Time Frame |
Through 360 days post first dose of Season 1 for MEDI8897 and Palivizumab groups, through 360 days post first dose of Season 2 for MEDI8897/MEDI8897, MEDI8897/Palivizumab, and Palivizumab/Palivizumab groups.
|
Adverse Event Reporting Description |
TEAEs of Season 1 are reported for MEDI8897 and Palivizumab groups. TEAEs of Season 2 are reported for MEDI8897/MEDI8897, MEDI8897/Palivizumab, and Palivizumab/Palivizumab groups.
Adverse events are reported based on as-treated population. Participants who were randomized and not dosed are not included in adverse event summaries.
|
|
Arm/Group Title
|
MEDI8897
|
Palivizumab
|
MEDI8897/MEDI8897
|
Palivizumab/MEDI8897
|
Palivizumab/Palivizumab
|
Arm/Group Description |
Subjects who received MEDI8897 in S...
|
Subjects who received Palivizumab i...
|
CHD/CLD subjects who received MEDI8...
|
CLD/CHD subjects who received paliv...
|
CLD/CHD subjects who received Paliv...
|
Arm/Group Description |
Subjects who received MEDI8897 in Season 1.
|
Subjects who received Palivizumab in Season 1.
|
CHD/CLD subjects who received MEDI8897 in both Season 1 and Season 2.
|
CLD/CHD subjects who received palivizumab in Season 1 and MEDI8897 in Season 2.
|
CLD/CHD subjects who received Palivizumab in both Season 1 and Season 2.
|
|
|
MEDI8897
|
Palivizumab
|
MEDI8897/MEDI8897
|
Palivizumab/MEDI8897
|
Palivizumab/Palivizumab
|
|
Affected / at Risk (%) |
|
Affected / at Risk (%) |
|
Affected / at Risk (%) |
|
Affected / at Risk (%) |
|
Affected / at Risk (%) |
|
Total |
5/614 (0.81%)
|
|
1/304 (0.33%)
|
|
0/180 (0.00%)
|
|
0/40 (0.00%)
|
|
0/42 (0.00%)
|
|
|
|
MEDI8897
|
Palivizumab
|
MEDI8897/MEDI8897
|
Palivizumab/MEDI8897
|
Palivizumab/Palivizumab
|
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Total |
80/614 (13.03%)
|
|
38/304 (12.50%)
|
|
23/180 (12.78%)
|
|
4/40 (10.00%)
|
|
2/42 (4.76%)
|
|
Blood and lymphatic system disorders |
|
|
|
|
|
Anaemia |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Cardiac disorders |
|
|
|
|
|
Arrhythmia |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Atrioventricular block second degree |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Bradycardia |
1/614 (0.16%)
|
1 |
2/304 (0.66%)
|
3 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Cardiac failure |
1/614 (0.16%)
|
1 |
2/304 (0.66%)
|
2 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Cardiac failure congestive |
1/614 (0.16%)
|
1 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Cardiogenic shock |
1/614 (0.16%)
|
1 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Tricuspid valve incompetence |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Congenital, familial and genetic disorders |
|
|
|
|
|
Atrial septal defect |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Atrioventricular septal defect |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Craniosynostosis |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Fallot's tetralogy |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Vascular malformation |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Ventricular septal defect |
1/614 (0.16%)
|
1 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Eye disorders |
|
|
|
|
|
Retinopathy of prematurity |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Gastrointestinal disorders |
|
|
|
|
|
Diarrhoea |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Duodenal ulcer |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Enterocolitis |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Gastric fistula |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Incarcerated inguinal hernia |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Inguinal hernia |
1/614 (0.16%)
|
1 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Intestinal obstruction |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Intussusception |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Vomiting |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Abdominal distension |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Anal fissure |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Ascites |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
General disorders |
|
|
|
|
|
Crying |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Fatigue |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Hyperthermia |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Oedema peripheral |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Pyrexia |
2/614 (0.33%)
|
2 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Systemic inflammatory response syndrome |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Infections and infestations |
|
|
|
|
|
Adenovirus infection |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Bacterial infection |
1/614 (0.16%)
|
1 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Bone abscess |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/40 (2.50%)
|
1 |
0/42 (0.00%)
|
0 |
Bronchiolitis |
11/614 (1.79%)
|
11 |
4/304 (1.32%)
|
4 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Bronchitis |
5/614 (0.81%)
|
5 |
2/304 (0.66%)
|
2 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Bronchitis viral |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
3/180 (1.67%)
|
3 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Covid-19 |
3/614 (0.49%)
|
3 |
1/304 (0.33%)
|
1 |
2/180 (1.11%)
|
2 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Dacryocystitis |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Ear infection |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/40 (2.50%)
|
1 |
0/42 (0.00%)
|
0 |
Gastric infection |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Gastroenteritis |
6/614 (0.98%)
|
6 |
1/304 (0.33%)
|
1 |
3/180 (1.67%)
|
3 |
1/40 (2.50%)
|
1 |
1/42 (2.38%)
|
1 |
Gastroenteritis norovirus |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Gastroenteritis viral |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Gastrointestinal infection |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/40 (2.50%)
|
1 |
0/42 (0.00%)
|
0 |
Gastrointestinal viral infection |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Hand-foot-and-mouth disease |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Lower respiratory tract infection |
1/614 (0.16%)
|
1 |
2/304 (0.66%)
|
2 |
2/180 (1.11%)
|
2 |
1/40 (2.50%)
|
1 |
0/42 (0.00%)
|
0 |
Lower respiratory tract infection viral |
2/614 (0.33%)
|
2 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
1/42 (2.38%)
|
1 |
Mastoiditis |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/40 (2.50%)
|
1 |
0/42 (0.00%)
|
0 |
Meningitis aseptic |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Metapneumovirus bronchiolitis |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Nasopharyngitis |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Otitis media |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/40 (2.50%)
