Non-serious adverse events
|
active_mother |
active_infant |
placebo_infant |
placebo_mother |
Total subjects affected by non serious adverse events
|
|
|
|
|
subjects affected / exposed
|
910 / 1227 (74.16%) |
197 / 1364 (14.44%) |
238 / 1374 (17.32%) |
930 / 1236 (75.24%) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
|
|
Acrochordon
|
|
|
|
|
Additional description: Acrochordon
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
1 / 1364 (0.07%) |
4 / 1374 (0.29%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
1 |
4 |
0 |
Melanocytic naevus
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
1 / 1374 (0.07%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
Vascular disorders
|
|
|
|
|
Gestational hypertension
|
|
|
|
|
Additional description: Gestational hypertension
|
|
|
|
|
subjects affected / exposed
|
20 / 1227 (1.63%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
12 / 1236 (0.97%) |
occurrences all number
|
20 |
0 |
0 |
12 |
Hypertension
|
|
|
|
|
Additional description: Hypertension
|
|
|
|
|
subjects affected / exposed
|
49 / 1227 (3.99%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
42 / 1236 (3.40%) |
occurrences all number
|
49 |
0 |
0 |
42 |
Subgaleal haematoma
|
|
|
|
|
Additional description: Subgaleal haematoma
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
1 / 1364 (0.07%) |
1 / 1374 (0.07%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
1 |
1 |
0 |
Hot flush
|
|
|
|
|
subjects affected / exposed
|
3 / 1227 (0.24%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
3 / 1236 (0.24%) |
occurrences all number
|
3 |
0 |
0 |
3 |
Labile hypertension
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
2 / 1236 (0.16%) |
occurrences all number
|
1 |
0 |
0 |
2 |
Thrombosis
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
1 / 1364 (0.07%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
1 |
0 |
1 |
Thrombophlebitis superficial
|
|
|
|
|
subjects affected / exposed
|
4 / 1227 (0.33%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
4 |
0 |
0 |
1 |
Thrombophlebitis
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Phlebitis
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Orthostatic hypotension
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Labile blood pressure
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Hypovolaemic shock
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
1 / 1374 (0.07%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
Hypotension
|
|
|
|
|
subjects affected / exposed
|
3 / 1227 (0.24%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
3 / 1236 (0.24%) |
occurrences all number
|
3 |
0 |
0 |
3 |
Haematoma
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
1 |
0 |
0 |
1 |
Surgical and medical procedures
|
|
|
|
|
Abortion induced
|
|
|
|
|
Additional description: Abortion induced
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
1 / 1364 (0.07%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
0 |
Bartholin's cyst removal
|
|
|
|
|
Additional description: Bartholin's cyst removal
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
External cephalic version
|
|
|
|
|
Additional description: Failed external cephalic version
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Respiratory support
|
|
|
|
|
Additional description: Respiratory support
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
2 / 1364 (0.15%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
0 |
Transfusion
|
|
|
|
|
Additional description: Transfusion
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Wound treatment
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Tooth extraction
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
3 / 1236 (0.24%) |
occurrences all number
|
0 |
0 |
0 |
3 |
Office visit
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
1 |
0 |
0 |
1 |
Ureteral stent insertion
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Surgery
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Tooth repair
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Physiotherapy
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
General anaesthesia
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Forceps delivery
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
1 / 1374 (0.07%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
Episiotomy
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Pregnancy, puerperium and perinatal conditions
|
|
|
|
|
Foetal growth restriction
|
|
|
|
|
Additional description: Foetal growth restriction
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
9 / 1364 (0.66%) |
14 / 1374 (1.02%) |
5 / 1236 (0.40%) |
occurrences all number
|
0 |
9 |
14 |
5 |
Foetal hypokinesia
|
|
|
|
|
Additional description: Foetal hypokinesia
|
|
|
|
|
subjects affected / exposed
|
93 / 1227 (7.58%) |
18 / 1364 (1.32%) |
27 / 1374 (1.97%) |
92 / 1236 (7.44%) |
occurrences all number
|
93 |
18 |
27 |
92 |
Gestational diabetes
|
|
|
|
|
Additional description: Gestational diabetes
|
|
|
|
|
subjects affected / exposed
|
89 / 1227 (7.25%) |
0 / 1364 (0.00%) |
1 / 1374 (0.07%) |
90 / 1236 (7.28%) |
occurrences all number
|
89 |
0 |
1 |
90 |
Jaundice neonatal
|
|
|
|
|
Additional description: Jaundice neonatal
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
14 / 1364 (1.03%) |
17 / 1374 (1.24%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
14 |
17 |
0 |
Polyhydramnios
|
|
|
|
|
Additional description: Polyhydramnios
|
|
|
|
|
subjects affected / exposed
|
8 / 1227 (0.65%) |
2 / 1364 (0.15%) |
1 / 1374 (0.07%) |
13 / 1236 (1.05%) |
occurrences all number
|
8 |
2 |
1 |
13 |
Postpartum haemorrhage
|
|
|
|
|
Additional description: Postpartum haemorrhage
|
|
|
|
|
subjects affected / exposed
|
25 / 1227 (2.04%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
32 / 1236 (2.59%) |
occurrences all number
|
25 |
0 |
0 |
32 |
Pre-eclampsia
|
|
|
|
|
Additional description: Pre-eclampsia
|
|
|
|
|
subjects affected / exposed
|
26 / 1227 (2.12%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
18 / 1236 (1.46%) |
occurrences all number
|
26 |
0 |
0 |
18 |
Premature baby
|
|
|
|
|
Additional description: Premature baby
|
|
|
|
|
subjects affected / exposed
|
3 / 1227 (0.24%) |
39 / 1364 (2.86%) |
26 / 1374 (1.89%) |
1 / 1236 (0.08%) |
occurrences all number
|
3 |
39 |
26 |
1 |
Premature rupture of membranes
|
|
|
|
|
Additional description: Premature rupture of membranes
|
|
|
|
|
subjects affected / exposed
|
18 / 1227 (1.47%) |
1 / 1364 (0.07%) |
1 / 1374 (0.07%) |
23 / 1236 (1.86%) |
occurrences all number
|
18 |
1 |
1 |
23 |
Uterine contractions during pregnancy
|
|
|
|
|
Additional description: Uterine contractions during pregnancy
|
|
|
|
|
subjects affected / exposed
|
37 / 1227 (3.02%) |
0 / 1364 (0.00%) |
1 / 1374 (0.07%) |
37 / 1236 (2.99%) |
occurrences all number
|
37 |
0 |
1 |
37 |
Born before arrival
|
|
|
|
|
Additional description: Born before arrival
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
1 / 1364 (0.07%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
Contractions, Premature rupture of membranes
|
|
|
|
|
Additional description: Contractions, Premature rupture of membranes
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Contractions, Vaginal haemorrhage
|
|
|
|
|
Additional description: Contractions, Vaginal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Contractions, Vaginal haemorrhage, Premature rupture of membranes
|
|
|
|
|
Additional description: Contractions, Vaginal haemorrhage, Premature rupture of membranes
|
|
|
|
|
subjects affected / exposed
|
2 / 1227 (0.16%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
0 |
Low birth weight baby, Oligohydramnios
|
|
|
|
|
Additional description: Low birth weight baby, Oligohydramnios
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Placental transfusion syndrome, Oligohydramnios
|
|
|
|
|
Additional description: Placental transfusion syndrome, Oligohydramnios
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Abdominal pain lower, Contractions
|
|
|
|
|
Additional description: Abdominal pain lower, Contractions
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Abortion threatened
|
|
|
|
|
Additional description: Abortion threatened
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Caesarean section
|
|
|
|
|
Additional description: Caesarean section
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
1 / 1364 (0.07%) |
0 / 1374 (0.00%) |
2 / 1236 (0.16%) |
occurrences all number
|
0 |
1 |
0 |
2 |
Cephalhaematoma
|
|
|
|
|
Additional description: Cephalhaematoma
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
2 / 1374 (0.15%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
0 |
2 |
0 |
Cervical incompetence
|
|
|
|
|
Additional description: Cervical incompetence
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Prenatal screening test abnormal
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
1 / 1364 (0.07%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
Low birth weight baby
|
|
|
|
|
Additional description: Low birth weight baby
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
1 / 1364 (0.07%) |
2 / 1374 (0.15%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
1 |
2 |
0 |
Amniorrhoea
|
|
|
|
|
Additional description: Amniorrhoea
|
|
|
|
|
subjects affected / exposed
|
2 / 1227 (0.16%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
2 / 1236 (0.16%) |
occurrences all number
|
2 |
0 |
0 |
2 |
Placenta accreta
|
|
|
|
|
Additional description: Placenta accreta
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
1 |
0 |
0 |
1 |
Labour pain
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Meconium stain
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
1 / 1374 (0.07%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
Foetal macrosomia
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
2 / 1364 (0.15%) |
6 / 1374 (0.44%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
2 |
6 |
1 |
Labour induction
|
|
|
|
|
subjects affected / exposed
|
2 / 1227 (0.16%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
2 |
0 |
0 |
1 |
Imminent abortion
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
1 / 1364 (0.07%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
Meconium abnormal
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
1 / 1364 (0.07%) |
1 / 1374 (0.07%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
1 |
1 |
0 |
Vomiting in pregnancy
|
|
|
|
|
subjects affected / exposed
|
2 / 1227 (0.16%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
4 / 1236 (0.32%) |
occurrences all number
|
2 |
0 |
0 |
4 |
Umbilical cord prolapse
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
1 |
0 |
0 |
1 |
Retained placenta or membranes
|
|
|
|
|
subjects affected / exposed
|
2 / 1227 (0.16%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
2 / 1236 (0.16%) |
occurrences all number
|
2 |
0 |
0 |
2 |
Placental disorder
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
2 / 1236 (0.16%) |
occurrences all number
|
1 |
0 |
0 |
2 |
Placenta praevia
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
1 |
0 |
0 |
1 |
Labour
|
|
|
|
|
subjects affected / exposed
|
2 / 1227 (0.16%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
3 / 1236 (0.24%) |
occurrences all number
|
2 |
0 |
0 |
3 |
Large for dates baby
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
1 / 1374 (0.07%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
1 |
1 |
Foetal distress syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
1 / 1374 (0.07%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
Placental insufficiency
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
2 / 1236 (0.16%) |
occurrences all number
|
0 |
0 |
0 |
2 |
General disorders and administration site conditions
|
|
|
|
|
Chest pain
|
|
|
|
|
Additional description: Chest pain
|
|
|
|
|
subjects affected / exposed
|
20 / 1227 (1.63%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
22 / 1236 (1.78%) |
occurrences all number
|
20 |
0 |
0 |
22 |
Fatigue
|
|
|
|
|
Additional description: Fatigue
|
|
|
|
|
subjects affected / exposed
|
35 / 1227 (2.85%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
37 / 1236 (2.99%) |
occurrences all number
|
35 |
0 |
0 |
37 |
Malaise
|
|
|
|
|
Additional description: Malaise
|
|
|
|
|
subjects affected / exposed
|
21 / 1227 (1.71%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
18 / 1236 (1.46%) |
occurrences all number
|
21 |
0 |
0 |
18 |
Oedema
|
|
|
|
|
Additional description: Oedema
|
|
|
|
|
