Non-serious adverse events
|
Observation |
Imatinib Mesylate |
Total subjects affected by non serious adverse events
|
|
|
subjects affected / exposed
|
205 / 454 (45.15%) |
442 / 454 (97.36%) |
Vascular disorders
|
|
|
COLD FEET
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
COLD FINGERS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
COLD HAND
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
2 |
COLD HAND, FEET
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
COLD HAND/FEET
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
COLD HANDS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
7 |
COLD HANDS AND FEET
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
ORAL
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
PHLEBITIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
POOR CIRCULATION FINGERTIPS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
6 |
POOR CIRCULATION IN FINGERTIPS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
3 |
POOR CIRCULATION OEDEMA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
RAYNAUD'S LIKE SYNDROME
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
REYNAUD'S LIKE SYNDROME
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
REYNAUD'S-LIKE SYNDROME
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
SENSATION OF HEAVY LEGS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
SEVERE BRUSING LEFT ARM
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
THROMBOSIS VENA MESENTERICA & PORTA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
VASCULAR FRAGILITY
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
VASCULARY WEAKNESS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
VENOUS INSUFFICIENCY IN MEMBERS INFERIORS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
Surgical and medical procedures
|
|
|
ABDOMEN NOS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
ABDOMINAL SCAR CALCIFICATION SURGERY
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
ABDOMINAL WALL RECONSTRUCTION BECAUSE OF LAPAROCELE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
ANUS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
APPENDECTOMY
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
BLADDER
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
BONE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
BRAIN
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
BREAST
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
BRONCHUS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
COLON
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
CONJUNCTIVA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
EXCISION OF PAPILLARY CARCINOMA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
EYE NOS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
ILEUM
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
JEJUNOSTOMY
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
JOINT
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
KIDNEY
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
LAPAROTOMY EVENTRATION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
5 |
0 |
LIVER
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
LUNG
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
MUSCLE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
NAILS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
NASAL CAVITY
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
NOSE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
ORAL
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
OTHER SURGICAL AND MEDICAL PROCEDURES
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
PHARYNX
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
PROSTATE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
PLEURA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
RECTUM
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
REN SURGERY FOR RENAL CELL CARCINOMA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
SALIVARY GLAND
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
SINUS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
SKIN
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
SMALL BOWEL NOS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
STOMACH
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
SPLEEN
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
SURGERY FOR METASTASIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
TEETH
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
TENDON
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
TONGUE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
THYROID
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
TRACHEA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
UPPER AIRWAY NOS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
URETHRA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
URINARY TRACT NOS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
UTERUS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
VAGINA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
VULVA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
General disorders and administration site conditions
|
|
|
ABDOMEN NOS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
19 / 454 (4.19%) |
46 / 454 (10.13%) |
occurrences all number
|
32 |
100 |
AGRESSIVENESS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
AGGRESSIVENESS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
ASTHENIC
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
CHILLS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
12 / 454 (2.64%) |
occurrences all number
|
0 |
31 |
CHILLY FEELING
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
COLD FEELING
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
COLD
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
8 / 454 (1.76%) |
occurrences all number
|
0 |
10 |
COMMON COLD
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
4 / 454 (0.88%) |
occurrences all number
|
0 |
4 |
CONJONCTIVAL
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
CRAMPS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
3 |
DULLED AFTER TAKING DRUG
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
DUMPING SYNDROM
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
DUMPING SYNDROME
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
6 |
FACE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
FATIGUE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
55 / 454 (12.11%) |
272 / 454 (59.91%) |
occurrences all number
|
112 |
1236 |
FEELS ASTHENIC, LETHARGIC AFTER TAKING DRUG
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
FEELS COLD
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
FEELS HANGOVER AFTER TAKING DRUG
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
FEVER
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
16 / 454 (3.52%) |
occurrences all number
|
1 |
22 |
FEVER (OCCASIONAL)
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
FEVER 38°
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
FEVER 39°C
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
FLU
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
FLU LIKE SYMPTOMS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
2 |
FLU LIKE SYNDROM
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
FLU LIKE SYNDROME
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
2 |
FLU SYMPTOMS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
FLU SYNDROME
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
FLU-LIKE SYNDROME
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
7 / 454 (1.54%) |
occurrences all number
|
0 |
7 |
FLUSHES
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
3 / 454 (0.66%) |
occurrences all number
|
1 |
3 |
FREEZING
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
GAIN WEIGHT
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
GRIPPAL SYNDROM
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
HEAD
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
INSOMNIA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
26 / 454 (5.73%) |
occurrences all number
|
3 |
67 |
LETHARGY
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
LOSS OF BODY WEIGHT
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
MALAISE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
MALAISE WITHOUT CONSCIOUSNESS LOSS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
MUSCLE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
NIGHT SWEAT
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
2 |
NIGHT SWEATS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
2 |
OTHER GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
PAIN NOS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
PELVIC
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
2 |
0 |
PELVIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
2 / 454 (0.44%) |
1 / 454 (0.22%) |
occurrences all number
|
3 |
1 |
REDUCE PHYSICAL POWER
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
RENAL TUMOR
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
RIGORS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
4 / 454 (0.88%) |
occurrences all number
|
0 |
12 |
RIGORS CRAMPS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
RIGORS, CRAMPS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
RIGORS/CHILLS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
8 / 454 (1.76%) |
occurrences all number
|
0 |
23 |
SHIVERS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
4 |
SICKNESS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
SLEEP DISORDER
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
3 |
0 |
SLEEP DISTURBANCE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
SLEEPING DISORDER
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
SWEAT (NIGHT)
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
SWEAT(NIGHT)
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
SWEATING
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
6 / 454 (1.32%) |
occurrences all number
|
6 |
8 |
SWEATS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
VITAMIN DEFICIENCY
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
WEAKNESS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
4 |
WEIGHT GAIN
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
2 |
WEIGHT GAIN
