How can we optimise inhaled beta2 agonist dose as ‘reliever’ medicine for wheezy pre-school children? Study protocol for a randomised controlled trial

Table 4 Procedure for reporting adverse events during the trial

Type of event^a	Hospital notes	CRF	Expedited reporting (immediately and within 24 h)
Adverse event	Yes	No	No
Adverse reaction	Yes	Yes	No
Serious adverse event	Yes	Yes	Yes
Serious adverse reaction	Yes	Yes	Yes

^aFor definitions see section on Safety reporting (ICH Guideline E2A 1994) in main text

ISSN: 1745-6215