Non-serious adverse events
|
AZD8931 40 mg bd |
AZD8931 80 mg bd |
AZD8931 120 mg bd |
AZD8931 160 mg bd |
AZD8931 40MG bd + Paclitaxel |
Placebo + Paclitaxel |
Total subjects affected by non serious adverse events
|
|
|
|
|
|
|
subjects affected / exposed
|
6 / 6 (100.00%) |
6 / 6 (100.00%) |
2 / 2 (100.00%) |
6 / 6 (100.00%) |
93 / 94 (98.94%) |
94 / 95 (98.95%) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
|
|
|
|
BREAST CANCER
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
UTERINE LEIOMYOMA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
Vascular disorders
|
|
|
|
|
|
|
FLUSHING
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
2 / 94 (2.13%) |
2 / 95 (2.11%) |
occurrences all number
|
0 |
0 |
0 |
0 |
11 |
5 |
HAEMATOMA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
2 / 94 (2.13%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
2 |
0 |
HAEMORRHAGE
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
HOT FLUSH
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
2 / 94 (2.13%) |
3 / 95 (3.16%) |
occurrences all number
|
0 |
0 |
0 |
0 |
2 |
3 |
HYPERAEMIA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
2 |
HYPERTENSION
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
2 / 6 (33.33%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
7 / 94 (7.45%) |
3 / 95 (3.16%) |
occurrences all number
|
0 |
2 |
0 |
0 |
24 |
4 |
HYPOTENSION
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
3 / 95 (3.16%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
3 |
LYMPHOEDEMA
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 6 (16.67%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
1 / 6 (16.67%) |
3 / 94 (3.19%) |
6 / 95 (6.32%) |
occurrences all number
|
1 |
0 |
0 |
1 |
3 |
6 |
ORTHOSTATIC HYPOTENSION
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
PHLEBITIS
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
VASCULITIS
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
VARICOSE VEIN
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
1 / 6 (16.67%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
1 |
General disorders and administration site conditions
|
|
|
|
|
|
|
ASTHENIA
|
|
|
|
|
|
|
subjects affected / exposed
|
5 / 6 (83.33%) |
6 / 6 (100.00%) |
2 / 2 (100.00%) |
5 / 6 (83.33%) |
25 / 94 (26.60%) |
12 / 95 (12.63%) |
occurrences all number
|
8 |
11 |
2 |
7 |
30 |
16 |
AXILLARY PAIN
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
CATHETER SITE ERYTHEMA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
CATHETER SITE HAEMATOMA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
CATHETER SITE INFLAMMATION
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
CATHETER SITE PAIN
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
CHEST DISCOMFORT
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
CHEST PAIN
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
2 / 95 (2.11%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
2 |
CHILLS
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
5 / 94 (5.32%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
5 |
0 |
DISCOMFORT
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
FACE OEDEMA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
2 / 94 (2.13%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
2 |
0 |
FATIGUE
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
25 / 94 (26.60%) |
25 / 95 (26.32%) |
occurrences all number
|
0 |
0 |
0 |
0 |
40 |
29 |
FEELING COLD
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
2 / 94 (2.13%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
4 |
0 |
GAIT DISTURBANCE
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
1 / 6 (16.67%) |
1 / 94 (1.06%) |
2 / 95 (2.11%) |
occurrences all number
|
0 |
0 |
0 |
1 |
1 |
2 |
INFLUENZA LIKE ILLNESS
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
3 / 95 (3.16%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
3 |
INFUSION SITE DISCOMFORT
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
IRRITABILITY
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
1 / 6 (16.67%) |
0 / 94 (0.00%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
1 |
0 |
0 |
MALAISE
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
2 / 94 (2.13%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
2 |
1 |
MUCOSAL DRYNESS
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
1 / 6 (16.67%) |
0 / 94 (0.00%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
1 |
0 |
0 |
MUCOSAL INFLAMMATION
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
1 / 6 (16.67%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
21 / 94 (22.34%) |
9 / 95 (9.47%) |
occurrences all number
|
0 |
1 |
0 |
0 |
35 |
9 |
NODULE
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
NON-CARDIAC CHEST PAIN
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 6 (16.67%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
5 / 94 (5.32%) |
0 / 95 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
5 |
0 |
OEDEMA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
1 / 6 (16.67%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
4 / 94 (4.26%) |
3 / 95 (3.16%) |
occurrences all number
|
0 |
1 |
0 |
0 |
4 |
3 |
OEDEMA PERIPHERAL
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 6 (33.33%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
10 / 94 (10.64%) |
11 / 95 (11.58%) |
occurrences all number
|
2 |
0 |
0 |
0 |
13 |
18 |
PAIN
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
9 / 94 (9.57%) |
4 / 95 (4.21%) |
occurrences all number
|
0 |
0 |
0 |
0 |
16 |
17 |
PYREXIA
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 6 (16.67%) |
1 / 6 (16.67%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
7 / 94 (7.45%) |
11 / 95 (11.58%) |
occurrences all number
|
1 |
2 |
0 |
0 |
9 |
11 |
SPINAL PAIN
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
1 |
XEROSIS
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
Immune system disorders
|
|
|
|
|
|
|
DRUG HYPERSENSITIVITY
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 6 (16.67%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
5 / 94 (5.32%) |
3 / 95 (3.16%) |
occurrences all number
|
1 |
0 |
0 |
0 |
5 |
4 |
HYPERSENSITIVITY
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
Reproductive system and breast disorders
|
|
|
|
|
|
|
BREAST DISCHARGE
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
BREAST ENGORGEMENT
