Table 5. Subjects with adverse events (AEs) by system organ class and treatment group.
| MeDRA SOCa | ddIb 200 mg HCc 300 mg | ddI 200 mgHC 600 mg | ddI 200 mgHC 900 mg | ddI 400 mgHC 300 mg | ddI 400 mgHC 600 mg | Total |
| Subjects/Arm | n = 12 | n = 11 | n = 10 | n = 12 | n = 13 | N = 58d |
| Subjects with AE, (%) | 8 (66.7) | 6 (54.5) | 4 (40.0) | 8 (66.7) | 10 (76.9) | 36 (62.1) |
| Blood/Lymph, (%) | 4 (33.3) | 1 (9.1) | 2 (20.0) | 2 (16.7) | 4 (30.8) | 13 (22.4) |
| Gastrointestinal, (%) | – | 2 (18.2) | 1 (10.0) | 1 (8.3) | 2 (15.4) | 6 (10.3) |
| General, (%) | 1 (8.3) | – | – | – | – | 1 (1.7) |
| Infections, (%) | 4 (33.3) | 2 (18.2) | 2 (20.0) | 1 (8.3) | 3 (23.1) | 12 (20.7) |
| Injury/Poisoning, (%) | – | – | – | 1 (8.3) | – | 1 (1.7) |
| Investigations, (%) | 2 (16.7) | 3 (27.3) | 2 (20.0) | 6 (50.0) | 4 (30.8) | 17 (29.3) |
| Musculoskeletal, (%) | – | 1 (9.1) | 1 (10.0) | 1 (8.3) | 1 (7.7) | 4 (6.9) |
| Nervous System, (%) | 1 (8.3) | – | 1 (10.0) | – | – | 2 (3.4) |
| Skin, (%) | – | – | – | 1 (8.3) | – | 1 (1.7) |
a
SOC = System Organ Class.
b
ddI = didanosine.
c
HC = hydroxycarbamide.
d
modified ITT population.