Table 5.
AEs Potentially Related to Autoimmunity
| Event | Study Phase | Duration, Days | Outcome | Maximum Toxicity Grade |
|---|---|---|---|---|
| Autoimmune hemolytic anemia | pre-treatment | NR | resolved | NA |
| Chronic autoimmune hemolytic anemia | pre-treatment | NA | not resolved | NA |
| Hypothyroidism | pre-treatment | NA | not resolved | grade 2 |
| Antinuclear antibody positive test | pre-treatment | 3,005 | resolved | grade 1 |
| Hypothyroidism | pre-treatment | 1,116 | resolved | grade 1 |
| Hypothyroidism | pre-treatment | NA | not resolved | grade 1 |
| Neutropenia | 3-month follow-up | 29 | resolved | grade 4 (SAE) |
| Autoimmune thrombocytopenia | 3-month follow-up | 12 | resolved | grade 3 (SAE) |
| Anti-thyroid antibody positive test | 3-month follow-up | 648 | resolved | grade 1 |
| Aplastic anemiaa | 3-year follow-up | 120 | resolved | grade 3 (SAE) |
| Autoimmune hepatitis | 3-year follow-up | 14 | resolved | grade 3 (SAE) |
| Autoimmune thrombocytopenia | 3-year follow-up | 16 | resolved | grade 3 (SAE) |
| Guillain-Barré syndrome | 3-year follow-up | 4 | resolved | grade 3 (SAE) |
| Autoimmune thrombocytopenia | 3-year follow-up | 46 | resolved | grade 3 |
| Autoimmune thrombocytopenia | 3-year follow-up | NA | not resolved | grade 3 |
| Autoimmune haemolytic anemia | 3-year follow-up | NR | resolved | grade 2 |
| Hypothyroidism | 3-year follow-up | NA | not resolved | grade 2 |
| Hypothyroidism | 3-year follow-up | NA | not resolved | grade 2 |
| Autoimmune hepatitis | 3-year follow-up | 211 | resolved | grade 1 |
| Autoimmune aplastic anemia | 7-year follow-up | 10 | resolved | grade 3 (SAE) |
| Autoimmune haemolytic anemia | 7-year follow-up | 145 | resolved | grade 2 |
| Anti-neutrophil cytoplasmic antibody | 7-year follow-up | NA | not resolved | grade 1 |
| Anti-nuclear antibody positive test | 7-year follow-up | 1,093 | resolved | grade 1 |
| Anti-nuclear antibody positive test | 7-year follow-up | 1,023 | resolved | grade 1 |
| Anti-nuclear antibody positive test | 7-year follow-up | NA | not resolved | grade 1 |
| Anti-nuclear antibody positive test | 7-year follow-up | NA | not resolved | grade 1 |
| Anti-smooth muscle antibody positive test | 7-year follow-up | 1,373 | resolved | grade 1 |
| Anti-smooth muscle antibody positive test | 7-year follow-up | 877 | resolved | grade 1 |
| Positive direct Coombs test | 7-year follow-up | 1,242 | resolved | grade 1 |
| Autoimmune thyroiditis | ≥8-year follow-up | 743 | resolved | grade 1 |
| Antinuclear antibody positive test | ≥8-year follow-up | NA | not resolved | grade 1 |
AE, adverse event; NA, not applicable; NR, not reported; SAE, serious adverse event. In any given phase, only those AEs that were new or worsened after the start of a particular phase were reported.
a
Event was identified in SAE narrative as possibly related to autoimmunity.