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) | |