Adverse events and outcome
ID no. . | Immune adverse event . | Other adverse event . | Outcome . |
|---|---|---|---|
| DIG001 | Rash, lymphadenopathy for 3 mo after transplantation, treated with topical steroids and a brief unsuccessful trial of interferon-gamma | Mild asthma (medications available as needed, oral steroids once a year), continues to require calcitriol | Age 9 years, in fourth grade, doing well. On calcitriol, free of infection |
| DIG002 | Not applicable | Intubation for stridor, respiratory collapse, tracheostomy for laryngomalacia | Death from intracerebral hemorrhage on d 66 after transplantation |
| DIG003 | Possible respiratory inflammation when T cell developed, treated d 35 after transplantation with 30 mg/kg/d methylprednisolone × 3 d | Not applicable | Death from sepsis and respiratory failure on d 130 after transplantation |
| DIG004 | Not applicable | Not applicable | Death from sepsis and respiratory failure 45 d after transplantation |
| DIG005 | Not applicable | Not applicable | Age 3.5 years, living at home with severe developmental delay, walking, no speech, hearing aids, glasses, sign language, tube feeding. Free of infection |
| DIG006 | Mild skin rash 4 mo after transplantation (treated with topical steroids), thrombocytopenia × 2 (d 313 and 466) treated with Rho(D) immunoglobulin containing IgG anti-D (anti-Rh) and IVIG; IgE 519 and 568 IU/mL at the 2 times of thrombocytopenia | Mild nephrocalcinosis d 36, seizure from hypocalcemia (d 319), admission for FTT d 432, RSV admission d 516, mild hearing loss | Age 27 months, doing well, speech delay, eating by mouth. Free of infection, on calcium and calcitriol |
| DIG007 | Hypothyroidism d 427 treated with thyroxine, alopecia d 838 treated with betamethasone foam | Episodes of sepsis (d -74, +72, +116), continuing aspiration on swallow studies, d 334; mild bilateral hearing loss secondary to fluid documented d 420; hospitalized d 795 for 5 d for RSV, parainfluenza virus and rotavirus | Age 22 months, doing well, slight developmental delay, speech delay, mainly tube feeding. On trimethoprim/sulfamethoxazole, IVIG, calcium, calcitriol, free of infection |
| DIG009 | Rash on d 22, eosinophilia requiring steroids at d 44 (2 mg/kg/d solumedrol × 2 wk then taper) | Fever d 40, febrile seizure at d 359 after thymus transplantation, treated as outpatient with oral antibiotics | Age 17 months, doing well, slight developmental delay, speech delay, on IVIG, calcium, calcitriol, free of infection |
| DIG010 | Rash starting 1 mo after transplantation, double-negative T cells to 3000/mm3 2 months after transplantation with adenopathy, eosinophilia to 3456/mm3, topical steroids used; all resolved | Unilateral vocal cord paralysis after cardiac surgery, rotavirus d 118, occasional episodes of otitis, hearing deficit d 202 | Age 18 months, doing well, moderate developmental delay, speech delay, tube feedings, hearing aids, on trimethoprim/sulfamethoxazole, IVIG, free of infection |
| DIG011 | Event d 77 after transplantation with increased ICP, high IgE to 14 400 IU/mL, poor neurologic status, worsening respiratory status, resolved with low-dose steroids (1 mg/kg/d methylprednisolone) | Subglottic stenosis, long ventilation needed secondary to CHF, tracheostomy because of long-term ventilation | Sepsis leading to death d 132 after transplantation |
| DIG012 | Rash at d 84 (resolved with topical steroids) | Heart failure on d 9 of life with pH of 6.6; nephrocalcinosis, multiple episodes of hypocalcemia | Age 12 months, doing well, on trimethoprim/sulfamethoxazole, IVIG, calcium and calcitriol, free of infection, speech delay, tube and oral feeding |
| DIG016 | Not applicable | Seizures from hypocalcemia prior to admission | Death from hemorrhage due to calcium accretion in IVC that ruptured during abdominal surgery on day of transplantation |
ID no. . | Immune adverse event . | Other adverse event . | Outcome . |
