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Table 1 Patient data for life-years gained analysis

From: Long-term clinical outcomes following treatment with alpha 1-proteinase inhibitor for COPD associated with alpha-1 antitrypsin deficiency: a look at the evidence

Subject

Treatment Arm

Last AE term

Reason for discharge

Age at randomization

Sex

Baseline FEV1 % predicted

Baseline lung density (g/L)

Last measured lung density (g/L)

Time from the study start date to last measured lung density (years)

RAPID-RCT

1

Placebo

Chest infection

Lung transplantation

57

M

44.9

6.5

3.5

0.40

2

A1-PI

Dyspnea

Withdrawal by patient

50

F

26.7

14.3

12.5

1.11

3

Placebo

Pulmonary infiltration

Withdrawal by patient

56

M

34.5

31.3

29.4

1.11

4

A1-PI

Severe respiratory insufficiency

Death

58

F

35.3

25.1

25.1

0.00

5

A1-PI

UTI

Lung transplantation

55

M

62.6

22.8

24.3

0.25

RAPID-OLE

6

A1-PI (Early-Start)

Cross reactivity to birch allergy

Death

56

M

40.2

35.1

25.7

2.99

7

A1-PI (Delayed-Start)

Mycobacteria infection

Lung transplantation

48

F

33.0

32.7

23.2

3.94

  1. A 1 -PI alpha 1-proteinase inhibitor, AE adverse event, F female, FEV 1 forced expiratory volume in one second, M male, RAPID-OLE 2-year open-label RAPID Extension trial, RAPID-RCT 2-year, placebo-controlled RAPID trial, UTI urinary tract infection