subjects affected / exposed
|
33 / 1227 (2.69%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
38 / 1236 (3.07%) |
occurrences all number
|
33 |
0 |
0 |
38 |
Oedema peripheral
|
|
|
|
|
Additional description: Oedema peripheral
|
|
|
|
|
subjects affected / exposed
|
93 / 1227 (7.58%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
102 / 1236 (8.25%) |
occurrences all number
|
93 |
0 |
0 |
102 |
Pyrexia
|
|
|
|
|
Additional description: Pyrexia
|
|
|
|
|
subjects affected / exposed
|
13 / 1227 (1.06%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
7 / 1236 (0.57%) |
occurrences all number
|
13 |
0 |
0 |
7 |
Abdominal cramping, Vaginal discharge
|
|
|
|
|
Additional description: Abdominal cramping, Vaginal discharge
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Abdominal discomfort, Pelvic pain
|
|
|
|
|
Additional description: Abdominal discomfort, Pelvic pain
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Abdominal pain, Amniotic fluid leak
|
|
|
|
|
Additional description: Abdominal pain, Amniotic fluid leak
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Abdominal pain, Back pain
|
|
|
|
|
Additional description: Abdominal pain, Back pain
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
1 |
0 |
0 |
1 |
Abdominal pain, Contractions
|
|
|
|
|
Additional description: Abdominal pain, Contractions
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Abdominal pain, Pyrexia
|
|
|
|
|
Additional description: Abdominal pain, Pyrexia
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Abdominal pain, Vaginal discharge
|
|
|
|
|
Additional description: Abdominal pain, Vaginal discharge
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Abdominal pain, Vaginal haemorrhage
|
|
|
|
|
Additional description: Abdominal pain, Vaginal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
6 / 1227 (0.49%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
4 / 1236 (0.32%) |
occurrences all number
|
6 |
0 |
0 |
4 |
Abdominal pain lower, Back pain
|
|
|
|
|
Additional description: Abdominal pain lower, Back pain
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Abdominal pain lower, Vaginal haemorrhage, Back pain
|
|
|
|
|
Additional description: Abdominal pain lower, Vaginal haemorrhage, Back pain
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Abdominal pain upper, Dyspnoea
|
|
|
|
|
Additional description: Abdominal pain upper, Dyspnoea
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Abdominal pain upper, Headache
|
|
|
|
|
Additional description: Abdominal pain upper, Headache
|
|
|
|
|
subjects affected / exposed
|
3 / 1227 (0.24%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
2 / 1236 (0.16%) |
occurrences all number
|
3 |
0 |
0 |
2 |
Abdominal pain upper, Nausea
|
|
|
|
|
Additional description: Abdominal pain upper, Nausea
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Abdominal pain upper, Headache, Oedema peripheral
|
|
|
|
|
Additional description: Abdominal pain upper, Headache, Oedema peripheral
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
2 / 1236 (0.16%) |
occurrences all number
|
1 |
0 |
0 |
2 |
Abdominal pain, Diarrhoea, Back pain, Vaginal discharge
|
|
|
|
|
Additional description: Abdominal pain, Diarrhoea, Back pain, Vaginal discharge
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Abdominal pain, Back pain, Visual impairment
|
|
|
|
|
Additional description: Abdominal pain, Back pain, Visual impairment
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Abdominal pain, Headache, Oedema peripheral
|
|
|
|
|
Additional description: Abdominal pain, Headache, Oedema peripheral
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Abdominal pain, Malaise, Heart rate increased, Dehydration
|
|
|
|
|
Additional description: Abdominal pain, Malaise, Heart rate increased, Dehydration
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Abdominal pain, Vaginal haemorrhage, Cholestasis of pregnancy
|
|
|
|
|
Additional description: Abdominal pain, Vaginal haemorrhage, Cholestasis of pregnancy
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Abdominal pain, Vomiting, Tachypnoea
|
|
|
|
|
Additional description: Abdominal pain, Vomiting, Tachypnoea
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Back pain, Constipation
|
|
|
|
|
Additional description: Back pain, Constipation
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Back pain, Contractions
|
|
|
|
|
Additional description: Back pain, Contractions
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
1 |
0 |
0 |
1 |
Back pain, Pollakiuria
|
|
|
|
|
Additional description: Back pain, Pollakiuria
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Back pain, Right sided pain, Vomiting
|
|
|
|
|
Additional description: Back pain, Right sided pain, Vomiting
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Back pain, Oropharyngeal pain, Diarrhoea, Pollakiuria
|
|
|
|
|
Additional description: Back pain, Oropharyngeal pain, Diarrhoea, Pollakiuria
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Blood glucose, Urine ketone body present
|
|
|
|
|
Additional description: Blood glucose and Urine ketone body present
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Blood glucose increased, Nausea
|
|
|
|
|
Additional description: Blood glucose increased, Nausea
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Blood pressure increased, Dyspnoea
|
|
|
|
|
Additional description: Blood pressure increased, Dyspnoea
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Blood pressure increased, Anogenital warts
|
|
|
|
|
Additional description: Blood pressure increased, Anogenital warts
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Blood pressure increased, Headache
|
|
|
|
|
Additional description: Blood pressure increased, Headache
|
|
|
|
|
subjects affected / exposed
|
3 / 1227 (0.24%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
3 / 1236 (0.24%) |
occurrences all number
|
3 |
0 |
0 |
3 |
Blood pressure increased, Oedema peripheral
|
|
|
|
|
Additional description: Blood pressure increased, Oedema peripheral
|
|
|
|
|
subjects affected / exposed
|
2 / 1227 (0.16%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
3 / 1236 (0.24%) |
occurrences all number
|
2 |
0 |
0 |
3 |
Blood pressure increased, Visual impairment
|
|
|
|
|
Additional description: Blood pressure increased, Visual impairment
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Blood pressure increased, Headache, Blurred vision
|
|
|
|
|
Additional description: Blood pressure increased, Headache, Blurred vision
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Blood pressure increased, Oedema
|
|
|
|
|
Additional description: Blood pressure increased, Oedema
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Vision blurred, Dizziness, Protein urine
|
|
|
|
|
Additional description: Vision blurred, Dizziness, Protein urine
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Chest discomfort, Cough
|
|
|
|
|
Additional description: Chest discomfort, Cough
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Chorioamniotis, Creatine urine increased
|
|
|
|
|
Additional description: Chorioamniotis, Creatine urine increased
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Constipation, Urinary tract infection, Vaginal discharge
|
|
|
|
|
Additional description: Constipation, Urinary tract infection, Vaginal discharge
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Contractions, Pelvic pain
|
|
|
|
|
Additional description: Contractions, Pelvic pain
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Contractions, Candida infection
|
|
|
|
|
Additional description: Contractions, Candida infection
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Contractions, Vomiting
|
|
|
|
|
Additional description: Contractions, Vomiting
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Diarrhoea, Nausea, Sensation of pressure, Vaginal discharge
|
|
|
|
|
Additional description: Diarrhoea, Nausea, Sensation of pressure, Vaginal discharge
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Dry eye, Dry mouth
|
|
|
|
|
Additional description: Dry eye, Dry mouth
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Dyspnoea, Asthenia, Vision blurred
|
|
|
|
|
Additional description: Dyspnoea, Asthenia, Vision blurred
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Dyspnoea, Diarrhoea, Myalgia, Abdominal pain, Back pain
|
|
|
|
|
Additional description: Dyspnoea, Diarrhoea, Myalgia, Abdominal pain, Back pain
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Dyspnoea, Headache, Oedema, Protein urine, Blood urine
|
|
|
|
|
Additional description: Dyspnoea, Headache, Oedema, Protein urine, Blood urine
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Dyspnoea, Chest pain
|
|
|
|
|
Additional description: Dyspnoea, Chest pain
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Fatigue, Abdominal pain, Nausea
|
|
|
|
|
Additional description: Fatigue, Abdominal pain, Nausea
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Fatigue, Oropharyngeal pain, Abdominal pain upper
|
|
|
|
|
Additional description: Fatigue, Oropharyngeal pain, Abdominal pain upper
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Headache, Amylase increased
|
|
|
|
|
Additional description: Headache, Amylase increased
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Headache, Arthralgia
|
|
|
|
|
Additional description: Headache, Arthralgia
|
|
|
|
|
subjects affected / exposed
|
2 / 1227 (0.16%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
0 |
Headache, Back pain
|
|
|
|
|
Additional description: Headache, Back pain
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
2 / 1236 (0.16%) |
occurrences all number
|
0 |
0 |
0 |
2 |
Headache, Diarrhoea
|
|
|
|
|
Additional description: Headache, Diarrhoea
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Headache, Oedema
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
1 |
0 |
0 |
1 |
Headache, Oedema peripheral
|
|
|
|
|
Additional description: Headache, Oedema peripheral
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Headache, Pain in extremity
|
|
|
|
|
Additional description: Headache, Pain in extremity
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
1 |
0 |
0 |
1 |
Headache, Protein urine
|
|
|
|
|
Additional description: Headache, Protein urine
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
1 |
0 |
0 |
1 |
Headache, Proteinuria
|
|
|
|
|
Additional description: Headache, Proteinuria
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Headache, Urine protein/creatinine ratio
|
|
|
|
|
Additional description: Headache, Urine protein/creatinine ratio
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Headache, Dizziness, Night sweats
|
|
|
|
|
Additional description: Headache, Dizziness, Night sweats
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Headache, Ear pain, Nausea, Dyspepsia
|
|
|
|
|
Additional description: Headache, Ear pain, Nausea, Dyspepsia
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Headache, Pain in extremity, Diarrhoea
|
|
|
|
|
Additional description: Headache, Pain in extremity, Diarrhoea
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Headache, Nausea, Back pain
|
|
|
|
|
Additional description: Headache, Nausea, Back pain
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Headache, Oedema, Visual impairment
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Headache, Oedema peripheral, Visual impairment, Abdominal pain upper, Dyspepsia
|
|
|
|
|
Additional description: Headache, Oedema peripheral, Visual impairment, Abdominal pain upper, Dyspepsia
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Headache, Oedema, Abdominal pain, Hypertension
|
|
|
|
|
Additional description: Headache, Oedema, Abdominal pain, Hypertension
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Headache, Oedema, Abdominal pain upper, Malaise
|
|
|
|
|
Additional description: Headache, Oedema, Abdominal pain upper, Malaise
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Headache, Oedema, Blood pressure increased, Protein urine
|
|
|
|
|
Additional description: Headache, Oedema, Blood pressure increased, Protein urine
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Headache, Dysuria, Candida infection
|
|
|
|
|
Additional description: Headache, Dysuria, Candida infection
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Headache, Visual impairment, Nausea, Diarrhoea
|
|
|
|
|
Additional description: Headache, Visual impairment, Nausea, Diarrhoea
