Summary of treatment duration and exposure
| . | Copanlisib + R-B (n = 263) . | Placebo + R-B (n = 257) . |
|---|---|---|
| Median extent of copanlisib/placebo exposure for patients receiving R-B, mo (range)∗,† | ||
| Overall iNHL | 8.5 (0.2-12.9) | 11.4 (0.1-12.6) |
| FL | 6.8 (0.2-12.6) | 11.3 (0.1-12.6) |
| Median extent of R/B exposure, mo (range)∗,† | ||
| Overall iNHL | 5.6 (0.2-12.4) | 5.5 (0.1-7.2) |
| FL | 5.5 (0.9-8.7) | 5.5 (0.1-7.2) |
| Copanlisib/placebo dose modifications (any), n (%) | 219 (83.3) | 172 (66.9) |
| Copanlisib/placebo dose reductions, n (%) | ||
| Reduction to 45 mg | 81 (30.8) | 28 (10.9) |
| Reduction to 30 mg | 30 (11.4) | 4 (1.6) |
| Copanlisib/placebo dose interruptions/delays, n (%) | 215 (81.7) | 169 (65.8) |
| Median duration of delay from copanlisib/placebo, d (range) | 7 (1-173) | 7 (1-50) |
| Rituximab dose interruptions/delays‡, n (%) | 136 (51.7) | 95 (37.0) |
| Bendamustine dose interruptions/delays, n (%) | 137 (52.1) | 93 (36.2) |
| . | Copanlisib + R-B (n = 263) . | Placebo + R-B (n = 257) . |
|---|---|---|
| Median extent of copanlisib/placebo exposure for patients receiving R-B, mo (range)∗,† | ||
| Overall iNHL | 8.5 (0.2-12.9) | 11.4 (0.1-12.6) |
| FL | 6.8 (0.2-12.6) | 11.3 (0.1-12.6) |
| Median extent of R/B exposure, mo (range)∗,† | ||
| Overall iNHL | 5.6 (0.2-12.4) | 5.5 (0.1-7.2) |
| FL | 5.5 (0.9-8.7) | 5.5 (0.1-7.2) |
| Copanlisib/placebo dose modifications (any), n (%) | 219 (83.3) | 172 (66.9) |
| Copanlisib/placebo dose reductions, n (%) | ||
| Reduction to 45 mg | 81 (30.8) | 28 (10.9) |
| Reduction to 30 mg | 30 (11.4) | 4 (1.6) |
| Copanlisib/placebo dose interruptions/delays, n (%) | 215 (81.7) | 169 (65.8) |
| Median duration of delay from copanlisib/placebo, d (range) | 7 (1-173) | 7 (1-50) |
| Rituximab dose interruptions/delays‡, n (%) | 136 (51.7) | 95 (37.0) |
| Bendamustine dose interruptions/delays, n (%) | 137 (52.1) | 93 (36.2) |
An interruption is when an infusion is either stopped earlier than specified in the protocol or stopped and restarted. A delay is when an infusion is not given as expected and 0 dose is administered during this period. Multiple interruptions with the same start date were counted as 1 interruption.
Includes interruptions/delays and drug holidays. If the treatment ended with interruptions, the day of the last actual dose was considered the last day.
One patient with FL received R-CHOP in each treatment arm.
Per protocol, there are no dose reductions or re-escalations for rituximab in any cycle.