|
1 |
0/42 (0.00%)
|
0 |
Otitis media acute |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/40 (2.50%)
|
1 |
0/42 (0.00%)
|
0 |
Pharyngitis |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Pneumonia |
5/614 (0.81%)
|
5 |
1/304 (0.33%)
|
1 |
2/180 (1.11%)
|
2 |
2/40 (5.00%)
|
2 |
0/42 (0.00%)
|
0 |
Pneumonia respiratory syncytial viral |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Pneumonia viral |
1/614 (0.16%)
|
1 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Pyelonephritis |
1/614 (0.16%)
|
2 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Pyelonephritis acute |
1/614 (0.16%)
|
1 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Respiratory syncytial virus bronchiolitis |
4/614 (0.65%)
|
4 |
2/304 (0.66%)
|
2 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Rotavirus infection |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Scrotal infection |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Sepsis |
2/614 (0.33%)
|
2 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Septic shock |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Upper respiratory tract infection |
1/614 (0.16%)
|
1 |
4/304 (1.32%)
|
5 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Urinary tract infection |
2/614 (0.33%)
|
2 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Varicella |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Viral infection |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Viral upper respiratory tract infection |
3/614 (0.49%)
|
4 |
1/304 (0.33%)
|
1 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Injury, poisoning and procedural complications |
|
|
|
|
|
Endotracheal intubation complication |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Gastrostomy tube site complication |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Head injury |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Lower limb fracture |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Skull fracture |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Vaccination complication |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Investigations |
|
|
|
|
|
Catheterisation cardiac |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Oxygen saturation decreased |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Metabolism and nutrition disorders |
|
|
|
|
|
Dehydration |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Failure to thrive |
2/614 (0.33%)
|
2 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Feeding disorder |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Feeding intolerance |
2/614 (0.33%)
|
2 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Hypophagia |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Underweight |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
|
|
|
|
Haemangioma |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Nervous system disorders |
|
|
|
|
|
Dyskinesia |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Embolic stroke |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Epilepsy |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
2 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Haemorrhage intracranial |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Hypotonia |
1/614 (0.16%)
|
2 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Loss of consciousness |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Nystagmus |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/40 (2.50%)
|
1 |
0/42 (0.00%)
|
0 |
Syncope |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Renal and urinary disorders |
|
|
|
|
|
Calculus urinary |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Hydronephrosis |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Reproductive system and breast disorders |
|
|
|
|
|
Intermenstrual bleeding |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Respiratory, thoracic and mediastinal disorders |
|
|
|
|
|
Anaemic hypoxia |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Apnoea |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Bronchopulmonary dysplasia |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Chylothorax |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Diaphragm muscle weakness |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Hypoxia |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Infantile apnoea |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Laryngeal stenosis |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Pleural effusion |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
2/180 (1.11%)
|
2 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Pulmonary artery stenosis |
1/614 (0.16%)
|
2 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Pulmonary hypertensive crisis |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Pulmonary oedema |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Respiratory distress |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Skin and subcutaneous tissue disorders |
|
|
|
|
|
Angioedema |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Social circumstances |
|
|
|
|
|
Social problem |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Social stay hospitalisation |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Vascular disorders |
|
|
|
|
|
Cyanosis |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Term from vocabulary, MedDRA 25.1
Indicates events were collected by systematic assessment
|
|
Frequency Threshold for Reporting Other Adverse Events
|
0%
|
|
MEDI8897
|
Palivizumab
|
MEDI8897/MEDI8897
|
Palivizumab/MEDI8897
|
Palivizumab/Palivizumab
|
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Total |
435/614 (70.85%)
|
|
211/304 (69.41%)
|
|
129/180 (71.67%)
|
|
31/40 (77.50%)
|
|
29/42 (69.05%)
|
|
Blood and lymphatic system disorders |
|
|
|
|
|
Pancytopenia |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Thrombocytopenia |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Thrombocytosis |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Anaemia |
12/614 (1.95%)
|
12 |
5/304 (1.64%)
|
5 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Anaemia neonatal |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Heparin-induced thrombocytopenia |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Iron deficiency anaemia |
5/614 (0.81%)
|
5 |
3/304 (0.99%)
|
3 |
3/180 (1.67%)
|
3 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Lymphadenitis |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Lymphadenopathy |
2/614 (0.33%)
|
2 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Monocytosis |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Neutropenia |
0/614 (0.00%)
|
0 |
2/304 (0.66%)
|
2 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Cardiac disorders |
|
|
|
|
|
Atrial fibrillation |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Atrioventricular block |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Atrioventricular block complete |
