Table 7. List of grade 2 or worse adverse events through end of study.
| 1200mg FCZ N = 22 | 1600mg FCZ N = 50 | 2000mg FCZ N = 48 | AMB N = 48 | p | |
|---|---|---|---|---|---|
| Any Grade > = 2 | 22 (100%) | 39 (78%) | 43 (90%) | 36 (75%) | 0.02 |
| Any Neurological | 16 (73%) | 25(50%) | 34 (71%) | 28 (58%) | 0.18 |
| • headaches | 12 (55%) | 22 (44%) | 29 (60%) | 26 (24%) | |
| • worsening level of consciousness/lethargy | 4 (18%) | 1 (2%) | 4 (8%) | 0 (0%) | |
| • confusion/difficulty concentrating | 6 (27%) | 3 (6%) | 8 (17%) | 3 (6%) | |
| Any gastrointestinal* | 6 (27%) | 12 (24%) | 22 (46%) | 13 (27%) | 0.21 |
| • nausea | 1 (5%) | 1 (2%) | 3 (6%) | 2 (4%) | |
| • vomiting | 2 (9%) | 7 (14%) | 15 (31%) | 8 (17%) | |
| Any circulatory/cardiac | 11 (50%) | 17 (34%) | 23 (48%) | 18 (38%) | 0.23 |
| • QTc prolongation | 10 (45%) | 16 (32%) | 21 (44%) | 16 (33%) | |
| Any haematology | 10 (45%) | 24 (48%) | 20 (42%) | 27 (56%) | 0.26 |
| • neutropaenia | 4 (18%) | 16 (32%) | 13 (27%) | 15 (31%) | |
| • anaemia | 7 (32%) | 10 (20%) | 9 (19%) | 22 (46%) | |
| • thrombocytopaenia | 6 (27%) | 6 (12%) | 5 (10%) | 7 (15%) | |
| Any hepatic | 4 (18%) | 7 (14%) | 5 (10%) | 8 (17%) | 0.39 |
| ALT (SGPT)* | 3 (14%) | 5 (10%) | 4 (8%) | 3 (6%) | |
| Renal (creatinine) | 4 (18%) | 5 (10%) | 5 (10%) | 14 (29%) | 0.05 |
| Hypo/hyperkalaemia | 10 (45%) | 3 (6%) | 7 (15%) | 22 (46%) | |
| Hypo/hypernatraemia | 11 (50%) | 23 (46%) | 22 (46%) | 16 (33%) |
Any (sign/symptom or lab) includes more levels than listed here
Any gastrointestinal includes: Appetite loss/decreased/anorexia, Constipation, Diarrhea/loose stools, Nausea, Vomiting, Gastrointestinal dysfunction.
All p-values are calculated using the Kruskal-Wallis test for differences across the four treatment arms.