Table 9.

Comparison of adverse events by treatment groups in the Modified ITT population

Adverse event	Steroid + Azithromycin N = 105 n (Incidence %)	Azithromycin N = 100 n (Incidence %)	Lopinavir/Ritonavir N = 110 n (Incidence %)	Total N = 315 n (Incidence %)	P-value
Treatment group
Anaphylaxis	1 (0.95)	0 (0)	2 (1.82)	3 (0.95)	0.399
Erythema	1 (0.95)	0 (0)	1 (0.91)	2 (0.63)
Itching	1 (0.95)	0 (0)	1 (0.91)	2 (0.63)
Bronchospasm	0 (0)	0 (0)	1 (0.91)	1 (0.32)
Nausea	0 (0)	0 (0)	1 (0.91)	1 (0.32)
Wheezing	0 (0)	0 (0)	1 (0.91)	1 (0.32)
Vomiting	0 (0)	0 (0)	1 (0.91)	1 (0.32)
Gastrointestinal	11 (10.48)	7 (7)	15 (13.64)	33 (10.48)	0.292
Anorexia	1 (0.95)	1 (1)	3 (2.73)	5 (1.59)
Nausea	4 (3.81)	2 (2)	7 (6.36)	13 (4.13)
Vomiting	0 (0)	1 (1)	3 (2.73)	4 (1.27)
Diarrhea	3 (2.86)	3 (3)	10 (9.09)	16 (5.08)
Abdominal pain	3 (2.86)	1 (1)	5 (4.55)	9 (2.86)
Dry mouth	1 (0.95)	1 (1)	2 (1.82)	4 (1.27)
Neurologic	3 (2.86)	3 (3)	3 (2.73)	9 (2.86)	0.993
Fatigue	1 (0.95)	0 (0)	0 (0)	1 (0.32)
Headache	1 (0.95)	1 (1)	3 (2.73)	5 (1.59)
Unbalanced	0 (0)	1 (1)	0 (0)	1 (0.32)
Ophtalmic	0 (0)	0 (0)	1 (0.91)	1 (0.32)	0.393
Endocrinologic	0 (0)	0 (0)	0 (0)	0 (0)	N/A
Cardiac	0 (0)	0 (0)	1 (0.91)	1 (0.32)	0.393
Cardiomyopathic	0 (0)	0 (0)	1 (0.91)	1 (0.32)
Hematologic	2 (1.9)	0 (0)	0 (0)	2 (0.63)	0.134
Leukopenia	1 (0.95)	0 (0)	0 (0)	1 (0.32)
Anemia	1 (0.95)	0 (0)	0 (0)	1 (0.32)
Respiratoric	5 (4.76)	3 (3)	2 (1.82)	10 (3.17)	0.466
Dyspnea	3 (2.86)	2 (2)	2 (1.82)	7 (2.22)
Coughing	4 (3.81)	1 (1)	1 (0.91)	6 (1.9)
Dermatologic	0 (0)	0 (0)	2 (1.82)	2 (0.63)	0.153
Skin rash	0 (0)	0 (0)	1 (0.91)	1 (0.32)
Nephrologic	0 (0)	1 (1)	3 (2.73)	4 (1.27)	0.195
Enuresis	0 (0)	1 (1)	0 (0)	1 (0.32)
Polyuria	0 (0)	1 (1)	1 (0.91)	2 (0.63)