1/614 (0.16%)
|
1 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Atrioventricular block second degree |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Bundle branch block right |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Cardiac failure |
0/614 (0.00%)
|
0 |
3/304 (0.99%)
|
3 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Cardiac failure chronic |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Cardiac septal hypertrophy |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Low cardiac output syndrome |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Mitral valve incompetence |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Pericardial effusion |
2/614 (0.33%)
|
3 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Right atrial dilatation |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Sinus bradycardia |
0/614 (0.00%)
|
0 |
2/304 (0.66%)
|
2 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Supraventricular tachycardia |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Tachycardia |
1/614 (0.16%)
|
1 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Tricuspid valve incompetence |
1/614 (0.16%)
|
2 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Congenital, familial and genetic disorders |
|
|
|
|
|
Anomalous pulmonary venous connection |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Atrial septal defect |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Brachycephaly |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Cerebellar hypoplasia |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Cerebral palsy |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Cleft palate |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Congenital choroid plexus cyst |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Congenital nystagmus |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Congenital oral malformation |
0/614 (0.00%)
|
0 |
2/304 (0.66%)
|
2 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Cryptorchism |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Cystic fibrosis |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Dacryostenosis congenital |
0/614 (0.00%)
|
0 |
2/304 (0.66%)
|
2 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Dysmorphism |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Eyelid ptosis congenital |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Hydrocele |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Laryngomalacia |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Left ventricle outflow tract obstruction |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Phimosis |
1/614 (0.16%)
|
1 |
2/304 (0.66%)
|
2 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
1/42 (2.38%)
|
1 |
Plagiocephaly |
1/614 (0.16%)
|
1 |
3/304 (0.99%)
|
3 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Vascular malformation |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Ear and labyrinth disorders |
|
|
|
|
|
Cerumen impaction |
3/614 (0.49%)
|
3 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Deafness |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Ear pain |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Eustachian tube dysfunction |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
External ear inflammation |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Hypoacusis |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Neurosensory hypoacusis |
1/614 (0.16%)
|
1 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
1/40 (2.50%)
|
1 |
0/42 (0.00%)
|
0 |
Noninfective myringitis |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Otorrhoea |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Tympanic membrane perforation |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
1/42 (2.38%)
|
1 |
Endocrine disorders |
|
|
|
|
|
Hypothyroidism |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
1/42 (2.38%)
|
1 |
Eye disorders |
|
|
|
|
|
Anisocoria |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Anisometropia |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Astigmatism |
1/614 (0.16%)
|
1 |
2/304 (0.66%)
|
2 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Blepharitis |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
1/180 (0.56%)
|
2 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Blepharospasm |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/40 (2.50%)
|
1 |
0/42 (0.00%)
|
0 |
Cataract |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Chalazion |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Choroidal effusion |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Conjunctivitis allergic |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Eye allergy |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Eye discharge |
1/614 (0.16%)
|
2 |
4/304 (1.32%)
|
5 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Eye inflammation |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Eyelid function disorder |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Eyelid ptosis |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Heterophoria |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Hypermetropia |
3/614 (0.49%)
|
3 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Inflammation of lacrimal passage |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Myopia |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Periorbital swelling |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Retinopathy |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Retinopathy of prematurity |
2/614 (0.33%)
|
2 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Strabismus |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Gastrointestinal disorders |
|
|
|
|
|
Diarrhoea |
29/614 (4.72%)
|
33 |
11/304 (3.62%)
|
12 |
10/180 (5.56%)
|
12 |
2/40 (5.00%)
|
3 |
7/42 (16.67%)
|
7 |
Diarrhoea haemorrhagic |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Dysbiosis |
2/614 (0.33%)
|
3 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Dyschezia |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Dyspepsia |
3/614 (0.49%)
|
3 |
0/304 (0.00%)
|
0 |
2/180 (1.11%)
|
2 |
1/40 (2.50%)
|
1 |
0/42 (0.00%)
|
0 |
Dysphagia |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Enteritis |
3/614 (0.49%)
|
4 |
2/304 (0.66%)
|
3 |
3/180 (1.67%)
|
5 |
0/40 (0.00%)
|
0 |
1/42 (2.38%)
|
1 |
Enterocolitis |
2/614 (0.33%)
|
2 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/40 (2.50%)
|
1 |
0/42 (0.00%)
|
0 |
Faecaloma |
2/614 (0.33%)
|
3 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Faeces discoloured |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Faeces pale |
1/614 (0.16%)
|
1 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Faeces soft |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Flatulence |
1/614 (0.16%)
