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. Author manuscript; available in PMC: 2017 Jul 1.
Published in final edited form as: Ann Thorac Surg. 2016 Apr 19;102(1):239–246. doi: 10.1016/j.athoracsur.2016.01.063

Table 1.

Entry criteria for enrollment in ACOSOG Z4032. Patients must have either one major or two minor criteria.

Major Criteria SR**
(N=114)
SRB**
(N=108)

  1. FEV1 ≤ 50% predicted 67 (58.8%) 49 (45.4%)
  2. DLCO ≤ 50% predicted 72 (63.2%) 74 (68.5%)

Minor Criteria

  1. Age ≥75 43 (37.7%) 42 (38.9%)
  2. FEV1 51–60% predicted 18 (15.8%) 25 (23.1%)
  3. DLCO 51–60% predicted 19 (16.7%) 19 (17.6%)
  4. Pulmonary hypertension (defined as a pulmonary
      artery systolic pressure greater than
      40mmHg) as estimated by echocardiography or right
      heart catheterization
4 (3.5%) 1 (0.9%)
  5. Poor left ventricular function (defined as an ejection
      fraction of 40% or less)
9 (7.9%) 3 (2.8%)
  6. Resting or Exercise Arterial pO2 ≤ 55 mm Hg or
      SpO2 ≤ 88%
5 (4.4%) 6 (5.6%)
  7. pCO2 > 45 mm Hg 3 (2.6%) 3 (2.8%)
  8. Modified Medical Research Council (MMRC)
      Dyspnea Scale ≥ 3.
31 (27.2%) 17 (15.7%)
**

One patient may have multiple criteria; all randomized non-excluded patients