haemoptysis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
8 / 277 (2.89%) |
2 / 276 (0.72%) |
occurrences all number
|
9 |
2 |
hiccups
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
6 / 277 (2.17%) |
5 / 276 (1.81%) |
occurrences all number
|
7 |
6 |
hypoxia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
increased upper airway secretion
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
interstitial lung disease
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
laryngeal inflammation
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
lung infiltration
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
nasal discomfort
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
nasal dryness
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
nasal mucosal disorder
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
oropharyngeal pain
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
6 / 277 (2.17%) |
2 / 276 (0.72%) |
occurrences all number
|
6 |
2 |
pleural effusion
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
8 / 277 (2.89%) |
9 / 276 (3.26%) |
occurrences all number
|
11 |
11 |
pleurisy
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
pneumonitis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
2 / 276 (0.72%) |
occurrences all number
|
0 |
2 |
productive cough
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
7 / 277 (2.53%) |
5 / 276 (1.81%) |
occurrences all number
|
7 |
5 |
pulmonary artery thrombosis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
pulmonary congestion
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
pulmonary embolism
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
rales
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
4 / 277 (1.44%) |
1 / 276 (0.36%) |
occurrences all number
|
4 |
1 |
rhinitis allergic
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
2 / 276 (0.72%) |
occurrences all number
|
1 |
2 |
rhinorrhoea
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
2 / 276 (0.72%) |
occurrences all number
|
2 |
2 |
rhonchi
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
sinus congestion
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
tachypnoea
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
upper-airway cough syndrome
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
wheezing
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
Psychiatric disorders
|
|
|
abnormal dreams
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
agitation
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
1 / 276 (0.36%) |
occurrences all number
|
1 |
1 |
anxiety
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
7 / 276 (2.54%) |
occurrences all number
|
2 |
18 |
bulimia nervosa
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
confusional state
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
8 / 277 (2.89%) |
3 / 276 (1.09%) |
occurrences all number
|
9 |
3 |
delirium
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
depressed mood
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
1 / 276 (0.36%) |
occurrences all number
|
1 |
1 |
depression
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
9 / 277 (3.25%) |
1 / 276 (0.36%) |
occurrences all number
|
9 |
6 |
disorientation
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
1 / 276 (0.36%) |
occurrences all number
|
1 |
1 |
insomnia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
19 / 277 (6.86%) |
20 / 276 (7.25%) |
occurrences all number
|
20 |
20 |
mood altered
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
nightmare
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
psychotic disorder
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
psychomotor retardation
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
Investigations
|
|
|
activated partial thromboplastin time prolonged
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
2 / 276 (0.72%) |
occurrences all number
|
1 |
2 |
alanine aminotransferase increased
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
13 / 277 (4.69%) |
21 / 276 (7.61%) |
occurrences all number
|
34 |
33 |
albumin urine present
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
alpha 1 foetoprotein increased
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
1 / 276 (0.36%) |
occurrences all number
|
2 |
1 |
ammonia increased
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
aspartate aminotransferase increased
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
30 / 277 (10.83%) |
39 / 276 (14.13%) |
occurrences all number
|
59 |
70 |
biopsy liver
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
blood albumin decreased
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
8 / 277 (2.89%) |
1 / 276 (0.36%) |
occurrences all number
|
37 |
1 |
blood alkaline phosphatase increased
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
18 / 277 (6.50%) |
14 / 276 (5.07%) |
occurrences all number
|
40 |
25 |
blood bilirubin increased
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
19 / 277 (6.86%) |
24 / 276 (8.70%) |
occurrences all number
|
39 |
38 |
blood chloride decreased
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
2 / 276 (0.72%) |
occurrences all number
|
0 |
2 |
blood creatinine increased
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
5 / 277 (1.81%) |
10 / 276 (3.62%) |
occurrences all number
|
15 |
12 |
blood chloride increased
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
blood lactate dehydrogenase increased
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
1 / 276 (0.36%) |
occurrences all number
|
2 |
1 |
blood magnesium decreased
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
2 / 276 (0.72%) |
occurrences all number
|
0 |
2 |
blood potassium increased
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
2 / 276 (0.72%) |
occurrences all number
|
0 |
2 |
blood pressure abnormal
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
blood pressure increased
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
blood urea increased
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
1 / 276 (0.36%) |
occurrences all number
|
1 |
2 |
blood urine present
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
2 |
0 |
blood uric acid increased
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
4 / 277 (1.44%) |
1 / 276 (0.36%) |
occurrences all number
|
7 |
1 |
body temperature increased
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
3 / 277 (1.08%) |
1 / 276 (0.36%) |
occurrences all number
|
4 |
1 |
breath sounds abnormal
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
breath sounds
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
c-reactive protein increased
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
3 / 276 (1.09%) |
occurrences all number