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Headache, Vomiting, Hypertension
|
|
|
|
|
Additional description: Headache, Vomiting, Hypertension
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Hypertension, Oedema peripheral
|
|
|
|
|
Additional description: Hypertension, Oedema peripheral
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Hypertension, Proteinuria
|
|
|
|
|
Additional description: Hypertension, Proteinuria
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Hypertension, Heart rate increased, Palpitations
|
|
|
|
|
Additional description: Hypertension, Heart rate increased, Palpitations
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Pain in extremity, Oedema peripheral, Haemoptysis
|
|
|
|
|
Additional description: Pain in extremity, Oedema peripheral, Haemoptysis
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Lethargy, Dizziness, Dyspepsia
|
|
|
|
|
Additional description: Lethargy, Dizziness, Dyspepsia
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Loss of consciousness, Foetal hypokinesia
|
|
|
|
|
Additional description: Loss of consciousness, Foetal hypokinesia
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Malaise, Oedema peripheral
|
|
|
|
|
Additional description: Malaise, Oedema peripheral
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Maternal exposure during pregnancy to Varicella
|
|
|
|
|
Additional description: Maternal exposure during pregnancy to Varicella
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Migraine, Syncope, Bell's palsy
|
|
|
|
|
Additional description: Migraine, Syncope, Bell's palsy
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Musculoskeletal pain, Urinary tract infection, Dyspepsia
|
|
|
|
|
Additional description: Musculoskeletal pain, Urinary tract infection, Dyspepsia
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Myalgia, Vaginal discharge
|
|
|
|
|
Additional description: Myalgia, Vaginal discharge
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Nausea, Palpitations, Insomnia
|
|
|
|
|
Additional description: Nausea, Palpitations, Insomnia
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Jaundice neonatal, Hypoglycaemia neonatal, Sepsis neonatal
|
|
|
|
|
Additional description: Jaundice neonatal, Hypoglycaemia neonatal, Sepsis neonatal
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
1 / 1364 (0.07%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
Oedema peripheral, Dizziness
|
|
|
|
|
Additional description: Oedema peripheral, Dizziness
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Oedema peripheral, Candida infection
|
|
|
|
|
Additional description: Oedema peripheral, Candida infection
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Oedema peripheral, Vulvovaginal swelling
|
|
|
|
|
Additional description: Oedema peripheral, Vulvovaginal swelling
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Pain in extremity, Vaginal haemorrhage, Abdominal pain
|
|
|
|
|
Additional description: Pain in extremity, Vaginal haemorrhage, Abdominal pain
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Premature rupture of membranes, Chorioamniotis
|
|
|
|
|
Additional description: Premature rupture of membranes, Chorioamniotis
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Premature rupture of membranes, Vaginal haemorrhage
|
|
|
|
|
Additional description: Premature rupture of membranes, Vaginal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Protein urine, Oedema peripheral
|
|
|
|
|
Additional description: Protein urine, Oedema peripheral
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
1 |
0 |
0 |
1 |
Proteinuria, Oedema peripheral
|
|
|
|
|
Additional description: Proteinuria, Oedema peripheral
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Pruritus, Back pain, Oedema
|
|
|
|
|
Additional description: Pruritus, Back pain, Oedema
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Rash, Foetal hypokinesia
|
|
|
|
|
Additional description: Rash, Foetal hypokinesia
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Rash, Pyrexia
|
|
|
|
|
Additional description: Rash, Pyrexia
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Reflux gastritis, Ketone body in urine
|
|
|
|
|
Additional description: Reflux gastritis, Ketone body in urine
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Sciatica, Skin infection
|
|
|
|
|
Additional description: Sciatica, Skin infection
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Shoulder dystocia, Erb's palsy
|
|
|
|
|
Additional description: Shoulder dystocia, Erb's palsy
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
2 / 1374 (0.15%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
0 |
2 |
0 |
Musculoskeletal pain, Rash
|
|
|
|
|
Additional description: Shoulder pain, Rash
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Thirst, Hyperhidrosis
|
|
|
|
|
Additional description: Thirst, Hyperhidrosis
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Vaginal discomfort, Back pain, Dysuria
|
|
|
|
|
Additional description: Vaginal discomfort, Back pain, Dysuria
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Vaginal haemorrhage, Pain
|
|
|
|
|
Additional description: Vaginal haemorrhage, Pain
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Vaginal haemorrhage, Pelvic pain
|
|
|
|
|
Additional description: Vaginal haemorrhage, Pelvic pain
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Vaginal haemorrhage, Vaginal discharge
|
|
|
|
|
Additional description: Vaginal haemorrhage, Vaginal discharge
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Vaginal haemorrhage, Diarrhoea, Incontinence
|
|
|
|
|
Additional description: Vaginal haemorrhage, Diarrhoea, Incontinence
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Visual impairment, Dyspnoea, Polyhydramnios
|
|
|
|
|
Additional description: Visual impairment, Dyspnoea, Polyhydramnios
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Vomiting, Dizziness, Migraine
|
|
|
|
|
Additional description: Vomiting, Dizziness, Migraine
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Abdominal pain, Back pain, Vaginal discharge
|
|
|
|
|
Additional description: Abdominal pain, Back pain, Vaginal discharge
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Asthenia
|
|
|
|
|
Additional description: Asthenia
|
|
|
|
|
subjects affected / exposed
|
7 / 1227 (0.57%) |
0 / 1364 (0.00%) |
7 / 1374 (0.51%) |
0 / 1236 (0.00%) |
occurrences all number
|
7 |
0 |
7 |
0 |
Chest discomfort
|
|
|
|
|
Additional description: Chest discomfort
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
1 |
0 |
0 |
1 |
Drug level changed
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Fat necrosis
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
1 / 1364 (0.07%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
General symptom
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Injection site nodule
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Thirst
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
2 / 1236 (0.16%) |
occurrences all number
|
1 |
0 |
0 |
2 |
Swelling
|
|
|
|
|
subjects affected / exposed
|
3 / 1227 (0.24%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
5 / 1236 (0.40%) |
occurrences all number
|
3 |
0 |
0 |
5 |
Sensation of pressure
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
4 / 1236 (0.32%) |
occurrences all number
|
0 |
0 |
0 |
4 |
Pre-existing condition improved
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Pain
|
|
|
|
|
subjects affected / exposed
|
11 / 1227 (0.90%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
6 / 1236 (0.49%) |
occurrences all number
|
11 |
0 |
0 |
6 |
Irritability
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
3 / 1236 (0.24%) |
occurrences all number
|
0 |
0 |
0 |
3 |
Impaired healing
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
1 |
0 |
0 |
1 |
Hypothermia neonatal
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
1 / 1374 (0.07%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
Feeling abnormal
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Face oedema
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
3 / 1236 (0.24%) |
occurrences all number
|
1 |
0 |
0 |
3 |
Feeling hot
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
2 / 1236 (0.16%) |
occurrences all number
|
1 |
0 |
0 |
2 |
Immune system disorders
|
|
|
|
|
ABO incompatibility
|
|
|
|
|
Additional description: ABO incompatibility
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
3 / 1364 (0.22%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
3 |
0 |
0 |
Drug hypersensitivity
|
|
|
|
|
Additional description: Drug hypersensitivity
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
3 / 1236 (0.24%) |
occurrences all number
|
1 |
0 |
0 |
3 |
House dust allergy
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Seasonal allergy
|
|
|
|
|
subjects affected / exposed
|
8 / 1227 (0.65%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
4 / 1236 (0.32%) |
occurrences all number
|
8 |
0 |
0 |
4 |
Food allergy
|
|
|
|
|
subjects affected / exposed
|
2 / 1227 (0.16%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
0 |
Reproductive system and breast disorders
|
|
|
|
|
Pelvic pain
|
|
|
|
|
Additional description: Pelvic pain
|
|
|
|
|
subjects affected / exposed
|
32 / 1227 (2.61%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
31 / 1236 (2.51%) |
occurrences all number
|
32 |
0 |
0 |
31 |
Vaginal discharge
|
|
|
|
|
Additional description: Vaginal discharge
|
|
|
|
|
subjects affected / exposed
|
14 / 1227 (1.14%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
18 / 1236 (1.46%) |
occurrences all number
|
14 |
0 |
0 |
18 |
Vaginal haemorrhage
|
|
|
|
|
Additional description: Vaginal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
56 / 1227 (4.56%) |
1 / 1364 (0.07%) |
0 / 1374 (0.00%) |
61 / 1236 (4.94%) |
occurrences all number
|
56 |
1 |
0 |
61 |
Bartholinitis
|
|
|
|
|
Additional description: Bartholinitis
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Breast cyst
|
|
|
|
|
Additional description: Breast cyst
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
1 / 1374 (0.07%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
Breast pain
|
|
|
|
|
Additional description: Breast pain
|
|
|
|
|
subjects affected / exposed
|
4 / 1227 (0.33%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
4 |
0 |
0 |
1 |
Breast tenderness
|
|
|
|
|
Additional description: Breast tenderness
|
|
|
|
|
subjects affected / exposed
|
2 / 1227 (0.16%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
3 / 1236 (0.24%) |
occurrences all number
|
2 |
0 |
0 |
3 |
Cervix disorder
|
|
|
|
|
Additional description: Cervix disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Vulvovaginal pain
|
|
|
|
|
Additional description: Vulovaginal pain
|
|
|
|
|
subjects affected / exposed
|
2 / 1227 (0.16%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
3 / 1236 (0.24%) |
occurrences all number
|
2 |
0 |
0 |
3 |
Vulvovaginal burning sensation
|
|
|
|
|
Additional description: Vulvovaginal burning sensation
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Coital bleeding
|
|
|
|
|
Additional description: Coital bleeding
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
2 / 1236 (0.16%) |
occurrences all number
|
0 |
0 |
0 |
2 |
Pelvic discomfort
|
|
|
|
|
Additional description: Pelvic discomfort
|
|
|
|
|
subjects affected / exposed
|
7 / 1227 (0.57%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
7 / 1236 (0.57%) |
occurrences all number
|
7 |
0 |
0 |
7 |
Uterine cervical pain
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Vulvovaginal pruritus
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
1 |
0 |
0 |
1 |
Cervical friability
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Cervix haematoma uterine
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Vaginal lesion
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Vulvovaginal discomfort
|
|
|
|
|
subjects affected / exposed
|
3 / 1227 (0.24%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
2 / 1236 (0.16%) |
occurrences all number
|
3 |
0 |
0 |
2 |
Varicose veins vulval
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Vaginal odour
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Vaginal laceration
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Uterine spasm
|
|
|
|
|
subjects affected / exposed
|
4 / 1227 (0.33%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
3 / 1236 (0.24%) |
occurrences all number
|
4 |
0 |
0 |
3 |
Uterine atony
