Table 3 Treatment emergent adverse events (TEAE) with MGTA-145.
a | |
|---|---|
TEAEs | n (%) |
Grade 1 | 13 patients (52%) |
Pain | 11 (44%) |
9 patients with acute pain after MGTA-145 infusion | |
AST/ALT increased | 1 (4%) |
Nausea | 2 (8%) |
Headache | 1 (4%) |
Hyperhidrosis | 1 (4%) |
Low platelet count | 2 (4%) |
Grade 2 | 2 patients (8%) |
Vomiting | 1 (4%) |
Other -Poor Graft Function | 1 (4%) |
b: Acute pain with MGTA-145 (AE of special interest), N = 9 | |
Location of pain (n) | |
Back | 5 |
Hip | 1 |
Sternum | 1 |
Generalized | 1 |
Severity of pain on a scale of 1-10, median (range) | 8 (3-10) |
Onset, minutes after MGTA-145 infusion start, median (range) | 5 minutes (3-10) |
Duration of pain, median (range) | 7 minutes (3-28) |
Analgesics needed to treat acute pain | 1 of 9 |
Treatment interruption due to pain | 0 |
Recurrence of pain on Day 2 | |
Recurrence of pain with MGTA-145 infusion on day 2, n | 2 |
Duration of pain, median (range) | 5 minutes (4-5) |
