Appendix 6Non-serious adverse events and reactions listing by MedDRA-preferred term
TABLE 38
Non-serious adverse events and reactions listing by MedDRA-preferred term
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| Preferred Term | Omalizumab arm | Placebo arm | Total |
|---|
| Number of events | Number of participants | Number of events | Number of participants | Number of events | Number of participants |
|---|
| Accidental needle stick | 0 | 0 | 1 | 1 | 1 | 1 |
| Aching in limb | 0 | 0 | 1 | 1 | 1 | 1 |
| Acid reflux | 0 | 0 | 1 | 1 | 1 | 1 |
| Allergic reaction | 2 | 2 | 0 | 0 | 2 | 2 |
| Allergic reaction (baked egg) | 0 | 0 | 1 | 1 | 1 | 1 |
| Allergic reaction (coconut oil) | 0 | 0 | 1 | 1 | 1 | 1 |
| Allergic reaction (cooked egg) | 0 | 0 | 1 | 1 | 1 | 1 |
| Allergic reaction (cow’s milk) | 0 | 0 | 1 | 1 | 1 | 1 |
| Allergic reaction (dog) | 0 | 0 | 1 | 1 | 1 | 1 |
| Allergic reaction (egg) | 1 | 1 | 1 | 1 | 2 | 2 |
| Allergic reaction (exposure to cashew) | 1 | 1 | 0 | 0 | 1 | 1 |
| Allergic reaction (milk) | 1 | 1 | 1 | 1 | 2 | 2 |
| Allergic reaction (necklace) | 1 | 1 | 0 | 0 | 1 | 1 |
| Allergic reaction (not otherwise specified) | 1 | 1 | 0 | 0 | 1 | 1 |
| Allergic reaction (pine nut drink) | 1 | 1 | 0 | 0 | 1 | 1 |
| Allergic reaction (pollen) | 0 | 0 | 1 | 1 | 1 | 1 |
| Allergic reaction (possible) | 2 | 1 | 0 | 0 | 2 | 1 |
| Allergic reaction (raspberries) | 0 | 0 | 1 | 1 | 1 | 1 |
| Allergic reaction (shea butter) | 0 | 0 | 1 | 1 | 1 | 1 |
| Allergic reaction (butter) | 0 | 0 | 1 | 1 | 1 | 1 |
| Allergic rhinitis | 1 | 1 | 0 | 0 | 1 | 1 |
| Alopecia | 0 | 0 | 1 | 1 | 1 | 1 |
| Angioedema | 0 | 0 | 1 | 1 | 1 | 1 |
| Asthma aggravated | 1 | 1 | 0 | 0 | 1 | 1 |
| Asthma attack | 1 | 1 | 0 | 0 | 1 | 1 |
| Blisters | 1 | 1 | 0 | 0 | 1 | 1 |
| Breast lump | 1 | 1 | 0 | 0 | 1 | 1 |
| Burning sensation skin | 0 | 0 | 1 | 1 | 1 | 1 |
| Chest infection | 0 | 0 | 5 | 3 | 5 | 3 |
| Chickenpox | 1 | 1 | 0 | 0 | 1 | 1 |
| Circumcision | 0 | 0 | 1 | 1 | 1 | 1 |
| Cold | 1 | 1 | 3 | 2 | 4 | 3 |
| Cold sore | 0 | 0 | 6 | 2 | 6 | 2 |
| Cold symptoms | 1 | 1 | 6 | 3 | 7 | 4 |
| Congestion | 0 | 0 | 2 | 1 | 2 | 1 |
| Coryzal symptoms | 6 | 5 | 12 | 8 | 18 | 13 |
| Cough | 2 | 2 | 9 | 6 | 11 | 8 |
| Coughing (vomiting) | 0 | 0 | 1 | 1 | 1 | 1 |
| Diarrhoea | 1 | 1 | 0 | 0 | 1 | 1 |
| Difficulty breathing | 0 | 0 | 2 | 1 | 2 | 1 |
| Dizziness | 1 | 1 | 0 | 0 | 1 | 1 |
| Ear infection | 1 | 1 | 0 | 0 | 1 | 1 |
| Eczema aggravated | 25 | 14 | 27 | 16 | 52 | 30 |
| Eczema aggravated (infected) | 0 | 0 | 1 | 1 | 1 | 1 |
| Eczema aggravated (puppy) | 0 | 0 | 1 | 1 | 1 | 1 |
