Demographics and baseline characteristics of the analyzed and excluded population.
| Baseline characteristics | Trial population | ||
| Primary analysis population N = 86 | Population not analyzed N = 113 | Total N = 199 | |
| Mean (SD) | Mean (SD) | Mean(SD) | |
| Age (years) | 39.0 (13.8) | 36.8 (14.3) | 37. (14.1) |
| SES-CD score | 6.0 (4.9) | 4.9 (3.4) | 5.5 (4.3) |
| MRE score | 6.4 (1.7) | 5.9 (2.2) | 6.3 (1.8) |
| C-reactive protein (mg/l) | 10.9 (13.0) | 12.2 (14.8) | 11.6 (14.0) |
| EQ-5D-5L | 0.8 (0.2) | 0.8 (0.2) | 0.8 (0.2) |
| CUCQ-8 | 32.5 (22.1) | 37.2 (24.2) | 35.1 (23.4) |
| IBD-Control-8 | 8.3 (3.3) | 8.5 (3.3) | 8.4 (3.3) |
| Fecal calprotectin (μg/g) | 140.9 (164.1) | 209.9 (355.4) | 166.6 (253.0) |
| n (%) | n (%) | n (%) | |
| Smoking Status | |||
| Non-smoker | 39 (45.35) | 59 (52.21) | 98 (49.25) |
| Current smoker | 13 (15.12) | 17 (15.04) | 30 (15.08) |
| Ex-smoker | 13 (15.12) | 18 (15.93) | 31 (15.58) |
| Missing | 21 (24.42) | 19 (16.81) | 40 (20.10) |
| Previous bowel surgery | |||
| No surgery | 57 (66.28) | 69 (61.06) | 126 (63.32) |
| Single surgery | 17 (19.77) | 26 (23.01) | 43 (21.61) |
| Multiple surgeries | 12 (13.95) | 18 (15.93) | 30 (15.08) |
| History of biological therapy | |||
| No | 70 (81.40) | 105 (92.92) | 175 (87.94) |
| Yes | 16 (18.60) | 8 (7.08) | 24 (12.06) |
| Age at diagnosis (years) | |||
| A1 (<= 16) | 6 (6.98) | 16 (14.16) | 22 (11.06) |
| A2 (17–40) | 65 (75.58) | 77 (68.14) | 142 (71.36) |
| A3 (> 40) | 15 (17.44) | 18 (15.93) | 33 (16.58) |
| Missing | 0 (0) | 2 (1.77) | 2 (1.01) |
| L1 (ileal) | |||
| No | 22 (25.58) | 27 (23.89) | 49 (24.62) |
| Yes | 59 (68.60) | 70 (61.95) | 129 (64.82) |
| Missing | 5 (5.81) | 16 (14.16) | 21 (10.55) |
| L2 (colonic) | |||
| No | 61 (70.93) | 70 (61.95) | 131 (65.83) |
| Yesa | 1 (1.16) | 1 (0.88) | 2 (1.01) |
| Missing | 24 (27.91) | 42 (37.17) | 66 (33.17) |
| L3 (ileocolonic) | |||
| No | 39 (45.35) | 44 (38.94) | 83 (41.71) |
| Yes | 28 (32.56) | 40 (35.40) | 68 (34.17) |
| Missing | 19 (22.09) | 29 (25.66) | 48 (24.12) |
| L4 (upper digestive modifier) | |||
| No | 61 (70.93) | 69 (61.06) | 130 (65.33) |
| Yes | 0 (0) | 2 (1.77) | 2 (1.01) |
| Missing | 25 (29.07) | 42 (37.17) | 67 (33.67) |
| Behavior | |||
| B1 (non-stricturing, non-penetration) | 45 (52.33) | 55 (48.67) | 100 (50.25) |
| B2 (stricturing) | 29 (33.72) | 39 (34.51) | 68 (34.17) |
| B3 (penetrating) | 11 (12.79) | 10 (8.85) | 21 (10.55) |
| Missing | 1 (1.16) | 9 (7.96) | 10 (5.03) |
| Perianal disease modifier (p) | |||
| No | 79 (91.86) | 95 (84.07) | 174 (87.44) |
| Yes | 6 (6.98) | 6 (5.31) | 12 (6.03) |
| Missing | 1 (1.16) | 12 (10.62) | 13 (6.53) |
| Baseline characteristics | Trial population | ||