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Uterine haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Respiratory, thoracic and mediastinal disorders
|
|
|
|
|
Cough
|
|
|
|
|
Additional description: Cough
|
|
|
|
|
subjects affected / exposed
|
16 / 1227 (1.30%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
26 / 1236 (2.10%) |
occurrences all number
|
16 |
0 |
0 |
26 |
Dyspnoea
|
|
|
|
|
Additional description: Dyspnoea
|
|
|
|
|
subjects affected / exposed
|
86 / 1227 (7.01%) |
1 / 1364 (0.07%) |
2 / 1374 (0.15%) |
86 / 1236 (6.96%) |
occurrences all number
|
86 |
1 |
2 |
86 |
Epistaxis
|
|
|
|
|
Additional description: Epistaxis
|
|
|
|
|
subjects affected / exposed
|
14 / 1227 (1.14%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
22 / 1236 (1.78%) |
occurrences all number
|
14 |
0 |
0 |
22 |
Oropharyngeal pain
|
|
|
|
|
Additional description: Oropharyngeal pain
|
|
|
|
|
subjects affected / exposed
|
19 / 1227 (1.55%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
13 / 1236 (1.05%) |
occurrences all number
|
19 |
0 |
0 |
13 |
Atelectasis, Pneumothorax
|
|
|
|
|
Additional description: Atelectasis, Pneumothorax
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Bronchospasm
|
|
|
|
|
Additional description: Bronchospasm
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Chronic obstructive pulmonary disease
|
|
|
|
|
Additional description: Chronic obstructive pulmonary disease
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Dyspnoea exertional
|
|
|
|
|
Additional description: Dyspnoea exertional
|
|
|
|
|
subjects affected / exposed
|
5 / 1227 (0.41%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
4 / 1236 (0.32%) |
occurrences all number
|
5 |
0 |
0 |
4 |
Wheezing
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Transient tachypnoea of the newborn
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
5 / 1364 (0.37%) |
2 / 1374 (0.15%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
5 |
2 |
0 |
Sleep apnoea syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
2 / 1236 (0.16%) |
occurrences all number
|
0 |
0 |
0 |
2 |
Sinus congestion
|
|
|
|
|
subjects affected / exposed
|
3 / 1227 (0.24%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
3 |
0 |
0 |
1 |
Rhinorrhoea
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Rhinitis allergic
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
3 / 1236 (0.24%) |
occurrences all number
|
1 |
0 |
0 |
3 |
Productive cough
|
|
|
|
|
subjects affected / exposed
|
2 / 1227 (0.16%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
0 |
Pleural effusion
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Nasal congestion
|
|
|
|
|
subjects affected / exposed
|
8 / 1227 (0.65%) |
0 / 1364 (0.00%) |
1 / 1374 (0.07%) |
12 / 1236 (0.97%) |
occurrences all number
|
8 |
0 |
1 |
12 |
Pulmonary haemorrhage neonatal
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
1 / 1364 (0.07%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
Psychiatric disorders
|
|
|
|
|
Insomnia
|
|
|
|
|
Additional description: Insomnia
|
|
|
|
|
subjects affected / exposed
|
16 / 1227 (1.30%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
17 / 1236 (1.38%) |
occurrences all number
|
16 |
0 |
0 |
17 |
Anxiety
|
|
|
|
|
Additional description: Anxiety
|
|
|
|
|
subjects affected / exposed
|
7 / 1227 (0.57%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
5 / 1236 (0.40%) |
occurrences all number
|
7 |
0 |
0 |
5 |
Anxiety attack
|
|
|
|
|
Additional description: Anxiety attack
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Breath holding
|
|
|
|
|
Additional description: Breath holding
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Depressed mood
|
|
|
|
|
Additional description: Depressed mood
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
1 |
0 |
0 |
1 |
Depression
|
|
|
|
|
Additional description: Depression
|
|
|
|
|
subjects affected / exposed
|
4 / 1227 (0.33%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
2 / 1236 (0.16%) |
occurrences all number
|
4 |
0 |
0 |
2 |
Disturbance in attention
|
|
|
|
|
Additional description: Disturbance in attention
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Postpartum depression
|
|
|
|
|
subjects affected / exposed
|
2 / 1227 (0.16%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
4 / 1236 (0.32%) |
occurrences all number
|
2 |
0 |
0 |
4 |
Sleep disorder
|
|
|
|
|
subjects affected / exposed
|
2 / 1227 (0.16%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
2 / 1236 (0.16%) |
occurrences all number
|
2 |
0 |
0 |
2 |
Panic attack
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
2 / 1236 (0.16%) |
occurrences all number
|
1 |
0 |
0 |
2 |
Nervousness
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
1 |
0 |
0 |
1 |
Mood swings
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
2 / 1236 (0.16%) |
occurrences all number
|
1 |
0 |
0 |
2 |
Hepatobiliary disorders
|
|
|
|
|
Hyperbilirubinaemia neonatal
|
|
|
|
|
Additional description: Hyperbilirubinaemia neonatal
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
14 / 1364 (1.03%) |
18 / 1374 (1.31%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
14 |
18 |
0 |
Cholecystitis
|
|
|
|
|
Additional description: Cholecystitis
|
|
|
|
|
subjects affected / exposed
|
2 / 1227 (0.16%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
2 / 1236 (0.16%) |
occurrences all number
|
2 |
0 |
0 |
2 |
Hepatomegaly
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
1 / 1364 (0.07%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
Hepatic pain
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Investigations
|
|
|
|
|
Blood pressure increased
|
|
|
|
|
Additional description: Blood pressure increased
|
|
|
|
|
subjects affected / exposed
|
52 / 1227 (4.24%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
40 / 1236 (3.24%) |
occurrences all number
|
52 |
0 |
0 |
40 |
Protein urine present
|
|
|
|
|
Additional description: Protein urine present
|
|
|
|
|
subjects affected / exposed
|
13 / 1227 (1.06%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
13 / 1236 (1.05%) |
occurrences all number
|
13 |
0 |
0 |
13 |
Serum ferritin
|
|
|
|
|
Additional description: Serum ferritin
|
|
|
|
|
subjects affected / exposed
|
14 / 1227 (1.14%) |
1 / 1364 (0.07%) |
0 / 1374 (0.00%) |
7 / 1236 (0.57%) |
occurrences all number
|
14 |
1 |
0 |
7 |
Blood pressure increased, Protein in urine
|
|
|
|
|
Additional description: Blood pressure increased, Protein in urine
|
|
|
|
|
subjects affected / exposed
|
2 / 1227 (0.16%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
2 |
0 |
0 |
1 |
Blood pressure increased, Proteinuria
|
|
|
|
|
Additional description: Blood pressure increased, Proteinuria
|
|
|
|
|
subjects affected / exposed
|
4 / 1227 (0.33%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
2 / 1236 (0.16%) |
occurrences all number
|
4 |
0 |
0 |
2 |
Alanine aminotransferase increased
|
|
|
|
|
Additional description: Alanine aminotransferase increased
|
|
|
|
|
subjects affected / exposed
|
4 / 1227 (0.33%) |
0 / 1364 (0.00%) |
1 / 1374 (0.07%) |
0 / 1236 (0.00%) |
occurrences all number
|
4 |
0 |
1 |
0 |
Albumin urine
|
|
|
|
|
Additional description: Albumin urine test
|
|
|
|
|
subjects affected / exposed
|
3 / 1227 (0.24%) |
0 / 1364 (0.00%) |
2 / 1374 (0.15%) |
0 / 1236 (0.00%) |
occurrences all number
|
3 |
0 |
2 |
0 |
Aspartate aminotransferase increased
|
|
|
|
|
Additional description: Aspartate aminotransferase increased
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
3 / 1236 (0.24%) |
occurrences all number
|
0 |
0 |
0 |
3 |
Blood bicarbonate
|
|
|
|
|
Additional description: Blood bicarbonate
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Blood bilirubin
|
|
|
|
|
Additional description: Blood bilirubin
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
1 / 1364 (0.07%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
Blood calcium
|
|
|
|
|
Additional description: Blood calcium
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Blood chloride
|
|
|
|
|
Additional description: Blood chloride
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
2 / 1236 (0.16%) |
occurrences all number
|
0 |
0 |
0 |
2 |
Blood creatine
|
|
|
|
|
Additional description: Blood creatine
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Blood fibrinogen increased
|
|
|
|
|
Additional description: Blood fibrinogen increased
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Blood gases abnormal
|
|
|
|
|
Additional description: Blood gases abnormal
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
3 / 1374 (0.22%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
0 |
3 |
0 |
Blood iron decreased
|
|
|
|
|
Additional description: Blood iron decreased
|
|
|
|
|
subjects affected / exposed
|
8 / 1227 (0.65%) |
0 / 1364 (0.00%) |
3 / 1374 (0.22%) |
0 / 1236 (0.00%) |
occurrences all number
|
8 |
0 |
3 |
0 |
Blood lactate dehydrogenase
|
|
|
|
|
Additional description: Blood lactate dehydrogenase
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Blood potassium decreased
|
|
|
|
|
Additional description: Blood potassium decreased
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Blood pressure abnormal
|
|
|
|
|
Additional description: Blood pressure abnormal
|
|
|
|
|
subjects affected / exposed
|
2 / 1227 (0.16%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
2 |
0 |
0 |
1 |
Blood pressure decreased
|
|
|
|
|
Additional description: Blood pressure decreased
|
|
|
|
|
subjects affected / exposed
|
4 / 1227 (0.33%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
2 / 1236 (0.16%) |
occurrences all number
|
4 |
0 |
0 |
2 |
Blood sodium
|
|
|
|
|
Additional description: Blood sodium
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Blood sodium abnormal
|
|
|
|
|
Additional description: Blood sodium abnormal
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Blood thyroid stimulating hormone
|
|
|
|
|
Additional description: Blood thyroid stimulating hormone
|
|
|
|
|
subjects affected / exposed
|
2 / 1227 (0.16%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
2 / 1236 (0.16%) |
occurrences all number
|
2 |
0 |
0 |
2 |
Blood urea
|
|
|
|
|
Additional description: Blood urea
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Blood uric acid increased
|
|
|
|
|
Additional description: Blood uric acid increased
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
1 |
0 |
0 |
1 |
Blood urine
|
|
|
|
|
Additional description: Blood urine
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
3 / 1236 (0.24%) |
occurrences all number
|
1 |
0 |
0 |
3 |
Human rhinovirus test positive
|
|
|
|
|
Additional description: Human rhinovirus test positive
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
1 / 1364 (0.07%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
Streptococcus test positive
|
|
|
|
|
Additional description: Streptococcus test positive
|
|
|
|
|
subjects affected / exposed
|
7 / 1227 (0.57%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
8 / 1236 (0.65%) |
occurrences all number
|
7 |
0 |
0 |
8 |
Respiratory syncytial virus test positive
|
|
|
|
|
Additional description: Respiratory syncytial virus test positive
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Venous oxygen partial pressure decreased
|
|
|
|
|
Additional description: Venous oxygen partial pressure decreased
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Total bile acids increased
|
|
|
|
|
Additional description: Total bile acids increased
|
|
|
|
|
subjects affected / exposed
|
2 / 1227 (0.16%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
2 |
0 |
0 |
1 |
Fibronectin increased
|
|
|
|
|
Additional description: Fibronectin increased
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
1 |
0 |
0 |
1 |
Amniotic fluid volume increased
|
|
|
|
|
Additional description: Amniotic fluid volume increased
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Amniotic fluid volume decreased
|
|
|
|
|
Additional description: Amniotic fluid volume decreased
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Urine cannabinoids increased
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Urine analysis abnormal
|
|
|
|
|
subjects affected / exposed
|
5 / 1227 (0.41%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
9 / 1236 (0.73%) |
occurrences all number
|
5 |
0 |
0 |
9 |
Hepatic enzyme increased
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Gastric pH decreased
|
|
|
|
|
subjects affected / exposed
|
8 / 1227 (0.65%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