|
1 |
5/304 (1.64%)
|
5 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
1/42 (2.38%)
|
1 |
Functional gastrointestinal disorder |
1/614 (0.16%)
|
1 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Gastric fistula |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Gastritis |
1/614 (0.16%)
|
1 |
2/304 (0.66%)
|
2 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Gastrointestinal pain |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Gastrooesophageal reflux disease |
13/614 (2.12%)
|
13 |
9/304 (2.96%)
|
9 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Haematochezia |
1/614 (0.16%)
|
2 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Ileus |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Infantile colic |
9/614 (1.47%)
|
9 |
6/304 (1.97%)
|
6 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Infantile spitting up |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Inguinal hernia |
3/614 (0.49%)
|
3 |
2/304 (0.66%)
|
2 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Oesophagitis |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/40 (2.50%)
|
1 |
0/42 (0.00%)
|
0 |
Small intestinal obstruction |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Stomatitis |
2/614 (0.33%)
|
2 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/40 (2.50%)
|
1 |
0/42 (0.00%)
|
0 |
Teething |
31/614 (5.05%)
|
35 |
16/304 (5.26%)
|
19 |
7/180 (3.89%)
|
7 |
0/40 (0.00%)
|
0 |
2/42 (4.76%)
|
2 |
Tongue erythema |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Toothache |
0/614 (0.00%)
|
0 |
2/304 (0.66%)
|
3 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Umbilical hernia |
2/614 (0.33%)
|
2 |
2/304 (0.66%)
|
2 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Vomiting |
15/614 (2.44%)
|
17 |
11/304 (3.62%)
|
14 |
6/180 (3.33%)
|
7 |
4/40 (10.00%)
|
5 |
3/42 (7.14%)
|
8 |
Abdominal distension |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Abdominal pain |
1/614 (0.16%)
|
1 |
1/304 (0.33%)
|
1 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
1/42 (2.38%)
|
1 |
Abdominal pain upper |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Anal erythema |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Anal fissure |
1/614 (0.16%)
|
1 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Anal fissure haemorrhage |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Ankyloglossia acquired |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Aphthous ulcer |
4/614 (0.65%)
|
4 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Constipation |
37/614 (6.03%)
|
39 |
20/304 (6.58%)
|
28 |
5/180 (2.78%)
|
5 |
2/40 (5.00%)
|
2 |
2/42 (4.76%)
|
2 |
General disorders |
|
|
|
|
|
Calcinosis |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Catheter site haematoma |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Developmental delay |
1/614 (0.16%)
|
1 |
1/304 (0.33%)
|
1 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Discomfort |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
2 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Drug tolerance |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Drug withdrawal syndrome |
2/614 (0.33%)
|
2 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Fatigue |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/40 (2.50%)
|
1 |
0/42 (0.00%)
|
0 |
Fever neonatal |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Hyperthermia |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Impaired healing |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Incarcerated hernia |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Injection site erythema |
2/614 (0.33%)
|
2 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Injection site induration |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Injection site reaction |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Medical device site irritation |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Medical device site rash |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Oedema |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Pain |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Peripheral swelling |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Pyrexia |
81/614 (13.19%)
|
109 |
43/304 (14.14%)
|
57 |
23/180 (12.78%)
|
37 |
9/40 (22.50%)
|
12 |
6/42 (14.29%)
|
14 |
Secretion discharge |
1/614 (0.16%)
|
1 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Swelling |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Systemic inflammatory response syndrome |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Vaccination site erythema |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Vaccination site reaction |
1/614 (0.16%)
|
1 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Vaccination site swelling |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Vaccination site urticaria |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Hepatobiliary disorders |
|
|
|
|
|
Hepatitis |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Hypertransaminasaemia |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Jaundice |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Sphincter of oddi dysfunction |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Immune system disorders |
|
|
|
|
|
Drug hypersensitivity |
1/614 (0.16%)
|
1 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Food allergy |
6/614 (0.98%)
|
6 |
3/304 (0.99%)
|
3 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
1/42 (2.38%)
|
1 |
Hypersensitivity |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Milk allergy |
6/614 (0.98%)
|
6 |
3/304 (0.99%)
|
3 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Nutritional supplement allergy |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Seasonal allergy |
2/614 (0.33%)
|
2 |
0/304 (0.00%)
|
0 |
2/180 (1.11%)
|
2 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Infections and infestations |
|
|
|
|
|
Acarodermatitis |
4/614 (0.65%)
|
4 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Acute sinusitis |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/40 (2.50%)
|
1 |
0/42 (0.00%)
|
0 |
Adenoiditis |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
1/42 (2.38%)
|
1 |
Adenovirus infection |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
1/42 (2.38%)
|
1 |
Anal fungal infection |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Bacterial blepharitis |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Body tinea |
1/614 (0.16%)
|
1 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Bronchiolitis |
22/614 (3.58%)
|
27 |
9/304 (2.96%)
|
12 |
9/180 (5.00%)
|
11 |
0/40 (0.00%)
|
0 |
2/42 (4.76%)
|
2 |
Bronchitis |
20/614 (3.26%)
|
28 |
10/304 (3.29%)
|
16 |
7/180 (3.89%)
|
7 |
4/40 (10.00%)
|
7 |
1/42 (2.38%)
|
1 |
Covid-19 |
8/614 (1.30%)
|
8 |
2/304 (0.66%)
|
2 |
14/180 (7.78%)
|
14 |
3/40 (7.50%)
|
3 |
5/42 (11.90%)
|
5 |
Candida infection |
