Safety Profile
A FAVOURABLE SAFETY PROFILE WITH LOW TOXICITY
Low incidence of ≥grade 3 treatment-related AEs1
| Most common AEs | All grades (%) | Grades 3-4 (%) |
| Fatigue | 26.8 | 2.8 |
| Decreased appetite | 23.5 | 0.3 |
| Cough | 23.2 | 0.3 |
| Nausea | 17.7 | 0.7 |
| Diarrhoea |
15.4 | 0.7 |
| Asthenia |
19 | 1.3 |
| Dyspnoea |
19.4 | 2.5 |
| Anemia | 11.5 | 2.3 |
| Constipation | 17.6 | 0.3 |
| Pyrexia |
17.7 | 0.2 |
| Vomiting | 12.2 | 0.3 |
| Arthralgia | 12 | 0.5 |
AEs=adverse events
*Includes reports of rash maculopapular, erythema, rash pruritic, dermatitis acneiform, eczema, rash papular, rash macular, dermatitis, rash erythematous, acne, skin exfoliation, skin ulcer, seborrhoeic dermatitis, erythema multiforme, dermatitis bullous, rash generalised, skin toxicity, dermatitis allergic, dermatitis exfoliative, palmar-plantar erythrodysaesthesia syndrome, rash papulosquamous, toxic skin eruption, erythema of eyelid, eyelid rash, folliculitis, furuncle, and rash.
Low incidence of immune-related AEs1
| Immune-related AEs | All grades (%) | Grades 3-4 (%) |
| Pneumonitis | 1 | 0.7 |
| Hepatitis | 0.3 | 0.3 |
| Colitis | 0.3 | 0 |
Endocrinopathies Hypothyroidism Hyperthyroidism Adrenal insufficiency Diabetes mellitus Hypophysitis |
3 1.1 0.3 0.2 0.2 |
0 0 0 0 0 |
Meningoencephalitis Meningitis Encephalitis |
0.5 0.2 |
0 0 |
| Pancreatitis |
0.2 | 0.2 |
| Peripheral neuropathy | 3.9 | 0 |
References:
1. Rittmeyer A, Barlesi F, Waterkamp D, et al; OAK Study Group. Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK):
a phase 3, open-label, multicentre randomised controlled trial [published online December 12, 2016] [supplementary appendix]. Lancet.doi:10.1016/S0140-6736(16)32517-X.
MatCode Approval No.: -1905-V2-3253