Table 6—

Nonfatal asthma-related serious adverse events (SAEs)# by daily dose of formoterol (overall data set)

Daily dose of formoterolPatients nMean duration daysPatients reporting SAEs n (%)
9 μg+530621857 (1.07)
18 μg1592313192 (0.58)
36 μg9092394 (0.44)
As-needed use/adjustable dosing27768185221 (0.80)
Total§49906173374 (0.75)
  • #: defined using International Conference on Harmonisation recommendations; : at least one asthma-related nonfatal SAE per patient; +: includes children who received 80/4.5 μg budesonide/formoterol once daily plus terbutaline as needed in trial SD-039-0673; §: all trials combined.