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
7 / 454 (1.54%) |
175 / 454 (38.55%) |
occurrences all number
|
10 |
508 |
WIEGHT GAIN
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
Immune system disorders
|
|
|
ALLERGIC RHINITIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
ALLERGY
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
IODINE ALLERGY
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
12 |
RHINITIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
1 / 454 (0.22%) |
occurrences all number
|
1 |
1 |
Reproductive system and breast disorders
|
|
|
CONISATION ON INTRAEPITHELIAL LESIONS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
DYSMENORRHOEA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
EJACULATORY DYSFUNCTION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
ENDOMETRIOSIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
2 |
ERECTILE DYSFUNCTION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
5 |
ERECTILE IMPOTENCE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
3 |
0 |
GYNECOMASTIA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
GYNECOMASTY
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
HYPERMENORRHEA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
HYPERMENORRHOEA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
HYSTERECTOMY
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
IMPOTENCE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
1 / 454 (0.22%) |
occurrences all number
|
2 |
1 |
MENORRHAGIA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
2 |
MENSES UNREGULARLY
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
PRIAPISM
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
2 |
TESTICLE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
UNREGULARLY MENSES
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
URETHRA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
2 |
0 |
VAGINA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
VAGINAL MUCOSITIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
VAGINITIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
2 |
Respiratory, thoracic and mediastinal disorders
|
|
|
ACUTE RESPIRATORY INSUFICIENCY
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
ASTHMA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
1 / 454 (0.22%) |
occurrences all number
|
1 |
2 |
BILATERAL PULMONARY INFILTRATES
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
BRONCHITIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
2 |
BRONCHUS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
CATARRH
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
2 |
CHEST/THORAX NOS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
2 / 454 (0.44%) |
2 / 454 (0.44%) |
occurrences all number
|
2 |
2 |
COLD
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
3 / 454 (0.66%) |
occurrences all number
|
0 |
3 |
COLD SYMPTOMS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
COMMON COLD
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
1 / 454 (0.22%) |
occurrences all number
|
1 |
1 |
COPD
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
2 |
COUGH
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
2 / 454 (0.44%) |
28 / 454 (6.17%) |
occurrences all number
|
4 |
50 |
DEEP VOICES
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
DYSPHONIA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
3 |
DYSPNEA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
6 / 454 (1.32%) |
37 / 454 (8.15%) |
occurrences all number
|
9 |
96 |
FEW BASAL CREPS + RONCHI
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
FLU
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
HEAD
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
HOARSE VOICE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
3 / 454 (0.66%) |
occurrences all number
|
0 |
3 |
HOARSENESS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
INTERSTITIAL PNEUMOPATHY
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
2 |
LUNG
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
NASAL CONGESTION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
NASAL OBSTRUCTION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
2 |
ORAL CAVITY
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
PARANASAL
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
2 |
PHARYNGITIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
PHARYNX
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
PLEURA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
2 |
PNEUMONIA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
PNEUMONITIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
PNEUMOPATHY
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
POLLENOSIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
PULMONARY EMPHYSEME
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
PULMONITIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
2 |
RESPIRATORY DISTRESS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
SINUS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
SORE THROAT
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
THORAX
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
3 |
THROAT IRRITATION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
TONSILITIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
TRACHEA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
TRACHEITIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
URTI
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
VOICE CHANGES
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
VOICE CHANGES (HOARSENESS)
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
WHEEZING (EXPIRATORY WHEEZING)
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
Investigations
|
|
|
WEIGHT LOSS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
7 / 454 (1.54%) |
64 / 454 (14.10%) |
occurrences all number
|
9 |
153 |
Cardiac disorders
|
|
|
ATRIAL FLUTTER
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
CARDIAC (GENERAL)
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
21 / 454 (4.63%) |
38 / 454 (8.37%) |
occurrences all number
|
32 |
79 |
PALPITATIONS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
PERICADIAL EFFUSION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
PERICARDIAL EFFUSION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
3 |
PLEURA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
SICK SINUS SYNDROME
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
SINUS BRADYCARDIA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
Nervous system disorders
|
|
|
ACOUSTIC NEUROMA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
AGITATION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
2 |
ANXIETY
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
5 / 454 (1.10%) |
11 / 454 (2.42%) |
occurrences all number
|
6 |
24 |
ARMS : TINGLING/NUMBNESS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
BUTTOCK
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
BUZZING IN THE EARS (RIGHT)
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
CARPAL TUNNEL SYNDROME
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
CNS CEREBROVASCULAR ISCHEMIA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
COENCENTRATION DIFFICULTY
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
COGNITIVE DISTURBANCE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
3 / 454 (0.66%) |
occurrences all number
|
3 |
3 |
CONCENTRATION ALTERATION (DIFFICULTY)
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
CRAMPS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
4 / 454 (0.88%) |
occurrences all number
|
0 |
18 |
CRAMPS + SMARTING
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
CRAMPS LEG
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
CRAMPS LOWER LIMB
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
2 |
CUBITAL TUNNEL SYNDROM
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
DECLINED SIGHT
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
DEPRESSION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
6 / 454 (1.32%) |
18 / 454 (3.96%) |
occurrences all number
|
13 |
39 |
DIFFICULTY WITH SHORT TERM MEMORY
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
DIZZINES
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
2 |
DIZZINESS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
3 / 454 (0.66%) |
32 / 454 (7.05%) |
occurrences all number
|
5 |
57 |
DIZZY
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
DIZZY SPELL
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
DIZZYNESS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
EYE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
FACIAL
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
10 |
FAINTING
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
FORGETFULNESS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
HEAD
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
INSOMNIA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
3 / 454 (0.66%) |
occurrences all number
|
0 |
8 |
IRASCIBLE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
LACK OF CONCENTRATION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
LEFT LIMB PARESTHESIA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
LEG CRAMPS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
MEMORY IMPAIRMENT
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
2 / 454 (0.44%) |
occurrences all number
|
1 |
2 |
MEMORY INPAIRMENT
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
MIGRAINES
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
MOOD ALTERATION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
4 / 454 (0.88%) |
occurrences all number
|
1 |
6 |
MUSCLE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
3 / 454 (0.66%) |
occurrences all number
|
0 |
8 |
MOOD ALTERATION-DEPRSSION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
NEUROPATHY CRAMP HANDS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
NEUROPATHY SENSORY
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
5 |
NECK
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
2 |
0 |
NEUROPATHY- SENSORY (FORMICATION IN HANDS)
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
NEUROPATHY: CRAMP HANDS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
8 |
