Table 3.
Reported adverse events within the two study groups
|
Group II (placebo) (n = 32) |
Group I (ALA) (n = 32) |
p value | |||
|---|---|---|---|---|---|
| No | % | No | % | ||
| Nausea | 2 | 6.3 | 2 | 6.3 | 1.00 |
| Abdominal pain | 1 | 3.1 | 2 | 6.3 | 0.554 |
| Dizziness | 3 | 9.4 | 2 | 6.3 | 0.641 |
| Headache | 2 | 6.3 | 3 | 9.4 | 0.641 |
| Grade 1 & 2 neutropenia | 6 | 18.8 | 7 | 21.9 | 0.756 |
| Grade 1 & 2 leukopenia | 11 | 34.4 | 9 | 28.1 | 0.590 |
| Infection | 5 | 15.6 | 3 | 9.4 | 0.450 |
| Grade 1 fatigue | 27 | 84.4 | 24 | 75.1 | 0.351 |
| Grade 2 and 3 fatigue | 2 | 6.3 | 0 | 0 | 0.151 |
Data are presented as number and percent
Data were analyzed by chi-square test
Significance level was set at p < 0.05
Grade 1 neutropenia (neutrophils count: 2000–1500/mm3); grade 2 neutropenia (neutrophils count: 1000– < 1500/mm3); grade 1 leukopenia (WBCS count: < 4000–3000/mm3); grade 2 leukopenia (WBCS count: < 3000–2000/mm3); grade 1 fatigue (fatigue relieved by rest); grade 2 fatigue (fatigue not relieved by rest and limits instrumental activity); grade 3 fatigue (fatigue not relieved by rest and limits self-care activity)
GIT gastrointestinal tract