Table 5.
Incidence of treatment-emergent adverse events and duration of exposure by race group
| AE | RAM + ERL | PBO + ERL | ||
|---|---|---|---|---|
| Asian (n = 170) |
Non-Asian (n = 51) |
Asian (n = 174) |
Non-Asian (n = 51) |
|
| AE | 170 (100) | 51 (100) | 174 (100) | 51 (100) |
| Paronychiaa | 100 (58.8) | 18 (35.2) | 100 (57.5) | 14 (27.5) |
| Proteinuriaa | 63 (37.1) | 12 (23.5) | 13 (7.5) | 6 (11.8) |
| Epistaxisa | 61 (35.9) | 13 (25.5) | 23 (13.2) | 4 (7.8) |
| Platelet count decreaseda | 28 (16.5) | 3 (5.9) | 6 (3.4) | 0 |
| Gastritisa | 19 (11.2) | 0 | 8 (4.6) | 1 (2.0) |
| Grade ≥ 3 AE | 121 (71.2) | 38 (74.5) | 87 (50.0) | 34 (66.7) |
| Hypertensionb | 38 (22.4) | 14 (27.5) | 8 (4.6) | 4 (7.8) |
| Diarrheab | 10 (5.9) | 6 (11.8) | 2 (1.1) | 1 (2.0) |
| Dermatitis acneiformc | 31 (18.2) | 2 (3.9) | 15 (8.6) | 5 (9.8) |
| Event of interest | ||||
| ILD any graded | 3 (1.8) | 1 (2.0) | 6 (3.4) | 1 (2.0) |
| ILD grade ≥3d | 1 (0.6) | 0 | 3 (1.7) | 0 |
| SAE | 54 (31.8) | 11 (21.6) | 40 (23.0) | 7 (13.7) |
| Infection any grade | 19 (11.2) | 3 (5.9) | 5 (2.9) | 1 (2.0) |
| Infection grade ≥3 | 16 (9.4) | 3 (5.9) | 3 (1.7) | 0 |
| Pneumoniae | 7 (4.1) | 0 | 1 (0.6) | 0 |
| Cellulitise | 4 (2.4) | 0 | 0 | 0 |
| Pneumothoraxe | 4 (2.4) | 0 | 3 (1.7) | 0 |
| Discontinued all study treatment because of AEf | 23 (13.5) | 6 (11.8) | 23 (13.2) | 1 (2.0) |
| Discontinued RAM/PBO alone because of AE | 63 (37.1) | 3 (5.9) | 29 (16.7) | 2 (3.9) |
| Proteinuriag | 16 (9.4) | 3 (5.9) | 0 | 0 |
| Blood bilirubin increasedgh | 12 (7.1) | 1 (2.0) | 12 (6.9) | 3 (5.9) |
| Platelet count decreasedg | 6 (3.5) | 1 (2.0) | 1 (0.6) | 0 |
| Neutropeniagi | 5 (3.0) | 1 (2.0) | 2 (1.1) | 0 |
| Discontinued ERL alone because of AEf | 3 (1.8) | 0 | 2 (1.1) | 0 |
| Death due to TEAEs on study treatmentj | 5 (3.0) | 1 (2.0) | 0 (0) | 0 (0) |
| Duration of exposure, months | ||||
| RAM/PBO | 11.3 (7.8–13.8) | 13.8 (10.1–20.7) | 10.4 (8.2–11.4) | 9.8 (7.4–13.5) |
| Erlotinib | 15.1 (13.1–17.9) | 14.8 (11.1–22.9) | 11.3 (10.4–12.4) | 9.8 (7.8–13.8) |
Data are presented as n (%) or median (95% confidence interval). Censored analysis excluding patients still on treatment. Data cutoff date was 23 January 2019
AE treatment-emergent adverse event, ERL erlotinib, ILD interstitial lung disease, PBO placebo, RAM ramucirumab, SAE serious adverse event
aAny-grade AEs occurring with a ≥ 10% higher incidence in the RAM + ERL arm in Asian vs. non-Asian patients
bGrade ≥ 3 AEs occurring with a ≥ 5% higher incidence in the RAM + ERL arm in Asian vs. non-Asian patients
cGrade ≥ 3 AEs occurring with a ≥ 5% higher incidence in the RAM + ERL arm in non-Asian vs. Asian patients
dILD includes pneumonitis
eSAEs occurring in ≥ 2% Asian patients in the RAM + ERL arm
fNo AEs occurred in ≥ 2% Asian patients in the RAM + ERL arm
gAEs occurring in ≥ 2% Asian patients in the RAM + ERL arm
hBlood bilirubin increased includes hyperbilirubinemia
iNeutropenia includes neutrophil count decreased
jDeaths during treatment and within 30 days of discontinuation