| Primary analysis population N = 86 | Population not analyzed N = 113 | Total N = 199 | |
| Mean (SD) | Mean (SD) | Mean(SD) | |
| Age (years) | 39.0 (13.8) | 36.8 (14.3) | 37. (14.1) |
| SES-CD score | 6.0 (4.9) | 4.9 (3.4) | 5.5 (4.3) |
| MRE score | 6.4 (1.7) | 5.9 (2.2) | 6.3 (1.8) |
| C-reactive protein (mg/l) | 10.9 (13.0) | 12.2 (14.8) | 11.6 (14.0) |
| EQ-5D-5L | 0.8 (0.2) | 0.8 (0.2) | 0.8 (0.2) |
| CUCQ-8 | 32.5 (22.1) | 37.2 (24.2) | 35.1 (23.4) |
| IBD-Control-8 | 8.3 (3.3) | 8.5 (3.3) | 8.4 (3.3) |
| Fecal calprotectin (μg/g) | 140.9 (164.1) | 209.9 (355.4) | 166.6 (253.0) |
| n (%) | n (%) | n (%) | |
| Smoking Status | |||
| Non-smoker | 39 (45.35) | 59 (52.21) | 98 (49.25) |
| Current smoker | 13 (15.12) | 17 (15.04) | 30 (15.08) |
| Ex-smoker | 13 (15.12) | 18 (15.93) | 31 (15.58) |
| Missing | 21 (24.42) | 19 (16.81) | 40 (20.10) |
| Previous bowel surgery | |||
| No surgery | 57 (66.28) | 69 (61.06) | 126 (63.32) |
| Single surgery | 17 (19.77) | 26 (23.01) | 43 (21.61) |
| Multiple surgeries | 12 (13.95) | 18 (15.93) | 30 (15.08) |
| History of biological therapy | |||
| No | 70 (81.40) | 105 (92.92) | 175 (87.94) |
| Yes | 16 (18.60) | 8 (7.08) | 24 (12.06) |
| Age at diagnosis (years) | |||
| A1 (<= 16) | 6 (6.98) | 16 (14.16) | 22 (11.06) |
| A2 (17–40) | 65 (75.58) | 77 (68.14) | 142 (71.36) |
| A3 (> 40) | 15 (17.44) | 18 (15.93) | 33 (16.58) |
| Missing | 0 (0) | 2 (1.77) | 2 (1.01) |
| L1 (ileal) | |||
| No | 22 (25.58) | 27 (23.89) | 49 (24.62) |
| Yes | 59 (68.60) | 70 (61.95) | 129 (64.82) |
| Missing | 5 (5.81) | 16 (14.16) | 21 (10.55) |
| L2 (colonic) | |||
| No | 61 (70.93) | 70 (61.95) | 131 (65.83) |
| Yesa | 1 (1.16) | 1 (0.88) | 2 (1.01) |
| Missing | 24 (27.91) | 42 (37.17) | 66 (33.17) |
| L3 (ileocolonic) | |||
| No | 39 (45.35) | 44 (38.94) | 83 (41.71) |
| Yes | 28 (32.56) | 40 (35.40) | 68 (34.17) |
| Missing | 19 (22.09) | 29 (25.66) | 48 (24.12) |
| L4 (upper digestive modifier) | |||
| No | 61 (70.93) | 69 (61.06) | 130 (65.33) |
| Yes | 0 (0) | 2 (1.77) | 2 (1.01) |
| Missing | 25 (29.07) | 42 (37.17) | 67 (33.67) |
| Behavior | |||
| B1 (non-stricturing, non-penetration) | 45 (52.33) | 55 (48.67) | 100 (50.25) |
| B2 (stricturing) | 29 (33.72) | 39 (34.51) | 68 (34.17) |
| B3 (penetrating) | 11 (12.79) | 10 (8.85) | 21 (10.55) |
| Missing | 1 (1.16) | 9 (7.96) | 10 (5.03) |
| Perianal disease modifier (p) | |||
| No | 79 (91.86) | 95 (84.07) | 174 (87.44) |
| Yes | 6 (6.98) | 6 (5.31) | 12 (6.03) |
| Missing | 1 (1.16) | 12 (10.62) | 13 (6.53) |
aOne participant had been classified as L1 and L2 disease on the site CRF; for the purposes of analysis, this individual was taken to have L3 (ileocolonic) disease.
