Serious adverse events.
| Dose Level, DRP/ml | Age, yrs, Sex | Type of Arthritis | Arthritis Medications | Target Joint | Most Recent Injection | Days Since Last Dose | Symptoms/Diagnosis | Toxicity Grade | Relationship to Study Agent |
|---|---|---|---|---|---|---|---|---|---|
| Placebo | 77 F | RA | ADA, MTX | R MCP2 | First | 14 | Degenerative joint disease requiring L knee replacement | Severe | Not related |
| 1 × 1011 | 57 M | RA | AZA | R elbow | First | 34 | Infected incision after repair of traumatic ankle fracture | Severe | Not related |
| 64 F | AS | LEF, PRED | R wrist | First | 97 | Abdominal pain from constipation | Severe | Unlikely | |
| Second | 7 | Cellulitis and ulcer leg calf | Severe | Unlikely | |||||
| 61 F | RA | ETAN, MTX, PRED | L knee | Second | 90 | Acute pyelonephritis | Severe | Unlikely | |
| 1 × 1012 | 56 F | RA | LEF | L knee | First | 102 | Septic arthritis of injected joint | Severe | Probable |
| 33 F | RA | HCQ, MTX, PRED | R MCP2 | Second | 58 | Myocardial infarction | Life-threatening | Unlikely | |
| 67 F | PsA | ETAN, MTX | L ankle | Second | 30 | Massive pulmonary emboli | Fatal | Unlikely | |
| 75 M | RA | ETAN, MTX, PRED | L wrist | Second | 163 | Pneumonia | Severe | Unlikely | |
| 1 × 1013 | 64 M | RA | MTX, PRED | R wrist | First | 70 | Syncope from coronary artery disease | Moderate | Not related |
| 36 F | RA | ADA, MTX, PRED | R knee | Second | 1 15 | Disseminated histoplasmosis Retroperitoneal hemorrhage | Fatal | Unlikely |
ADA: adalimumab; AS: ankylosing spondylitis; AZA: azathioprine; DRP: DNase-resistant particles; ETAN: etanercept; HCQ: hydroxychloroquine; LEF: leflunomide; MCP: metacarpophalangeal; MTX: methotrexate; PRED: prednisone; PsA: psoriatic arthritis.