Table 3.

Overview of all severe treatment-related AEs and treatment-related SAEs reported by subjects on 12 SQ-HDM in the 2 trials

Trial	Dose	MedDRA preferred term	Action taken to intervention medication	Day of onset	Duration, days
Severe treatment-related AEs
MT-04	12 SQ-HDM	Submaxillary gland enlargement	Discontinued	8	2
MT-04	12 SQ-HDM	Mouth oedema	Discontinued	2	5
MT-04	12 SQ-HDM	Tongue oedema	Discontinued	38	37
MT-04	12 SQ-HDM	Oral pruritus	Discontinued	38	NR
MT-04	12 SQ-HDM	Dysphagia	Interrupted	1	153
MT-04	12 SQ-HDM	Asthma	Discontinued	257	16
MT-06	12 SQ-HDM	Throat irritation	Discontinued	1	83
MT-06	12 SQ-HDM	Mouth oedema	Discontinued	15	11
MT-06	12 SQ-HDM	Oral pain	Discontinued	15	11
MT-06	12 SQ-HDM	Lip oedema	None	274	1
MT-06	12 SQ-HDM	Throat irritation	None	1	1
MT-06	12 SQ-HDM	Oral pruritus	None	1	1
Treatment-related SAEsa
MT-04	12 SQ-HDM	Asthma exacerbation (moderate)	Discontinued	1	79

AE, adverse event; SAE, serious adverse event; MedDRA, Medical Dictionary for Regulatory Activities; NR, not recovered.

^aAssessed as serious by investigator or sponsor.