NEUROPATHY: CRANIAL - CN I SMELL
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
NEUROPATHY: CRANIAL : CN V
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
NEUROPATHY: CRANIAL -CN I SMELL
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
NEUROPATHY: CRANIAL: CN V
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
NEUROPATHY:SENSORY (PARAESTHESIAS)
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
NEUROPATHY-SENSORY
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
2 |
NEUROPATHY-SENSORY (PARESTHESIA HANDS)
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
NUMB FINGERS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
NUMBNESS OF LEFT THIGH
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
NUMBNESS AROUND OPERATION SITE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
NUMBNESS-COLATERAL HAND
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
OBNUBILATION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
5 |
OTH DISC DEGENERATION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
PARAESTHESIA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
PARASHESIA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
PARASTHESIA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
5 |
PARASTHESIAS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
PARESTHESIA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
2 |
PARESTHESIAS ON HANDS AND FEET
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
PARESTHESIE FOOT BILATERAL
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
PERIPHERAL POLYNEURITIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
PINS+NEEDLE SENSATION DOWN LEG
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
POOR CIRCULATION FINGER TIPS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
3 |
POLYNEUROPATHY
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
POOR CONCENTRATION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
POOR CONCENTRATION (ADD)
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
R SCIATICA NERVE PAIN
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
SEIZURE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
1 / 454 (0.22%) |
occurrences all number
|
1 |
1 |
SENSITIVE DYESHESIA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
SENSORY
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
SENSORY NEUROPATHY
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
SENSORY NEUROPATHY (HANDS)
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
2 |
SENSORY NEUROPHATY
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
SEVERE NUMBNESS LEFT FOOT
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
SENSORY: LEFT UPPER LEG
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
SMARTING
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
2 |
SLUMBER TROUBLE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
2 |
SMELL LOSS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
SOMNOLENCE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
3 / 454 (0.66%) |
occurrences all number
|
0 |
3 |
STIFFNESS FINGERS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
2 |
SYNCOPE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
2 |
TINGLING FINGERS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
TINGLING LEFT ARM + FINGERS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
TRANSISCHEMIC ATTACK
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
TREMOR
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
10 |
TRENSION OF UPPER EXTREMITIES
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
TWO LYPOTHYMIC EPISODES
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
VAGAL DISCONFORT
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
VERTIGO
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
4 / 454 (0.88%) |
occurrences all number
|
1 |
18 |
WEEKNESS RIGHT LEG
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
Blood and lymphatic system disorders
|
|
|
ABDOMINAL
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
5 |
ANEMIA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
6 / 454 (1.32%) |
occurrences all number
|
1 |
17 |
ANKLE SLIGHTY SWOLLEN
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
BLOCKED RIGHT EAR
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
DIC
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
EDEMA FINGERS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
EDEMA LEGS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
EDEMA VISCERA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
7 / 454 (1.54%) |
occurrences all number
|
0 |
11 |
EDEMA, HEAD&NECK
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
4 / 454 (0.88%) |
284 / 454 (62.56%) |
occurrences all number
|
8 |
1555 |
EDEMA, LIMBS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
3 / 454 (0.66%) |
127 / 454 (27.97%) |
occurrences all number
|
3 |
386 |
EDEMA, TRUNK/GENITAL
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
6 |
EOSINOPHILIA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
3 |
EXCESSIVE LACRIMATION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
2 |
EYE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
3 |
HEMATOMA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
5 / 454 (1.10%) |
occurrences all number
|
2 |
7 |
HEMOGLOBIN
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
IRON DEFICIENCY
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
LEGS VENOUS FAILURE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
LYMPH NODE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
MESENTERIC PANNICULITIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
NEUTROPENIA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
OEDEMA BUT LOCATION NOT RECORDED
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
PALPABLE LYMPHNODE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
PALPABLE LYMPHNODE SUBMANDIBULAR
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
RIGHT KNEE SWOLLEN
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
SIDEROPENIC ANAEMIA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
SWOLLEN GLAND (SUBMANDIBULAR)
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
SWOLLEN GLANDS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
2 |
UNSPECIFIED OEDEMA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
WATER RETENTION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
Ear and labyrinth disorders
|
|
|
AUDITORY/EAR -> BLOCKED EARS WITH MAX
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
DEAFNESS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
2 |
EAR NOISES
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
HEARING (ACOUSTIC PROBLEMS)
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
HYPOACUSIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
LEFT EAR RINGING
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
OTITIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
2 |
TINNITUS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
4 / 454 (0.88%) |
occurrences all number
|
0 |
6 |
VESTIBULAR FAILURE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
Eye disorders
|
|
|
ALLERGICAL CONJUNCTIVITIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
BLEPHARITIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
BLURRED VISION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
7 / 454 (1.54%) |
occurrences all number
|
1 |
11 |
BURN
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
CATARACT
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
CONJONCTIVITIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
4 / 454 (0.88%) |
occurrences all number
|
0 |
5 |
CONJUNCTIVA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
CONJUNCTIVITIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
7 / 454 (1.54%) |
occurrences all number
|
0 |
23 |
DECREASE OF VISUAL FUNCTION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
DECREASE VISUAL FUNCTION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
DIPLOPIA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
2 |
DRY EYE SYNDROME
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
6 |
DRY MUCOUS MEMBRANE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
DRY MUCUOUS MEMBRANE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
EYE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
22 / 454 (4.85%) |
occurrences all number
|
0 |
34 |
GLAUCOMA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
3 |
HYPEREMIA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
IMPAIRED VISION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
ITCHING PERIORBITAL
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
2 |
LACRIMATION INCREASED
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
2 |
MACULAR DEGENERATION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
1 / 454 (0.22%) |
occurrences all number
|
1 |
1 |
NYSTAGMUS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
OCULAR
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
OCULAR SURFACE DISEASE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
18 / 454 (3.96%) |
occurrences all number
|
0 |
33 |
OPHTALMIC TROUBLE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
PHOTOPHOBIA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
TEARING
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
6 |
TEARING (+COPING PROBLEMS)
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
VISION DISTURB
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
VISUAL DISTURBANCE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
VISUAL TROUBLE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
WATERY EYE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
26 / 454 (5.73%) |
occurrences all number
|
1 |
84 |
Gastrointestinal disorders
|
|
|
ABDO PART, BLOATING
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
ABDOMEN
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
20 / 454 (4.41%) |
29 / 454 (6.39%) |
occurrences all number
|
38 |
48 |
ABDOMEN NOS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
2 |
ABDOMINAL
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
18 / 454 (3.96%) |
37 / 454 (8.15%) |
occurrences all number
|
29 |
65 |
ABDOMINAL BLOATING
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
2 / 454 (0.44%) |
occurrences all number
|
1 |
2 |
ABDOMINAL COLIC
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