|
1 |
4 |
cd4 lymphocytes increased
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
cardiac murmur
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
1 / 276 (0.36%) |
occurrences all number
|
2 |
2 |
coagulation time abnormal
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
ejection fraction decreased
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
electrocardiogram qt prolonged
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
2 / 276 (0.72%) |
occurrences all number
|
0 |
2 |
electrocardiogram t wave inversion
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
gamma-glutamyltransferase increased
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
3 / 277 (1.08%) |
6 / 276 (2.17%) |
occurrences all number
|
14 |
8 |
general physical condition abnormal
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
2 / 276 (0.72%) |
occurrences all number
|
0 |
2 |
haematocrit decreased
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
haemoglobin decreased
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
1 / 276 (0.36%) |
occurrences all number
|
5 |
1 |
heart sounds abnormal
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
international normalised ratio increased
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
2 / 276 (0.72%) |
occurrences all number
|
2 |
2 |
lipase increased
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
liver function test abnormal
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
2 / 276 (0.72%) |
occurrences all number
|
2 |
2 |
mean cell volume decreased
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
2 / 276 (0.72%) |
occurrences all number
|
0 |
2 |
monocyte count increased
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
neutrophil count decreased
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
2 |
0 |
occult blood
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
platelet count decreased
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
1 / 276 (0.36%) |
occurrences all number
|
2 |
1 |
protein total decreased
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
3 |
0 |
protein urine present
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
3 / 277 (1.08%) |
0 / 276 (0.00%) |
occurrences all number
|
7 |
0 |
prothrombin time prolonged
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
sputum abnormal
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
urine output decreased
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
1 / 276 (0.36%) |
occurrences all number
|
1 |
1 |
urine ketone body present
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
waist circumference increased
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
2 |
0 |
weight decreased
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
9 / 277 (3.25%) |
6 / 276 (2.17%) |
occurrences all number
|
12 |
6 |
weight increased
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
4 / 277 (1.44%) |
1 / 276 (0.36%) |
occurrences all number
|
6 |
1 |
white blood cell count decreased
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
2 |
0 |
white blood cells urine positive
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
Injury, poisoning and procedural complications
|
|
|
anal injury
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
animal bite
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
chest injury
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
chillblains
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
clavicle fracture
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
contusion
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
4 / 277 (1.44%) |
4 / 276 (1.45%) |
occurrences all number
|
4 |
4 |
craniocerebral injury
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
excoriation
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
3 / 276 (1.09%) |
occurrences all number
|
1 |
3 |
facial bones fracture
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
fall
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
7 / 277 (2.53%) |
0 / 276 (0.00%) |
occurrences all number
|
8 |
0 |
foreign body
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
incision site pruritus
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
infusion related reaction
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
12 / 277 (4.33%) |
1 / 276 (0.36%) |
occurrences all number
|
13 |
1 |
laceration
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
limb injury
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
lumbar vertebral fracture
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
postoperative wound complication
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
procedural pain
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
1 / 276 (0.36%) |
occurrences all number
|
2 |
1 |
rib fracture
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
1 / 276 (0.36%) |
occurrences all number
|
1 |
1 |
sternal fracture
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
sternal injury
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
stress fracture
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
tongue injury
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
tooth fracture
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
1 / 276 (0.36%) |
occurrences all number
|
1 |
1 |
wound
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
1 / 276 (0.36%) |
occurrences all number
|
2 |
1 |
wound haemorrhage
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
Cardiac disorders
|
|
|
aortic valve incompetence
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
bradycardia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
1 / 276 (0.36%) |
occurrences all number
|
1 |
1 |
bundle branch block right
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
cardiomyopathy
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
cyanosis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
myocardial infarction
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
palpitations
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
2 / 276 (0.72%) |
occurrences all number
|
2 |
2 |
sinus arrhythmia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
sinus tachycardia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
supraventricular tachycardia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
tachycardia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
tricuspid valve disease
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
Nervous system disorders
|
|
|
ageusia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
amnesia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
4 / 277 (1.44%) |
1 / 276 (0.36%) |
occurrences all number
|
4 |
1 |
aphasia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
0 / 276 (0.00%) |
