Table 5.
Treatment-related adverse events in the Asian subpopulation of CheckMate 9LA
| NIVO + IPI + chemoa (n = 28) | Chemob (n = 30) | |||
|---|---|---|---|---|
| Any grade | Grade 3–4 | Any grade | Grade 3–4 | |
| Total patients with an event,c n (%) | 28 (100) | 16 (57) | 29 (97) | 18 (60) |
| TRAEs occurring in ≥ 15% of patients in either treatment arm, n (%) | ||||
| Decreased appetite | 13 (46) | 2 (7) | 12 (40) | 3 (10) |
| Constipation | 12 (43) | 0 | 17 (57) | 0 |
| Nausea | 11 (39) | 0 | 18 (60) | 0 |
| Neutrophil count decreased | 10 (36) | 5 (18) | 8 (27) | 5 (17) |
| Fatigue | 8 (29) | 1 (4) | 7 (23) | 0 |
| Malaise | 8 (29) | 0 | 8 (27) | 0 |
| Maculopapular rash | 8 (29) | 3 (11) | 2 (7) | 0 |
| Anemia | 8 (29) | 1 (4) | 15 (50) | 7 (23) |
| Rash | 7 (25) | 2 (7) | 0 | 0 |
| Alopecia | 6 (21) | 0 | 8 (27) | 0 |
| White blood cell count decreased | 6 (21) | 3 (11) | 6 (20) | 2 (7) |
| Diarrhea | 5 (18) | 0 | 3 (10) | 1 (3) |
| Pyrexia | 5 (18) | 0 | 2 (7) | 0 |
| Platelet count decreased | 4 (14) | 1 (4) | 7 (23) | 1 (3) |
| Peripheral sensory neuropathy | 3 (11) | 0 | 9 (30) | 0 |
| Hiccups | 3 (11) | 0 | 8 (27) | 0 |
| TRAEs leading to treatment discontinuationd, n (%) | 6 (21) | 3 (11) | 5 (17) | 2 (7) |
| Serious TRAEse, n (%) | 10 (36) | 6 (21) | 9 (30) | 6 (20) |
| Treatment-related deathsf, g, n | 0 | 0 | ||
Chemo chemotherapy, IPI ipilimumab, n number of patients, NIVO nivolumab, TRAE treatment-related adverse event
aNivolumab plus ipilimumab combined with chemotherapy (2 cycles)
bChemotherapy alone (4 cycles, with optional pemetrexed maintenance for nonsquamous histology)
cIncludes events reported between first dose and 30 days after last dose of study drug
dIncludes discontinuation of any component of the regimen
eSerious adverse events are defined as any untoward medical occurrence that, at any dose, result in the following: death or risk of death at the time of the event; inpatient hospitalization or prolongation of existing hospitalization, with the following exceptions: a visit to the emergency room or other hospital departments < 24 h, elective surgery (planned prior to signing consent), admissions as per protocol for a planned medical/surgical procedure, routine health assessment requiring admission for baseline/trending of health status, medical/surgical admission other than to remedy ill health and planned prior to entry into the study, admission for another life circumstance that is unrelated to health status and requires no medical/surgical intervention, and admission for administration of anticancer therapy in the absence of any other serious adverse event; persistent or significant disability/incapacity; and congenital abnormalities/birth defects. Important medical events (defined as events that may not be immediately life threatening or result in death or hospitalization but, based upon appropriate medical and scientific judgement, may jeopardize the participant or require intervention to prevent other serious outcomes listed above) are also classified as serious adverse events
fWithin 100 days of last dose
gOne grade 5 TRAE was reported in the chemotherapy arm, but cause of death was recorded as unknown