Table 2.
Description of drug reactions during eflornithine treatment in 1055 patients with newly diagnosed second stage human African trypanosomiasis. Values are numbers (percentages) of patients unless stated otherwise
| Drug reactions | No of reactions* | Median (range) onset (days) | Onset within 7 days† |
|---|---|---|---|
| Death | 15 (1.4) | 12 (1-23) | 2 (13) |
| Gastrointestinal: | |||
| Diarrhoea (major)‡ | 376 (17) (35.6) | 7 (0-23) | 169 (45) |
| Nausea, vomiting | 162 (15.4) | 5 (0-17) | 93 (57) |
| Anorexia | 22 (2.1) | 8 (0-14) | 9 (41) |
| Neurological: | |||
| Tremor | 140 (13.3) | 5 (1-17) | 87 (62) |
| Dizziness | 93 (8.8) | 6 (0-14) | 54 (58) |
| Seizures (major) | 51 (41) (4.8) | 3 (0-15) | 36 (71) |
| Confusion (major) | 38 (4) (3.6) | 5 (0-14) | 22 (58) |
| Coma (major) | 4 (4) (0.4) | 8 (2-13) | 2 (50) |
| Ataxia | 1 (0.1) | 11 | 0 (0) |
| Cardiovascular: | |||
| Arrhythmia | 12 (1.1) | 9.5 (3-13) | 4 (33) |
| Oedema (major) | 15 (10) (1.4) | 6 (2-14) | 8 (53) |
| Shock (major) | 1 (1) (0.1) | 14 | 0 (0) |
| Dermatological: | |||
| Reaction at injection site (major) | 261 (3) (24.7) | 6 (0-19) | 138 (53) |
| Pruritus | 67 (6.4) | 4 (0-17) | 48 (72) |
| Rash | 6 (0.6) | 12 (5-19) | 1 (17) |
| Infection: | |||
| Tissue infection (major) | 37 (6) (3.5) | 9 (0-19) | 11 (30) |
| Pneumonia (major) | 23 (3) (2.2) | 8 (0-29) | 10 (44) |
| Pain: | |||
| Abdominal pain | 398 (37.7) | 5 (0-22) | 241 (61) |
| Headache (major) | 329 (1) (31.2) | 4 (0-21) | 233 (71) |
| Muscle or joint pain | 91 (8.6) | 6 (0-17) | 52 (57) |
| Chest pain | 48 (4.5) | 5 (0-23) | 32 (67) |
| Other: | |||
| Fever (major) | 325 (67) (30.8) | 5 (0-19) | 200 (62) |
| Cough | 172 (16.3) | 6 (0-16) | 99 (58) |
| Other (major) | 137 (10) (13.0) | 8 (0-22) | 54 (40) |
| Total No of drug reactions | 2824 (2.7)§ | 6 (0-29) | 1605 (57) |
| No of patients with major reactions: | 138 (13.1) | ||
| 1 reaction | 116 (11) | — | — |
| ≥2 reactions | 22 (2) | — | — |
| Total No of major reactions | 167 (0.2)§ | 6 (0-23) | |
| Interruptions to treatment: | 109 (10.3) | ||
| Suspended for <24 hours | 57 (5.4) | — | — |
| Suspended for >24 hours | 42 (4.0) | — | — |
| Treatment stopped | 10 (0.9) | — | — |
*Percentage of entire cohort.
†Percentage of patients with reaction.
‡Grade 3 and 4 of National Cancer Institute common toxicity criteria.
§Incidence of reactions per patient in whole cohort during hospital stay.