Table 1.
Poisson regression model showing adjusted and unadjusted associations between identified factors and first paradoxical reactions rates
| Number (%) in cohort | Number (%) experiencing a PR |
Follow-up (years) |
Rate per 100 person-years (95% CI) | Crude rate ratio (95% CI) | p-value* | Adjusted rate ratio (95% CI) | p-value# | |
|---|---|---|---|---|---|---|---|---|
| Sex | ||||||||
| Male |
86 (55.1) |
15 (17.4) |
72.5 |
20.7 (12.5,34.3) |
1 |
0.26 |
1 |
0.64 |
| Female |
70 (44.9) |
17 (24.3) |
55.0 |
30.8 (19.1,49.5) |
1.48 (0.74,2.98) |
0.83 (0.38,1.81) |
||
| Age (years) | ||||||||
| 0-<15 |
13 (8.3) |
3 (23.1) |
9.9 |
30.4 (9.8,94.2) |
2.94 (0.74,11.76) |
0.01 |
2.77 (0.67,11.38) |
0.16 |
| 15-<60 |
62 (39.7) |
6 (9.7) |
58.1 |
10.3 (4.6,23.0) |
1 |
1 |
|
|
| ≥60 |
81 (51.9) |
23 (28.4) |
59.8 |
38.4 (25.5,57.9) |
3.72 (1.51,9.14) |
2.84 (1.12,7.17) |
0.03 |
|
| Lesion type | ||||||||
| Ulcer |
137 (87.8) |
24 (17.5) |
116.0 |
20.7 (13.9,30.9) |
1 |
0.03 |
1 |
|
| Nodule |
10 (6.4) |
4 (40.0) |
6.3 |
63.3 (23.7,168.6) |
3.06 (1.06,8.81) |
1.98 (0.57,6.91) |
0.29 |
|
| Oedematous |
9 (5.8) |
4 (44.4) |
5.4 |
73.9 (27.7,196.8) |
3.57 (1.24,10.29) |
3.44 (1.11,10.70) |
0.03 |
|
| Lesion site | ||||||||
| Upper limb |
55 (35.3) |
11 (20.0) |
44.7 |
24.6 (13.9,44.4) |
1 |
|
|
|
| Lower limb |
99 (63.5) |
21 (21.2) |
80.3 |
25.9 (16.9,39.7) |
1.05 (0.51,2.18) |
0.60 |
- |
- |
| Torso |
2 (1.3) |
0 (0.0) |
- |
- |
- |
|
|
|
| Lesion position | ||||||||
| Proximal |
16 (10.3) |
2 (12.5) |
14.2 |
14.1 (3.5,56.5) |
1 |
0.35 |
- |
- |
| Distal |
140 (89.7) |
30 (21.3) |
113.6 |
26.4 (18.5, 37.8) |
1.87 ( 0.45,7.82) |
|
|
|
| Over a joint | ||||||||
| No |
91 (58.3) |
17 (18.7) |
76.2 |
22.5 (13.9,35.9) |
1 |
0.45 |
- |
- |
| Yes |
65 (41.7) |
15 (23.1) |
51.5 |
29.1 (17.6,48.3) |
1.31 (0.65,2.61) |
|
|
|
| Positive margins | ||||||||
| No |
36 (32.7) |
4 (11.0) |
32.5 |
12.3 (4.6,32.8) |
1 |
0.03 |
- |
- |
| Yes |
74 (67.3) |
20 (27.0) |
56.5 |
35.4 (22.8,54.8) |
2.87 (0.98,8.41) |
|||
| Any excision | ||||||||
| No |
42 (27.0) |
6 (14.3) |
36.5 |
16.5 (7.4, 36.6) |
1 |
0.20 |
- |
- |
| Yes |
114 (73.0) |
26 (22.8) |
91.3 |
28.5 (19.4,41.8) |
1.72 (0.71,4.20) |
|||
| Major excision | ||||||||
| No |
82 (52.6) |
11 (13.4) |
71.9 |
15.3 (8.5,27.6) |
1 |
0.01 |
1 |
0.14 |
| Yes |
74 (47.4) |
21 (28.4) |
55.9 |
37.6 (24.5,57.6) |
2.45 (1.18,5.09) |
1.78 (0.82,3.87) |
||
| Diabetes | ||||||||
| No |
143 (91.7) |
27 (18.9) |
118.9 |
22.7 (15.6,33.1) |
1 |
0.09 |
1 |
0.77 |
| Yes |
13 (8.3) |
5 (38.5) |
8.8 |
56.7 (23.6,136.2) |
2.50 (0.96,6.49) |
1.19 (0.37,3.89) |
||
| Immune suppression | ||||||||
| No |
145 (93.0) |
28 (19.3) |
120.0 |
23.3 (16.1,33.8) |
1 |
0.18 |
- |
- |
| Yes |
11 (7.1) |
4 (36.4) |
7.7 |
51.7 (19.4,137.6) |
2.21 (0.78,6.31) |
|||
| Rifampicin | ||||||||
| No |
9 (5.8) |
2 (22.2) |
7.4 |
26.9 (6.7,107.5) |
1 |
0.92 |
- |
- |
| Yes |
147 (94.2) |
30 (20.4) |
120.3 |
24.9 (17.4,35.7) |
0.93 (0.22,3.88) |
|||
| Ciprofloxacin | ||||||||
| No |
55 (35.3) |
13 (23.6) |
43.5 |
29.9 (17.4,51.5) |
1 |
0.44 |
- |
- |
| Yes |
101 (64.7) |
19 (18.8) |
84.3 |
22.5 (14.5,35.7) |
0.75 (0.37,1.53) |
|||
| Clarithromycin | ||||||||
| No |
108 (69.2) |
24 (22.2) |
87.1 |
27.6 (18.5,41.1) |
1 |
0.40 |
- |
- |
| Yes |
48 (30.8) |
8 (16.7) |
40.7 |
19.7 (9.8,39.3) |
0.71 (0.32,1.59) |
|||
| Ethambutol | ||||||||
| No |
145 (93.0) |
28 (19.3) |
120.1 |
23.3 (16.1,33.8) |
1 |
0.17 |
- |
- |
| Yes |
11 (7.1) |
4 (36.4) |
7.6 |
52.3 (19.6,139.5) |
2.25 (0.79,6.40) |
|||
| Amikacin | ||||||||
| No |
151 (96.8) |
28 (18.5) |
126.0 |
22.2 (15.3,32.2) |
1 |
<0.001 |
1 |
<0.01 |
| Yes |
5 (3.2) |
4 (80.0) |
1.8 |
228.6 (85.8,609.2) |
10.29 (3.61,29.33) |
6.33 (2.09,19.18) |
||
| Moxifloxacin | ||||||||
| No |
151 (96.8) |
30 (19.9) |
124.6 |
24.1 (16.8,34.4) |
1 |
|
- |
|
| Yes | 5 (3.2) | 2 (40.0) | 3.1 | 64.0 (16.0,255.8) | 2.66 (0.64,11.12) | 0.24 | - | |
CI confidence interval, PR paradoxical reaction, *likelihood ratio test, #Wald test.