occurrences all number
|
2 |
0 |
aphonia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
asterixis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
autonomic nervous system imbalance
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
balance disorder
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
0 / 276 (0.00%) |
occurrences all number
|
2 |
0 |
cerebral ischaemia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
circadian rhythm sleep disorder
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
clumsiness
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
2 / 276 (0.72%) |
occurrences all number
|
0 |
2 |
consciousness fluctuating
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
convulsion
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
1 / 276 (0.36%) |
occurrences all number
|
2 |
1 |
diabetic neuropathy
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
disturbance in attention
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
3 / 277 (1.08%) |
0 / 276 (0.00%) |
occurrences all number
|
3 |
0 |
dizziness
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
23 / 277 (8.30%) |
16 / 276 (5.80%) |
occurrences all number
|
25 |
18 |
dysaesthesia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
dysgeusia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
7 / 277 (2.53%) |
3 / 276 (1.09%) |
occurrences all number
|
9 |
3 |
encephalopathy
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
headache
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
53 / 277 (19.13%) |
15 / 276 (5.43%) |
occurrences all number
|
69 |
18 |
hemiparesis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
hepatic encephalopathy
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
9 / 277 (3.25%) |
3 / 276 (1.09%) |
occurrences all number
|
10 |
3 |
hyperaesthesia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
hypoaesthesia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
3 / 277 (1.08%) |
4 / 276 (1.45%) |
occurrences all number
|
3 |
5 |
hypotonia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
intercostal neuralgia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
lethargy
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
loss of proprioception
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
memory impairment
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
3 / 277 (1.08%) |
0 / 276 (0.00%) |
occurrences all number
|
3 |
0 |
movement disorder
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
nervous system disorder
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
neuropathy peripheral
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
2 / 276 (0.72%) |
occurrences all number
|
1 |
2 |
paraesthesia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
8 / 277 (2.89%) |
5 / 276 (1.81%) |
occurrences all number
|
14 |
6 |
parkinson's disease
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
2 |
peripheral sensory neuropathy
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
2 / 276 (0.72%) |
occurrences all number
|
2 |
2 |
petit mal epilepsy
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
polyneuropathy
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
2 / 276 (0.72%) |
occurrences all number
|
2 |
2 |
radiculitis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
restless legs syndrome
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
sciatica
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
2 / 276 (0.72%) |
occurrences all number
|
0 |
2 |
somnolence
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
4 / 277 (1.44%) |
1 / 276 (0.36%) |
occurrences all number
|
6 |
1 |
spinal cord compression
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
status epilepticus
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
stupor
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
syncope
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
0 / 276 (0.00%) |
occurrences all number
|
2 |
0 |
transient ischaemic attack
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
tremor
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
3 / 276 (1.09%) |
occurrences all number
|
1 |
3 |
vocal cord paralysis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
Blood and lymphatic system disorders
|
|
|
anaemia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
29 / 277 (10.47%) |
31 / 276 (11.23%) |
occurrences all number
|
54 |
44 |
disseminated intravascular coagulation
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
eosinophilia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
2 / 276 (0.72%) |
occurrences all number
|
0 |
2 |
hypochromic anaemia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
8 |
0 |
leukocytosis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
3 / 277 (1.08%) |
5 / 276 (1.81%) |
occurrences all number
|
3 |
5 |
leukopenia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
14 / 277 (5.05%) |
7 / 276 (2.54%) |
occurrences all number
|
54 |
19 |
lymphopenia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
7 / 277 (2.53%) |
4 / 276 (1.45%) |
occurrences all number
|
16 |
7 |
lymphadenopathy
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
neutropenia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
16 / 277 (5.78%) |
4 / 276 (1.45%) |
occurrences all number
|
80 |
8 |
neutrophilia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
splenomegaly
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
1 / 276 (0.36%) |
occurrences all number
|
1 |
1 |
thrombocytopenia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
48 / 277 (17.33%) |
12 / 276 (4.35%) |
occurrences all number
|
189 |
26 |
thrombocytosis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
Ear and labyrinth disorders
|
|
|
deafness
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
1 / 276 (0.36%) |
occurrences all number
|
1 |
1 |
deafness neurosensory
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
ear congestion
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
ear discomfort
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
ear haemorrhage
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
hearing impaired
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
0 / 276 (0.00%) |
occurrences all number
|
2 |
0 |
tinnitus
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
4 / 277 (1.44%) |
3 / 276 (1.09%) |
occurrences all number
|
6 |
4 |
vertigo
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
4 / 277 (1.44%) |
5 / 276 (1.81%) |
occurrences all number
|
4 |
8 |
vestibular disorder
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
Eye disorders
|
|
|
asthenopia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
cataract
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
3 / 276 (1.09%) |
occurrences all number
|