9 / 1236 (0.73%) |
occurrences all number
|
8 |
0 |
0 |
9 |
Total bile acids
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
1 |
0 |
0 |
1 |
Base excess
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Urine ketone body present
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
2 / 1236 (0.16%) |
occurrences all number
|
0 |
0 |
0 |
2 |
Urine protein/creatinine ratio increased
|
|
|
|
|
subjects affected / exposed
|
4 / 1227 (0.33%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
4 |
0 |
0 |
0 |
Urine albumin/creatinine ratio increased
|
|
|
|
|
subjects affected / exposed
|
3 / 1227 (0.24%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
3 |
0 |
0 |
0 |
Foetal heart rate abnormal
|
|
|
|
|
subjects affected / exposed
|
3 / 1227 (0.24%) |
0 / 1364 (0.00%) |
3 / 1374 (0.22%) |
2 / 1236 (0.16%) |
occurrences all number
|
3 |
0 |
3 |
2 |
Urine leukocyte esterase positive
|
|
|
|
|
subjects affected / exposed
|
6 / 1227 (0.49%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
5 / 1236 (0.40%) |
occurrences all number
|
6 |
0 |
0 |
5 |
White blood cell count decreased
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
1 / 1374 (0.07%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
Vitamin B12
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
1 |
0 |
0 |
1 |
Tri-iodothyronine
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
3 / 1236 (0.24%) |
occurrences all number
|
0 |
0 |
0 |
3 |
Serum ferritin decreased
|
|
|
|
|
subjects affected / exposed
|
2 / 1227 (0.16%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
0 |
Platelet count decreased
|
|
|
|
|
subjects affected / exposed
|
2 / 1227 (0.16%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
2 |
0 |
0 |
1 |
Platelet count
|
|
|
|
|
subjects affected / exposed
|
3 / 1227 (0.24%) |
2 / 1364 (0.15%) |
1 / 1374 (0.07%) |
3 / 1236 (0.24%) |
occurrences all number
|
3 |
2 |
1 |
3 |
Physical examination
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Oxygen saturation decreased
|
|
|
|
|
subjects affected / exposed
|
2 / 1227 (0.16%) |
1 / 1364 (0.07%) |
1 / 1374 (0.07%) |
0 / 1236 (0.00%) |
occurrences all number
|
2 |
1 |
1 |
0 |
Heart rate increased
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
1 |
0 |
0 |
1 |
Heart rate abnormal
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
1 / 1374 (0.07%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
Haemoglobin
|
|
|
|
|
subjects affected / exposed
|
12 / 1227 (0.98%) |
0 / 1364 (0.00%) |
2 / 1374 (0.15%) |
11 / 1236 (0.89%) |
occurrences all number
|
12 |
0 |
2 |
11 |
Haemoglobin decreased
|
|
|
|
|
subjects affected / exposed
|
12 / 1227 (0.98%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
5 / 1236 (0.40%) |
occurrences all number
|
12 |
0 |
0 |
5 |
Haematocrit
|
|
|
|
|
subjects affected / exposed
|
2 / 1227 (0.16%) |
0 / 1364 (0.00%) |
2 / 1374 (0.15%) |
2 / 1236 (0.16%) |
occurrences all number
|
2 |
0 |
2 |
2 |
Glycosylated haemoglobin
|
|
|
|
|
subjects affected / exposed
|
6 / 1227 (0.49%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
7 / 1236 (0.57%) |
occurrences all number
|
6 |
0 |
0 |
7 |
Glucose urine present
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
2 / 1236 (0.16%) |
occurrences all number
|
0 |
0 |
0 |
2 |
Glucose urine
|
|
|
|
|
subjects affected / exposed
|
2 / 1227 (0.16%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
0 |
Glucose tolerance test
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
1 |
0 |
0 |
1 |
Injury, poisoning and procedural complications
|
|
|
|
|
Fall
|
|
|
|
|
Additional description: Fall
|
|
|
|
|
subjects affected / exposed
|
9 / 1227 (0.73%) |
0 / 1364 (0.00%) |
1 / 1374 (0.07%) |
13 / 1236 (1.05%) |
occurrences all number
|
9 |
0 |
1 |
13 |
Accidental overdose
|
|
|
|
|
Additional description: Accidental overdose
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Accidental poisoning
|
|
|
|
|
Additional description: Accidental poisoning
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Animal bite
|
|
|
|
|
Additional description: Animal bite (dog)
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
1 / 1374 (0.07%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
Ankle fracture
|
|
|
|
|
Additional description: Ankle fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Clavicle fracture
|
|
|
|
|
Additional description: Clavicle fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
1 / 1364 (0.07%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
Maternal exposure during pregnancy to Hand-foot-and-mouth disease
|
|
|
|
|
Additional description: Maternal exposure during pregnancy to Hand-foot-and-mouth disease
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Foreign body
|
|
|
|
|
Additional description: Foreign body
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
2 / 1236 (0.16%) |
occurrences all number
|
1 |
0 |
0 |
2 |
Skeletal injury
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Limb injury
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
2 / 1236 (0.16%) |
occurrences all number
|
0 |
0 |
0 |
2 |
Procedural complication
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Thermal burn
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Contusion
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
1 / 1374 (0.07%) |
2 / 1236 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
2 |
Muscle strain
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
4 / 1236 (0.32%) |
occurrences all number
|
0 |
0 |
0 |
4 |
Excoriation
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Uterine rupture
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Sunburn
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Seroma
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Road traffic accident
|
|
|
|
|
subjects affected / exposed
|
7 / 1227 (0.57%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
5 / 1236 (0.40%) |
occurrences all number
|
7 |
0 |
0 |
5 |
Perineal laceration
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Ligament sprain
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
3 / 1236 (0.24%) |
occurrences all number
|
0 |
0 |
0 |
3 |
Foot fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
2 / 1236 (0.16%) |
occurrences all number
|
0 |
0 |
0 |
2 |
Femoral nerve injury
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Congenital, familial and genetic disorders
|
|
|
|
|
Congenital cardiovascular anomaly
|
|
|
|
|
Additional description: Congenital cardiovascular anomaly
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
1 / 1364 (0.07%) |
1 / 1374 (0.07%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
1 |
1 |
0 |
Apert's syndrome
|
|
|
|
|
Additional description: Apert's syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
1 / 1374 (0.07%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
Atrial septal defect
|
|
|
|
|
Additional description: Atrial septal defect
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
1 / 1364 (0.07%) |
2 / 1374 (0.15%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
1 |
2 |
0 |
Cataract congenital
|
|
|
|
|
Additional description: Cataract congenital
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
1 / 1364 (0.07%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
Congenital anomaly
|
|
|
|
|
Additional description: Congenital anomaly
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
1 / 1374 (0.07%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
Congenital central nervous system anomaly
|
|
|
|
|
Additional description: Congenital central nervous system anomaly
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Cryptorchism
|
|
|
|
|
Additional description: Cryptorchism
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
1 / 1374 (0.07%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
Developmental hip dysplasia
|
|
|
|
|
Additional description: Developmental hip dysplasia
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
1 / 1364 (0.07%) |
1 / 1374 (0.07%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
1 |
1 |
0 |
Congenital skin dimples
|
|
|
|
|
Additional description: Congenital skin dimples
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
3 / 1374 (0.22%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
0 |
3 |
0 |
Skeletal dysplasia
|
|
|
|
|
Additional description: Skeletal dysplasia
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
1 / 1364 (0.07%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
Congenital naevus
|
|
|
|
|
Additional description: Congenital naevus
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
1 / 1364 (0.07%) |
1 / 1374 (0.07%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
1 |
1 |
0 |
Naevus flammeus
|
|
|
|
|
Additional description: Naevus flammeus
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
1 / 1374 (0.07%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
Ectopic kidney
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
1 / 1374 (0.07%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
Skull malformation
|
|
|
|
|
Additional description: Skull malformation
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
1 / 1364 (0.07%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
Anomaly of external ear congenital
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
1 / 1374 (0.07%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
Congenital Eustachian tube anomaly
|
|
|
|
|
Additional description: Congenital Eustachian tube anomaly
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Congenital oral malformation
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
1 / 1374 (0.07%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
Laryngomalacia
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
1 / 1364 (0.07%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
Trisomy 18
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Congenital eye naevus
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
2 / 1364 (0.15%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
0 |
Congenital hydronephrosis
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
2 / 1364 (0.15%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
2 |
0 |
0 |
Macrocephaly
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
1 / 1364 (0.07%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
Congenital adrenal gland hypoplasia
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
1 / 1364 (0.07%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
Trisomy 21
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Talipes
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
1 / 1364 (0.07%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
Sebaceous naevus
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
1 / 1374 (0.07%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
Pyloric stenosis
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
1 / 1364 (0.07%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
Pulmonary malformation
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
1 / 1374 (0.07%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
Pulmonary artery stenosis congenital
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
1 / 1374 (0.07%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
Patent ductus arteriosus
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
1 / 1364 (0.07%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
Limb malformation
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
1 / 1374 (0.07%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
Kidney duplex
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
1 / 1374 (0.07%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
Hypospadias
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
1 |
0 |
0 |
1 |
Hydrocele
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
3 / 1364 (0.22%) |
3 / 1374 (0.22%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
3 |
3 |
0 |
Heart disease congenital
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Haemangioma congenital
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
1 / 1364 (0.07%) |
2 / 1374 (0.15%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
1 |
2 |
0 |
Gastroschisis
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
1 / 1374 (0.07%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
Galactosaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
1 / 1364 (0.07%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
Exomphalos
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
1 |
0 |
0 |
1 |
Congenital hypothyroidism