2/614 (0.33%)
|
2 |
3/304 (0.99%)
|
5 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Candida nappy rash |
1/614 (0.16%)
|
1 |
1/304 (0.33%)
|
1 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Catheter site infection |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Cellulitis |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Clostridium difficile infection |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Conjunctivitis |
25/614 (4.07%)
|
31 |
10/304 (3.29%)
|
12 |
11/180 (6.11%)
|
11 |
1/40 (2.50%)
|
1 |
3/42 (7.14%)
|
3 |
Conjunctivitis bacterial |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
2/180 (1.11%)
|
2 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Conjunctivitis viral |
1/614 (0.16%)
|
2 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
2 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Coronavirus infection |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Croup infectious |
1/614 (0.16%)
|
1 |
1/304 (0.33%)
|
1 |
1/180 (0.56%)
|
1 |
1/40 (2.50%)
|
1 |
0/42 (0.00%)
|
0 |
Dacryocystitis |
2/614 (0.33%)
|
2 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Dermatitis infected |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Device related sepsis |
1/614 (0.16%)
|
1 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Ear infection |
5/614 (0.81%)
|
8 |
5/304 (1.64%)
|
6 |
2/180 (1.11%)
|
3 |
1/40 (2.50%)
|
1 |
2/42 (4.76%)
|
2 |
Enterobiasis |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/40 (2.50%)
|
2 |
0/42 (0.00%)
|
0 |
Enterovirus infection |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
1/42 (2.38%)
|
1 |
Exanthema subitum |
9/614 (1.47%)
|
9 |
4/304 (1.32%)
|
4 |
1/180 (0.56%)
|
1 |
1/40 (2.50%)
|
1 |
0/42 (0.00%)
|
0 |
Eye infection |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
2 |
1/180 (0.56%)
|
1 |
1/40 (2.50%)
|
1 |
0/42 (0.00%)
|
0 |
Fungal skin infection |
7/614 (1.14%)
|
7 |
3/304 (0.99%)
|
3 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Gastroenteritis |
19/614 (3.09%)
|
21 |
15/304 (4.93%)
|
15 |
11/180 (6.11%)
|
19 |
1/40 (2.50%)
|
1 |
2/42 (4.76%)
|
3 |
Gastroenteritis adenovirus |
1/614 (0.16%)
|
1 |
1/304 (0.33%)
|
1 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Gastroenteritis norovirus |
2/614 (0.33%)
|
2 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Gastroenteritis rotavirus |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/40 (2.50%)
|
1 |
0/42 (0.00%)
|
0 |
Gastroenteritis sapovirus |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Gastroenteritis viral |
3/614 (0.49%)
|
3 |
2/304 (0.66%)
|
2 |
4/180 (2.22%)
|
4 |
2/40 (5.00%)
|
2 |
0/42 (0.00%)
|
0 |
Gastroenteritis yersinia |
2/614 (0.33%)
|
2 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Gastrointestinal bacterial overgrowth |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Gastrointestinal infection |
2/614 (0.33%)
|
2 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Gastrointestinal viral infection |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Genital infection fungal |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Giardiasis |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Gingivitis |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Hand-foot-and-mouth disease |
15/614 (2.44%)
|
15 |
6/304 (1.97%)
|
6 |
9/180 (5.00%)
|
9 |
0/40 (0.00%)
|
0 |
2/42 (4.76%)
|
2 |
Herpes virus infection |
2/614 (0.33%)
|
2 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Hordeolum |
2/614 (0.33%)
|
3 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Human herpesvirus 6 infection |
1/614 (0.16%)
|
1 |
1/304 (0.33%)
|
1 |
3/180 (1.67%)
|
3 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Impetigo |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Infection |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Infectious mononucleosis |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Laryngitis |
11/614 (1.79%)
|
12 |
7/304 (2.30%)
|
12 |
3/180 (1.67%)
|
4 |
2/40 (5.00%)
|
2 |
1/42 (2.38%)
|
1 |
Laryngopharyngitis |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Lice infestation |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
1/42 (2.38%)
|
1 |
Lower respiratory tract infection |
18/614 (2.93%)
|
21 |
10/304 (3.29%)
|
13 |
1/180 (0.56%)
|
3 |
3/40 (7.50%)
|
4 |
0/42 (0.00%)
|
0 |
Lower respiratory tract infection viral |
3/614 (0.49%)
|
3 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/40 (2.50%)
|
1 |
0/42 (0.00%)
|
0 |
Molluscum contagiosum |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
1/42 (2.38%)
|
1 |
Nasopharyngitis |
57/614 (9.28%)
|
84 |
39/304 (12.83%)
|
50 |
26/180 (14.44%)
|
55 |
7/40 (17.50%)
|
16 |
9/42 (21.43%)
|
15 |
Oral candidiasis |
10/614 (1.63%)
|
10 |
6/304 (1.97%)
|
7 |
3/180 (1.67%)
|
3 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Oropharyngeal candidiasis |
1/614 (0.16%)
|
1 |
1/304 (0.33%)
|
2 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Otitis externa |
0/614 (0.00%)
|
0 |
3/304 (0.99%)
|
3 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
1/42 (2.38%)
|
1 |
Otitis media |
27/614 (4.40%)
|
37 |
11/304 (3.62%)
|
14 |
12/180 (6.67%)
|
16 |
3/40 (7.50%)
|
3 |
2/42 (4.76%)
|
3 |
Otitis media acute |
16/614 (2.61%)
|
20 |
14/304 (4.61%)
|
18 |
11/180 (6.11%)
|
19 |
5/40 (12.50%)
|
6 |
2/42 (4.76%)
|
4 |
Otitis media chronic |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
1/42 (2.38%)
|
1 |
Otitis media viral |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Otosalpingitis |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Parasitic gastroenteritis |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Pharyngitis |
23/614 (3.75%)
|
29 |
8/304 (2.63%)
|
8 |
7/180 (3.89%)
|
9 |
2/40 (5.00%)
|
2 |
0/42 (0.00%)
|
0 |
Pharyngitis streptococcal |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
2 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Pharyngotonsillitis |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Pneumonia |
4/614 (0.65%)
|
4 |
3/304 (0.99%)
|
3 |
2/180 (1.11%)
|
2 |
0/40 (0.00%)
|
0 |
1/42 (2.38%)
|
1 |
Pneumonia aspiration |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
2 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Pneumonia bacterial |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Pneumonia haemophilus |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Pneumonia parainfluenzae viral |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Post procedural infection |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Pustule |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Pyelonephritis |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Pyoderma |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Rash pustular |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Respiratory syncytial virus bronchiolitis |
2/614 (0.33%)
|
2 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Respiratory syncytial virus infection |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Respiratory tract infection viral |