1 |
3 |
conjunctival haemorrhage
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
conjunctival hyperaemia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
conjunctivitis allergic
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
diabetic retinopathy
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
disorder of orbit
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
dry eye
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
2 / 276 (0.72%) |
occurrences all number
|
0 |
2 |
entropion
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
eye disorder
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
eye irritation
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
eye pruritus
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
2 / 276 (0.72%) |
occurrences all number
|
2 |
2 |
eye swelling
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
eyelid oedema
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
foreign body sensation in eyes
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
hypermetropia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
ocular hyperaemia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
ocular icterus
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
1 / 276 (0.36%) |
occurrences all number
|
2 |
1 |
periorbital oedema
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
photophobia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
1 / 276 (0.36%) |
occurrences all number
|
1 |
1 |
presbyopia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
retinal vascular disorder
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
retinopathy
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
visual impairment
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
vision blurred
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
4 / 277 (1.44%) |
3 / 276 (1.09%) |
occurrences all number
|
4 |
3 |
vitreous floaters
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
2 / 276 (0.72%) |
occurrences all number
|
2 |
2 |
Gastrointestinal disorders
|
|
|
abdominal discomfort
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
7 / 276 (2.54%) |
occurrences all number
|
2 |
8 |
abdominal distension
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
19 / 277 (6.86%) |
28 / 276 (10.14%) |
occurrences all number
|
27 |
31 |
abdominal hernia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
abdominal pain
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
45 / 277 (16.25%) |
58 / 276 (21.01%) |
occurrences all number
|
63 |
86 |
abdominal pain lower
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
2 / 276 (0.72%) |
occurrences all number
|
0 |
2 |
abdominal pain upper
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
26 / 277 (9.39%) |
25 / 276 (9.06%) |
occurrences all number
|
34 |
32 |
abdominal rigidity
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
abdominal tenderness
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
2 / 276 (0.72%) |
occurrences all number
|
2 |
2 |
anal fissure
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
anal haemorrhage
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
1 / 276 (0.36%) |
occurrences all number
|
1 |
1 |
anal pruritus
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
aphthous stomatitis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
ascites
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
72 / 277 (25.99%) |
40 / 276 (14.49%) |
occurrences all number
|
110 |
47 |
breath odour
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
colitis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
0 / 276 (0.00%) |
occurrences all number
|
3 |
0 |
constipation
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
36 / 277 (13.00%) |
34 / 276 (12.32%) |
occurrences all number
|
39 |
39 |
dental caries
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
1 / 276 (0.36%) |
occurrences all number
|
2 |
1 |
diarrhoea
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
50 / 277 (18.05%) |
38 / 276 (13.77%) |
occurrences all number
|
74 |
52 |
dry mouth
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
6 / 277 (2.17%) |
4 / 276 (1.45%) |
occurrences all number
|
7 |
4 |
duodenal ulcer
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
1 / 276 (0.36%) |
occurrences all number
|
1 |
1 |
dyspepsia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
6 / 277 (2.17%) |
11 / 276 (3.99%) |
occurrences all number
|
7 |
14 |
dysphagia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
4 / 277 (1.44%) |
2 / 276 (0.72%) |
occurrences all number
|
4 |
3 |
enteritis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
2 / 276 (0.72%) |
occurrences all number
|
0 |
2 |
epigastric discomfort
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
3 / 276 (1.09%) |
occurrences all number
|
2 |
3 |
eructation
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
faecal incontinence
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
faeces discoloured
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
0 / 276 (0.00%) |
occurrences all number
|
2 |
0 |
flatulence
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
4 / 277 (1.44%) |
6 / 276 (2.17%) |
occurrences all number
|
4 |
7 |
food poisoning
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
frequent bowel movements
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
gastric mucosal lesion
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
gastric ulcer
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
2 / 276 (0.72%) |
occurrences all number
|
2 |
2 |
gastritis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
5 / 277 (1.81%) |
5 / 276 (1.81%) |
occurrences all number
|
6 |
5 |
gastroduodenitis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
gastrointestinal disorder
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
gastrointestinal haemorrhage
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
1 / 276 (0.36%) |
occurrences all number
|
1 |
1 |
gastrointestinal pain
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
gastrooesophageal reflux disease
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
5 / 277 (1.81%) |
4 / 276 (1.45%) |
occurrences all number
|
6 |
4 |
gingival bleeding
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
18 / 277 (6.50%) |
4 / 276 (1.45%) |
occurrences all number
|
22 |
4 |
gingival disorder
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
gingival pain
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
0 / 276 (0.00%) |
occurrences all number
|
3 |
0 |
gingival swelling
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
glossodynia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
haematemesis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
2 / 276 (0.72%) |
occurrences all number
|