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
1 / 1364 (0.07%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
Cardiac disorders
|
|
|
|
|
Palpitations
|
|
|
|
|
Additional description: Palpitations
|
|
|
|
|
subjects affected / exposed
|
14 / 1227 (1.14%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
15 / 1236 (1.21%) |
occurrences all number
|
14 |
0 |
0 |
15 |
Arrhythmia
|
|
|
|
|
Additional description: Arrhythmia
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
1 / 1364 (0.07%) |
1 / 1374 (0.07%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
1 |
1 |
0 |
Bradycardia foetal
|
|
|
|
|
Additional description: Bradycardia foetal
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
1 / 1364 (0.07%) |
3 / 1374 (0.22%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
1 |
3 |
0 |
Bradycardia
|
|
|
|
|
Additional description: Bradycardia
|
|
|
|
|
subjects affected / exposed
|
2 / 1227 (0.16%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
2 |
0 |
0 |
1 |
Bundle branch block left
|
|
|
|
|
Additional description: Bundle branch block left
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Cardiomegaly
|
|
|
|
|
Additional description: Cardiomegaly
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Cyanosis
|
|
|
|
|
Additional description: Cyanosis
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
3 / 1374 (0.22%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
0 |
3 |
0 |
Foetal heart rate deceleration abnormality
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
1 / 1364 (0.07%) |
3 / 1374 (0.22%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
1 |
3 |
0 |
Bradycardia neonatal
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
1 / 1374 (0.07%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
Pericardial cyst
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
1 / 1374 (0.07%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
Wolff-Parkinson-White syndrome
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Ventricular extrasystoles
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Tachycardia
|
|
|
|
|
subjects affected / exposed
|
7 / 1227 (0.57%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
2 / 1236 (0.16%) |
occurrences all number
|
7 |
0 |
0 |
2 |
Tachycardia foetal
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
1 / 1374 (0.07%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
Sinus tachycardia
|
|
|
|
|
subjects affected / exposed
|
2 / 1227 (0.16%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
0 |
Pericarditis
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Pericardial effusion
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
1 / 1364 (0.07%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
Klinefelter's syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
1 / 1374 (0.07%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
Extrasystoles
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Nervous system disorders
|
|
|
|
|
Carpal tunnel syndrome
|
|
|
|
|
Additional description: Carpal tunnel syndrome
|
|
|
|
|
subjects affected / exposed
|
19 / 1227 (1.55%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
17 / 1236 (1.38%) |
occurrences all number
|
19 |
0 |
0 |
17 |
Dizziness
|
|
|
|
|
Additional description: Dizziness
|
|
|
|
|
subjects affected / exposed
|
64 / 1227 (5.22%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
44 / 1236 (3.56%) |
occurrences all number
|
64 |
0 |
0 |
44 |
Headache
|
|
|
|
|
Additional description: Headache
|
|
|
|
|
subjects affected / exposed
|
276 / 1227 (22.49%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
302 / 1236 (24.43%) |
occurrences all number
|
276 |
0 |
0 |
302 |
Hypoaesthesia
|
|
|
|
|
Additional description: Hypoaesthesia
|
|
|
|
|
subjects affected / exposed
|
12 / 1227 (0.98%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
13 / 1236 (1.05%) |
occurrences all number
|
12 |
0 |
0 |
13 |
Migraine
|
|
|
|
|
Additional description: Migraine
|
|
|
|
|
subjects affected / exposed
|
26 / 1227 (2.12%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
22 / 1236 (1.78%) |
occurrences all number
|
26 |
0 |
0 |
22 |
Sciatica
|
|
|
|
|
Additional description: Sciatica
|
|
|
|
|
subjects affected / exposed
|
12 / 1227 (0.98%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
18 / 1236 (1.46%) |
occurrences all number
|
12 |
0 |
0 |
18 |
Aphasia
|
|
|
|
|
Additional description: Aphasia
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
1 / 1374 (0.07%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
Apraxia
|
|
|
|
|
Additional description: Apraxia
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Burning sensation
|
|
|
|
|
Additional description: Burning sensation
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
1 |
0 |
0 |
1 |
Convulsion
|
|
|
|
|
Additional description: Convulsion
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Depressed level of consciousness
|
|
|
|
|
Additional description: Depressed level of consciousness
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Hyperglycaemic seizure
|
|
|
|
|
Additional description: Hyperglycaemic seizure
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
1 / 1364 (0.07%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
Restless legs syndrome
|
|
|
|
|
subjects affected / exposed
|
3 / 1227 (0.24%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
6 / 1236 (0.49%) |
occurrences all number
|
3 |
0 |
0 |
6 |
VIIth nerve paralysis
|
|
|
|
|
subjects affected / exposed
|
2 / 1227 (0.16%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
0 |
VIth nerve paralysis
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Tremor
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Tension headache
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Syncope
|
|
|
|
|
subjects affected / exposed
|
4 / 1227 (0.33%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
6 / 1236 (0.49%) |
occurrences all number
|
4 |
0 |
0 |
6 |
Somnolence
|
|
|
|
|
subjects affected / exposed
|
2 / 1227 (0.16%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
2 |
0 |
0 |
1 |
Sinus headache
|
|
|
|
|
subjects affected / exposed
|
5 / 1227 (0.41%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
5 |
0 |
0 |
0 |
Presyncope
|
|
|
|
|
subjects affected / exposed
|
2 / 1227 (0.16%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
6 / 1236 (0.49%) |
occurrences all number
|
2 |
0 |
0 |
6 |
Paraesthesia
|
|
|
|
|
subjects affected / exposed
|
4 / 1227 (0.33%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
8 / 1236 (0.65%) |
occurrences all number
|
4 |
0 |
0 |
8 |
Nerve compression
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Migraine with aura
|
|
|
|
|
subjects affected / exposed
|
2 / 1227 (0.16%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
4 / 1236 (0.32%) |
occurrences all number
|
2 |
0 |
0 |
4 |
Loss of consciousness
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
1 |
0 |
0 |
1 |
Lethargy
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Hypotonic-hyporesponsive episode
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
1 / 1374 (0.07%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
Blood and lymphatic system disorders
|
|
|
|
|
Anaemia
|
|
|
|
|
Additional description: Anaemia
|
|
|
|
|
subjects affected / exposed
|
63 / 1227 (5.13%) |
1 / 1364 (0.07%) |
3 / 1374 (0.22%) |
54 / 1236 (4.37%) |
occurrences all number
|
63 |
1 |
3 |
54 |
Splenic cyst
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
1 / 1374 (0.07%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
Thrombocytopenia neonatal
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
2 / 1374 (0.15%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
0 |
2 |
0 |
Thrombocytopenia
|
|
|
|
|
subjects affected / exposed
|
2 / 1227 (0.16%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
0 |
Lymphadenopathy
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
3 / 1236 (0.24%) |
occurrences all number
|
1 |
0 |
0 |
3 |
Ear and labyrinth disorders
|
|
|
|
|
Acoustic stimulation tests abnormal
|
|
|
|
|
Additional description: Acoustic stimulation tests abnormal
|
|
|
|
|
subjects affected / exposed
|
2 / 1227 (0.16%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
0 |
Deafness
|
|
|
|
|
Additional description: Deafness
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Ear pain
|
|
|
|
|
Additional description: Ear pain
|
|
|
|
|
subjects affected / exposed
|
2 / 1227 (0.16%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
7 / 1236 (0.57%) |
occurrences all number
|
2 |
0 |
0 |
7 |
Ear discomfort
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Tinnitus
|
|
|
|
|
subjects affected / exposed
|
2 / 1227 (0.16%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
2 / 1236 (0.16%) |
occurrences all number
|
2 |
0 |
0 |
2 |
Eye disorders
|
|
|
|
|
Conjunctivitis
|
|
|
|
|
Additional description: Conjunctivitis
|
|
|
|
|
subjects affected / exposed
|
14 / 1227 (1.14%) |
1 / 1364 (0.07%) |
6 / 1374 (0.44%) |
13 / 1236 (1.05%) |
occurrences all number
|
14 |
1 |
6 |
13 |
Vision Blurred
|
|
|
|
|
Additional description: Vision Blurred
|
|
|
|
|
subjects affected / exposed
|
20 / 1227 (1.63%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
19 / 1236 (1.54%) |
occurrences all number
|
20 |
0 |
0 |
19 |
Visual impairment
|
|
|
|
|
Additional description: Visual impairment
|
|
|
|
|
subjects affected / exposed
|
53 / 1227 (4.32%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
61 / 1236 (4.94%) |
occurrences all number
|
53 |
0 |
0 |
61 |
Diabetic retinopathy
|
|
|
|
|
Additional description: Diabetic retinopathy
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Dry eye
|
|
|
|
|
Additional description: Dry eye
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Sunset eyes
|
|
|
|
|
Additional description: Sunset Eyes/ Setting sun phenomenon
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
1 / 1374 (0.07%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
Chorioretinopathy
|
|
|
|
|
Additional description: Chorioretinopathy
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Vitreous floaters
|
|
|
|
|
subjects affected / exposed
|
3 / 1227 (0.24%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
4 / 1236 (0.32%) |
occurrences all number
|
3 |
0 |
0 |
4 |
Visual field defect
|
|
|
|
|
subjects affected / exposed
|
2 / 1227 (0.16%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
2 |
0 |
0 |
1 |
Scintillating scotoma
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Photopsia
|
|
|
|
|
subjects affected / exposed
|
10 / 1227 (0.81%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
7 / 1236 (0.57%) |
occurrences all number
|
10 |
0 |
0 |
7 |
Photophobia
|
|
|
|
|
subjects affected / exposed
|
3 / 1227 (0.24%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
2 / 1236 (0.16%) |
occurrences all number
|
3 |
0 |
0 |
2 |
Periorbital oedema
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Eye pain
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
2 / 1236 (0.16%) |
occurrences all number
|
1 |
0 |
0 |
2 |
Gastrointestinal disorders
|
|
|
|
|
Abdominal pain lower
|
|
|
|
|
Additional description: Abdominal pain lower
|
|
|
|
|
subjects affected / exposed
|
8 / 1227 (0.65%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
20 / 1236 (1.62%) |
occurrences all number
|
8 |
0 |
0 |
20 |
Abdominal pain
|
|
|
|
|
Additional description: Abdominal pain
|
|
|
|
|
subjects affected / exposed
|
57 / 1227 (4.65%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
58 / 1236 (4.69%) |
occurrences all number
|
57 |
0 |
0 |
58 |
Abdominal pain upper
|
|
|
|
|
Additional description: Abdominal pain upper
|
|
|
|
|
subjects affected / exposed
|
82 / 1227 (6.68%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
64 / 1236 (5.18%) |
occurrences all number
|
82 |
0 |
0 |
64 |
Diarrhoea
|
|
|
|
|
Additional description: Diarrhoea
|
|
|
|
|
subjects affected / exposed
|
33 / 1227 (2.69%) |
0 / 1364 (0.00%) |
1 / 1374 (0.07%) |
34 / 1236 (2.75%) |
occurrences all number
|
33 |
0 |
1 |
34 |
Constipation
|
|
|
|
|
Additional description: Constipation
|
|
|
|
|
subjects affected / exposed
|
46 / 1227 (3.75%) |
0 / 1364 (0.00%) |
2 / 1374 (0.15%) |
53 / 1236 (4.29%) |
occurrences all number
|
46 |
0 |
2 |
53 |
Dyspepsia
|
|
|
|
|
Additional description: Dyspepsia
|
|
|
|
|
subjects affected / exposed
|
126 / 1227 (10.27%) |
1 / 1364 (0.07%) |
0 / 1374 (0.00%) |
136 / 1236 (11.00%) |
occurrences all number
|
126 |
1 |
0 |
136 |
Gastrooesophageal reflux disease
