Abstract P169 Table 1

Summary of TEAEsa

Preferred TermNo. of Patients With an EventPatient Incidence
(n = 1058)		Adjusted Rateb,c
No. of EventsRate per Patient-Exposure Year
Most Frequent TEAEs (incidence in ≥20% of patients)
Cough 47739.2%7160.213
Nausea 47138.7%7980.237
IPF 42434.9%6690.199
Dyspnea 41534.1%5730.170
Upper RTI 40533.3%7890.234
Diarrhea 37430.8%6570.195
Fatigue 35929.5%5050.150
Rash 33127.2%5400.160
Bronchitis 32526.7%6240.185
Headache 28123.1%4780.142
Nasopharyngitis 28023.0%5360.159
Dizziness 27622.7%4090.122
Dyspepsia 24320.0%3060.091
Most Frequent Serious TEAEs (incidence in ≥5% of patients)
IPF 26221.5%3200.095
Pneumonia 1139.3%1300.039
TEAEs With Outcome of Death(incidence in ≥1% of patients)
Deaths 27322.5%2730.081
IPF 14812.2%1480.044
Respiratory failure 262.1%260.008
Pneumonia 131.1%130.004

  • IPF, idiopathic pulmonary fibrosis; RTI, respiratory tract infection; TEAE, treatment-emergent adverse event.

    a TEAEs are any events that occurred between the first dose and 28 days after the last dose.

    b 3366 total exposure years.

    c Adjusted rate = total number of events/total exposure years.