| Eczema aggravated (temperature) | 0 | 0 | 1 | 1 | 1 | 1 |
| Eczema exacerbated | 7 | 2 | 5 | 2 | 12 | 4 |
| Eczema weeping (hands) | 1 | 1 | 0 | 0 | 1 | 1 |
| Exacerbation of asthma | 1 | 1 | 7 | 7 | 8 | 8 |
| Exertional headache | 1 | 1 | 0 | 0 | 1 | 1 |
| Eczema herpeticum | 0 | 0 | 1 | 1 | 1 | 1 |
| Fractured wrist | 0 | 0 | 1 | 1 | 1 | 1 |
| Head injury | 1 | 1 | 0 | 0 | 1 | 1 |
| Head lice | 0 | 0 | 1 | 1 | 1 | 1 |
| Headache | 7 | 2 | 4 | 3 | 11 | 5 |
| Headaches | 2 | 2 | 0 | 0 | 2 | 2 |
| Hives | 1 | 1 | 1 | 1 | 2 | 2 |
| Hot flushes | 1 | 1 | 0 | 0 | 1 | 1 |
| Infected eczema | 17 | 11 | 27 | 18 | 44 | 29 |
| Infected eczema (eye) | 1 | 1 | 0 | 0 | 1 | 1 |
| Infected nail bed | 1 | 1 | 0 | 0 | 1 | 1 |
| Infected penis | 1 | 1 | 0 | 0 | 1 | 1 |
| Infection of gum | 1 | 1 | 0 | 0 | 1 | 1 |
| Iron deficiency | 3 | 3 | 2 | 2 | 5 | 5 |
| Itchy eyes | 0 | 0 | 2 | 2 | 2 | 2 |
| Jaw pain | 0 | 0 | 1 | 1 | 1 | 1 |
| Leg pain (muscular) | 1 | 1 | 0 | 0 | 1 | 1 |
| Leg pain (site of injection) | 0 | 0 | 1 | 1 | 1 | 1 |
| Loose stools | 0 | 0 | 1 | 1 | 1 | 1 |
| Low iron level | 0 | 0 | 1 | 1 | 1 | 1 |
| Nausea | 5 | 1 | 1 | 1 | 6 | 2 |
| Nightmares | 1 | 1 | 1 | 1 | 2 | 2 |
| Pain (groups and legs) | 1 | 1 | 0 | 0 | 1 | 1 |
| Pain in group (site of injection) | 0 | 0 | 1 | 1 | 1 | 1 |
| Paronychia | 1 | 1 | 0 | 0 | 1 | 1 |
| Pneumonia | 0 | 0 | 1 | 1 | 1 | 1 |
| Pruritus | 0 | 0 | 2 | 1 | 2 | 1 |
| Pustules | 0 | 0 | 2 | 2 | 2 | 2 |
| Pyrexia | 1 | 1 | 1 | 1 | 2 | 2 |
| Rash | 0 | 0 | 2 | 2 | 2 | 2 |
| Runny nose | 0 | 0 | 3 | 2 | 3 | 2 |
| Secondary suture of wound | 0 | 0 | 1 | 1 | 1 | 1 |
| Shaking | 0 | 0 | 1 | 1 | 1 | 1 |
| Skin infection | 3 | 3 | 5 | 3 | 8 | 6 |
| Skin peeling | 1 | 1 | 0 | 0 | 1 | 1 |
| Skin thinning (steroid use on arms) | 0 | 0 | 1 | 1 | 1 | 1 |
| Sore feet | 0 | 0 | 1 | 1 | 1 | 1 |
| Sore throat | 1 | 1 | 0 | 0 | 1 | 1 |
| Stomach ache | 6 | 4 | 2 | 2 | 8 | 6 |
| Swelling to ear | 0 | 0 | 1 | 1 | 1 | 1 |
| Swollen ankles | 0 | 0 | 1 | 1 | 1 | 1 |
| Thirsty | 1 | 1 | 1 | 1 | 2 | 2 |
| Tightness in chest | 1 | 1 | 0 | 0 | 1 | 1 |
| Toothache | 1 | 1 | 0 | 0 | 1 | 1 |
| Unwell | 0 | 0 | 1 | 1 | 1 | 1 |
| Upper respiratory tract infection | 9 | 6 | 13 | 10 | 22 | 16 |
| Urticaria | 7 | 3 | 1 | 1 | 8 | 4 |
| Viral infection | 7 | 4 | 2 | 2 | 9 | 6 |
| Vitamin D deficiency | 1 | 1 | 1 | 1 | 2 | 2 |
| Vomiting | 1 | 1 | 3 | 3 | 4 | 4 |
| Wheeze | 4 | 3 | 4 | 3 | 8 | 6 |
| Total | 153 | 29 | 202 | 32 | 355 | 61 |
Adapted from Chan et al.81 Adapted with permission from JAMA Pediatrics. 2020. 174(1): 29–37. Copyright © (2020) American Medical Association. All rights reserved.