|---|---|---|---|
| DIG001 | Rash, lymphadenopathy for 3 mo after transplantation, treated with topical steroids and a brief unsuccessful trial of interferon-gamma | Mild asthma (medications available as needed, oral steroids once a year), continues to require calcitriol | Age 9 years, in fourth grade, doing well. On calcitriol, free of infection |
| DIG002 | Not applicable | Intubation for stridor, respiratory collapse, tracheostomy for laryngomalacia | Death from intracerebral hemorrhage on d 66 after transplantation |
| DIG003 | Possible respiratory inflammation when T cell developed, treated d 35 after transplantation with 30 mg/kg/d methylprednisolone × 3 d | Not applicable | Death from sepsis and respiratory failure on d 130 after transplantation |
| DIG004 | Not applicable | Not applicable | Death from sepsis and respiratory failure 45 d after transplantation |
| DIG005 | Not applicable | Not applicable | Age 3.5 years, living at home with severe developmental delay, walking, no speech, hearing aids, glasses, sign language, tube feeding. Free of infection |
| DIG006 | Mild skin rash 4 mo after transplantation (treated with topical steroids), thrombocytopenia × 2 (d 313 and 466) treated with Rho(D) immunoglobulin containing IgG anti-D (anti-Rh) and IVIG; IgE 519 and 568 IU/mL at the 2 times of thrombocytopenia | Mild nephrocalcinosis d 36, seizure from hypocalcemia (d 319), admission for FTT d 432, RSV admission d 516, mild hearing loss | Age 27 months, doing well, speech delay, eating by mouth. Free of infection, on calcium and calcitriol |
| DIG007 | Hypothyroidism d 427 treated with thyroxine, alopecia d 838 treated with betamethasone foam | Episodes of sepsis (d -74, +72, +116), continuing aspiration on swallow studies, d 334; mild bilateral hearing loss secondary to fluid documented d 420; hospitalized d 795 for 5 d for RSV, parainfluenza virus and rotavirus | Age 22 months, doing well, slight developmental delay, speech delay, mainly tube feeding. On trimethoprim/sulfamethoxazole, IVIG, calcium, calcitriol, free of infection |
| DIG009 | Rash on d 22, eosinophilia requiring steroids at d 44 (2 mg/kg/d solumedrol × 2 wk then taper) | Fever d 40, febrile seizure at d 359 after thymus transplantation, treated as outpatient with oral antibiotics | Age 17 months, doing well, slight developmental delay, speech delay, on IVIG, calcium, calcitriol, free of infection |
| DIG010 | Rash starting 1 mo after transplantation, double-negative T cells to 3000/mm3 2 months after transplantation with adenopathy, eosinophilia to 3456/mm3, topical steroids used; all resolved | Unilateral vocal cord paralysis after cardiac surgery, rotavirus d 118, occasional episodes of otitis, hearing deficit d 202 | Age 18 months, doing well, moderate developmental delay, speech delay, tube feedings, hearing aids, on trimethoprim/sulfamethoxazole, IVIG, free of infection |
| DIG011 | Event d 77 after transplantation with increased ICP, high IgE to 14 400 IU/mL, poor neurologic status, worsening respiratory status, resolved with low-dose steroids (1 mg/kg/d methylprednisolone) | Subglottic stenosis, long ventilation needed secondary to CHF, tracheostomy because of long-term ventilation | Sepsis leading to death d 132 after transplantation |
| DIG012 | Rash at d 84 (resolved with topical steroids) | Heart failure on d 9 of life with pH of 6.6; nephrocalcinosis, multiple episodes of hypocalcemia | Age 12 months, doing well, on trimethoprim/sulfamethoxazole, IVIG, calcium and calcitriol, free of infection, speech delay, tube and oral feeding |
| DIG016 | Not applicable | Seizures from hypocalcemia prior to admission | Death from hemorrhage due to calcium accretion in IVC that ruptured during abdominal surgery on day of transplantation |
IVIG indicates intravenous immunoglobulin; FTT, failure to thrive; ICP, intracranial pressure; CHF, congestive heart failure; and IVC, inferior vena cava