Table 4.
Treatment-emergent adverse events under forced upward titration conditions in Pump-Assisted Flow Rate Cohort (safety analysis set)a
| Pump-Assisted Flow Rate Cohort | 25 mL/h (N = 18; Inf = 70) | 50 mL/h (N = 14; Inf = 55) | 75 mL/h (N = 13; Inf = 50) | 100 mL/h (N = 12; Inf = 47) | ||||
|---|---|---|---|---|---|---|---|---|
| n (%) | E (Rate) | n (%) | E (Rate) | n (%) | E (Rate) | n (%) | E (Rate) | |
| Any TEAE | 7 (38.9) | 23 (0.329) | 4 (28.6) | 14 (0.255) | 3 (23.1) | 7 (0.140) | 3 (25.0) | 4 (0.085) |
| Treatment related | 5 (27.8) | 21 (0.300) | 3 (21.4) | 9 (0.164) | 1 (7.7) | 2 (0.040) | 2 (16.7) | 3 (0.064) |
| Intensity of TEAEs | ||||||||
| Mild | 5 (27.8) | 19 (0.271) | 4 (28.6) | 14 (0.255) | 1 (7.7) | 4 (0.080) | 1 (8.3) | 1 (0.021) |
| Moderate | 3 (16.7) | 4 (0.057) | 0 | 0 | 2 (15.4) | 3 (0.060) | 1 (8.3) | 1 (0.021) |
| Severe | 0 | 0 | 0 | 0 | 0 | 0 | 1 (8.3) | 2 (0.043) |
| Serious TEAEs | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Deaths | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Study discontinuation due to TEAE | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Study drug withdrawal due to TEAE | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Local TEAEs | 5 (27.8) | 20 (0.286) | 3 (21.4) | 8 (0.145) | 1 (7.7) | 2 (0.040) | 1 (8.3) | 1 (0.021) |
| Treatment related | 5 (27.8) | 20 (0.286) | 3 (21.4) | 8 (0.145) | 0 | 0 | 1 (8.3) | 1 (0.021) |
| Most common (> 1 event at any flow rate) TEAEs by preferred term | ||||||||
| Injection site pain | 2 (11.1) | 7 (0.100) | 2 (14.3) | 5 (0.091) | 0 | 0 | 1 (8.3) | 1 (0.021) |
| Injection site erythema | 3 (16.7) | 8 (0.114) | 0 | 0 | 0 | 0 | 0 | 0 |
| Injection site pruritus | 2 (11.1) | 2 (0.029) | 1 (7.1) | 2 (0.036) | 0 | 0 | 0 | 0 |
| Injection site swelling | 2 (11.1) | 3 (0.043) | 0 | 0 | 0 | 0 | 0 | 0 |
| Injection site hemorrhage | 10 | 0 | 0 | 0 | 1 (7.7) | 2 (0.040) | 0 | 0 |
| Headache | 0 | 2 (14.3) | 2 (0.036) | 1 (7.7) | 1 (0.020) | 1 (8.3) | 1 (0.021) | |
| Most common (> 1 event at any flow rate) treatment-related TEAEs by preferred term | ||||||||
| Injection site pain | 2 (11.1) | 7 (0.100) | 2 (14.3) | 5 (0.091) | 0 | 0 | 1 (8.3) | 1 (0.021) |
| Injection site erythema | 3 (16.7) | 8 (0.114) | 0 | 0 | 0 | 0 | 0 | 0 |
| Injection site pruritus | 2 (11.1) | 2 (0.029) | 1 (7.1) | 2 (0.036) | 0 | 0 | 0 | 0 |
| Injection site swelling | 2 (11.1) | 3 (0.043) | 0 | 0 | 0 | 0 | 0 | 0 |
Rate = number of events/total number of infusions prior to patient’s start date of non-response
aExcludes TEAEs occurring after non-response
E number of events, Inf infusions, n number of patients, TEAE treatment-emergent adverse event