0 |
2 |
haematochezia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
1 / 276 (0.36%) |
occurrences all number
|
2 |
1 |
haemorrhoidal haemorrhage
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
5 / 277 (1.81%) |
1 / 276 (0.36%) |
occurrences all number
|
6 |
1 |
haemorrhoids
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
6 / 277 (2.17%) |
4 / 276 (1.45%) |
occurrences all number
|
6 |
4 |
inguinal hernia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
1 / 276 (0.36%) |
occurrences all number
|
3 |
1 |
irritable bowel syndrome
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
lip dry
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
lower gastrointestinal haemorrhage
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
1 / 276 (0.36%) |
occurrences all number
|
1 |
1 |
melaena
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
3 / 276 (1.09%) |
occurrences all number
|
2 |
3 |
mouth ulceration
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
3 / 277 (1.08%) |
3 / 276 (1.09%) |
occurrences all number
|
3 |
3 |
mouth haemorrhage
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
6 / 277 (2.17%) |
0 / 276 (0.00%) |
occurrences all number
|
20 |
0 |
nausea
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
52 / 277 (18.77%) |
52 / 276 (18.84%) |
occurrences all number
|
71 |
74 |
odynophagia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
1 / 276 (0.36%) |
occurrences all number
|
1 |
1 |
oesophageal varices haemorrhage
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
2 / 276 (0.72%) |
occurrences all number
|
0 |
3 |
oesophagitis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
2 / 276 (0.72%) |
occurrences all number
|
2 |
3 |
oral disorder
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
oral mucosal blistering
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
painful defaecation
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
paraesthesia oral
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
peptic ulcer
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
periodontal disease
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
0 / 276 (0.00%) |
occurrences all number
|
4 |
0 |
portal hypertensive gastropathy
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
proctalgia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
1 / 276 (0.36%) |
occurrences all number
|
1 |
1 |
rectal haemorrhage
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
5 / 277 (1.81%) |
3 / 276 (1.09%) |
occurrences all number
|
5 |
3 |
rectal tenesmus
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
small intestinal obstruction
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
steatorrhoea
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
stomatitis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
8 / 277 (2.89%) |
4 / 276 (1.45%) |
occurrences all number
|
9 |
4 |
submaxillary gland enlargement
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
tongue geographic
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
tooth disorder
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
toothache
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
5 / 277 (1.81%) |
2 / 276 (0.72%) |
occurrences all number
|
7 |
2 |
umbilical hernia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
upper gastrointestinal haemorrhage
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
1 / 276 (0.36%) |
occurrences all number
|
1 |
1 |
varices oesophageal
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
3 / 277 (1.08%) |
2 / 276 (0.72%) |
occurrences all number
|
3 |
2 |
vomiting
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
30 / 277 (10.83%) |
40 / 276 (14.49%) |
occurrences all number
|
39 |
47 |
Hepatobiliary disorders
|
|
|
biliary colic
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
1 / 276 (0.36%) |
occurrences all number
|
1 |
1 |
cholangitis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
4 / 277 (1.44%) |
0 / 276 (0.00%) |
occurrences all number
|
6 |
0 |
cholangitis acute
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
3 |
cholecystitis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
cholelithiasis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
4 |
0 |
cholestasis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
hepatic cirrhosis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
1 / 276 (0.36%) |
occurrences all number
|
2 |
1 |
hepatic failure
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
5 / 276 (1.81%) |
occurrences all number
|
2 |
5 |
hepatic function abnormal
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
3 / 277 (1.08%) |
1 / 276 (0.36%) |
occurrences all number
|
3 |
1 |
hepatic pain
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
2 / 276 (0.72%) |
occurrences all number
|
3 |
3 |
hepatobiliary disease
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
hepatocellular injury
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
1 / 276 (0.36%) |
occurrences all number
|
1 |
1 |
hepatorenal syndrome
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
2 / 276 (0.72%) |
occurrences all number
|
0 |
2 |
hepatomegaly
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
6 / 277 (2.17%) |
8 / 276 (2.90%) |
occurrences all number
|
6 |
8 |
hyperbilirubinaemia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
10 / 277 (3.61%) |
15 / 276 (5.43%) |
occurrences all number
|
16 |
32 |
hypertransaminasaemia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
3 / 277 (1.08%) |
1 / 276 (0.36%) |
occurrences all number
|
4 |
1 |
jaundice
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
12 / 277 (4.33%) |
13 / 276 (4.71%) |
occurrences all number
|
13 |
14 |
liver disorder
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
portal hypertension
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
1 / 276 (0.36%) |
occurrences all number
|
1 |
1 |
portal vein thrombosis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
4 / 276 (1.45%) |
occurrences all number
|
0 |
4 |
Skin and subcutaneous tissue disorders
|
|
|
acne
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
3 / 276 (1.09%) |
occurrences all number
|
0 |
3 |
alopecia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
12 / 277 (4.33%) |
12 / 276 (4.35%) |
occurrences all number
|
13 |
13 |
asteatosis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
blister
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
blood blister
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
cold sweat
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
cutis laxa
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
decubitus ulcer
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
0 / 276 (0.00%) |
occurrences all number
|
2 |
0 |
dermatitis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
