Table 4.
Treatment Course and Toxicity
| Treatment and Toxicity | Uganda (n = 21) | Kenya (n = 28) | Total (n = 49) |
|---|---|---|---|
| Total No. of cycles of therapy | 32.5 | 47 | 79.5 |
| Median per patient | 2 | 2 | 2 |
| Range per patient | 0.5-2.0 | 0.5-2.0 | 0.5-2.0 |
| Toxicity, No. of patients | |||
| Grade 3 diarrhea/dehydration | 1 | 2 | 3 |
| Grade 3 infection (OI)* | 4 | 0 | 4 |
| Grade 3 neutropenia | 6 | 2 | 8 |
| Grade 4 dehydration | 1 | 0 | 1 |
| Grade 3/4 febrile neutropenia | 3 | 1 | 4 |
| Grade 4 ANC/thrombocytopenia | 3 | 4 | 7 |
| Toxicity (grade 5, death), No. of patients | |||
| Treatment related | 2 | 1 | 3 |
| Not treatment related† | 1 | 4 | 5 |
Abbreviations: OI, opportunistic infection; ANC, absolute neutrophil count.
*
The four grade 3 infections included two cryptococcal meningitis, one Pneumocystis pneumonia, and one tuberculosis.
†
The five other causes of death on study that were not considered treatment-related included progressive lymphoma in two patients, progressive AIDS in two patients, and undetermined cause in one patient with no associated myelosuppression.