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
BREAST HAEMORRHAGE
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
BREAST INFLAMMATION
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
BREAST PAIN
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
3 / 94 (3.19%) |
2 / 95 (2.11%) |
occurrences all number
|
0 |
0 |
0 |
0 |
5 |
2 |
GENITAL DISCHARGE
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
GENITAL RASH
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
1 / 6 (16.67%) |
0 / 94 (0.00%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
1 |
0 |
0 |
VAGINAL INFLAMMATION
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
1 / 6 (16.67%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
2 |
0 |
VULVAL ULCERATION
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
VULVOVAGINAL BURNING SENSATION
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
VULVOVAGINAL PRURITUS
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
1 |
Respiratory, thoracic and mediastinal disorders
|
|
|
|
|
|
|
BRONCHOPNEUMOPATHY
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
BRONCHOSPASM
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
COUGH
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 6 (33.33%) |
2 / 6 (33.33%) |
0 / 2 (0.00%) |
2 / 6 (33.33%) |
12 / 94 (12.77%) |
19 / 95 (20.00%) |
occurrences all number
|
3 |
3 |
0 |
2 |
14 |
26 |
DYSPHONIA
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 6 (16.67%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
1 / 6 (16.67%) |
2 / 94 (2.13%) |
3 / 95 (3.16%) |
occurrences all number
|
1 |
0 |
0 |
1 |
2 |
3 |
DYSPNOEA
|
|
|
|
|
|
|
subjects affected / exposed
|
3 / 6 (50.00%) |
0 / 6 (0.00%) |
1 / 2 (50.00%) |
0 / 6 (0.00%) |
7 / 94 (7.45%) |
8 / 95 (8.42%) |
occurrences all number
|
5 |
0 |
1 |
0 |
10 |
8 |
DYSPNOEA EXERTIONAL
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
2 / 94 (2.13%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
2 |
1 |
EPISTAXIS
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 6 (33.33%) |
3 / 6 (50.00%) |
0 / 2 (0.00%) |
1 / 6 (16.67%) |
19 / 94 (20.21%) |
11 / 95 (11.58%) |
occurrences all number
|
2 |
4 |
0 |
1 |
21 |
12 |
HAEMOPTYSIS
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
HICCUPS
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
HYPEROXIA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
HYPOXIA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
2 / 94 (2.13%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
2 |
0 |
NASAL CONGESTION
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
NASAL DISCOMFORT
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
NASAL DRYNESS
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
1 / 6 (16.67%) |
3 / 94 (3.19%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
1 |
3 |
0 |
NASAL MUCOSAL DISORDER
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
2 |
NASAL OBSTRUCTION
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
OBSTRUCTIVE AIRWAYS DISORDER
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
2 / 94 (2.13%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
2 |
0 |
OROPHARYNGEAL DISCOMFORT
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
1 / 6 (16.67%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
0 |
OROPHARYNGEAL PAIN
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
2 / 94 (2.13%) |
3 / 95 (3.16%) |
occurrences all number
|
0 |
0 |
0 |
0 |
2 |
3 |
PLEURITIC PAIN
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
PNEUMOTHORAX
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
PRODUCTIVE COUGH
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
2 / 94 (2.13%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
2 |
0 |
PULMONARY EMBOLISM
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
2 |
PULMONARY OEDEMA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
RHINALGIA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
2 / 94 (2.13%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
4 |
0 |
SINUS CONGESTION
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
THROAT IRRITATION
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
UPPER AIRWAY OBSTRUCTION
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
WHEEZING
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
2 |
0 |
RHINORRHOEA
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 6 (16.67%) |
2 / 6 (33.33%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
3 / 94 (3.19%) |
1 / 95 (1.05%) |
occurrences all number
|
1 |
2 |
0 |
0 |
3 |
1 |
Psychiatric disorders
|
|
|
|
|
|
|
AFFECT LABILITY
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
ANXIETY
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
6 / 94 (6.38%) |
11 / 95 (11.58%) |
occurrences all number
|
0 |
0 |
0 |
0 |
6 |
13 |
APATHY
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
BRADYPHRENIA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
1 / 6 (16.67%) |
0 / 94 (0.00%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
1 |
0 |
0 |
CONFUSIONAL STATE
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
1 |
DEPRESSED MOOD
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
3 / 94 (3.19%) |
4 / 95 (4.21%) |
occurrences all number
|
0 |
0 |
0 |
0 |
4 |
4 |
DEPRESSION
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
2 / 94 (2.13%) |
4 / 95 (4.21%) |
occurrences all number
|
0 |
0 |
0 |
0 |
2 |
4 |
INSOMNIA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
1 / 6 (16.67%) |
12 / 94 (12.77%) |
14 / 95 (14.74%) |
occurrences all number
|
0 |
0 |
0 |
1 |
13 |
14 |
MOOD ALTERED
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
2 |
NERVOUSNESS
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
2 / 95 (2.11%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
2 |
RESTLESSNESS
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
SLEEP DISORDER
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
Investigations
|
|
|
|
|
|
|
ASPARTATE AMINOTRANSFERASE INCREASED
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
3 / 95 (3.16%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
3 |
BLOOD ALKALINE PHOSPHATASE INCREASED
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
BLOOD BILIRUBIN INCREASED
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
BLOOD CHOLESTEROL INCREASED
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
BLOOD CREATININE INCREASED
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 6 (16.67%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