dermatitis acneiform
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
5 / 277 (1.81%) |
2 / 276 (0.72%) |
occurrences all number
|
5 |
3 |
dermatitis bullous
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
dermatitis contact
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
dermatitis diaper
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
dry skin
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
16 / 277 (5.78%) |
12 / 276 (4.35%) |
occurrences all number
|
17 |
13 |
ecchymosis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
eczema
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
1 / 276 (0.36%) |
occurrences all number
|
2 |
1 |
erythema
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
4 / 277 (1.44%) |
6 / 276 (2.17%) |
occurrences all number
|
5 |
6 |
haemorrhage subcutaneous
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
hair colour changes
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
hand dermatitis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
hyperhidrosis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
5 / 276 (1.81%) |
occurrences all number
|
1 |
5 |
hyperkeratosis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
3 / 276 (1.09%) |
occurrences all number
|
1 |
3 |
koilonychia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
leukocytoclastic vasculitis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
lichenoid keratosis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
nail disorder
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
2 |
0 |
nail dystrophy
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
night sweats
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
1 / 276 (0.36%) |
occurrences all number
|
1 |
1 |
onychoclasis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
1 / 276 (0.36%) |
occurrences all number
|
2 |
1 |
onychomadesis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
palmar-plantar erythrodysaesthesia syndrome
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
11 / 277 (3.97%) |
5 / 276 (1.81%) |
occurrences all number
|
19 |
5 |
papule
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
1 / 276 (0.36%) |
occurrences all number
|
1 |
1 |
petechiae
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
0 / 276 (0.00%) |
occurrences all number
|
2 |
0 |
photodermatosis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
photosensitivity reaction
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
pigmentation disorder
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
0 / 276 (0.00%) |
occurrences all number
|
2 |
0 |
prurigo
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
pruritus
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
28 / 277 (10.11%) |
29 / 276 (10.51%) |
occurrences all number
|
33 |
41 |
pruritus generalised
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
purpura
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
1 / 276 (0.36%) |
occurrences all number
|
2 |
1 |
purpura senile
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
rash
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
23 / 277 (8.30%) |
12 / 276 (4.35%) |
occurrences all number
|
27 |
16 |
rash erythematous
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
rash maculo-papular
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
3 / 277 (1.08%) |
1 / 276 (0.36%) |
occurrences all number
|
3 |
1 |
scar pain
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
skin atrophy
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
skin disorder
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
1 / 276 (0.36%) |
occurrences all number
|
1 |
1 |
skin exfoliation
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
skin haemorrhage
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
skin hyperpigmentation
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
0 / 276 (0.00%) |
occurrences all number
|
2 |
0 |
skin hypopigmentation
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
skin lesion
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
3 / 277 (1.08%) |
1 / 276 (0.36%) |
occurrences all number
|
3 |
1 |
skin mass
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
3 / 277 (1.08%) |
0 / 276 (0.00%) |
occurrences all number
|
3 |
0 |
skin tightness
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
skin ulcer
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
3 / 277 (1.08%) |
2 / 276 (0.72%) |
occurrences all number
|
5 |
2 |
swelling face
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
urticaria
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
2 / 276 (0.72%) |
occurrences all number
|
1 |
3 |
xeroderma
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
Renal and urinary disorders
|
|
|
anuria
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
dysuria
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
1 / 276 (0.36%) |
occurrences all number
|
2 |
1 |
haematuria
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
3 / 276 (1.09%) |
occurrences all number
|
1 |
3 |
nephropathy
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
nocturia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
1 / 276 (0.36%) |
occurrences all number
|
2 |
2 |
oliguria
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
0 / 276 (0.00%) |
occurrences all number
|
2 |
0 |
pollakiuria
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
4 / 277 (1.44%) |
1 / 276 (0.36%) |
occurrences all number
|
4 |
1 |
polyuria
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
proteinuria
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
46 / 277 (16.61%) |
13 / 276 (4.71%) |
occurrences all number
|
117 |
18 |
renal cyst
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
1 / 276 (0.36%) |
occurrences all number
|
1 |
1 |
renal failure
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
2 / 276 (0.72%) |
occurrences all number
|
2 |
2 |
renal failure acute
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
3 / 276 (1.09%) |
occurrences all number
|
2 |
3 |
renal impairment
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
1 / 276 (0.36%) |
occurrences all number
|
1 |
1 |
renal pain
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
renal vein thrombosis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
urinary incontinence
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
1 / 276 (0.36%) |
occurrences all number
|
3 |
1 |
urinary retention
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
1 / 276 (0.36%) |
occurrences all number
|
3 |
1 |
Endocrine disorders
|
|
|
adrenal insufficiency
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
hyperparathyroidism
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
hyperthyroidism
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