|
|
|
|
|
Additional description: Gastrooesophageal reflux disease
|
|
|
|
|
subjects affected / exposed
|
61 / 1227 (4.97%) |
5 / 1364 (0.37%) |
4 / 1374 (0.29%) |
54 / 1236 (4.37%) |
occurrences all number
|
61 |
5 |
4 |
54 |
Nausea
|
|
|
|
|
Additional description: Nausea
|
|
|
|
|
subjects affected / exposed
|
85 / 1227 (6.93%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
96 / 1236 (7.77%) |
occurrences all number
|
85 |
0 |
0 |
96 |
Toothache
|
|
|
|
|
Additional description: Toothache
|
|
|
|
|
subjects affected / exposed
|
7 / 1227 (0.57%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
14 / 1236 (1.13%) |
occurrences all number
|
7 |
0 |
0 |
14 |
Vomiting
|
|
|
|
|
Additional description: Vomiting
|
|
|
|
|
subjects affected / exposed
|
90 / 1227 (7.33%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
85 / 1236 (6.88%) |
occurrences all number
|
90 |
0 |
0 |
85 |
Abdominal pain, Nausea
|
|
|
|
|
Additional description: Abdominal pain, Nausea
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Constipation, Dyspepsia
|
|
|
|
|
Additional description: Constipation, Dyspepsia
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Abdominal discomfort
|
|
|
|
|
Additional description: Abdominal discomfort
|
|
|
|
|
subjects affected / exposed
|
8 / 1227 (0.65%) |
0 / 1364 (0.00%) |
6 / 1374 (0.44%) |
0 / 1236 (0.00%) |
occurrences all number
|
8 |
0 |
6 |
0 |
Dry mouth
|
|
|
|
|
Additional description: Dry mouth
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
1 |
0 |
0 |
1 |
Gastrointestinal inflammation
|
|
|
|
|
Additional description: Gastrointestinal inflammation
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
1 / 1374 (0.07%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
Tooth abscess
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
4 / 1236 (0.32%) |
occurrences all number
|
1 |
0 |
0 |
4 |
Retching
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Rectal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
2 / 1236 (0.16%) |
occurrences all number
|
0 |
0 |
0 |
2 |
Proctitis
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Periodontal disease
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Oesophageal spasm
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Mouth ulceration
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
1 |
0 |
0 |
1 |
Lip swelling
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Intestinal dilatation
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
1 / 1374 (0.07%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
Infantile colic
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
1 / 1374 (0.07%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
Haemorrhoids
|
|
|
|
|
subjects affected / exposed
|
10 / 1227 (0.81%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
9 / 1236 (0.73%) |
occurrences all number
|
10 |
0 |
0 |
9 |
Haematemesis
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
1 |
0 |
0 |
1 |
Gingivitis
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Gingival swelling
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
2 / 1236 (0.16%) |
occurrences all number
|
0 |
0 |
0 |
2 |
Gingival bleeding
|
|
|
|
|
subjects affected / exposed
|
5 / 1227 (0.41%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
3 / 1236 (0.24%) |
occurrences all number
|
5 |
0 |
0 |
3 |
Gastrointestinal disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Gastritis
|
|
|
|
|
subjects affected / exposed
|
5 / 1227 (0.41%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
5 |
0 |
0 |
1 |
Frequent bowel movements
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Food poisoning
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Flatulence
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
2 / 1236 (0.16%) |
occurrences all number
|
1 |
0 |
0 |
2 |
Flank pain
|
|
|
|
|
subjects affected / exposed
|
2 / 1227 (0.16%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
2 |
0 |
0 |
1 |
Oral pain
|
|
|
|
|
subjects affected / exposed
|
2 / 1227 (0.16%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
0 |
Skin and subcutaneous tissue disorders
|
|
|
|
|
Pruritus
|
|
|
|
|
Additional description: Pruritus
|
|
|
|
|
subjects affected / exposed
|
48 / 1227 (3.91%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
41 / 1236 (3.32%) |
occurrences all number
|
48 |
0 |
0 |
41 |
Rash
|
|
|
|
|
Additional description: Rash
|
|
|
|
|
subjects affected / exposed
|
19 / 1227 (1.55%) |
1 / 1364 (0.07%) |
0 / 1374 (0.00%) |
11 / 1236 (0.89%) |
occurrences all number
|
19 |
1 |
0 |
11 |
Acne
|
|
|
|
|
Additional description: Acne
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Cafe au lait spots
|
|
|
|
|
Additional description: Cafe au lait spots
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
1 / 1364 (0.07%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
Dermatitis atopic
|
|
|
|
|
Additional description: Dermatitis atopic
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
1 |
0 |
0 |
1 |
Dermatitis diaper
|
|
|
|
|
Additional description: Dermatitis diaper
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
2 / 1364 (0.15%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
0 |
Polymorphic eruption of pregnancy
|
|
|
|
|
Additional description: Polymorphic eruption of pregnancy
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
5 / 1236 (0.40%) |
occurrences all number
|
0 |
0 |
0 |
5 |
Scar pain
|
|
|
|
|
subjects affected / exposed
|
2 / 1227 (0.16%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
0 |
Swelling face
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Skin irritation
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Rosacea
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Rash pruritic
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
5 / 1236 (0.40%) |
occurrences all number
|
0 |
0 |
0 |
5 |
Petechiae
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
1 / 1374 (0.07%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
Night sweats
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Keloid scar
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Ingrowing nail
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Hyperhidrosis
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
2 / 1236 (0.16%) |
occurrences all number
|
0 |
0 |
0 |
2 |
Hypersensitivity
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
3 / 1236 (0.24%) |
occurrences all number
|
0 |
0 |
0 |
3 |
Erythema
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
1 |
0 |
0 |
1 |
Erythema nodosum
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Urticaria
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Renal and urinary disorders
|
|
|
|
|
Proteinuria
|
|
|
|
|
Additional description: Proteinuria
|
|
|
|
|
subjects affected / exposed
|
31 / 1227 (2.53%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
28 / 1236 (2.27%) |
occurrences all number
|
31 |
0 |
0 |
28 |
Bladder pain
|
|
|
|
|
Additional description: Bladder pain
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
2 / 1236 (0.16%) |
occurrences all number
|
0 |
0 |
0 |
2 |
Dysuria
|
|
|
|
|
Additional description: Dysuria
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
6 / 1236 (0.49%) |
occurrences all number
|
1 |
0 |
0 |
6 |
Pyelocaliectasis
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
1 / 1364 (0.07%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
Renal injury
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Urine odour abnormal
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Kidney enlargement
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
1 / 1374 (0.07%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
Tachypnoea
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
2 / 1364 (0.15%) |
3 / 1374 (0.22%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
2 |
3 |
0 |
Renal tubular acidosis
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Renal pain
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Renal cyst
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
1 / 1374 (0.07%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
Pollakiuria
|
|
|
|
|
subjects affected / exposed
|
2 / 1227 (0.16%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
0 |
Nephrotic syndrome
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
2 / 1236 (0.16%) |
occurrences all number
|
1 |
0 |
0 |
2 |
Nephropathy
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Micturition urgency
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Ketonuria
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Haematuria
|
|
|
|
|
subjects affected / exposed
|
2 / 1227 (0.16%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
0 |
Glycosuria
|
|
|
|
|
subjects affected / exposed
|
2 / 1227 (0.16%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
2 / 1236 (0.16%) |
occurrences all number
|
2 |
0 |
0 |
2 |
Urinary hesitation
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Endocrine disorders
|
|
|
|
|
Basedow's disease
|
|
|
|
|
Additional description: Basedow's disease
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
1 / 1374 (0.07%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
Hypothyroidism
|
|
|
|
|
subjects affected / exposed
|
9 / 1227 (0.73%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
3 / 1236 (0.24%) |
occurrences all number
|
9 |
0 |
0 |
3 |
Hyperthyroidism
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
1 |
0 |
0 |
1 |
Musculoskeletal and connective tissue disorders
|
|
|
|
|
Arthralgia
|
|
|
|
|
Additional description: Arthralgia
|
|
|
|
|
subjects affected / exposed
|
19 / 1227 (1.55%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
20 / 1236 (1.62%) |
occurrences all number
|
19 |
0 |
0 |
20 |
Back pain
|
|
|
|
|
Additional description: Back pain
|
|
|
|
|
subjects affected / exposed
|
68 / 1227 (5.54%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
74 / 1236 (5.99%) |
occurrences all number
|
68 |
0 |
0 |
74 |
Muscle spasms
|
|
|
|
|
Additional description: Muscle spasms
|
|
|
|
|
subjects affected / exposed
|
36 / 1227 (2.93%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
35 / 1236 (2.83%) |
occurrences all number
|
36 |
0 |
0 |
35 |
Myalgia
|
|
|
|
|
Additional description: Myalgia
|
|
|
|
|
subjects affected / exposed
|
20 / 1227 (1.63%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
10 / 1236 (0.81%) |
occurrences all number
|
20 |
0 |
0 |
10 |
Musculoskeletal pain
|
|
|
|
|
Additional description: Musculoskeletal pain
|
|
|
|
|
subjects affected / exposed
|
16 / 1227 (1.30%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
14 / 1236 (1.13%) |
occurrences all number
|
16 |
0 |
0 |
14 |
Pain in extremity
|
|
|
|
|
Additional description: Pain in extremity
|
|
|
|
|
subjects affected / exposed
|
19 / 1227 (1.55%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
19 / 1236 (1.54%) |
occurrences all number
|
19 |
0 |
0 |
19 |
Symphysiolysis
|
|
|
|
|
Additional description: Symphysiolysis
|
|
|
|
|
subjects affected / exposed
|
13 / 1227 (1.06%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
23 / 1236 (1.86%) |
occurrences all number
|
13 |
0 |
0 |
23 |
Bursitis
|
|
|
|
|
Additional description: Bursitis
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Coccydynia
|
|
|
|
|
Additional description: Coccydynia
|
|
|
|
|
subjects affected / exposed
|
2 / 1227 (0.16%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
0 |
Costochondritis
|
|
|
|
|
Additional description: Costochondritis
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Ligament pain
|
|
|
|
|
Additional description: Ligament pain
|
|
|
|
|
subjects affected / exposed
|
3 / 1227 (0.24%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
6 / 1236 (0.49%) |
occurrences all number
|
3 |
0 |
0 |
6 |
Tenosynovitis stenosans
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Musculoskeletal stiffness
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Musculoskeletal chest pain
|
|
|
|
|
subjects affected / exposed
|
7 / 1227 (0.57%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
11 / 1236 (0.89%) |
occurrences all number
|
7 |
0 |
0 |
11 |
Systemic lupus erythematosus
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Psoriatic arthropathy
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Polyarthritis
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Plantar fasciitis
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Pain in jaw
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Neck pain
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
