Table 2.
Number of studies and participants reporting adverse events*
| Organ system | AE—category | AE—specific | No of studies | No of participants |
| Infection and respiratory GI |
Severe infections | 5 | 1235 | |
| (1) | Sepsis | 1 | 32 | |
| (2) | Superinfection | 2 | 354 | |
| (3) | UTI | 1 | 720 | |
| (4) | Streptococcal infection | 1 | 129 | |
| Systemic infections | 5 | 1635 | ||
| (1) | Fever | 3 | 963 | |
| (2) | Common viral/bacterial/fungal infection | 2 | 792 | |
| (3) | Varicella | 3 | 1449 | |
| Lung/trachea | 10 | 2053 | ||
| (1) | Empyema | 1 | 600 | |
| (2) | Pneumonia | 8 | 2051 | |
| (3) | Respiratory distress | 2 | 2 | |
| Upper respiratory tract | 14 | 2457 | ||
| (1) | Bacterial tracheitis | 5 | 1023 | |
| (2) | Sinusitis | 2 | 849 | |
| (3) | Croup | 2 | 131 | |
| (4) | Viral parotitis | 1 | 27 | |
| (5) | Pharyngitis | 1 | 129 | |
| (6) | Persistent cough | 1 | 27 | |
| (7) | Oral thrush | 3 | 837 | |
| (8) | Otitis media | 4 | 1173 | |
| (9) | Ear, nose, throat infection | 3 | 862 | |
| (10) | Nasal discharge | 1 | 720 | |
| (11) | Eye discharge | 1 | 720 | |
| Voice complaints | 5 | 794 | ||
| GI bleeding | 8 | 2669 | ||
| (1) | Bleeding | 5 | 1577 | |
| (2) | Gross hematochezia | 1 | 118 | |
| (3) | Occult blood in stools | 2 | 292 | |
| (4) | Dark stools | 1 | 800 | |
| Vomiting | 27 | 6067 | ||
| (1) | Vomiting | 24 | 5983 | |
| (2) | Nausea | 6 | 586 | |
| (3) | Palatability | 3 | 170 | |
| Abdominal pain | 5 | 1332 | ||
| Diarrhoea | 8 | 1346 | ||
| (1) | Diarrhoea | 7 | 1217 | |
| (2) | Gastroenteritis | 1 | 129 | |
| CNS and behaviour | Tremor/jitteriness | 8 | 1274 | |
| (1) | Tremor | 7 | 1226 | |
| (2) | Jittery | 1 | 48 | |
| Behaviour change | 14 | 2078 | ||
| (1) | Violent behaviour | 1 | 198 | |
| (2) | Mood change | 7 | 1430 | |
| (3) | Hyperactivity | 2 | 268 | |
| (4) | Restlessness | 3 | 297 | |
| (5) | New sleep problems | 3 | 408 | |
| (6) | Emotional distress due to nebulizer mask | 1 | 82 | |
| (7) | Psychosis | 1 | 1 | |
| Headache | 3 | 291 | ||
| Dermatological | Burn | 1 | 198 | |
| Integument | 10 | 1954 | ||
| (1) | Hives | 2 | 199 | |
| (2) | Rash | 8 | 1954 | |
| (3) | Eczema | 1 | 129 | |
| (4) | Eye irritation | 2 | 211 | |
| (5) | Tongue irritation | 1 | 82 | |
| (6) | Positive weal | 1 | 1 | |
| (7) | Bleeding from ear | 1 | 720 | |
| Phlebitis | 1 | 32 | ||
| Endocrine/metabolic and musculoskeletal | Fluid and electrolyte abnormalities | 7 | 1849 | |
| (1) | Hyperkalemia | 1 | 800 | |
| (2) | Hyperglycemia | 3 | 154 | |
| (3) | Glycosuria | 1 | 125 | |
| (4) | Sodium retention | 1 | 50 | |
| (5) | Dehydration | 1 | 720 | |
| Growth | 6 | 731 | ||
| Adrenal suppression | 5 | 249 | ||
| Bone health | 5 | 579 | ||
| Cardiovascular | Arrhythmia | 3 | 312 | |
| (1) | Tachycardia | 2 | 178 | |
| (2) | Palpitations | 1 | 134 | |
| Hypertension | 5 | 1491 | ||
| Congestive heart failure | 1 | 50 | ||
| General | General complaints | 5 | 1146 | |
| (1) | Dizziness | 1 | 87 | |
| (2) | Pallor | 2 | 869 | |
| (3) | Excessive urination | 1 | 134 | |
| (4) | Normal tooth eruption | 1 | 56 | |
| Haematology, gum bleeding | 1 | 1 | ||
| Immune system and oncology | Immunosuppression | 4 | 147 | |
| (1) | Immunosuppression | 3 | 146 | |
| (2) | Tumour cell proliferation | 1 | 1 |
*Each adverse event was clustered into its related organ system; a panel of clinicians ranked each AE category and its corresponding adverse events in order of clinical significance/severity. The organ systems are presented in order of frequency of reporting, beginning with the most frequently reported (ie, infection and respiratory).
AE, adverse event; CNS, central nervous system; GI, gastrointestinal; URT, upper respiratory tract.