hypothyroidism
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
3 / 277 (1.08%) |
0 / 276 (0.00%) |
occurrences all number
|
3 |
0 |
Musculoskeletal and connective tissue disorders
|
|
|
amyotrophy
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
1 / 276 (0.36%) |
occurrences all number
|
1 |
1 |
arthralgia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
19 / 277 (6.86%) |
10 / 276 (3.62%) |
occurrences all number
|
26 |
12 |
arthritis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
0 / 276 (0.00%) |
occurrences all number
|
2 |
0 |
back pain
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
23 / 277 (8.30%) |
23 / 276 (8.33%) |
occurrences all number
|
27 |
32 |
bone pain
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
5 / 277 (1.81%) |
4 / 276 (1.45%) |
occurrences all number
|
20 |
4 |
bursitis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
1 / 276 (0.36%) |
occurrences all number
|
1 |
1 |
exostosis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
flank pain
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
3 / 277 (1.08%) |
11 / 276 (3.99%) |
occurrences all number
|
3 |
16 |
groin pain
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
1 / 276 (0.36%) |
occurrences all number
|
1 |
1 |
intervertebral disc protrusion
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
1 / 276 (0.36%) |
occurrences all number
|
2 |
1 |
joint crepitation
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
joint effusion
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
joint stiffness
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
joint swelling
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
2 / 276 (0.72%) |
occurrences all number
|
0 |
4 |
lumbar spinal stenosis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
metatarsalgia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
mobility decreased
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
muscle atrophy
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
muscle spasms
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
6 / 277 (2.17%) |
6 / 276 (2.17%) |
occurrences all number
|
11 |
7 |
muscular weakness
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
5 / 277 (1.81%) |
4 / 276 (1.45%) |
occurrences all number
|
6 |
4 |
musculoskeletal chest pain
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
7 / 277 (2.53%) |
11 / 276 (3.99%) |
occurrences all number
|
9 |
13 |
musculoskeletal pain
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
18 / 277 (6.50%) |
12 / 276 (4.35%) |
occurrences all number
|
26 |
13 |
musculoskeletal stiffness
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
myalgia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
11 / 277 (3.97%) |
7 / 276 (2.54%) |
occurrences all number
|
14 |
9 |
neck mass
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
neck pain
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
2 / 276 (0.72%) |
occurrences all number
|
2 |
2 |
osteoarthritis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
osteonecrosis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
pain in extremity
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
12 / 277 (4.33%) |
6 / 276 (2.17%) |
occurrences all number
|
14 |
8 |
pain in jaw
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
0 / 276 (0.00%) |
occurrences all number
|
2 |
0 |
pathological fracture
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
0 / 276 (0.00%) |
occurrences all number
|
2 |
0 |
rheumatic disorder
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
scleroderma
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
spinal osteoarthritis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
spinal pain
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
4 / 276 (1.45%) |
occurrences all number
|
0 |
4 |
temporomandibular joint syndrome
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
tenosynovitis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
Infections and infestations
|
|
|
abdominal infection
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
anal abscess
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
0 / 276 (0.00%) |
occurrences all number
|
2 |
0 |
anisakiasis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
biliary tract infection
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
bronchitis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
5 / 277 (1.81%) |
3 / 276 (1.09%) |
occurrences all number
|
5 |
3 |
bronchopneumonia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
0 / 276 (0.00%) |
occurrences all number
|
2 |
0 |
candida infection
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
2 / 276 (0.72%) |
occurrences all number
|
0 |
2 |
cellulitis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
cystitis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
diarrhoea infectious
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
ear infection
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
erysipelas
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
fungal infection
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
gastroenteritis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
3 / 277 (1.08%) |
0 / 276 (0.00%) |
occurrences all number
|
3 |
0 |
gastroenteritis bacterial
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
gingival abscess
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
gingivitis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
4 / 277 (1.44%) |
0 / 276 (0.00%) |
occurrences all number
|
6 |
0 |
hepatitis a
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
herpes simplex
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
2 |
herpes zoster
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
infection
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
3 / 276 (1.09%) |
occurrences all number
|
1 |
3 |
influenza
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
1 / 276 (0.36%) |
occurrences all number
|
2 |
1 |
kidney infection
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
labyrinthitis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
laryngitis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
0 / 276 (0.00%) |
occurrences all number
|
2 |
0 |
lip infection
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
liver abscess
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
localised infection
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
lung infection
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
1 / 276 (0.36%) |
occurrences all number
|
1 |
1 |
nasopharyngitis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
15 / 277 (5.42%) |
14 / 276 (5.07%) |
occurrences all number
|
15 |
16 |
oesophageal candidiasis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