1/614 (0.16%)
|
2 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Rhinitis |
75/614 (12.21%)
|
109 |
40/304 (13.16%)
|
64 |
29/180 (16.11%)
|
38 |
6/40 (15.00%)
|
8 |
6/42 (14.29%)
|
16 |
Roseola |
8/614 (1.30%)
|
8 |
5/304 (1.64%)
|
5 |
3/180 (1.67%)
|
3 |
1/40 (2.50%)
|
1 |
2/42 (4.76%)
|
2 |
Rotavirus infection |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
1/42 (2.38%)
|
1 |
Salmonellosis |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Sepsis |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Sinusitis |
1/614 (0.16%)
|
1 |
1/304 (0.33%)
|
1 |
2/180 (1.11%)
|
4 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Skin candida |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Skin infection |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Staphylococcal skin infection |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Subglottic laryngitis |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Superinfection viral |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Suspected covid-19 |
2/614 (0.33%)
|
2 |
0/304 (0.00%)
|
0 |
3/180 (1.67%)
|
3 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Tinea infection |
2/614 (0.33%)
|
4 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Tonsillitis |
3/614 (0.49%)
|
3 |
0/304 (0.00%)
|
0 |
4/180 (2.22%)
|
4 |
0/40 (0.00%)
|
0 |
1/42 (2.38%)
|
1 |
Tracheitis |
3/614 (0.49%)
|
3 |
0/304 (0.00%)
|
0 |
2/180 (1.11%)
|
2 |
0/40 (0.00%)
|
0 |
1/42 (2.38%)
|
1 |
Tracheobronchitis |
1/614 (0.16%)
|
1 |
3/304 (0.99%)
|
3 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Upper respiratory tract infection |
148/614 (24.10%)
|
235 |
77/304 (25.33%)
|
131 |
48/180 (26.67%)
|
86 |
8/40 (20.00%)
|
12 |
9/42 (21.43%)
|
26 |
Urinary tract infection |
6/614 (0.98%)
|
8 |
3/304 (0.99%)
|
3 |
3/180 (1.67%)
|
3 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Urinary tract infection bacterial |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Varicella |
5/614 (0.81%)
|
5 |
0/304 (0.00%)
|
0 |
3/180 (1.67%)
|
3 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Varicella zoster virus infection |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Viral infection |
2/614 (0.33%)
|
2 |
2/304 (0.66%)
|
2 |
2/180 (1.11%)
|
2 |
1/40 (2.50%)
|
1 |
0/42 (0.00%)
|
0 |
Viral pharyngitis |
1/614 (0.16%)
|
1 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Viral rash |
7/614 (1.14%)
|
7 |
3/304 (0.99%)
|
3 |
1/180 (0.56%)
|
1 |
1/40 (2.50%)
|
1 |
0/42 (0.00%)
|
0 |
Viral rhinitis |
3/614 (0.49%)
|
3 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Viral upper respiratory tract infection |
33/614 (5.37%)
|
42 |
14/304 (4.61%)
|
15 |
14/180 (7.78%)
|
18 |
8/40 (20.00%)
|
8 |
2/42 (4.76%)
|
2 |
Vulvitis |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Yersinia infection |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Injury, poisoning and procedural complications |
|
|
|
|
|
Accidental exposure to product |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Arthropod bite |
2/614 (0.33%)
|
3 |
3/304 (0.99%)
|
3 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Arthropod sting |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Chillblains |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
1/40 (2.50%)
|
1 |
0/42 (0.00%)
|
0 |
Clavicle fracture |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Concussion |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Contusion |
3/614 (0.49%)
|
3 |
0/304 (0.00%)
|
0 |
2/180 (1.11%)
|
3 |
1/40 (2.50%)
|
1 |
0/42 (0.00%)
|
0 |
Eye injury |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Fall |
2/614 (0.33%)
|
2 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Foreign body in respiratory tract |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Head injury |
4/614 (0.65%)
|
4 |
1/304 (0.33%)
|
1 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Intestinal anastomosis complication |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Lip injury |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
2 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Penis injury |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Post procedural complication |
1/614 (0.16%)
|
1 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Post procedural haematoma |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Radial head dislocation |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Re-opening of ductus arteriosus |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Skin laceration |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Subcutaneous haematoma |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Subdural haematoma |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/40 (2.50%)
|
1 |
0/42 (0.00%)
|
0 |
Thermal burn |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Tongue injury |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
1/42 (2.38%)
|
1 |
Tooth avulsion |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Traumatic haematoma |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Vaccination complication |
25/614 (4.07%)
|
36 |
19/304 (6.25%)
|
25 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
2/42 (4.76%)
|
2 |
Wound dehiscence |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Investigations |
|
|
|
|
|
Aspartate aminotransferase increased |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Blood albumin decreased |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Blood potassium decreased |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/40 (2.50%)
|
1 |
0/42 (0.00%)
|
0 |
Body temperature abnormal |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Body temperature increased |
4/614 (0.65%)
|
4 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Cardiac murmur |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Coronavirus test positive |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Crystal urine present |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Echocardiogram |
1/614 (0.16%)
|
2 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Enterovirus test positive |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/40 (2.50%)
|
1 |
0/42 (0.00%)
|
0 |
Escherichia test positive |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Haemophilus test positive |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/40 (2.50%)
|
1 |
0/42 (0.00%)
|
0 |
Head circumference abnormal |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Herpes simplex test positive |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Human rhinovirus test positive |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Lymphocyte count decreased |
1/614 (0.16%)
|
2 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Platelet count decreased |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Respiratory syncytial virus test positive |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Sars-cov-2 test negative |
