Table 4.

Capture and Assessment of Pneumonia in the TRILOGY, KRONOS, FULFIL, TRIBUTE, ETHOS, and IMPACT Trials

Pneumonia Capture and Assessment	TRILOGY25	KRONOS20	FULFIL21,87	TRIBUTE23	ETHOS24	IMPACT22,89
Assessment method	NR	According to a clinical diagnosis of pneumonia by the investigator and confirmatory radiography within 14 days of diagnosis and treatment with antibiotics and at least two clinical signs, symptoms, or laboratory findingsa	A diagnosis of pneumonia was assigned according to the clinical judgement of the investigator. All suspected pneumonias were required to be confirmed by the presence of new infiltrate(s) on chest imaging and at least two signs or symptomsa	In cases of clinical features suggesting a diagnosis of pneumonia, investigators were asked to undertake, whenever possible, further investigations based on their clinical experience and judgement; over 80% of pneumonia cases were diagnosed based on medical imaging	According to a clinical diagnosis of pneumonia by the investigator and confirmatory radiography within 14 days of diagnosis and treatment with antibiotics and increased respiratory symptomsa	A diagnosis of pneumonia was assigned according to the clinical judgement of the investigator. All suspected pneumonias were required to be confirmed by the presence of new infiltrate(s) on chest imaging and at least two signs or symptomsa
Capture and analysis/presentation method	Events reported as AEs, according to MedDRA v16.0 preferred terms: pneumonia, bronchopneumonia, and pneumonia aspiration	Events reported as AEs	Events reported as AEs and analyzed/presented as AESIs (according to a selection of 69 MedDRA preferred terms)	Events reported as AEs, according to MedDRA v18.0 preferred terms: pneumonia, bronchopneumonia, lobar pneumonia, pneumonia bacterial, pneumonia streptococcal, pneumonia viral, and interstitial lung diseaseb	Events reported as AEs	Events reported as AEs and analyzed/presented as AESIs (according to a selection of MedDRA preferred terms)
Adjudication	No	All AEs reported as pneumonia were reviewed by an independent clinical endpoint committee	All SAEs were adjudicated by an independent clinical endpoint committee	No	All AEs reported as pneumonia were reviewed by an independent clinical endpoint committee	All SAEs were adjudicated by an independent adjudication committee blinded to treatment assignment

Notes: AESIs/serious AESIs were defined as AEs/SAEs that are pharmacologically related to the use of ICS, LAMA, or LABA. ^aIncreased cough, increased sputum purulence or production, adventitious breath sounds on auscultation, dyspnea or tachypnoea, fever, elevated white blood cell counts, hypoxemia; ^bin addition, one event of pulmonary tuberculosis was considered, since the investigator reported that this was a tuberculous pneumonia; other events belonging to the pulmonary tuberculosis preferred term were not considered.

Abbreviations: AE, adverse event; AESI, adverse event of special interest; COPD, chronic obstructive pulmonary disease; ICS, inhaled corticosteroid; LABA, long-acting β₂-agonist; LAMA, long-acting muscarinic antagonist; MedDRA, Medical Dictionary for Regulatory Activities; NR, not reported; SAE, serious adverse event.