3 / 1236 (0.24%) |
occurrences all number
|
0 |
0 |
0 |
3 |
Joint stiffness
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Groin pain
|
|
|
|
|
subjects affected / exposed
|
3 / 1227 (0.24%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
7 / 1236 (0.57%) |
occurrences all number
|
3 |
0 |
0 |
7 |
Infections and infestations
|
|
|
|
|
Candidiasis
|
|
|
|
|
Additional description: Candidiasis
|
|
|
|
|
subjects affected / exposed
|
9 / 1227 (0.73%) |
1 / 1364 (0.07%) |
0 / 1374 (0.00%) |
17 / 1236 (1.38%) |
occurrences all number
|
9 |
1 |
0 |
17 |
Fungal infection
|
|
|
|
|
Additional description: Fungal infection
|
|
|
|
|
subjects affected / exposed
|
16 / 1227 (1.30%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
10 / 1236 (0.81%) |
occurrences all number
|
16 |
0 |
0 |
10 |
Gastroenteritis viral
|
|
|
|
|
Additional description: Gastroenteritis viral
|
|
|
|
|
subjects affected / exposed
|
34 / 1227 (2.77%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
35 / 1236 (2.83%) |
occurrences all number
|
34 |
0 |
0 |
35 |
Influenza
|
|
|
|
|
Additional description: Influenza
|
|
|
|
|
subjects affected / exposed
|
16 / 1227 (1.30%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
29 / 1236 (2.35%) |
occurrences all number
|
16 |
0 |
0 |
29 |
Lower respiratory tract infection
|
|
|
|
|
Additional description: Lower respiratory tract infection
|
|
|
|
|
subjects affected / exposed
|
24 / 1227 (1.96%) |
1 / 1364 (0.07%) |
0 / 1374 (0.00%) |
16 / 1236 (1.29%) |
occurrences all number
|
24 |
1 |
0 |
16 |
Nasopharyngitis
|
|
|
|
|
Additional description: Nasopharyngitis
|
|
|
|
|
subjects affected / exposed
|
80 / 1227 (6.52%) |
2 / 1364 (0.15%) |
1 / 1374 (0.07%) |
85 / 1236 (6.88%) |
occurrences all number
|
80 |
2 |
1 |
85 |
Postoperative wound infection
|
|
|
|
|
Additional description: Postoperative wound infection
|
|
|
|
|
subjects affected / exposed
|
7 / 1227 (0.57%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
14 / 1236 (1.13%) |
occurrences all number
|
7 |
0 |
0 |
14 |
Sinusitis
|
|
|
|
|
Additional description: Sinusitis
|
|
|
|
|
subjects affected / exposed
|
18 / 1227 (1.47%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
18 / 1236 (1.46%) |
occurrences all number
|
18 |
0 |
0 |
18 |
Upper respiratory tract infection
|
|
|
|
|
Additional description: Upper respiratory tract infection
|
|
|
|
|
subjects affected / exposed
|
15 / 1227 (1.22%) |
1 / 1364 (0.07%) |
1 / 1374 (0.07%) |
23 / 1236 (1.86%) |
occurrences all number
|
15 |
1 |
1 |
23 |
Urinary tract infection
|
|
|
|
|
Additional description: Urinary tract infection
|
|
|
|
|
subjects affected / exposed
|
82 / 1227 (6.68%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
89 / 1236 (7.20%) |
occurrences all number
|
82 |
0 |
0 |
89 |
Urinary tract infection, Wound infection
|
|
|
|
|
Additional description: Urinary tract infection, Wound infection
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Abscess
|
|
|
|
|
Additional description: Abscess
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
1 / 1374 (0.07%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
Abscess oral
|
|
|
|
|
Additional description: Abscess oral
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Acute sinusitis
|
|
|
|
|
Additional description: Acute sinusitis
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Croup infectious
|
|
|
|
|
Additional description: Croup infectious
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
1 / 1374 (0.07%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
Cystitis
|
|
|
|
|
Additional description: Cystitis
|
|
|
|
|
subjects affected / exposed
|
9 / 1227 (0.73%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
2 / 1236 (0.16%) |
occurrences all number
|
9 |
0 |
0 |
2 |
Dacryocystitis
|
|
|
|
|
Additional description: Dacryocystitis
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
1 / 1364 (0.07%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
Ear infection
|
|
|
|
|
Additional description: Ear infection
|
|
|
|
|
subjects affected / exposed
|
10 / 1227 (0.81%) |
0 / 1364 (0.00%) |
1 / 1374 (0.07%) |
6 / 1236 (0.49%) |
occurrences all number
|
10 |
0 |
1 |
6 |
Ureaplasma test positive
|
|
|
|
|
Additional description: Ureaplasma test positive
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Chikungunya virus infection
|
|
|
|
|
Additional description: Chikungunya virus infectiom
|
|
|
|
|
subjects affected / exposed
|
2 / 1227 (0.16%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
3 / 1236 (0.24%) |
occurrences all number
|
2 |
0 |
0 |
3 |
Oral herpes
|
|
|
|
|
Additional description: Oral herpes
|
|
|
|
|
subjects affected / exposed
|
2 / 1227 (0.16%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
2 / 1236 (0.16%) |
occurrences all number
|
2 |
0 |
0 |
2 |
Vulvovaginal mycotic infection
|
|
|
|
|
Additional description: Vulvovaginal mycotic infection
|
|
|
|
|
subjects affected / exposed
|
5 / 1227 (0.41%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
3 / 1236 (0.24%) |
occurrences all number
|
5 |
0 |
0 |
3 |
Uterine infection
|
|
|
|
|
Additional description: Uterine infection
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
1 |
0 |
0 |
1 |
Bacterial vaginosis
|
|
|
|
|
Additional description: Bacterial vaginosis
|
|
|
|
|
subjects affected / exposed
|
2 / 1227 (0.16%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
6 / 1236 (0.49%) |
occurrences all number
|
2 |
0 |
0 |
6 |
Nail infection
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Lung infection
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Escherichia infection
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
1 / 1374 (0.07%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
1 |
1 |
Staphylococcal infection
|
|
|
|
|
subjects affected / exposed
|
2 / 1227 (0.16%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
2 |
0 |
0 |
1 |
Parvovirus infection
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Escherichia bacteraemia
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
1 / 1374 (0.07%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
Perineal abscess
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Escherichia urinary tract infection
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Febrile infection
|
|
|
|
|
subjects affected / exposed
|
2 / 1227 (0.16%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
2 |
0 |
0 |
1 |
Haematoma infection
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Abscess limb
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Vaginal abscess
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Tooth infection
|
|
|
|
|
subjects affected / exposed
|
4 / 1227 (0.33%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
5 / 1236 (0.40%) |
occurrences all number
|
4 |
0 |
0 |
5 |
Oral infection
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Vulvovaginal candidiasis
|
|
|
|
|
subjects affected / exposed
|
6 / 1227 (0.49%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
9 / 1236 (0.73%) |
occurrences all number
|
6 |
0 |
0 |
9 |
Varicella
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
1 |
0 |
0 |
1 |
Vaginal infection
|
|
|
|
|
subjects affected / exposed
|
4 / 1227 (0.33%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
6 / 1236 (0.49%) |
occurrences all number
|
4 |
0 |
0 |
6 |
Trichomoniasis
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Tonsillitis
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Subcutaneous abscess
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Skin infection
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Pilonidal cyst
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Pharyngitis streptococcal
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Pharyngitis
|
|
|
|
|
subjects affected / exposed
|
4 / 1227 (0.33%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
3 / 1236 (0.24%) |
occurrences all number
|
4 |
0 |
0 |
3 |
Oral candidiasis
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
2 / 1374 (0.15%) |
1 / 1236 (0.08%) |
occurrences all number
|
1 |
0 |
2 |
1 |
Omphalitis
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
1 / 1364 (0.07%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
0 |
Lice infestation
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Influenza like illness
|
|
|
|
|
subjects affected / exposed
|
12 / 1227 (0.98%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
8 / 1236 (0.65%) |
occurrences all number
|
12 |
0 |
0 |
8 |
Infected bite
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Hordeolum
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Herpes zoster
|
|
|
|
|
subjects affected / exposed
|
2 / 1227 (0.16%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
2 / 1236 (0.16%) |
occurrences all number
|
2 |
0 |
0 |
2 |
Herpes virus infection
|
|
|
|
|
subjects affected / exposed
|
3 / 1227 (0.24%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
3 |
0 |
0 |
1 |
Herpes simplex
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Hand-foot-and-mouth disease
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Furuncle
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
1 |
0 |
0 |
1 |
Folliculitis
|
|
|
|
|
subjects affected / exposed
|
2 / 1227 (0.16%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
0 |
Eye infection
|
|
|
|
|
subjects affected / exposed
|
2 / 1227 (0.16%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
0 |
Impetigo
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Laryngitis
|
|
|
|
|
subjects affected / exposed
|
2 / 1227 (0.16%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
0 |
Metabolism and nutrition disorders
|
|
|
|
|
Hypoglycaemia
|
|
|
|
|
Additional description: Hypoglycaemia
|
|
|
|
|
subjects affected / exposed
|
5 / 1227 (0.41%) |
9 / 1364 (0.66%) |
14 / 1374 (1.02%) |
4 / 1236 (0.32%) |
occurrences all number
|
5 |
9 |
14 |
4 |
Cow's milk intolerance
|
|
|
|
|
Additional description: Cow's milk intolerance
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
1 / 1364 (0.07%) |
1 / 1374 (0.07%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
1 |
1 |
0 |
Decreased appetite
|
|
|
|
|
subjects affected / exposed
|
4 / 1227 (0.33%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
3 / 1236 (0.24%) |
occurrences all number
|
4 |
0 |
0 |
3 |
Metabolic disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
1 / 1364 (0.07%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
Decreased insulin requirement
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Vitamin D deficiency
|
|
|
|
|
subjects affected / exposed
|
9 / 1227 (0.73%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
8 / 1236 (0.65%) |
occurrences all number
|
9 |
0 |
0 |
8 |
Vitamin B12 deficiency
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
4 / 1236 (0.32%) |
occurrences all number
|
1 |
0 |
0 |
4 |
Metabolic acidosis
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
1 / 1374 (0.07%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
Lactose intolerance
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
1 / 1374 (0.07%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
Hyponatraemia
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
1 / 1374 (0.07%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
1 |
0 |
Hypomagnesaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
0 |
1 |
Hypokalaemia
|
|
|
|
|
subjects affected / exposed
|
3 / 1227 (0.24%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
3 |
0 |
0 |
0 |
Hypoglycaemia neonatal
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
5 / 1364 (0.37%) |
6 / 1374 (0.44%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
5 |
6 |
0 |
Hypocalcaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
0 / 1364 (0.00%) |
1 / 1374 (0.07%) |
1 / 1236 (0.08%) |
occurrences all number
|
0 |
0 |
1 |
1 |
Hypercalcaemia
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
1 / 1236 (0.08%) |
occurrences all number
|
1 |
0 |
0 |
1 |
Glucose tolerance impaired
|
|
|
|
|
subjects affected / exposed
|
2 / 1227 (0.16%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
0 |
Feeding disorder neonatal
|
|
|
|
|
subjects affected / exposed
|
0 / 1227 (0.00%) |
3 / 1364 (0.22%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
0 |
3 |
0 |
0 |
Electrolyte imbalance
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
Increased insulin requirement
|
|
|
|
|
subjects affected / exposed
|
1 / 1227 (0.08%) |
0 / 1364 (0.00%) |
0 / 1374 (0.00%) |
0 / 1236 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |