Table 3.
Opportunistic Infections
| Event | Study Phase | Duration, Days | Outcome | Maximum Toxicity Grade |
|---|---|---|---|---|
| Candida infection | pre-treatment | 14 | resolved | grade1 |
| Candida infection | pre-treatment | NR | resolved | grade 1 |
| Oral candidiasis | pre-treatment | 25 | resolved | grade 1 |
| Oral candidiasis | pre-treatment | 4 | resolved | grade 1 |
| Oral candidiasis | pre-treatment | 51 | resolved | grade 1 |
| Skin Candida | pre-treatment | 13 | resolved | grade 1 |
| Epstein-Barr virus infection | 3-month follow-up | 9 | resolved | grade 3 (SAE) |
| Candida infection | 3-month follow-up | 13 | resolved | grade 2 |
| Clostridium difficile infection | 3-month follow-up | 45 | resolved | grade 2 |
| Epstein-Barr virus infection | 3-month follow-up | 26 | resolved | grade 2 |
| Epstein-Barr virus infection | 3-month follow-up | 6 | resolved | grade 2 |
| Positive Candida test | 3-month follow-up | 23 | resolved | grade 2 |
| Pulmonary mycosis | 3-month follow-up | 10 | resolved | grade 2 |
| Clostridium difficile colitis | 3-month follow-up | 5 | resolved | grade 1 |
| Clostridium difficile colitis | 3-month follow-up | 6 | resolved | grade 1 |
| Clostridium difficile infection | 3-month follow-up | 217 | resolved | grade 1 |
| Cytomegalovirus | 3-month follow-up | 22 | resolved | grade 1 |
| Oral candidiasis | 3-month follow-up | 7 | resolved | grade 1 |
| Oral candidiasis | 3-month follow-up | 13 | resolved | grade 1 |
| Oral candidiasis | 3-month follow-up | 12 | resolved | grade 1 |
| Oral candidiasis | 3-month follow-up | 120 | resolved | grade 1 |
| Oral candidiasis | 3-month follow-up | 6 | resolved | grade 1 |
| Oral candidiasis | 3-month follow-up | NR | resolved | grade 1 |
| Positive Clostridium test | 3-month follow-up | 15 | resolved | grade 1 |
| Varicella | 3-year follow-up | 6 | resolved | grade 3 (SAE) |
| Oral candidiasis | 3-year follow-up | NR | resolved | grade 2 |
| Oral candidiasis | 3-year follow-up | 10 | resolved | grade 2 |
| Varicella | 3-year follow-up | 23 | resolved | grade 2 |
| Varicella | 3-year follow-up | 19 | resolved | grade 2 |
| Aspergillus infection | 3-year follow-up | 16 | resolved | grade 1 |
| Candida infection | 3-year follow-up | 335 | resolved | grade 1 |
| Oral candidiasis | 3-year follow-up | 13 | resolved | grade 1 |
| Positive Aspergillus test | 3-year follow-up | 7 | resolved | grade 1 |
| Varicella | 7-year follow-up | 8 | resolved | grade 3 (SAE) |
| Gastroenteritis (cryptosporidial) | 7-year follow-up | NR | resolved | grade 1 |
| Oral candidiasis | 7-year follow-up | NR | resolved | grade 1 |
AE, adverse event; NR, not reported; SAE, serious adverse event. CMV and EBV reactivation occurred each in one patient early after treatment; primary Varicella infection occurred in four patients without complications, followed by specific antibody responses. In any given phase, only those AEs that were new or worsened after the start of a particular phase were reported.