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Table 2 Treatment-emergent AEs and grade 3–4 laboratory abnormalities

From: Cobicistat-boosted darunavir in HIV-1-infected adults: week 48 results of a Phase IIIb, open-label single-arm trial

 

All patients

Treatment-naïve patients

Incidence, [n (%)]

Week 24 analysis

Week 48 analysis

Week 48 analysis

N = 313

N = 313

N = 295

Grade 3–4 AEs

18 (6)

24 (8)

21 (7)

Any AE

275 (88)

286 (91)

270 (92)

Any drug-related AE

123 (39)

128 (41)

122 (41)

Serious AEs

15 (5)

26 (8)

21 (7)

Deaths

0

0

0

AEs any grade, regardless of relationship to study treatment and occurring in ≥10% of patients

Diarrhea

78 (25)

86 (27)

80 (27)

Nausea

67 (21)

72 (23)

69 (23)

Upper respiratory tract infection

31 (10)

44 (14)

43 (15)

Headache

29 (9)

38 (12)

35 (12)

AEs leading to discontinuation*

Any, n

15 (5)

16 (5)

16 (5)

Maculo-papular rash

3 (1)

3 (1)

3 (1)

Rash

3 (1)

3 (1)

3 (1)

Nausea

2 (0.6)

2 (0.6)

2 (0.7)

Hypersensitivity

2 (0.6)

2 (0.6)

2 (0.7)

Idiopathic thrombocytopenic purpura

1 (0.3)

1 (0.3)

1 (0.3)

Dyspepsia

1 (0.3)

1 (0.3)

1 (0.3)

Vomiting

1 (0.3)

1 (0.3)

1 (0.3)

Mycobacterium avium complex infection

1 (0.3)

1 (0.3)

1 (0.3)

Headache

1 (0.3)

1 (0.3)

1 (0.3)

Dysgeusia

1 (0.3)

1 (0.3)

1 (0.3)

Renal tubular disorder

1 (0.3)

1 (0.3)

Allergic dermatitis

1 (0.3)

1 (0.3)

1 (0.3)

Macular rash

1 (0.3)

1 (0.3)

1 (0.3)

Vesicular rash

1 (0.3)

1 (0.3)

1 (0.3)

Treatment-emergent grade 3–4 laboratory abnormalities occurring in ≥2% patients

 

n = 310

n = 310

n = 292

Increased creatine kinase

18 (6)

22 (7)

22 (8)

Increased alanine amino transferase

7 (2)

9 (3)

9 (3)

Increased aspartate amino transferase

6 (2)

8 (3)

7 (2)

Increased amylase

6 (2)

8 (3)

7 (2)

Increased lipase

5 (2)

7 (2)

7 (2)

  1. N number of patients; n number of patients with observations; AE adverse event. Serious AEs included any AE that occurred at any dose that resulted in death, a life-threatening situation, inpatient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of a patient who received investigational medicinal product; *Patients may have discontinued due to more than 1 AE.