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Table 3 Study arm differences in neurotoxicity (probable depression, cognitive complaint, poor sleep quality, and peripheral neuropathy) by analysis visit week. Values are presented as N/Total N [% (95% CI)] or OR (95% CI)

From: Prevalence of neurotoxicity symptoms among postpartum women on isoniazid preventive therapy and efavirenz-based treatment for HIV: an exploratory objective of the IMPAACT P1078 randomized trial

Analysis Visit

Probable Depressiona

Cognitive Complaintb

Poor Sleep Qualityc

Peripheral Neuropathyd

Immediate INH

Deferred INH

ORe

(95% CI)

Immediate INH

Deferred INH

ORe

(95% CI)

Immediate INH

Deferred INH

ORe

(95% CI)

Immediate INH

Deferred INH

ORe

(95% CI)

AP Visit

0/38

[0 (0, < 0.5)]

0/40

[0 (0, < 0.5)]

-

2/38

[5 (1, 18)]

3/40

[8 (2, 20)]

1.67

(0.26, 10.88)

5/36

[14 (5, 29)]

6/37

[16 (6, 32)]

1.31

(0.35, 4.82)

47/477

[10 (7, 13)]

56/479

[12 (9, 15)]

1.23

(0.81, 1.86)

PP Week 4

0/64

[0 (0, 6)]

2/72

[3 (0, 10)]

-

3/64

[5 (1, 13)]

2/71

[3 (0, 10)]

0.50

(0.08, 3.21)

1/58

[2 (0, 9)]

4/63

[6 (2, 15)]

4.25 (0.46, 39.68)

27/439

[6 (4, 9)]

30/440

[7 (5, 10)]

1.13

(0.66, 1.94)

PP Week 12

2/111

[2 (0, 6)]

3/118

[3 (1, 7)]

1.41

(0.16, 17.12)

6/113

[5 (2, 11)]

13/119

[11 (6, 18)]

2.19

(0.80, 5.97)

8/97

[8 (4, 16)]

11/101

[11 (6, 19)]

1.36

(0.52, 3.54)

53/439

[12 (9, 15)]

60/447

[13 (10, 17)]

1.14

(0.77, 1.71)

PP Week 24

3/186

[2 (0, 5)]

3/192

[2 (0, 4)]

0.97

(0.13, 7.35)

11/186

[6 (3, 10)]

11/193

[6 (3, 10)]

0.96

(0.41, 2.28)

13/159

[8 (4, 14)]

12/163

[7 (4, 13)]

0.89

(0.39, 2.02)

56/415

[13 (10, 17)]

56/426

[13 (10, 17)]

0.97

(0.65, 1.45)

PP Week 36

7/270

[3 (1, 5)]

4/269

[1 (0, 4)]

0.56

(0.12, 2.25)

14/272

[5 (3, 8)]

17/272

[6 (4, 10)]

1.23

(0.59, 2.54)

13/227

[6 (3, 10)]

13/230

[6 (3, 9)]

1.01

(0.46, 2.24)

49/402

[12 (9, 16)]

52/410

[13 (10, 16)]

1.05

(0.69, 1.60)

PP Week 48

3/342

[1 (0, 3)]

2/347

[1 (0, 2)]

0.666

(0.05, 5.76)

10/344

[3 (1, 5)]

19/347

[5 (3, 8)]

1.93

(0.89, 4.22)

11/279

[4 (2, 7)]

21/294

[7 (4, 11)]

1.88

(0.89, 3.98)

38/389

[10 (7, 13)]

33/390

[8 (6, 12)]

0.86

(0.52, 1.40)

  1. Immediate INH Group. Model adjusted for gestational age stratum at baseline did not converge
  2. OR Odds ratio, CI Confidence interval, INH Isoniazid, AP Antepartum, PP Postpartum, PHQ-9 Patient health questionnaire 9, aPSQI Adapted pittsburgh sleep quality index, BPNS Brief peripheral neuropathy screening
  3. aProbable depression was defined as PHQ-9 score ≥ 10
  4. bCognitive complaint was defined as responding “Yes, Definitely” to any of three questions relating to neurocognitive impairment
  5. cPoor sleep quality was defined as aPSQI score ≥ 4
  6. dPeripheral neuropathy was defined as BPNS Grade ≥ 1
  7. eOR represents the ratio of the odds of neurotoxicity in the Deferred INH Group to the Immediate INH Group, adjusted for gestational age stratum at baseline
  8. fOR represents the ratio of the odds of neurotoxicity in the Deferred INH Group to the