Demographics and baseline characteristics of the analyzed and excluded population.
| Baseline characteristics | Trial population | ||
| Primary analysis population N = 86 | Population not analyzed N = 113 | Total N = 199 | |
| Mean (SD) | Mean (SD) | Mean(SD) | |
| Age (years) | 39.0 (13.8) | 36.8 (14.3) | 37. (14.1) |
| SES-CD score | 6.0 (4.9) | 4.9 (3.4) | 5.5 (4.3) |
| MRE score | 6.4 (1.7) | 5.9 (2.2) | 6.3 (1.8) |
| C-reactive protein (mg/l) | 10.9 (13.0) | 12.2 (14.8) | 11.6 (14.0) |
| EQ-5D-5L | 0.8 (0.2) | 0.8 (0.2) | 0.8 (0.2) |
| CUCQ-8 | 32.5 (22.1) | 37.2 (24.2) | 35.1 (23.4) |
| IBD-Control-8 | 8.3 (3.3) | 8.5 (3.3) | 8.4 (3.3) |
| Fecal calprotectin (μg/g) | 140.9 (164.1) | 209.9 (355.4) | 166.6 (253.0) |
| n (%) | n (%) | n (%) | |
| Smoking Status | |||
| Non-smoker | 39 (45.35) | 59 (52.21) | 98 (49.25) |
| Current smoker | 13 (15.12) | 17 (15.04) | 30 (15.08) |
| Ex-smoker | 13 (15.12) | 18 (15.93) | 31 (15.58) |
| Missing | 21 (24.42) | 19 (16.81) | 40 (20.10) |
| Previous bowel surgery | |||
| No surgery | 57 (66.28) | 69 (61.06) | 126 (63.32) |
| Single surgery | 17 (19.77) | 26 (23.01) | 43 (21.61) |
| Multiple surgeries | 12 (13.95) | 18 (15.93) | 30 (15.08) |
| History of biological therapy | |||
| No | 70 (81.40) | 105 (92.92) | 175 (87.94) |
| Yes | 16 (18.60) | 8 (7.08) | 24 (12.06) |
| Age at diagnosis (years) | |||
| A1 (<= 16) | 6 (6.98) | 16 (14.16) | 22 (11.06) |
| A2 (17–40) | 65 (75.58) | 77 (68.14) | 142 (71.36) |
| A3 (> 40) | 15 (17.44) | 18 (15.93) | 33 (16.58) |
| Missing | 0 (0) | 2 (1.77) | 2 (1.01) |
| L1 (ileal) | |||
| No | 22 (25.58) | 27 (23.89) | 49 (24.62) |
| Yes | 59 (68.60) | 70 (61.95) | 129 (64.82) |
| Missing | 5 (5.81) | 16 (14.16) | 21 (10.55) |
| L2 (colonic) | |||
| No | 61 (70.93) | 70 (61.95) | 131 (65.83) |
| Yesa | 1 (1.16) | 1 (0.88) | 2 (1.01) |
| Missing | 24 (27.91) | 42 (37.17) | 66 (33.17) |
| L3 (ileocolonic) | |||
| No | 39 (45.35) | 44 (38.94) | 83 (41.71) |
| Yes | 28 (32.56) | 40 (35.40) | 68 (34.17) |
| Missing | 19 (22.09) | 29 (25.66) | 48 (24.12) |
| L4 (upper digestive modifier) | |||
| No | 61 (70.93) | 69 (61.06) | 130 (65.33) |
| Yes | 0 (0) | 2 (1.77) | 2 (1.01) |
| Missing | 25 (29.07) | 42 (37.17) | 67 (33.67) |
| Behavior | |||
| B1 (non-stricturing, non-penetration) | 45 (52.33) | 55 (48.67) | 100 (50.25) |
| B2 (stricturing) | 29 (33.72) | 39 (34.51) | 68 (34.17) |
| B3 (penetrating) | 11 (12.79) | 10 (8.85) | 21 (10.55) |
| Missing | 1 (1.16) | 9 (7.96) | 10 (5.03) |
| Perianal disease modifier (p) | |||
| No | 79 (91.86) | 95 (84.07) | 174 (87.44) |
| Yes | 6 (6.98) | 6 (5.31) | 12 (6.03) |
| Missing | 1 (1.16) | 12 (10.62) | 13 (6.53) |
| Baseline characteristics | Trial population | ||