1 / 95 (1.05%) |
occurrences all number
|
1 |
0 |
0 |
0 |
1 |
1 |
BLOOD POTASSIUM DECREASED
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
CAPILLARY FRAGILITY TEST
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
ELECTROCARDIOGRAM CHANGE
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
ELECTROCARDIOGRAM QT PROLONGED
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
4 / 94 (4.26%) |
4 / 95 (4.21%) |
occurrences all number
|
0 |
0 |
0 |
0 |
6 |
5 |
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
2 / 94 (2.13%) |
2 / 95 (2.11%) |
occurrences all number
|
0 |
0 |
0 |
0 |
2 |
2 |
HAEMOGLOBIN DECREASED
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
LIVER FUNCTION TEST ABNORMAL
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
NEUTROPHIL COUNT DECREASED
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
2 / 94 (2.13%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
3 |
0 |
PULMONARY PHYSICAL EXAMINATION ABNORMAL
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
TRANSAMINASES INCREASED
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
URINE COLOUR ABNORMAL
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
WEIGHT DECREASED
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
8 / 94 (8.51%) |
3 / 95 (3.16%) |
occurrences all number
|
0 |
0 |
0 |
0 |
9 |
3 |
WEIGHT INCREASED
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
3 / 95 (3.16%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
3 |
WHITE BLOOD CELL COUNT DECREASED
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
2 |
ALANINE AMINOTRANSFERASE INCREASED
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
2 / 94 (2.13%) |
4 / 95 (4.21%) |
occurrences all number
|
0 |
0 |
0 |
0 |
2 |
4 |
Injury, poisoning and procedural complications
|
|
|
|
|
|
|
ARTHROPOD BITE
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
ARTHROPOD STING
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
CONTUSION
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
ESCHAR
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
FALL
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
HEAD INJURY
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
INFUSION RELATED REACTION
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
3 / 95 (3.16%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
6 |
LACERATION
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
LIGAMENT SPRAIN
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
2 / 95 (2.11%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
2 |
LIMB INJURY
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
1 / 6 (16.67%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
1 |
1 |
0 |
POST PROCEDURAL COMPLICATION
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
PROCEDURAL PAIN
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
RECALL PHENOMENON
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
RIB FRACTURE
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
2 |
SKIN INJURY
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
THERMAL BURN
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
1 / 6 (16.67%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
0 |
TOOTH FRACTURE
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
WOUND
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
WOUND DEHISCENCE
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
1 / 6 (16.67%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
2 |
0 |
Cardiac disorders
|
|
|
|
|
|
|
ANGINA UNSTABLE
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
2 / 94 (2.13%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
2 |
0 |
PALPITATIONS
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
2 / 95 (2.11%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
2 |
PERICARDIAL EFFUSION
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
VENTRICULAR EXTRASYSTOLES
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
CARDIAC FAILURE
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
LEFT VENTRICULAR DYSFUNCTION
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
1 / 6 (16.67%) |
0 / 94 (0.00%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
1 |
0 |
0 |
TACHYCARDIA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
2 / 94 (2.13%) |
2 / 95 (2.11%) |
occurrences all number
|
0 |
0 |
0 |
0 |
2 |
4 |
Nervous system disorders
|
|
|
|
|
|
|
AGEUSIA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
AMNESIA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
2 / 95 (2.11%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
2 |
ANOSMIA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
APHASIA
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 6 (16.67%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
0 / 95 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
0 |
0 |
0 |
APHONIA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
1 / 6 (16.67%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
3 / 94 (3.19%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
3 |
0 |
ATAXIA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
COGNITIVE DISORDER
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
1 / 6 (16.67%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
1 |
0 |
1 |
DIZZINESS
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 6 (33.33%) |
3 / 6 (50.00%) |
0 / 2 (0.00%) |
1 / 6 (16.67%) |
7 / 94 (7.45%) |
7 / 95 (7.37%) |
occurrences all number
|
2 |
3 |
0 |
1 |
10 |
10 |
DYSAESTHESIA
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 6 (16.67%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
1 |
DYSARTHRIA
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 6 (16.67%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
0 / 95 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
0 |
DYSGEUSIA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
1 / 6 (16.67%) |
0 / 2 (0.00%) |
1 / 6 (16.67%) |
9 / 94 (9.57%) |
2 / 95 (2.11%) |
occurrences all number
|
0 |
1 |
0 |
1 |
13 |
2 |
FACIAL NEURALGIA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
HEADACHE
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
2 / 6 (33.33%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
13 / 94 (13.83%) |
16 / 95 (16.84%) |
occurrences all number
|
0 |
2 |
0 |
0 |
21 |
18 |
HYPOAESTHESIA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
2 / 94 (2.13%) |
4 / 95 (4.21%) |
occurrences all number