19/614 (3.09%)
|
40 |
10/304 (3.29%)
|
15 |
4/180 (2.22%)
|
10 |
3/40 (7.50%)
|
5 |
1/42 (2.38%)
|
1 |
Sars-cov-2 test positive |
4/614 (0.65%)
|
4 |
3/304 (0.99%)
|
3 |
4/180 (2.22%)
|
4 |
1/40 (2.50%)
|
1 |
2/42 (4.76%)
|
2 |
Weight abnormal |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Metabolism and nutrition disorders |
|
|
|
|
|
Decreased appetite |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Dehydration |
3/614 (0.49%)
|
3 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Electrolyte imbalance |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Failure to thrive |
1/614 (0.16%)
|
1 |
2/304 (0.66%)
|
2 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Feeding disorder |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
1/42 (2.38%)
|
1 |
Feeding intolerance |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Hypercalcaemia |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Hyperglycaemia |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Hyperkalaemia |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Hypocalcaemia |
2/614 (0.33%)
|
2 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Hypoglycaemia |
2/614 (0.33%)
|
2 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Hypokalaemia |
2/614 (0.33%)
|
2 |
2/304 (0.66%)
|
3 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Hypomagnesaemia |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Hypophagia |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Iron deficiency |
1/614 (0.16%)
|
1 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Malnutrition |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Underweight |
1/614 (0.16%)
|
1 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Vitamin b12 deficiency |
2/614 (0.33%)
|
2 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Weight gain poor |
2/614 (0.33%)
|
2 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Zinc deficiency |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Musculoskeletal and connective tissue disorders |
|
|
|
|
|
Chest wall haematoma |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Growth failure |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Musculoskeletal chest pain |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Myosclerosis |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Myositis |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Rickets |
1/614 (0.16%)
|
1 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Torticollis |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
|
|
|
|
Haemangioma |
2/614 (0.33%)
|
2 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Skin papilloma |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Nervous system disorders |
|
|
|
|
|
Ataxia |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Cerebral ventricle dilatation |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Diplegia |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Dyskinesia |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Dystonia |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Febrile convulsion |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Haemorrhage intracranial |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Hypotonia |
2/614 (0.33%)
|
2 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Infant irritability |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Motor developmental delay |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Posthaemorrhagic hydrocephalus |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Psychomotor hyperactivity |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Seizure |
2/614 (0.33%)
|
2 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Somnolence |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Speech disorder developmental |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/40 (2.50%)
|
1 |
2/42 (4.76%)
|
2 |
Tremor |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Vocal cord paralysis |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/40 (2.50%)
|
1 |
0/42 (0.00%)
|
0 |
Product Issues |
|
|
|
|
|
Device dislocation |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Psychiatric disorders |
|
|
|
|
|
Agitation |
3/614 (0.49%)
|
3 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Anxiety |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Drug dependence |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Insomnia |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Irritability |
6/614 (0.98%)
|
11 |
2/304 (0.66%)
|
3 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Restlessness |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Sleep terror |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Staring |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Renal and urinary disorders |
|
|
|
|
|
Acute kidney injury |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Hydronephrosis |
2/614 (0.33%)
|
2 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Nephrolithiasis |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Oliguria |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Vesicoureteric reflux |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Reproductive system and breast disorders |
|
|
|
|
|
Balanoposthitis |
1/614 (0.16%)
|
1 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Enlarged clitoris |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Genital labial adhesions |
2/614 (0.33%)
|
2 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Scrotal dermatitis |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Vulvovaginal discomfort |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Respiratory, thoracic and mediastinal disorders |
|
|
|
|
|
Adenoidal hypertrophy |
1/614 (0.16%)
|
2 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
1/40 (2.50%)
|
1 |
0/42 (0.00%)
|
0 |
Allergic cough |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Aspiration |
2/614 (0.33%)
|
2 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Asthma |
3/614 (0.49%)
|
3 |
0/304 (0.00%)
|
0 |
2/180 (1.11%)
|
2 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Atelectasis |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/40 (2.50%)
|
1 |
0/42 (0.00%)
|
0 |
Bronchial hyperreactivity |
2/614 (0.33%)
|
2 |
0/304 (0.00%)
|
0 |
2/180 (1.11%)
|
2 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Bronchopulmonary dysplasia |
3/614 (0.49%)
|
3 |
1/304 (0.33%)
|
1 |
3/180 (1.67%)
|
4 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Bronchospasm |
2/614 (0.33%)
|
3 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Catarrh |
3/614 (0.49%)
|
4 |
1/304 (0.33%)
|
1 |
3/180 (1.67%)
|
4 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Chronic respiratory disease |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Chylothorax |
1/614 (0.16%)
|