| Primary analysis population N = 86 | Population not analyzed N = 113 | Total N = 199 | |
| Mean (SD) | Mean (SD) | Mean(SD) | |
| Age (years) | 39.0 (13.8) | 36.8 (14.3) | 37. (14.1) |
| SES-CD score | 6.0 (4.9) | 4.9 (3.4) | 5.5 (4.3) |
| MRE score | 6.4 (1.7) | 5.9 (2.2) | 6.3 (1.8) |
| C-reactive protein (mg/l) | 10.9 (13.0) | 12.2 (14.8) | 11.6 (14.0) |
| EQ-5D-5L | 0.8 (0.2) | 0.8 (0.2) | 0.8 (0.2) |
| CUCQ-8 | 32.5 (22.1) | 37.2 (24.2) | 35.1 (23.4) |
| IBD-Control-8 | 8.3 (3.3) | 8.5 (3.3) | 8.4 (3.3) |
| Fecal calprotectin (μg/g) | 140.9 (164.1) | 209.9 (355.4) | 166.6 (253.0) |
| n (%) | n (%) | n (%) | |
| Smoking Status | |||
| Non-smoker | 39 (45.35) | 59 (52.21) | 98 (49.25) |
| Current smoker | 13 (15.12) | 17 (15.04) | 30 (15.08) |
| Ex-smoker | 13 (15.12) | 18 (15.93) | 31 (15.58) |
| Missing | 21 (24.42) | 19 (16.81) | 40 (20.10) |
| Previous bowel surgery | |||
| No surgery | 57 (66.28) | 69 (61.06) | 126 (63.32) |
| Single surgery | 17 (19.77) | 26 (23.01) | 43 (21.61) |
| Multiple surgeries | 12 (13.95) | 18 (15.93) | 30 (15.08) |
| History of biological therapy | |||
| No | 70 (81.40) | 105 (92.92) | 175 (87.94) |
| Yes | 16 (18.60) | 8 (7.08) | 24 (12.06) |
| Age at diagnosis (years) | |||
| A1 (<= 16) | 6 (6.98) | 16 (14.16) | 22 (11.06) |
| A2 (17–40) | 65 (75.58) | 77 (68.14) | 142 (71.36) |
| A3 (> 40) | 15 (17.44) | 18 (15.93) | 33 (16.58) |
| Missing | 0 (0) | 2 (1.77) | 2 (1.01) |
| L1 (ileal) | |||
| No | 22 (25.58) | 27 (23.89) | 49 (24.62) |
| Yes | 59 (68.60) | 70 (61.95) | 129 (64.82) |
| Missing | 5 (5.81) | 16 (14.16) | 21 (10.55) |
| L2 (colonic) | |||
| No | 61 (70.93) | 70 (61.95) | 131 (65.83) |
| Yesa | 1 (1.16) | 1 (0.88) | 2 (1.01) |
| Missing | 24 (27.91) | 42 (37.17) | 66 (33.17) |
| L3 (ileocolonic) | |||
| No | 39 (45.35) | 44 (38.94) | 83 (41.71) |
| Yes | 28 (32.56) | 40 (35.40) | 68 (34.17) |
| Missing | 19 (22.09) | 29 (25.66) | 48 (24.12) |
| L4 (upper digestive modifier) | |||
| No | 61 (70.93) | 69 (61.06) | 130 (65.33) |
| Yes | 0 (0) | 2 (1.77) | 2 (1.01) |
| Missing | 25 (29.07) | 42 (37.17) | 67 (33.67) |
| Behavior | |||
| B1 (non-stricturing, non-penetration) | 45 (52.33) | 55 (48.67) | 100 (50.25) |
| B2 (stricturing) | 29 (33.72) | 39 (34.51) | 68 (34.17) |
| B3 (penetrating) | 11 (12.79) | 10 (8.85) | 21 (10.55) |
| Missing | 1 (1.16) | 9 (7.96) | 10 (5.03) |
| Perianal disease modifier (p) | |||
| No | 79 (91.86) | 95 (84.07) | 174 (87.44) |
| Yes | 6 (6.98) | 6 (5.31) | 12 (6.03) |
| Missing | 1 (1.16) | 12 (10.62) | 13 (6.53) |
aOne participant had been classified as L1 and L2 disease on the site CRF; for the purposes of analysis, this individual was taken to have L3 (ileocolonic) disease.
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