Table 7 Serious adverse events
Patient education + information brochure (n = 138) | Information brochure only (n = 106) | P value | |
|---|---|---|---|
Occurrence of SAE | 13 (9.4%) | 10 (9.4%) | 0.997* |
Severity | 0.772* | ||
Grade IV* | 11 (84.6%) | 8 (80.0%) | |
Grade V* | 2 (15.4%) | 2 (20.0%) | |
Causality | Not applicable | ||
Unrelated | 13 (100%) | 10 (100%) | |
Possibly related | 0 (0%) | 0 (0%) | |
Definitely related | 0 (0%) | 0 (0%) | |
Outcome | 0.361* | ||
Recovered completely | 3 (23.1%) | 3 (30.0%) | |
Recovered with sequelae | 4 (30.8%) | 2 (20.0%) | |
Death | 2 (15.4%) | 2 (20.0%) | |
Unknown | 1 (7.7%) | 3 (30.0%) | |
Ongoing | 3 (23.1%) | 0 (0%) |