10 May 2022: Original Paper
Long-Term Effectiveness, Safety, and Patient-Reported Outcomes of Self-Administered Subcutaneous Hepatitis B Immunoglobulin in Liver Post-Transplant Hepatitis B Prophylaxis: A Prospective Non-Interventional Study
Bruno Roche 1BCDE , Artur Bauhofer 2ACDEF* , Miguel Ãngel Gomez Bravo 3BCDE , Georges Philippe Pageaux 4ABCDE , Fabien Zoulim 5BDE , Alejandra Otero 6BC , Martin Prieto 78BC , Carmen Baliellas 9BC , Didier Samuel 1ACDEDOI: 10.12659/AOT.936162
Ann Transplant 2022; 27:e936162
Table 5 Summary of adverse drug reactions.
| Full analysis set (N=195) | |
|---|---|
| Total (serious+nonserious) | 29 |
| Serious | 12 |
| Total (serious+nonserious) | 16 (8.2) |
| Serious | 5 (2.6) |
| Asthenia | 3 (1.5) |
| Back pain | 2 (1.0) |
| Headache | 2 (1.0) |
| Nausea | 2 (1.0) |
| Pyrexia | 2 (1.0) |
| Rash pruritic | 2 (1.0) |
| Arthralgia, blood pressure increased, decreased appetite, discomfort, dizziness, drug ineffective, erythema, fatigue, hepatitis B antibody abnormal, hepatitis B surface antigen, hernia, muscle injury, myalgia, product dose omission issue, pruritus, vomiting | |