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Table 2 Non- immediate AEs by treatment course (n = 4,112)

From: Safety of poly-L-lactic acid (New-Fill®) in the treatment of facial lipoatrophy: a large observational study among HIV-positive patients

 

Incidence1per course

Delay of onset (days)2

Regression of AEs3

Nodule/induration

234

(5.7%)

[5.0 %; 6.4 %]

55 [29 – 91]

62/62 (100%)

Inflammation

27

(0.7%)

[0.4%; 1.0%]

21 [0 – 57]

19/19 (100%)

Granuloma

13

(0.3%)

[0.2%; 0.5%]

101 [69 – 117]

6/13 (46%)

Decolouration

9

(0.2%)

[0.1 %; 0.4%]

92 [11 – 138]

2/2 (100%)

Skin hypertrophy

6

(0.1%)

[0.1%; 0.3%]

84 [40 – 93]

1/1 (100%)

Allergic reactions

3

(0.1%)

[0.0%; 0.2%]

1 [0 – 94]

1/1 (100%)

Skin atrophy

2

(0.0%)

[0.0%; 0.2%]

66 [13 – 119]4

-

  1. 1n (%) [CI 95% exact].
  2. 2Median [Q1 – Q3] (calculated on documented data).
  3. 3n (% calculated on documented data).
  4. 4Reported values for the 2 cases.
  5. A treatment course had a mean of 3.8 injections.