Table 1 Baseline demographic, clinical, disease-related and cough-related information for the patients enrolled in the cough study

From: Pregabalin for chronic cough due to lung cancer: randomized, double-blind, placebo-controlled trial

Characteristic

All patients, in number (%) (n = 166)

Pregabalin arm, in number (%) (n = 83)

Placebo arm, in number (%) (n = 83)

P-value

Age, in years

 Median (IQR)

56 (47–63)

56 (48–63)

56 (46–62)

0.889

 ≥60 years

60 (36.1)

29 (34.9)

31 (37.3)

0.747

Sex

 Male

112 (67.5)

58 (69.9)

54 (65.1)

0.508

 Female

54 (32.5)

25 (30.1)

29 (34.9)

Tobacco use

 None

68 (41.0)

29 (34.9)

39 (47.0)

0.114

 Smoking

65 (39.2)

32 (38.6)

33 (39.8)

0.874

 Smokeless

43 (25.9)

28 (33.7)

15 (18.1)

0.021

Comorbidities

 None

80 (48.2)

45 (54.2)

35 (42.2)

0.120

 Present

86 (51.8)

38 (45.8)

48 (57.8)

ECOG performance statusa

 1

143 (86.1)

70 (84.3)

73 (88.0)

0.500

 2

23 (13.9)

13 (15.7)

10 (12.0)

Extent of disease

 Locally advanced

11 (6.6)

7 (8.4)

4 (4.8)

0.535

 Metastatic

155 (93.4)

76 (91.6)

79 (95.2)

Histopathology

 Adenocarcinoma

121 (72.9)

63 (75.9)

58 (69.9)

0.729

 Squamous

28 (16.9)

12 (14.5)

16 (19.3)

 Otherb

17 (10.2)

8 (19.6)

74 (10.8)

Molecular test report

 No driver alteration

71 (42.8)

38 (45.8)

33 (39.8)

0.290

 EGFR

32 (19.3)

17 (20.5)

15 (18.1)

 ALK

25 (15.1)

11 (13.3)

14 (16.9)

 ERBB2

3 (1.8)

3 (3.6)

0

 Otherc

24 (13.8)

11 (13.2)

13 (14.4)

 Molecular testing not done

12 (7.2)

3 (3.6)

9 (10.8)

Intent of cancer-directed therapy

 Palliative

159 (95.8)

79 (95.2)

80 (96.4)

1.000

 Curative

7 (4.2)

4 (4.8)

3 (3.6)

Dyspnea severity at baseline

 Grade 0

69 (41.6)

34 (41.0)

35 (42.2)

0.763

 Grade 1

68 (41.0)

34 (41.0)

34 (41.0)

 Grade 2

28 (16.9)

13 (15.7)

15 (18.1)

 Grade 3

1 (0.6)

0

1 (1.2)

Cough severity at baseline

 Grade 2

128 (77.1)

66 (79.5)

62 (74.7)

0.460

 Grade 3

38 (22.9)

17 (20.5)

21 (25.3)

Cough duration at presentation, in weeks

 Median (IQR)

12 (6–20)

12 (7–20)

12 (4–20)

0.897

 Range

2–104

2–79

2–104

Number of therapies given for cough, at presentation

 Median (IQR)

1 (1–1)

1 (1–1)

1 (1–1)

0.684

 Range

0–3

0–3

1–3

Cancer-directed therapy started

 Yes

150 (90.4)

78 (94.0)

72 (86.7)

0.187

 No

16 (9.6)

5 (6.0)

11 (13.3)

  1. IQR interquartile range, COPD chronic obstructive pulmonary disease, ECOG Eastern Cooperative Oncology Group, EGFR epidermal growth factor receptor, ALK anaplastic lymphoma kinase, ERBB2 v-erb-b2 avian erythroblastic leukemia viral oncogene homologue 2 [HER2].
  2. aThe ECOG PS is a measure of the patient’s functionality, particularly in terms of their ability to care for themselves, do work, and their physical activities. It is scored from 0 to 5, where 0 indicates that the patient is fully functional and carrying out all activities without any restrictions, 1 indicates that the patient is ambulatory, can carry out light work like basic housework and office work, but is unable to perform physically strenuous work, and 2 indicates a patient who is ambulatory, can carry out all selfcare activities, is up and about more than half the waking hours, but is unable to do any work.
  3. bOther histopathologies- large cell neuroendocrine [2 (2.4), 1 (1.20)], non-small cell lung carcinoma, not otherwise specified [3 (3.6), 5 (6.0)], poorly differentiated carcinoma [2 (2.4), 2 (2.4)], adenosquamous [0, 1 (1.2)], carcinoma with hepatoid differentiation [1 (1.2), 0] in pregabalin and placebo arms, respectively.
  4. cOther molecular test reports – ROS1 [0, 2 (2.4)], MET [0, 1 (1.2)], EGFR exon 20 insertion [2 (2.4), 2 (2.4)], EGFR sensitizing mutation +ALK fusion [1 (1.2), 0], BRAF [3 (3.6), 1 (1.2)], KRAS [5 (6.60), 6 (7.2)] in pregabalin and placebo arms, respectively.
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