Table 8. Summary of adverse events by ribavirin randomisation.
| With ribavirin | Without ribavirin | Total | p-value * | |
|---|---|---|---|---|
| Number randomised | N=100 | N=102 | N=202 | |
| Median weeks follow-up (IQR) | 32.1
(30.4, 50.4) |
32.1
(31.9, 49.0) |
32.1
(31.2, 50.4) |
|
| SAEs | 5 (5%) [5] | 5 (5%) [5] | 10 (5%) [10] | p=1.00 |
| SAE criteria | ||||
| Life-threatening | 1 (1%) [1] | 1 (1%) [1] | 2 (1%) [2] | |
| Required or prolonged hospitalisation | 5 (5%) [5] | 4 (4%) [4] | 9 (4%) [9] | |
| Other important medical condition | 0 | 1 (1%) [1] | 1 (<1%) [1] | |
| Relationship to ribavirin (% of SAEs) | ||||
| Unlikely | 2 (40%) | 2 (40%) | 4 (40%) | |
| Not related | 3 (60%) | 3 (60%) | 6 (60%) | |
| Severe AEs | 9 (9%) [15] | 5 (5%) [6] | 14 (7%) [21] | p=0.28 |
| Relationship to trial drug (% of severe AEs) | ||||
| Definitely | 8 (53%) | 0 | 8 (38%) | |
| Probably | 1 (7%) | 3 (50%) | 4 (19%) | |
| Possibly | 3 (20%) | 0 | 3 (14%) | |
| Unlikely | 1 (7%) | 0 | 1 (5%) | |
| Not related | 2 (13%) | 3 (50%) | 5 (24%) | |
| AEs probably/definitely related to first line drugs | 3 (3%) [3] | 1 (1%) [1] | 4 (2%) [4] | p=0.37 |
| AEs probably/definitely related to retreatment drugs | 2 (2%) [6] | 2 (2%) [2] | 4 (2%) [8] | p=1.00 |
| First line drug changes due to AEs | 4 (4%) [4] | 0 | 4 (2%) [4] | p=0.06 |
| Retreatment drug changes due to AEs | 4 (4%) [8] | 3 (3%) [4] | 7 (3%) [12] | p=0.72 |
| Grade 3/4 anaemia | 3(3%) [3] | 0 | 3 (1%) [3] | p=0.12 |
*p-values calculated using chi-square tests or Fishers exact test when numbers are small.
Note: no. of patients (% of patients) [no. of events]. Tables include data for both first-line and retreatment phases. For SAEs, HR=1.05 (95% CI 0.30, 3.63) p=0.94. For severe (grade 3/4 AEs), HR=1.92 (0.64, 5.72) p=0.59.