oral candidiasis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
1 / 276 (0.36%) |
occurrences all number
|
1 |
1 |
oral herpes
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
3 / 276 (1.09%) |
occurrences all number
|
1 |
3 |
oral infection
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
paronychia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
periodontitis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
peritonitis bacterial
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
pharyngitis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
1 / 276 (0.36%) |
occurrences all number
|
1 |
1 |
pharyngotonsillitis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
pneumonia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
2 |
proteus infection
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
pyelonephritis acute
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
rash pustular
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
3 / 277 (1.08%) |
0 / 276 (0.00%) |
occurrences all number
|
3 |
0 |
respiratory tract infection
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
3 / 277 (1.08%) |
1 / 276 (0.36%) |
occurrences all number
|
3 |
1 |
rhinitis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
6 / 277 (2.17%) |
0 / 276 (0.00%) |
occurrences all number
|
7 |
0 |
sepsis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
sinusitis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
4 / 277 (1.44%) |
1 / 276 (0.36%) |
occurrences all number
|
4 |
1 |
skin candida
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
staphylococcal infection
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
tinea cruris
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
tinea pedis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
1 / 276 (0.36%) |
occurrences all number
|
2 |
1 |
tinea infection
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
1 / 276 (0.36%) |
occurrences all number
|
1 |
1 |
tonsillitis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
tooth abscess
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
1 / 276 (0.36%) |
occurrences all number
|
2 |
1 |
tooth infection
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
tracheitis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
upper respiratory tract infection
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
11 / 277 (3.97%) |
6 / 276 (2.17%) |
occurrences all number
|
14 |
8 |
urinary tract infection
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
10 / 277 (3.61%) |
6 / 276 (2.17%) |
occurrences all number
|
10 |
6 |
urinary tract infection bacterial
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
vulvovaginal candidiasis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed [6]
|
0 / 47 (0.00%) |
1 / 40 (2.50%) |
occurrences all number
|
0 |
2 |
vulvitis
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed [7]
|
1 / 47 (2.13%) |
0 / 40 (0.00%) |
occurrences all number
|
1 |
0 |
Metabolism and nutrition disorders
|
|
|
cachexia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
1 / 276 (0.36%) |
occurrences all number
|
1 |
1 |
decreased appetite
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
59 / 277 (21.30%) |
50 / 276 (18.12%) |
occurrences all number
|
81 |
62 |
dehydration
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
8 / 277 (2.89%) |
5 / 276 (1.81%) |
occurrences all number
|
9 |
5 |
diabetes mellitus
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
4 / 276 (1.45%) |
occurrences all number
|
2 |
4 |
fluid retention
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
0 / 276 (0.00%) |
occurrences all number
|
2 |
0 |
glucose tolerance impaired
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
0 / 276 (0.00%) |
occurrences all number
|
2 |
0 |
gout
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
1 / 276 (0.36%) |
occurrences all number
|
1 |
1 |
hyperammonaemia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
2 / 276 (0.72%) |
occurrences all number
|
1 |
2 |
hypercalcaemia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
3 / 276 (1.09%) |
occurrences all number
|
2 |
4 |
hypercreatininaemia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
0 / 276 (0.00%) |
occurrences all number
|
3 |
0 |
hyperglycaemia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
9 / 277 (3.25%) |
11 / 276 (3.99%) |
occurrences all number
|
26 |
15 |
hyperkalaemia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
13 / 277 (4.69%) |
11 / 276 (3.99%) |
occurrences all number
|
17 |
11 |
hypernatraemia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
hyperphagia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
hypertriglyceridaemia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
3 |
0 |
hyperuricaemia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
8 / 277 (2.89%) |
4 / 276 (1.45%) |
occurrences all number
|
20 |
5 |
hypoalbuminaemia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
33 / 277 (11.91%) |
14 / 276 (5.07%) |
occurrences all number
|
66 |
27 |
hypocalcaemia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
4 / 277 (1.44%) |
3 / 276 (1.09%) |
occurrences all number
|
11 |
3 |
hypoglycaemia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
1 / 276 (0.36%) |
occurrences all number
|
1 |
1 |
hypokalaemia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
7 / 277 (2.53%) |
10 / 276 (3.62%) |
occurrences all number
|
9 |
15 |
hypomagnesaemia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
4 / 277 (1.44%) |
3 / 276 (1.09%) |
occurrences all number
|
5 |
3 |
hyponatraemia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
13 / 277 (4.69%) |
15 / 276 (5.43%) |
occurrences all number
|
21 |
20 |
hypophosphataemia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
5 / 277 (1.81%) |
3 / 276 (1.09%) |
occurrences all number
|
9 |
6 |
increased appetite
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
2 / 277 (0.72%) |
0 / 276 (0.00%) |
occurrences all number
|
2 |
0 |
iron deficiency
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
1 / 276 (0.36%) |
occurrences all number
|
1 |
1 |
malnutrition
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
2 / 276 (0.72%) |
occurrences all number
|
0 |
2 |
polydipsia
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
type 2 diabetes mellitus
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
0 / 277 (0.00%) |
1 / 276 (0.36%) |
occurrences all number
|
0 |
1 |
vitamin b1 deficiency
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
vitamin b6 deficiency
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
1 |
0 |
vitamin d deficiency
|
|
|
alternative dictionary used: MedDRA
16.1
|
|
|
subjects affected / exposed
|
1 / 277 (0.36%) |
0 / 276 (0.00%) |
occurrences all number
|
2 |
0 |