|
0 |
0 |
0 |
0 |
3 |
4 |
HYPOGEUSIA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
2 / 94 (2.13%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
2 |
0 |
HYPOKINESIA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
HYPOSMIA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
LETHARGY
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
6 / 94 (6.38%) |
4 / 95 (4.21%) |
occurrences all number
|
0 |
0 |
0 |
0 |
7 |
4 |
MIGRAINE
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
MIGRAINE WITH AURA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
MOTOR DYSFUNCTION
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
2 |
NEURALGIA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
6 |
NEUROPATHY PERIPHERAL
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
2 / 6 (33.33%) |
28 / 94 (29.79%) |
25 / 95 (26.32%) |
occurrences all number
|
0 |
0 |
0 |
3 |
34 |
27 |
PARAESTHESIA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
13 / 94 (13.83%) |
19 / 95 (20.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
18 |
22 |
PERIPHERAL SENSORY NEUROPATHY
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
11 / 94 (11.70%) |
11 / 95 (11.58%) |
occurrences all number
|
0 |
0 |
0 |
0 |
13 |
13 |
POLYNEUROPATHY
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
2 / 94 (2.13%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
3 |
1 |
PRESYNCOPE
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
1 |
RESTLESS LEGS SYNDROME
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
SCIATICA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
TREMOR
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
DISTURBANCE IN ATTENTION
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 6 (16.67%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
0 / 95 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
0 |
NEUROTOXICITY
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
4 / 6 (66.67%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
5 / 94 (5.32%) |
10 / 95 (10.53%) |
occurrences all number
|
0 |
4 |
0 |
0 |
8 |
19 |
Blood and lymphatic system disorders
|
|
|
|
|
|
|
ANAEMIA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
1 / 6 (16.67%) |
23 / 94 (24.47%) |
10 / 95 (10.53%) |
occurrences all number
|
0 |
0 |
0 |
1 |
34 |
14 |
GRANULOCYTOPENIA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
LEUKOPENIA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
5 / 94 (5.32%) |
5 / 95 (5.26%) |
occurrences all number
|
0 |
0 |
0 |
0 |
27 |
7 |
LYMPH NODE PAIN
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
LYMPHADENOPATHY
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
NEUTROPENIA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
1 / 6 (16.67%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
14 / 94 (14.89%) |
39 / 95 (41.05%) |
occurrences all number
|
0 |
1 |
0 |
0 |
42 |
86 |
Ear and labyrinth disorders
|
|
|
|
|
|
|
DEAFNESS
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
2 / 94 (2.13%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
2 |
0 |
EAR DISCOMFORT
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 6 (16.67%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
0 / 95 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
0 |
EAR PAIN
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 6 (16.67%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
1 / 95 (1.05%) |
occurrences all number
|
1 |
0 |
0 |
0 |
1 |
1 |
VERTIGO
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
3 / 95 (3.16%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
3 |
VERTIGO POSITIONAL
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
TINNITUS
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
Eye disorders
|
|
|
|
|
|
|
ASTHENOPIA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
BLEPHARITIS
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
CATARACT
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
CONJUNCTIVAL DISORDER
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
1 / 6 (16.67%) |
0 / 94 (0.00%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
1 |
0 |
0 |
CONJUNCTIVITIS
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
3 / 6 (50.00%) |
0 / 2 (0.00%) |
1 / 6 (16.67%) |
7 / 94 (7.45%) |
5 / 95 (5.26%) |
occurrences all number
|
0 |
3 |
0 |
1 |
7 |
5 |
DRY EYE
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
1 / 6 (16.67%) |
0 / 2 (0.00%) |
3 / 6 (50.00%) |
8 / 94 (8.51%) |
3 / 95 (3.16%) |
occurrences all number
|
0 |
1 |
0 |
4 |
8 |
3 |
ERYTHEMA OF EYELID
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
1 / 6 (16.67%) |
0 / 94 (0.00%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
1 |
0 |
0 |
EXOPHTHALMOS
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
1 / 6 (16.67%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
0 |
EXTRAOCULAR MUSCLE PARESIS
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
EYE DISORDER
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
1 |
EYE HAEMORRHAGE
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
EYE IRRITATION
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
4 / 94 (4.26%) |
5 / 95 (5.26%) |
occurrences all number
|
0 |
0 |
0 |
0 |
4 |
5 |
EYE PAIN
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
EYE PRURITUS
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
1 / 6 (16.67%) |
0 / 2 (0.00%) |
1 / 6 (16.67%) |
2 / 94 (2.13%) |
3 / 95 (3.16%) |
occurrences all number
|
0 |
1 |
0 |
1 |
2 |
3 |
EYELID OEDEMA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
2 / 94 (2.13%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
2 |
0 |
KERATITIS
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
1 / 6 (16.67%) |
0 / 2 (0.00%) |
1 / 6 (16.67%) |
1 / 94 (1.06%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
1 |
0 |
1 |
1 |
1 |
LACRIMATION INCREASED
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
1 / 6 (16.67%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
2 / 94 (2.13%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
1 |
0 |
0 |
6 |
1 |
MACULAR DEGENERATION
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
MYOPIA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
OCULAR HYPERAEMIA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
2 / 6 (33.33%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
3 / 94 (3.19%) |
3 / 95 (3.16%) |
occurrences all number
|
0 |
3 |
0 |
0 |
3 |
3 |
OCULAR TOXICITY
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
PHOTOPHOBIA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
1 / 6 (16.67%) |
2 / 94 (2.13%) |
2 / 95 (2.11%) |
occurrences all number
|
0 |
0 |
0 |
2 |
2 |
2 |
PUNCTATE KERATITIS
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
SCLERAL HYPERAEMIA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
VISUAL ACUITY REDUCED
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
2 / 94 (2.13%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
2 |
0 |
VISUAL IMPAIRMENT
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
3 / 94 (3.19%) |
2 / 95 (2.11%) |
occurrences all number
|
0 |
0 |
0 |
0 |
3 |
2 |
XEROPHTHALMIA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
VISION BLURRED
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
4 / 94 (4.26%) |
3 / 95 (3.16%) |
occurrences all number
|
0 |
0 |
0 |
0 |
4 |
3 |
Gastrointestinal disorders
|
|
|
|
|
|
|
ABDOMINAL DISCOMFORT
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
ABDOMINAL DISTENSION
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
ABDOMINAL PAIN
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
1 / 6 (16.67%) |
0 / 2 (0.00%) |
1 / 6 (16.67%) |
8 / 94 (8.51%) |
12 / 95 (12.63%) |
occurrences all number
|
0 |
1 |
0 |
1 |
9 |
17 |
ABDOMINAL PAIN LOWER
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
3 / 94 (3.19%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
3 |
0 |
ABDOMINAL PAIN UPPER
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
4 / 6 (66.67%) |
0 / 2 (0.00%) |
2 / 6 (33.33%) |
15 / 94 (15.96%) |
7 / 95 (7.37%) |
occurrences all number
|
0 |
6 |
0 |
2 |
20 |
11 |
ANAL FISSURE
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
3 / 94 (3.19%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
3 |
1 |
ANAL INFLAMMATION
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
ANAL PRURITUS
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
APHTHOUS STOMATITIS
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
4 / 94 (4.26%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
4 |
1 |
CHAPPED LIPS
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
CHEILITIS
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 6 (33.33%) |
1 / 6 (16.67%) |
0 / 2 (0.00%) |
1 / 6 (16.67%) |
5 / 94 (5.32%) |
0 / 95 (0.00%) |
occurrences all number
|
2 |
1 |
0 |
1 |
8 |
0 |
CONSTIPATION
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 6 (16.67%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
2 / 6 (33.33%) |
19 / 94 (20.21%) |
23 / 95 (24.21%) |
occurrences all number
|
1 |
0 |
0 |
2 |
25 |
29 |
DENTAL CARIES
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
DIARRHOEA
|
|
|
|
|
|
|
subjects affected / exposed
|
5 / 6 (83.33%) |
6 / 6 (100.00%) |
2 / 2 (100.00%) |
5 / 6 (83.33%) |
78 / 94 (82.98%) |
33 / 95 (34.74%) |
occurrences all number
|
12 |
25 |
3 |
15 |
247 |
65 |
DRY MOUTH
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 6 (16.67%) |
1 / 6 (16.67%) |
0 / 2 (0.00%) |
2 / 6 (33.33%) |
5 / 94 (5.32%) |
1 / 95 (1.05%) |
occurrences all number
|
1 |
2 |
0 |
2 |
5 |
1 |
DYSPEPSIA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
16 / 94 (17.02%) |
9 / 95 (9.47%) |
occurrences all number
|
0 |
0 |
0 |
0 |
19 |
9 |
DYSPHAGIA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
3 / 94 (3.19%) |
2 / 95 (2.11%) |
occurrences all number
|
0 |
0 |
0 |
0 |
3 |
2 |
EPIGASTRIC DISCOMFORT
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
GASTRIC DISORDER
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
GASTRIC ULCER
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
GASTRITIS
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
5 / 94 (5.32%) |
5 / 95 (5.26%) |
occurrences all number
|
0 |
0 |
0 |
0 |
5 |
5 |
GASTROOESOPHAGEAL REFLUX DISEASE
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
2 / 95 (2.11%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
2 |
GINGIVAL BLEEDING
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
GINGIVITIS
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
GLOSSITIS
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
GLOSSODYNIA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
HAEMORRHOIDS
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
5 / 94 (5.32%) |
3 / 95 (3.16%) |
occurrences all number
|
0 |
0 |
0 |
0 |
5 |
4 |
HYPOAESTHESIA ORAL
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
INTESTINAL POLYP
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
LIP DRY
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
LIP PAIN
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
MUCOUS STOOLS
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
NAUSEA
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 6 (16.67%) |
3 / 6 (50.00%) |
1 / 2 (50.00%) |
3 / 6 (50.00%) |
39 / 94 (41.49%) |
30 / 95 (31.58%) |
occurrences all number
|
1 |
3 |
1 |
5 |
69 |
39 |
ODYNOPHAGIA
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 6 (16.67%) |
0 / 6 (0.00%) |
1 / 2 (50.00%) |
0 / 6 (0.00%) |
3 / 94 (3.19%) |
1 / 95 (1.05%) |
occurrences all number
|
1 |
0 |
1 |
0 |
4 |
1 |
OESOPHAGEAL PAIN
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
OESOPHAGITIS
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
1 / 6 (16.67%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
0 |
ORAL DISCOMFORT
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
1 / 6 (16.67%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
1 |
0 |
ORAL DYSAESTHESIA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
2 / 94 (2.13%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
2 |
1 |
ORAL MUCOSAL BLISTERING
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
ORAL PAIN
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
ORAL TOXICITY
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
2 |
PERIANAL ERYTHEMA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
1 / 6 (16.67%) |
0 / 94 (0.00%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
1 |
0 |
0 |
PROCTALGIA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
2 / 94 (2.13%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
3 |
0 |
RECTAL FISSURE
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
RECTAL HAEMORRHAGE
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
2 / 94 (2.13%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
2 |
0 |
STOMATITIS
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 6 (33.33%) |
3 / 6 (50.00%) |
1 / 2 (50.00%) |
1 / 6 (16.67%) |
20 / 94 (21.28%) |
3 / 95 (3.16%) |
occurrences all number
|
2 |
7 |
1 |
1 |
26 |
3 |
TOOTHACHE
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
3 / 94 (3.19%) |
5 / 95 (5.26%) |
occurrences all number
|
0 |
0 |
0 |
0 |
3 |
8 |
VOMITING
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 6 (16.67%) |
2 / 6 (33.33%) |
1 / 2 (50.00%) |
2 / 6 (33.33%) |
24 / 94 (25.53%) |
14 / 95 (14.74%) |
occurrences all number
|
1 |
2 |
1 |
3 |
43 |
27 |
Hepatobiliary disorders
|
|
|
|
|
|
|
GALLBLADDER PAIN
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
HEPATOTOXICITY
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
HYPERBILIRUBINAEMIA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
Skin and subcutaneous tissue disorders
|
|
|
|
|
|
|
ACNE
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
2 / 94 (2.13%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
2 |
0 |
ALOPECIA
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 6 (33.33%) |
3 / 6 (50.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
45 / 94 (47.87%) |
48 / 95 (50.53%) |
occurrences all number
|
2 |
3 |
0 |
0 |
45 |
49 |
DERMAL CYST
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
DERMATITIS
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
2 / 94 (2.13%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
2 |
0 |
DERMATITIS ACNEIFORM
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
21 / 94 (22.34%) |
2 / 95 (2.11%) |
occurrences all number
|
0 |
0 |
0 |
0 |
40 |
2 |
DERMATITIS ALLERGIC
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
DRUG ERUPTION
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
1 / 6 (16.67%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
1 |
1 |
0 |
ECZEMA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
2 / 94 (2.13%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
2 |
0 |
ERYTHEMA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
7 / 94 (7.45%) |
2 / 95 (2.11%) |
occurrences all number
|
0 |
0 |
0 |
0 |
9 |
2 |
EXFOLIATIVE RASH
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
2 / 94 (2.13%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
2 |
1 |
HEAT RASH
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
INGROWING NAIL
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
INTERTRIGO
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 6 (16.67%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
1 |
0 |
MADAROSIS
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
1 |
NAIL DISCOLOURATION
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
4 / 94 (4.26%) |
2 / 95 (2.11%) |
occurrences all number
|
0 |
0 |
0 |
0 |
4 |
2 |
NAIL DISORDER
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 6 (16.67%) |
3 / 6 (50.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
7 / 94 (7.45%) |
8 / 95 (8.42%) |
occurrences all number
|
1 |
4 |
0 |
0 |
7 |
8 |
NAIL DYSTROPHY
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
3 / 94 (3.19%) |
3 / 95 (3.16%) |
occurrences all number
|
0 |
0 |
0 |
0 |
3 |
4 |
NAIL PIGMENTATION
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
ONYCHOCLASIS
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
ONYCHOLYSIS
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
4 / 94 (4.26%) |
5 / 95 (5.26%) |
occurrences all number
|
0 |
0 |
0 |
0 |
4 |
5 |
ONYCHOMADESIS
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
2 / 6 (33.33%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
4 / 94 (4.26%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
0 |
5 |
0 |
PHOTOSENSITIVITY REACTION
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
PRURITUS
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 6 (16.67%) |
1 / 6 (16.67%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
18 / 94 (19.15%) |
6 / 95 (6.32%) |
occurrences all number
|
1 |
4 |
0 |
0 |
19 |
6 |
PRURITUS GENERALISED
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
1 / 6 (16.67%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
1 |
0 |
PURPURA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
RASH
|
|
|
|
|
|
|
subjects affected / exposed
|
3 / 6 (50.00%) |
5 / 6 (83.33%) |
1 / 2 (50.00%) |
4 / 6 (66.67%) |
59 / 94 (62.77%) |
20 / 95 (21.05%) |
occurrences all number
|
5 |
19 |
1 |
15 |
136 |
26 |
RASH ERYTHEMATOUS
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
RASH GENERALISED
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
RASH MACULAR
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
RASH MACULO-PAPULAR
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
4 / 94 (4.26%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
4 |
0 |
RASH PAPULAR
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
2 / 94 (2.13%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
3 |
0 |
RASH PRURITIC
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
2 |
SKIN CHAPPED
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
SKIN DISORDER
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
SKIN EXFOLIATION
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
3 / 94 (3.19%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
4 |
0 |
SKIN FISSURES
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
1 / 6 (16.67%) |
0 / 2 (0.00%) |
1 / 6 (16.67%) |
7 / 94 (7.45%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
1 |
0 |
1 |
7 |
1 |
SKIN HYPERPIGMENTATION
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 6 (16.67%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
2 / 94 (2.13%) |
1 / 95 (1.05%) |
occurrences all number
|
1 |
0 |
0 |
0 |
2 |
1 |
SKIN IRRITATION
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
SKIN LESION
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
SKIN PLAQUE
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
SKIN REACTION
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
2 / 94 (2.13%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
2 |
0 |
SKIN STRIAE
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 6 (16.67%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
0 / 95 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
0 |
SKIN TOXICITY
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
3 / 94 (3.19%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
3 |
0 |
SKIN ULCER
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
SWELLING FACE
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
TELANGIECTASIA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
2 / 94 (2.13%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
2 |
0 |
TOXIC SKIN ERUPTION
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
URTICARIA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
DERMATOSIS
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
DRY SKIN
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 6 (16.67%) |
3 / 6 (50.00%) |
0 / 2 (0.00%) |
3 / 6 (50.00%) |
32 / 94 (34.04%) |
7 / 95 (7.37%) |
occurrences all number
|
1 |
3 |
0 |
3 |
36 |
7 |
HYPERHIDROSIS
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
Renal and urinary disorders
|
|
|
|
|
|
|
BLADDER PAIN
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
CYSTITIS HAEMORRHAGIC
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
DYSURIA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
10 / 94 (10.64%) |
3 / 95 (3.16%) |
occurrences all number
|
0 |
0 |
0 |
0 |
13 |
4 |
HAEMATURIA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
3 / 94 (3.19%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
4 |
0 |
POLLAKIURIA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
2 / 94 (2.13%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
3 |
0 |
PROTEINURIA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
PYURIA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
RENAL FAILURE
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
2 / 94 (2.13%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
2 |
0 |
RENAL FAILURE ACUTE
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
URINARY INCONTINENCE
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
2 / 94 (2.13%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
3 |
0 |
INCONTINENCE
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
LEUKOCYTURIA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
5 / 94 (5.32%) |
4 / 95 (4.21%) |
occurrences all number
|
0 |
0 |
0 |
0 |
6 |
5 |
Endocrine disorders
|
|
|
|
|
|
|
ADDISON'S DISEASE
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
Musculoskeletal and connective tissue disorders
|
|
|
|
|
|
|
ARTHRALGIA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
2 / 6 (33.33%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
14 / 94 (14.89%) |
19 / 95 (20.00%) |
occurrences all number
|
0 |
2 |
0 |
0 |
25 |
26 |
ARTHRITIS
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
BACK PAIN
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
13 / 94 (13.83%) |
16 / 95 (16.84%) |
occurrences all number
|
0 |
0 |
0 |
0 |
20 |
30 |
BONE PAIN
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
1 / 6 (16.67%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
3 / 94 (3.19%) |
2 / 95 (2.11%) |
occurrences all number
|
0 |
2 |
0 |
0 |
5 |
3 |
BURSITIS
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
1 / 6 (16.67%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
0 |
JOINT SWELLING
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
LIMB DISCOMFORT
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
MUSCLE CONTRACTURE
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
MUSCLE RIGIDITY
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
MUSCLE SPASMS
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
2 / 6 (33.33%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
2 / 95 (2.11%) |
occurrences all number
|
0 |
2 |
0 |
0 |
1 |
2 |
MUSCULAR WEAKNESS
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 6 (16.67%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
1 / 6 (16.67%) |
3 / 94 (3.19%) |
3 / 95 (3.16%) |
occurrences all number
|
1 |
0 |
0 |
1 |
3 |
5 |
MUSCULOSKELETAL CHEST PAIN
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
8 / 94 (8.51%) |
7 / 95 (7.37%) |
occurrences all number
|
0 |
0 |
0 |
0 |
9 |
7 |
MUSCULOSKELETAL PAIN
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 6 (33.33%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
6 / 94 (6.38%) |
11 / 95 (11.58%) |
occurrences all number
|
2 |
0 |
0 |
0 |
9 |
14 |
MYALGIA
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 6 (16.67%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
6 / 94 (6.38%) |
9 / 95 (9.47%) |
occurrences all number
|
1 |
0 |
0 |
0 |
6 |
9 |
NECK PAIN
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
3 / 95 (3.16%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
4 |
OSTEONECROSIS OF JAW
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
PAIN IN EXTREMITY
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 6 (16.67%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
12 / 94 (12.77%) |
16 / 95 (16.84%) |
occurrences all number
|
1 |
0 |
0 |
0 |
19 |
25 |
PAIN IN JAW
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
PATHOLOGICAL FRACTURE
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
SENSATION OF HEAVINESS
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
2 / 95 (2.11%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
2 |
Infections and infestations
|
|
|
|
|
|
|
ABSCESS
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
BACTERIAL INFECTION
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
CANDIDIASIS
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
CELLULITIS
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
4 / 95 (4.21%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
4 |
CONJUNCTIVITIS BACTERIAL
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
CONJUNCTIVITIS INFECTIVE
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
CYSTITIS
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 6 (16.67%) |
1 / 6 (16.67%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
9 / 94 (9.57%) |
3 / 95 (3.16%) |
occurrences all number
|
1 |
4 |
0 |
0 |
11 |
3 |
DERMATOPHYTOSIS
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
DEVICE RELATED SEPSIS
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
EAR INFECTION
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
ERYSIPELAS
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
FOLLICULITIS
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
FURUNCLE
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
2 / 94 (2.13%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
2 |
0 |
GASTROENTERITIS VIRAL
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
HERPES VIRUS INFECTION
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
2 / 95 (2.11%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
4 |
HERPES ZOSTER
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
2 / 95 (2.11%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
2 |
HORDEOLUM
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
2 / 95 (2.11%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
2 |
LARYNGITIS
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
1 |
LOCALISED INFECTION
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 6 (16.67%) |
1 / 6 (16.67%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
3 / 94 (3.19%) |
0 / 95 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
0 |
3 |
0 |
LOWER RESPIRATORY TRACT INFECTION
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
2 / 94 (2.13%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
4 |
1 |
LUNG INFECTION
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
NAIL BED INFECTION
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
NASOPHARYNGITIS
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 6 (16.67%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
7 / 94 (7.45%) |
9 / 95 (9.47%) |
occurrences all number
|
1 |
0 |
0 |
0 |
8 |
12 |
ONYCHOMYCOSIS
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
2 / 95 (2.11%) |
occurrences all number
|
0 |
0 |
0 |
0 |
2 |
2 |
ORAL CANDIDIASIS
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
ORAL HERPES
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
3 / 94 (3.19%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
3 |
0 |
ORAL PUSTULE
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
PARONYCHIA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
24 / 94 (25.53%) |
5 / 95 (5.26%) |
occurrences all number
|
0 |
0 |
0 |
0 |
30 |
6 |
PHARYNGITIS
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
2 / 94 (2.13%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
2 |
1 |
PHARYNGOTONSILLITIS
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
RASH PUSTULAR
|
|
|
|
|
|
|
subjects affected / exposed
|
3 / 6 (50.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
1 / 6 (16.67%) |
14 / 94 (14.89%) |
2 / 95 (2.11%) |
occurrences all number
|
3 |
0 |
0 |
1 |
18 |
2 |
RESPIRATORY TRACT INFECTION
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 6 (16.67%) |
0 / 6 (0.00%) |
1 / 2 (50.00%) |
0 / 6 (0.00%) |
3 / 94 (3.19%) |
6 / 95 (6.32%) |
occurrences all number
|
1 |
0 |
1 |
0 |
4 |
9 |
RHINITIS
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
1 / 6 (16.67%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
3 / 95 (3.16%) |
occurrences all number
|
0 |
1 |
0 |
0 |
1 |
3 |
SEPTIC SHOCK
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
SINUSITIS
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
1 / 6 (16.67%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
5 / 95 (5.26%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
6 |
SKIN INFECTION
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
TINEA PEDIS
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
TOOTH INFECTION
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
TRACHEITIS
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
UPPER RESPIRATORY TRACT INFECTION
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
1 / 6 (16.67%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
11 / 94 (11.70%) |
11 / 95 (11.58%) |
occurrences all number
|
0 |
1 |
0 |
0 |
11 |
13 |
URINARY TRACT INFECTION
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 6 (16.67%) |
1 / 6 (16.67%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
19 / 94 (20.21%) |
13 / 95 (13.68%) |
occurrences all number
|
1 |
2 |
0 |
0 |
29 |
22 |
VAGINAL INFECTION
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
2 / 95 (2.11%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
2 |
VIRAL INFECTION
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
1 / 6 (16.67%) |
2 / 94 (2.13%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
1 |
2 |
0 |
VULVITIS
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
VULVOVAGINAL CANDIDIASIS
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
1 |
FUNGAL SKIN INFECTION
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
INFLUENZA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
4 / 94 (4.26%) |
2 / 95 (2.11%) |
occurrences all number
|
0 |
0 |
0 |
0 |
4 |
2 |
SOFT TISSUE INFECTION
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
STAPHYLOCOCCAL INFECTION
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
2 / 94 (2.13%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
2 |
1 |
TINEA INFECTION
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
TONSILLITIS
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
3 / 94 (3.19%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
3 |
0 |
TOOTH ABSCESS
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
URETERITIS
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
Metabolism and nutrition disorders
|
|
|
|
|
|
|
DEHYDRATION
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
HYPERCALCAEMIA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
2 |
0 |
HYPERCHOLESTEROLAEMIA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
HYPERGLYCAEMIA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
7 / 94 (7.45%) |
5 / 95 (5.26%) |
occurrences all number
|
0 |
0 |
0 |
0 |
9 |
13 |
HYPERKALAEMIA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
3 / 94 (3.19%) |
2 / 95 (2.11%) |
occurrences all number
|
0 |
0 |
0 |
0 |
11 |
2 |
HYPOGLYCAEMIA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
2 / 94 (2.13%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
2 |
0 |
HYPOKALAEMIA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
7 / 94 (7.45%) |
5 / 95 (5.26%) |
occurrences all number
|
0 |
0 |
0 |
0 |
8 |
6 |
HYPOMAGNESAEMIA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
1 / 94 (1.06%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
HYPONATRAEMIA
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
0 / 6 (0.00%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
2 / 94 (2.13%) |
0 / 95 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
2 |
0 |
DECREASED APPETITE
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 6 (33.33%) |
2 / 6 (33.33%) |
1 / 2 (50.00%) |
2 / 6 (33.33%) |
21 / 94 (22.34%) |
15 / 95 (15.79%) |
occurrences all number
|
2 |
3 |
2 |
3 |
27 |
17 |
FLUID RETENTION
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 6 (0.00%) |
1 / 6 (16.67%) |
0 / 2 (0.00%) |
0 / 6 (0.00%) |
0 / 94 (0.00%) |
1 / 95 (1.05%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
1 |