2 |
ABDOMINAL COLICS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
ABDOMINAL CRAMP
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
ABDOMINAL CRAMPING
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
ABDOMINAL CRAMPING AFTER INTAKE OF IMATINIB
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
ABDOMINAL CRAMPS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
3 / 454 (0.66%) |
occurrences all number
|
2 |
3 |
ABDOMINAL DISCONFORT
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
3 |
ABDOMINAL DISTENSION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
2 / 454 (0.44%) |
0 / 454 (0.00%) |
occurrences all number
|
2 |
0 |
ABDOMINAL FULLNESS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
ABDOMINAL HERNIA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
2 / 454 (0.44%) |
0 / 454 (0.00%) |
occurrences all number
|
2 |
0 |
ABDOMINAL HERNIA OF THE SCAR
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
ABDOMINAL HERNIA SCAR
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
2 |
0 |
ABDOMINAL MASS STITCH ABCESS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
ABDOMINAL SCAR HERNIA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
2 |
0 |
ABDOMINAL SENSITIVE TOUCH
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
ACID REFLUX
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
ACID REGURGITATION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
1 / 454 (0.22%) |
occurrences all number
|
1 |
1 |
ACIDITY
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
1 / 454 (0.22%) |
occurrences all number
|
1 |
1 |
ACUTE GASTROENTERITIS WITH AUTOLIMITED RECTAL BLEEDING
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
ADDED DEJECTION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
ADENOMA OF THE SIGMA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
ADHESIONS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
ANAL MUCOSITIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
ANUS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
2 |
APHTOSIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
ASCITES
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
2 |
BELCHING
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
6 |
BLACK STOOL (2X)
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
BLACK STOOLS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
BLOATED FEELING
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
BLOATED FEELINGS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
BLOATING
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
3 / 454 (0.66%) |
occurrences all number
|
1 |
4 |
BLOATING AND INDIGESTION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
BORBORYGMUS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
BOWEL ADHESION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
BOWEL COMPLAINTS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
2 |
0 |
BOWEL OBSTRUCTION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
BUCCAL MUCOSITIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
BURN
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
2 |
CHOLELITHIASIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
COLIC POLYPS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
COLITIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
COLON
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
CONSIPATION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
CONSITPATION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
CONSTIPATION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
18 / 454 (3.96%) |
45 / 454 (9.91%) |
occurrences all number
|
30 |
110 |
COPROSTASE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
COPROSTASIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
DEFAECATION NOT REGULAR
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
DEHYDRATATION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
DENTAL
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
DENTAL/TEETH/PERIDONTAL
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
3 / 454 (0.66%) |
occurrences all number
|
0 |
3 |
DIARRHEA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
41 / 454 (9.03%) |
219 / 454 (48.24%) |
occurrences all number
|
76 |
874 |
DIFFICULTY OF SWALLOWING
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
DIFFICULTY SWALLOWING
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
DIGESTIVE DISORDER
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
DISCONFORT
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
DISGUEUSIA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
DISPESIA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
DISTENSION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
4 / 454 (0.88%) |
3 / 454 (0.66%) |
occurrences all number
|
4 |
3 |
DISTENSION/BLOATING
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
2 / 454 (0.44%) |
0 / 454 (0.00%) |
occurrences all number
|
3 |
0 |
DISTENSION/BLOATING, ABDOMINAL
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
DISTENSTION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
DISTENTION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
DRY MONTH
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
DRY MOUNTH
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
2 |
DRY MOUTH
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
13 / 454 (2.86%) |
occurrences all number
|
0 |
29 |
DRY THROAT
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
DUMPING
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
DUMPING SYNDROM
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
DUMPING SYNDROME
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
DYSFAGIA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
DYSGEUSIA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
DYSPEPSIA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
4 / 454 (0.88%) |
12 / 454 (2.64%) |
occurrences all number
|
4 |
19 |
DYSPESIA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
DYSPHAGIA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
7 / 454 (1.54%) |
occurrences all number
|
1 |
11 |
DYSPHAGY (ANASTOMOSE)
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
EARLU SATIETY
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
EARLY SATIETY
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
2 / 454 (0.44%) |
3 / 454 (0.66%) |
occurrences all number
|
3 |
7 |
ENTERITIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
1 / 454 (0.22%) |
occurrences all number
|
1 |
1 |
EPIDGASTRIC HEAVINESSES
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
EPIGASTRALGIA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
10 / 454 (2.20%) |
occurrences all number
|
0 |
19 |
EPIGASTRALGY
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
2 |
EPIGASTRIC BLOATING
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
EPIGASTRIC DISCOMFORT
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
2 / 454 (0.44%) |
2 / 454 (0.44%) |
occurrences all number
|
2 |
2 |
EPIGASTRIC DISCONFORT
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
EPIGASTRIC TENDERNESS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
2 |
EPYGASTRALGY
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
ERUCTATION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
2 / 454 (0.44%) |
occurrences all number
|
4 |
3 |
ESOPHAGEAL REFLUX
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
2 |
ESOPHAGITIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
7 / 454 (1.54%) |
occurrences all number
|
1 |
16 |
FAECAL PAIN
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
FEELING BLOATED
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
FEELING OF FULLNESS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
FISTULA COLO-CUTANEOUS PRESACRUM
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
2 |
0 |
FISTULA COLO-CUTANEOUS PRE-SACRUM
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
3 |
0 |
FLATULENCE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
10 / 454 (2.20%) |
12 / 454 (2.64%) |
occurrences all number
|
12 |
29 |
FUSTULA IN THE ANASTOMOSUS OESOPHAGA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
FUSTULA OF OESOPHAGEAL-JEJUNAL ANAST
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
GALLSTONES
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
GASTR- OESOPHAGEAL REFLUX
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
GASTRALGIA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
10 |
GASTRIC ACIDITY
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
4 |
GASTRIC DISCOMFORT
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
GASTRIC DISCONFORT
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
GASTRIC REFLUX
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
4 / 454 (0.88%) |
occurrences all number
|
1 |
4 |
GASTRIC TROUBLE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
2 |
GASTRITIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
4 / 454 (0.88%) |
10 / 454 (2.20%) |
occurrences all number
|
4 |
15 |
GASTRO ENTERITIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
GASTRO ESOPHAGEAL REFLUX
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
GASTRO ESOPHAGIAL REFLUX
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
GASTRO OESOPHAGEAL REFLUX
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
GASTROENTERITIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
7 / 454 (1.54%) |
occurrences all number
|
0 |
7 |
GASTRO-ENTERITIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
GASTROENTRETIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
GASTROESOPHOGAL REFLUX
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
GASTRO-INTESTINAL REFLUX
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
GASTRO-OESOPHAGAL REFLUX
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
2 |
GERD
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
4 |
0 |
GRAVITY
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
3 |
GRELIC OCCLUSION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
GUT CRAMP
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
2 |
HEARTBURN
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
10 / 454 (2.20%) |
29 / 454 (6.39%) |
occurrences all number
|
12 |
58 |
HEARTBURN/DYSPEPSIA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
2 |
HEMORRHOIDAL CONGESTION WITH UNCONTROLLED PAIN
