Table 2:
Treatment exposure and dose delay in all treated patients
| Nivolumab plus ipilimumab (N=404) |
Placebo (N=407) |
|||
|---|---|---|---|---|
| Median duration of therapy (range), months | 5·1 (<0·1–8·3) | 5·1 (<0·1–8·1) | ||
| Q1, Q3 | 2·8, 5·3 | 5·1, 5·3 | ||
|
Nivolumab
n=404 |
Ipilimumab
n=403 † |
Nivolumab-placebo
n=407 |
Ipilimumab-placebo
n=406 † |
|
| Median number of doses received (range) * | 12 (1–12) | 4 (1–4) | 12 (1–12) | 4 (1–4) |
| Last cycle received before treatment period ends |
Nivolumab
n=404 |
Ipilimumab
n=403 |
Nivolumab-placebo
n=407 |
Ipilimumab-placebo
n=406 |
| Cycle 1 | 17 | 51 | 5 | 8 |
| Cycle 2 | 21 | – | 2 | – |
| Cycle 3 | 14 | – | 2 | – |
| Cycle 4 | 22 | 50 | 4 | 12 |
| Cycle 5 | 16 | – | 2 | – |
| Cycle 6 | 12 | – | 5 | – |
| Cycle 7 | 13 | 36 | 6 | 14 |
| Cycle 8 | 13 | – | 3 | – |
| Cycle 9 | 10 | – | 6 | – |
| Cycle 10 | 12 | 266 | 5 | 372 |
| Cycle 11 | 24 | – | 6 | – |
| Cycle 12‡ | 230 | – | 361 | – |
|
Nivolumab
n=404 |
Ipilimumab
n=403 |
Nivolumab-placebo
n=407 |
Ipilimumab-placebo
n=406 |
|
| Patients with at least one dose delay, n (%) ¶ | 141 (35) | 136 (34) | 110 (27) | 104 (26) |
| Relative dose intensity, n (%) § |
Nivolumab
n=404 |
Ipilimumab
n=403 |
Nivolumab-placebo
n=407 |
Ipilimumab-placebo
n=406 |
| ≥110 | 0 | 0 | – | – |
| 90 to <110 | 332 (82) | 346 (86) | – | – |
| 70 to <90 | 63 (16) | 52 (13) | – | – |
| 50 to <70 | 7 (2) | 4 (1) | – | – |
| <50 | 2 (<1) | 1 (<1) | – | – |
Dose units are mg for nivolumab and mg/kg for ipilimumab.
Treated patients are defined as having received at least one dose of study drug (nivolumab or ipilimumab). One patient in the nivolumab plus ipilimumab treatment arm and one patient in the placebo arm did not receive the scheduled dose of ipilimumab or ipilimumab-placebo, respectively, at the time that nivolumab or nivolumab-placebo was given.
One patient in the nivolumab plus ipilimumab arm skipped nivolumab at cycle 3 and one patient in the placebo arm skipped ipilimumab-placebo at cycle 7.
A dose was considered as delayed if the delay exceeded 3 days for nivolumab or ipilimumab. Reasons for dose delay of nivolumab only (based on total number of doses delayed): adverse event, 123 (62%); other, 73 (37%); not reported, one (<1%). Reasons for dose delay of ipilimumab only (based on total number of doses delayed): adverse event, 44 (26%); other, 30 (18%); not reported, 94 (56%). Reasons for dose delay of nivolumab-placebo (based on total number of doses delayed): adverse event, 45 (31%); other, 100 (68%); not reported, one (<1%). Reasons for dose delay of ipilimumab-placebo (based on total number of doses delayed): adverse event, 20 (16%); other, 41 (32%); not reported, 67 (52%).
Defined as the actual dose received relative to the planned dose.
Q=quartile.