1 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Cough |
16/614 (2.61%)
|
18 |
6/304 (1.97%)
|
7 |
6/180 (3.33%)
|
6 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Cough variant asthma |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Epistaxis |
1/614 (0.16%)
|
1 |
1/304 (0.33%)
|
2 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Hypoxia |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Laryngeal stenosis |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Lung opacity |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Nasal congestion |
41/614 (6.68%)
|
53 |
13/304 (4.28%)
|
16 |
4/180 (2.22%)
|
5 |
1/40 (2.50%)
|
1 |
0/42 (0.00%)
|
0 |
Nasal obstruction |
7/614 (1.14%)
|
7 |
4/304 (1.32%)
|
5 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
1/42 (2.38%)
|
2 |
Oropharyngeal pain |
2/614 (0.33%)
|
2 |
2/304 (0.66%)
|
2 |
2/180 (1.11%)
|
2 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Pleural effusion |
2/614 (0.33%)
|
2 |
3/304 (0.99%)
|
3 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Productive cough |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Pulmonary hypertension |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Pulmonary hypertensive crisis |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Pulmonary oedema |
2/614 (0.33%)
|
2 |
2/304 (0.66%)
|
2 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Respiration abnormal |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Rhinitis allergic |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
1/42 (2.38%)
|
1 |
Rhinorrhoea |
23/614 (3.75%)
|
28 |
12/304 (3.95%)
|
14 |
14/180 (7.78%)
|
25 |
4/40 (10.00%)
|
6 |
2/42 (4.76%)
|
4 |
Sleep apnoea syndrome |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Stridor |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/40 (2.50%)
|
1 |
0/42 (0.00%)
|
0 |
Tonsillar hypertrophy |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
1/42 (2.38%)
|
1 |
Upper respiratory tract congestion |
1/614 (0.16%)
|
1 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Upper respiratory tract inflammation |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
4 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Wheezing |
2/614 (0.33%)
|
2 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
1/40 (2.50%)
|
1 |
0/42 (0.00%)
|
0 |
Skin and subcutaneous tissue disorders |
|
|
|
|
|
Acne |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Acne infantile |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Asteatosis |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Blister |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Butterfly rash |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Decubitus ulcer |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Dermatitis |
7/614 (1.14%)
|
8 |
0/304 (0.00%)
|
0 |
2/180 (1.11%)
|
2 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Dermatitis allergic |
3/614 (0.49%)
|
3 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Dermatitis atopic |
14/614 (2.28%)
|
15 |
7/304 (2.30%)
|
7 |
3/180 (1.67%)
|
4 |
0/40 (0.00%)
|
0 |
1/42 (2.38%)
|
1 |
Dermatitis contact |
11/614 (1.79%)
|
12 |
1/304 (0.33%)
|
1 |
1/180 (0.56%)
|
2 |
1/40 (2.50%)
|
1 |
1/42 (2.38%)
|
1 |
Dermatitis diaper |
28/614 (4.56%)
|
29 |
6/304 (1.97%)
|
6 |
8/180 (4.44%)
|
9 |
0/40 (0.00%)
|
0 |
1/42 (2.38%)
|
1 |
Drug eruption |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Dry skin |
14/614 (2.28%)
|
15 |
4/304 (1.32%)
|
4 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
1/42 (2.38%)
|
1 |
Eczema |
14/614 (2.28%)
|
14 |
11/304 (3.62%)
|
14 |
4/180 (2.22%)
|
4 |
0/40 (0.00%)
|
0 |
1/42 (2.38%)
|
1 |
Eczema asteatotic |
2/614 (0.33%)
|
2 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Eczema infantile |
10/614 (1.63%)
|
11 |
5/304 (1.64%)
|
5 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Eczema nummular |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Erythema |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Erythema toxicum neonatorum |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Erythrosis |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Excessive granulation tissue |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Miliaria |
18/614 (2.93%)
|
18 |
11/304 (3.62%)
|
12 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Papule |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Perioral dermatitis |
3/614 (0.49%)
|
3 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Rash |
21/614 (3.42%)
|
21 |
9/304 (2.96%)
|
9 |
4/180 (2.22%)
|
4 |
2/40 (5.00%)
|
2 |
1/42 (2.38%)
|
1 |
Rash erythematous |
2/614 (0.33%)
|
3 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Rash macular |
1/614 (0.16%)
|
1 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Rash maculo-papular |
4/614 (0.65%)
|
4 |
3/304 (0.99%)
|
3 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Rash neonatal |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Rash papular |
2/614 (0.33%)
|
3 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Seborrhoeic dermatitis |
3/614 (0.49%)
|
4 |
3/304 (0.99%)
|
3 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Skin discolouration |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Skin irritation |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
1/42 (2.38%)
|
2 |
Skin mass |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Urticaria |
2/614 (0.33%)
|
2 |
2/304 (0.66%)
|
2 |
2/180 (1.11%)
|
2 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Urticaria papular |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Surgical and medical procedures |
|
|
|
|
|
Adenoidectomy |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Dacryocystorhinostomy |
2/614 (0.33%)
|
2 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Ear operation |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Ear tube insertion |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Gastrostomy |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Myringotomy |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Orchidopexy |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Tongue tie operation |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Vascular disorders |
|
|
|
|
|
Capillary fragility |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Cyanosis |
2/614 (0.33%)
|
2 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Haematoma |
0/614 (0.00%)
|
0 |
0/304 (0.00%)
|
0 |
2/180 (1.11%)
|
2 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Hypertension |
1/614 (0.16%)
|
1 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Hypotension |
0/614 (0.00%)
|
0 |
1/304 (0.33%)
|
1 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Pelvic venous thrombosis |
1/614 (0.16%)
|
1 |
0/304 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/40 (0.00%)
|
0 |
0/42 (0.00%)
|
0 |
Term from vocabulary, MedDRA 25.1
Indicates events were collected by systematic assessment
|