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Table 3 Summary of serious adverse events and adverse events of special interest stratified by antiretroviral group

From: Efficacy and safety of dihydroartemisinin–piperaquine for treatment of Plasmodium falciparum uncomplicated malaria in adult patients on antiretroviral therapy in Malawi and Mozambique: an open label non-randomized interventional trial

Type of adverse event

DPQ and efavirenz-based ART regimen

N = 160

DPQ and nevirapine-based ART regimen

N = 61

na (%) [#]b

na (%) [#]b

Serious adverse events (SAEs)

8 (5.0), [10]

2 (3.3), [2]

Adverse event(s) of special interest (AESI)

54 (33.8), [54]

15 (24.6), [15]

 Fridericia corrected QT prolongationc

48 (30.0)

8 (13.1)

 Palpitations

4 (2.5)

2 (3.3)

 Dizziness

2 (1.3)

2 (3.3)

 Urticaria

0

1 (1.6)

 Itchiness

0

1 (1.6)

 Chest pain

0

1 (1.6)

Drug-related adverse events (SAEs)

  

 Not related

7 (4.4), [9]

2 (3.3), [2]

 Possibly related

1 (0.6), [1]

0

 Probably related

0

0

 Definitely related

0

0

Drug-related adverse events (AESI)

  

 Not related

1 (0.6), [1]

4 (6.6) [4]

 Possibly related

5 (3.1), [5]

3 (4.9), [3]

 Probably related

48 (30.0), [48]

8 (13.1), [8]

 Definitely related

0

0

  1. an The number of participants that experienced the event; % is percentage of participants experiencing that event in the intention-to-treat population
  2. b# The total number of events that occurred
  3. cFridericia corrected QT prolongation defined as change in QTc interval of > 60 ms from baseline to day 2 (last day) of antimalarial treatment, also reported separately (in detail) in Table 4