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
HEMORRHOIDS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
2 / 454 (0.44%) |
0 / 454 (0.00%) |
occurrences all number
|
2 |
0 |
HERNIE SCAR
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
2 |
0 |
HIATAL HERNIA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
14 |
ILEUM
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
ILEUS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
ILEUS (ADHESION)
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
INCISIONAL HERNIA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
INCREASE BELCHING
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
INCREASE OF APETITE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
2 |
INCREASED ABDOMINAL HERNIA SCAR
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
INCREASED APETITE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
2 |
INCREASED BOWEL OPENING 6-8 TIMES DAILY
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
INDIGESTION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
8 / 454 (1.76%) |
occurrences all number
|
3 |
10 |
INTERMITTENT GASTRIC REFLUX
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
INTESTINAL SUBOCCLUSION CRISIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
INTESTINAL TRANSIT
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
INTOLERANCE ON FATTY FOODS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
IRREGULAR DEFECATION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
LACK OF APETITE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
LEFT RECTUS ABDOMINIS NODULE ABLATION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
LOSS OF APETITE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
LOSS OF APPETITE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
2 |
MALNUTRITION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
MELAENA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
METEORISM
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
3 / 454 (0.66%) |
occurrences all number
|
0 |
4 |
METEORISMUS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
2 / 454 (0.44%) |
1 / 454 (0.22%) |
occurrences all number
|
2 |
1 |
MOUTH ULCER
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
MUCOSA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
MUCOSITIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
8 / 454 (1.76%) |
occurrences all number
|
1 |
20 |
MUSHY DEFECATION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
3 |
NAUSEA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
25 / 454 (5.51%) |
198 / 454 (43.61%) |
occurrences all number
|
33 |
675 |
OBSTIPATION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
3 / 454 (0.66%) |
5 / 454 (1.10%) |
occurrences all number
|
4 |
6 |
OESOPHAGEAL REFLUX
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
ORAL
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
ORAL CAVITY
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
PANCREATITIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
2 / 454 (0.44%) |
occurrences all number
|
1 |
2 |
PASSAGE PROBLEMS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
PERIANAL WARMTH POST GLIVEC
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
PHARYNX
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
PIROSIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
POST PANDRIAL FULLNESS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
2 |
POOR APPETITE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
POSTPANDRIAL HEAVINESS AFTER TO TAKE IMATINIB
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
POUTH DRYNESS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
PRESSURE EPIGASTRIC
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
PRESURE EPIGASTRIC
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
PYROSIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
2 / 454 (0.44%) |
10 / 454 (2.20%) |
occurrences all number
|
3 |
21 |
RCU
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
RECTAL BLEEDING
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
RECTAL INCONTINENCE (OCCASSIONAL)
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
RECTUM
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
1 / 454 (0.22%) |
occurrences all number
|
1 |
2 |
RECTAL TENESMUS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
4 |
REFLUX ( OCCASIONAL)
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
REFLUX
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
5 / 454 (1.10%) |
occurrences all number
|
4 |
9 |
REFLUX GASTROOESOPHAGEAL
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
RGO
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
3 / 454 (0.66%) |
occurrences all number
|
0 |
8 |
REGURGITATION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
1 / 454 (0.22%) |
occurrences all number
|
1 |
1 |
RUCTUS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
2 / 454 (0.44%) |
2 / 454 (0.44%) |
occurrences all number
|
3 |
6 |
SALIVARY GLAND
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
SLIGHT DYSPHAGY
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
SMALL BLISTER MOUTH
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
SMALL BOWEL NOS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
SMALL HERNIA UMBILICALIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
SORETHROAT
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
STOMA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
4 / 454 (0.88%) |
occurrences all number
|
1 |
5 |
SUBILEUS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
STOMACH
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
4 / 454 (0.88%) |
19 / 454 (4.19%) |
occurrences all number
|
6 |
34 |
TASTE ALTERATION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
29 / 454 (6.39%) |
occurrences all number
|
0 |
68 |
SUSPECTED GIST RECURRENCE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
SUBOCCLUSION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
TEETH
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
2 |
THIRST
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
THIRSTY SENSATION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
6 |
TONGUE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
6 |
TOOTH DECAY
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
TRACHEA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
TRANSIT-INTESTINAL GESTION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
ULCER OESPHAGUS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
VESICAL MUCOSITIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
VOMITING
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
14 / 454 (3.08%) |
89 / 454 (19.60%) |
occurrences all number
|
16 |
138 |
Hepatobiliary disorders
|
|
|
BILIARY COLI
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
HEPATIC
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
LIVER
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
PANCREATITIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
TOXIC HEPATITIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
5 |
Skin and subcutaneous tissue disorders
|
|
|
ACNE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
3 |
ALOPECIA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
2 / 454 (0.44%) |
31 / 454 (6.83%) |
occurrences all number
|
2 |
60 |
AURICULAR ECZEMA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
BACK
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
BASOCELLULAR EPITHELIOMA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
BLISTER RIGHT ARM
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
BRUISING
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
2 |
BUCCAL RHAGADES
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
BURN
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
3 |
CHANGE IN HAIR COLOR
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
CHEILITIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
2 |
CHELITIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
CONTACT DERMATITIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
CONTACT DERMATITIS ON HANDS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
CUT RIGHT HAND
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
CUTANEOUS DRYNESS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
6 / 454 (1.32%) |
occurrences all number
|
0 |
6 |
CUTANEOUS ERRUPTION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
CUTANEOUS ERUPTION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
3 / 454 (0.66%) |
occurrences all number
|
0 |
3 |
CUTANEOUS REACTION TO IODE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
DEPIGMENTATION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
DERMATITIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
DISCOMFORT FROM SCAR
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
DRY HANDS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
DRY LEGS+FEET/ATHLETES FOOT
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
DRY SKIN
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
4 / 454 (0.88%) |
32 / 454 (7.05%) |
occurrences all number
|
4 |
65 |
DRY SKYN
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
4 |
DYSCHROMIA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
2 |
ECZEMA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
6 / 454 (1.32%) |
occurrences all number
|
0 |
14 |
ECZEMA ( ARMS/TOUTH)
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
ECZEMA (LOWER LIMBS)
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
ECZEMA ON HAND
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
ECZEMA RIGHT HAND
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
ERYSIPELAS LEFT LEG
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
ERYSIPELOID LESION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
ERYTHEMA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
8 / 454 (1.76%) |
occurrences all number
|
1 |
23 |
ERYTHEMA FINGERS HANDS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
ERYTHEMA LESION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
ERYTHEMA ON THE HANDS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
ERYTHEMA PERIORBITAL
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
ERYTHEMA WITH HYPERKERATOSIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
5 |
