Study: NCT03969641

Adverse event: Opioid Dependence Relapse
Serious: yes
Organ System: General disorders
Notes: Hospitalized due to relapse of opioid dependence
Frequency: 1 affected / 190 at risk

Adverse event: Pre-eclampsia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 5 affected / 190 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 190 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 190 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Resulted in a laparoscopic appendectomy
Frequency: 1 affected / 190 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: Surgical site infection after laparoscopic appendectomy
Frequency: 1 affected / 190 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 190 at risk

Adverse event: Amniotic cavity infection
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 190 at risk

Adverse event: Hypervolaemia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 190 at risk

Adverse event: Enterocolitis with abdominal abscess
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 190 at risk

Adverse event: Intrauterine Fetal Demise
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 190 at risk

Adverse event: Congenital Fetal Cardiac Defect
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 190 at risk

Adverse event: Bilateral pyelectasis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 190 at risk

Adverse event: Supernumerary Digit- Left Hand
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 190 at risk

Adverse event: Pyloric stenosis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 190 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 16 affected / 190 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 16 affected / 190 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 190 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 11 affected / 190 at risk

Adverse event: Malaise (Fatigue)
Serious: no
Organ System: General disorders
Frequency: 11 affected / 190 at risk

Adverse event: Vaginal haemorrhage
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 192 at risk

Adverse event: Pre-eclampsia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 192 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 192 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 192 at risk

Adverse event: Retained products of conception
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 192 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 192 at risk

Adverse event: Preterm Premature Rupture of Membranes (PPROM)
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 192 at risk

Adverse event: Bilateral Subsegmental Pulmonary Embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 192 at risk

Adverse event: Retroperitoneal haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 192 at risk

Adverse event: Bladder outlet obstruction
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: Including hydronephrosis due to obstruction of bladder, Hydroureter, Chronic kidney disease
Frequency: 1 affected / 192 at risk

Adverse event: Ureterocele
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 192 at risk

Adverse event: Trisomy 21
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 192 at risk

Adverse event: Ventricular septal defect
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 192 at risk

Adverse event: Ectopic kidney
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 192 at risk

Adverse event: Absent thyroid
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 192 at risk

Adverse event: Short femur
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 192 at risk

Adverse event: Atrial septal defect
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 192 at risk

Adverse event: anomalous S1 hemivertebra
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 192 at risk

Adverse event: Sagittal Synostosis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 192 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 14 affected / 192 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 22 affected / 192 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 192 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 20 affected / 192 at risk

Adverse event: Malaise (Fatigue)
Serious: no
Organ System: General disorders
Frequency: 12 affected / 192 at risk