EXANTHEMA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
3 / 454 (0.66%) |
occurrences all number
|
0 |
5 |
EXCOLIATION BELOW KNEE BOTH LEGS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
EYE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
5 / 454 (1.10%) |
occurrences all number
|
0 |
12 |
FACE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
4 / 454 (0.88%) |
occurrences all number
|
0 |
12 |
FACIAL
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
FLUCHES
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
FLUSHING
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
2 / 454 (0.44%) |
occurrences all number
|
3 |
3 |
FOLLICLE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
FOLLICULITE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
4 |
FOLLICULITIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
FUNGAL RASH ON LEGS AND ARMS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
2 |
HAIR LOSS/ALOPECIA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
HAND +FOOT SYNDROME
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
HAND REACTION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
HAND-FOOT
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
HANDS ECZEMA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
HERPES SIMPLEX
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
HYPERPIGMENTATION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
4 / 454 (0.88%) |
occurrences all number
|
0 |
6 |
HYPOPIGMENTATION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
5 / 454 (1.10%) |
occurrences all number
|
0 |
15 |
INFECTED INSECT BITE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
INFLAMED UMBILICUS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
2 |
ITCHING
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
5 / 454 (1.10%) |
occurrences all number
|
0 |
11 |
ITCHING BOTH ARMS AND LEGS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
ITCHING RIGHT KNEE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
KERATOSIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
2 |
L ANKLE MACULOPAPULAR MARK IMPROVING
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
LASH AND BROW LOSS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
LASH LOSS, BROW LOSS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
3 |
LAT. UPPER L LEG ERYTEMA SCALY PLAQU
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
LESION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
LIP
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
4 / 454 (0.88%) |
occurrences all number
|
0 |
5 |
MACULAR LESION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
MACULOPAPULAR MASK ABOVE L ANKLE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
MULTIPLE KERATOACANTHOMA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
NAEVUS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
NAIL CHANGES
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
3 |
NAIL LOSS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
NAILS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
2 |
NOT SPECIFIED
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
1 / 454 (0.22%) |
occurrences all number
|
2 |
1 |
OCULAR
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
ONYCHORRHEXIS (UNGUEAL TOXICITY)
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
OTH DERMATITIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
PAPILLOMATOUS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
3 |
PERIORBITAL ERYTHEMA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
PHOTOSENSITIVITY
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
PRURIT
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
2 |
PRURITIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
13 / 454 (2.86%) |
occurrences all number
|
1 |
25 |
PRURITIS LEGS AND ARMS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
PRURITUS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
14 / 454 (3.08%) |
occurrences all number
|
2 |
37 |
PRUTITUS (INTERMITTENT PRURIT)
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
PSIORASIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
PSIORIASIS VULGARIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
PSORIASIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
3 / 454 (0.66%) |
occurrences all number
|
3 |
7 |
PSORIASIS LIKE LESIONS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
3 |
PSORIASIS-LIKE LESIONS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
PURITIS MEDIAL LEFT CALF
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
RASH
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
2 |
RASH (AXILLARY)
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
RASH RIGHT LEG
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
RECURRENT LESIONS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
RIGORS/CHILLS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
RING WORM
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
SCALP
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
2 / 454 (0.44%) |
occurrences all number
|
1 |
2 |
SCAR HERNIATION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
SEBORRHEIC KERATOSIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
SEBORRHEIC WART ERUPTION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
2 |
0 |
SKALP KIST
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
SKIN
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
12 / 454 (2.64%) |
occurrences all number
|
0 |
14 |
SUN SENSITIVITY
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
SWELLING & THICKENING SUBCUTAN TISS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
SWELLING THICKENING OF SUBCUTAN TISS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
SWELLING&THICKENING OF SUBCUT. TISSU
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
TELANGIECTASIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
TRUNK
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
2 |
ULCERATION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
2 |
ULCER-POSSIBLE SPIDER BITE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
UNGUEAL TOXICITY
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
WATER BLISTER (LOWER LEFT LEG)
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
WOUND
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
1 / 454 (0.22%) |
occurrences all number
|
1 |
1 |
Renal and urinary disorders
|
|
|
BLADDER
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
12 |
CHRONIC RENAL INSUFFICIENCY
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
2 |
0 |
CHRONIC RENAL INSUFICIENCY
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
COLITIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
CREATININ CLEARANCE DECREASE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
CYSTITIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
4 / 454 (0.88%) |
occurrences all number
|
0 |
6 |
DISURIA (URINARY PAIN)
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
DYSURIA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
4 / 454 (0.88%) |
occurrences all number
|
0 |
4 |
FIBROID UTERINE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
HEMATURIA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
HYDROCAELE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
INCREASE OF PSA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
KIDNEY
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
1 / 454 (0.22%) |
occurrences all number
|
1 |
1 |
LOW URINE OUTPUT (LOW VOLUME)
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
LOWERING OF CREATININ CLEARANCE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
OFFENSIVE SMELLING URINE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
PELVIC
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
2 |
0 |
PERSITENT PV DISCHARGE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
POLLAKIURIA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
PROSTATE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
PROSTATIC HYPERTROPHY
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
1 / 454 (0.22%) |
occurrences all number
|
1 |
1 |
PROSTATITIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
RENAL CHRONIC FAILURE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
RENAL COLIC
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
3 / 454 (0.66%) |
occurrences all number
|
0 |
4 |
RENAL FAILURE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
RENAL INSUFFICIENCY
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
1 / 454 (0.22%) |
occurrences all number
|
1 |
1 |
STOMA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
URETHRA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
URINARY DIFFICULTY
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
URINARY FREQUENCY
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
4 / 454 (0.88%) |
occurrences all number
|
1 |
7 |
URINARY FREQUENCY (NOCTURIA)
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
URINARY INFECTION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
URINARY TRACT SYMPTOMS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
UTERUS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
VAGINA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
Endocrine disorders
|
|
|
DIABETES
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
DIABETES (SURGERY RELATED)
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
FLUSHES
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
2 / 454 (0.44%) |
1 / 454 (0.22%) |
occurrences all number
|
2 |
2 |
HOT FLASHES
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
5 / 454 (1.10%) |
occurrences all number
|
0 |
14 |
HYPERTHYROIDISM
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
1 / 454 (0.22%) |
occurrences all number
|
1 |
1 |
THYROID
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
4 |
Musculoskeletal and connective tissue disorders
|
|
|
ABDOMEN
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
1 / 454 (0.22%) |
occurrences all number
|
1 |
1 |
ANKYLOSIS MAXILLA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
3 |
ARTHRITIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
2 / 454 (0.44%) |
occurrences all number
|
5 |
2 |
ARTHROSES
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
ARTHROSIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
2 / 454 (0.44%) |
0 / 454 (0.00%) |
occurrences all number
|
10 |
0 |
BURSITIS SHOULDER
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
2 |
BUTTOCK
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
2 |
CALF CRAMPS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
2 |
CALFS CRAMPS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
CERVICAL CONTRACTURE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
2 |
CRAMP
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
3 / 454 (0.66%) |
occurrences all number
|
0 |
9 |
CRAMP (HANDS)
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
CRAMP IN FEET AND FINGERS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
CRAMP IN FINGERS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
CRAMP IN THE CALF
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
CRAMP LEGS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
CRAMP ON BOTH FEET
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
CRAMPING LEGS (CA2+/MG ADVISED BY GP)
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
CRAMPING LEGS/HANDS NOW AND THEN
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
CRAMPS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
15 / 454 (3.30%) |
occurrences all number
|
0 |
41 |
CRAMPS CALVES
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
CRAMPS DURING THE NIGHT
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
5 |
CRAMPS FINGERS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
CRAMPS HAND AND FOOT
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
CRAMPS HANDS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
CRAMPS IN CALVES
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
CRAMPS IN HANDS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
CRAMPS IN HANDS AND LEG
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
CRAMPS IN HANDS/LEGS/FEET
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
CRAMPS IN LEGS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
CRAMPS IN THE HAND
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
2 |
CRAMPS IN THE LEGS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
CRAMPS LEFT THUMB
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
3 |
CRAMPS LEG/ARM
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
CRAMPS LEGS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
3 |
CRAMPS RIGHT TOE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
CRAMPS RIGHT TOES
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
CRAMPS-RIGHT TOES
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
CRAMS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
EXTREMITY-LIMB
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
4 / 454 (0.88%) |
9 / 454 (1.98%) |
occurrences all number
|
4 |
14 |
FACIAL
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
2 |
FALLEN ARCHES
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
10 |
FALLEN ARCHES (BOTH FEET)
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
FALLEN ARCHES BOTH FEET
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
FALLEN ARCHES FEET
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
2 |
FALLEN ARCHES -FEET
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
FALLEN ARCHES IN FEET
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
2 |
FALLEN ARCHES-FEET
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
FEET NOCTURNE CRAMPS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
FRACTURE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
3 / 454 (0.66%) |
occurrences all number
|
1 |
4 |
GENERALISED CRAMPS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
GOUT
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
2 / 454 (0.44%) |
2 / 454 (0.44%) |
occurrences all number
|
2 |
2 |
GOUT (R. FOOT)
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
GOUT L GREAT TOE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
HAND AND LEG CRAMPS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
HAND CRAMP
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
HAND CRAMPS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
2 |
HANDS AND CALF CRAMPS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
HANDS AND LEGS CRAMP
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
HANDS AND LEGS CRAMPS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
HAND'S CRAMP
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
HANDS CRAMPS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
2 |
HEAD
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
INGUEN HERNA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
INTERMITTANT CRAMPS IN THE HANDS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
2 |
L FOOT CRAMP
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
L THUMB CRAMP
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
3 |
L THUMB CRAMPS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
LEG CRAMP
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
2 |
LEG CRAMPS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
5 / 454 (1.10%) |
occurrences all number
|
0 |
9 |
LEG CRAMPS (MILD)
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
LEG/ARM CRAMP
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
LEG/ARM CRAMP
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
LEGS AND HANDS CRAMP
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
3 |
LEGS CRAMPS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
LUMBAGO
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
2 |
MASCULAR CRAMPS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
-MUS WEAKNESS EXTREMITY LOWER
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
MUSCLE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
54 / 454 (11.89%) |
occurrences all number
|
1 |
122 |
MUSCULAR CRAMPS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
7 |
MUSLE SPASMS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
NECK
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
2 / 454 (0.44%) |
1 / 454 (0.22%) |
occurrences all number
|
2 |
1 |
NIGHT CRAMPS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
2 |
NOCTURAL CRAMPS (FEET+CALVES)
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
NUMBNESS IN KNEE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
2 |
NUMBNESS IN L KNEE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
OCULAR
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
OSTEOPOROSIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
1 / 454 (0.22%) |
occurrences all number
|
1 |
1 |
PELVIC
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
PLANTAR FASCIITIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
2 |
0 |
R FOOT CRAMP
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
4 |
R FOOT CRAMPS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
RIGHT FOOT GOUT
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
SUBARCROMIAL IMPINGEMENT SYNDROME
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
TENDON
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
5 |
TENDOPATHY THIGH NIGHT
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
THORAX
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
TRISMUS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
TRUNK
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
Infections and infestations
|
|
|
ABDOMEN NOS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
ABSCESS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
3 / 454 (0.66%) |
occurrences all number
|
0 |
4 |
AIRWAY
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
ATHLETE'S FOOT
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
ANGINA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
2 |
BLADDER (URINARY)
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
BONE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
BORRELIOSIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
BRAIN
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
BRONCHITIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
7 / 454 (1.54%) |
occurrences all number
|
0 |
7 |
BRONCHITIS (5 DAYS)
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
BRONCHITIS (NORMAL ANC)
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
BRONCHUS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
5 / 454 (1.10%) |
occurrences all number
|
0 |
6 |
CELLULITIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
CELLULITIS, LEFT LEG
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
CHEST INFECTION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
3 / 454 (0.66%) |
occurrences all number
|
0 |
3 |
COLD
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
3 / 454 (0.66%) |
occurrences all number
|
1 |
3 |
COLD SORES
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
2 |
COLON
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
COMMON COLD WITH FEVER
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
CONJUNCTIVA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
2 / 454 (0.44%) |
occurrences all number
|
1 |
2 |
CONJUNCTIVITIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
3 / 454 (0.66%) |
occurrences all number
|
0 |
5 |
CYSTISIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
CYSTITIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
4 / 454 (0.88%) |
occurrences all number
|
0 |
8 |
DENTAL
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
3 / 454 (0.66%) |
occurrences all number
|
0 |
3 |
DENTAL-TOOTH
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
2 |
DIVERTICULITIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
EAR INFECTION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
2 |
ESOPHAGITIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
EXTERNAL EAR
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
EYE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
3 |
EYE NOS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
FEBRILE NEUTROPENIA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
5 |
FEVER BUTTON
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
FEVER DUE TO SWOLLEN GUMS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
FISTULA WITH ABCESS IN BURSA OMENTALIS MESENTERIAL PANNICULITIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
FLU
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
2 |
FLU LIKE ILLNESS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
GASTRIC ABCESS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
GENITAL CONDYLOMA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
GRIPPAL SYNDROM
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
HAND
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
HEAD
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
4 |
HELICOBACTER PYLORI
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
HELICOBECTER PYLORI
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
HEPATITIS B
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
HERPES SIMPLEX
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
2 |
HERPES VIRUS INFECTION (SHINGLES)
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
HERPES ZOSTER
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
2 / 454 (0.44%) |
occurrences all number
|
1 |
2 |
HERPES ZOSTER VIRUS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
2 |
ILEUM
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
INF GASTRIC MOCOSA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
INF GASTROENTERITIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
4 / 454 (0.88%) |
occurrences all number
|
0 |
4 |
INF GASTROINTESTINAL INFECTION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
2 |
INF GASTRO-INTESTINAL INFECTION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
2 |
INF PULMONARY SEPSIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
INF PULMONARY/UPPER RESPIRATORY
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
INFECTED PIMPLE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
INFECTED RIGHT EAR
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
INFECTED SEBACEOUS CYST
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
INFECTION ACNE OUTBREAK
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
INFECTION IN ORL SPHERE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
INFECTION WITH UKNOWN ANC
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
INFLUENZA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
5 / 454 (1.10%) |
occurrences all number
|
0 |
5 |
INFLUENZAL
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
JOINT
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
KIDNEY
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
LARYNGITIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
2 |
0 |
LEFT EAR INFECTION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
LEFT SIDE NECROTISING OTITIS LEFT EXTERNA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
LIP
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
LIVER
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
LOWER RESPIRATORY INFECTION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
LOWER RESPIRATORY TRACT INFECTION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
LUMP FLUID R ARMPIT WITH PURULENT
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
LUNG
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
LUNG (PNEUMONIA)
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
MRSA RESISTENT SEPSIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
MUCOSA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
MUSCLE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
MYCOSIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
NAILS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
NOSE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
OTH ACUTE GASTROENTERITIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
OTITIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
2 |
PARANASAL
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
PELVIC
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
PELVIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
2 |
PHARINGYTIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
PHARYNGITIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
PHARYNX
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
PNEUMATIC/BRONCHITIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
PNEUMONIA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
3 / 454 (0.66%) |
occurrences all number
|
0 |
3 |
PNEUMONIA (VIRAL INFECTION)
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
POSSIBLE RINGWORM
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
PROSTATE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
RECTUM
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
RESPIRATORY INFECTION WITHOUT NEUTROPENI
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
RHINITIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
RHINO-PHARINGITIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
RHINOPHARYNGITIS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
2 |
RIGHT FOOT
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
SALIVARY GLAND
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
SEASONAL INFECTION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
SHINGLES
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
SINUS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
2 |
SKIN
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
2 |
SMALL BOWEL NOS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
SPLEEN
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
STITCH ABSCESS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
STOMACH
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
TOOTH ABCESS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
TOOTH ABSCESS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
TOOTH INFECTION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
TOOTH SHAM
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
TRACHEA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
UNGUEAL INFECTION N/A LEVURE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
UPPER AIRWAY NOS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
4 / 454 (0.88%) |
occurrences all number
|
0 |
5 |
UPPER RESPIRATORY
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
UPPER RESPIRATORY INFECTION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
UPPER RESPIRATORY TRACT INFECTION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
3 / 454 (0.66%) |
occurrences all number
|
1 |
3 |
URETHRA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
URINARY
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
URINARY INFECTION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
3 |
URINARY TRACT INFECTION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
2 / 454 (0.44%) |
occurrences all number
|
1 |
2 |
URINARY TRACT NOS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
URINE INFECTION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
UTERUS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
VAGINA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
VEIN
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
VIRAL
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
VIRAL ILLNESS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
VIRAL INFECTION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
1 / 454 (0.22%) |
occurrences all number
|
1 |
1 |
VIRAL INFECTION (COMMON COLD VIRUS)
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
3 |
VIROLOFICAL HERPES ZOSTER
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
VIRUS
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
2 |
VIRUS INFECTION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
VULVA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
WOUND
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
3 / 454 (0.66%) |
occurrences all number
|
0 |
4 |
ZONA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
Metabolism and nutrition disorders
|
|
|
ALAT=40N, ASAT=20N ( HEPATO TOXICITY)
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
ALT
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
ALT, AST
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
ANOREXIA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
16 / 454 (3.52%) |
55 / 454 (12.11%) |
occurrences all number
|
27 |
121 |
BILIRUBIN INCREASE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
2 |
BILIRUBIN-INCREASE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
CHOLESTEROL
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
CPK
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
6 |
CREATININE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
3 / 454 (0.66%) |
occurrences all number
|
0 |
4 |
DEFICIENCY FE, FOLIC ACID,VIT B12
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
DEHYDRATION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
GGT (82U/L)
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
GGT INCREASE
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
3 |
HEPATIC
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
HYPERBILIRUBINEMIA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
HYPERCHOLESTREMIA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
HYPERGLYCEMIA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
3 / 454 (0.66%) |
occurrences all number
|
1 |
10 |
HYPERURICEMIA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
3 |
HYPOCALCEMIA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
HYPOGLYCEMIA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
3 / 454 (0.66%) |
occurrences all number
|
0 |
4 |
HYPOKALEMIA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
2 / 454 (0.44%) |
occurrences all number
|
0 |
9 |
HYPONATREMIA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
HYPOPHOSPHATEMIA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
6 |
INCREASE GGT
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
IRON DEFICIENCY
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
1 |
0 |
METRORRHAGIA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
OTH DEFICIT OF VIT B12
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
OTH IRON DEFICIENCY
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
0 / 454 (0.00%) |
occurrences all number
|
2 |
0 |
OTH UREA = 61 MG/DL [17-43]
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
PROTEINURIA
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
1 / 454 (0.22%) |
1 / 454 (0.22%) |
occurrences all number
|
1 |
9 |
RAISED CHOLESTEROL
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |
TSH ELEVATION
|
|
|
alternative dictionary used: CTCAE
3.0
|
|
|
subjects affected / exposed
|
0 / 454 (0.00%) |
1 / 454 (0.22%) |
occurrences all number
|
0 |
1 |