In the 1L treatment of patients with
metastatic esophageal squamous cell
carcinoma
Adverse reactions in
≥10% of patients
receiving OPDIVO®
and
chemotherapy1,2

Adverse reaction | OPDIVO + cisplatin and 5-FU (n=310) |
Cisplatin and 5-FU (n=304) |
---|---|---|
All grades (%) |
All grades (%) |
|
Adverse reactions |
99 | 99 |
Gastrointestinal | ||
Nausea | 65 | 56 |
Constipation | 44 | 43 |
Stomatitis* | 44 | 35 |
Diarrhea | 29 | 20 |
Vomiting | 23 | 19 |
Dysphagia | 14 | 12 |
Abdominal pain† | 13 | 11 |
Metabolism and nutrition |
||
Decreased appetite | 51 | 50 |
Hyponatremia | 17 | 10 |
Hypokalemia‡ | 15 | 9 |
General | ||
Fatigue§ | 32 | 26 |
Pyrexia|| | 19 | 12 |
Malaise | 18 | 17 |
Edema¶ | 16 | 13 |
Nervous system | ||
Peripheral neuropathy# |
18 | 13 |
Psychiatric | ||
Insomnia | 16 | 10 |
Investigations | ||
White blood cell count decreased |
16 | 10 |
Blood creatine increased |
14 | 12 |
Weight decreased | 12 | 11 |
Transaminases increased** | 11 | 4.6 |
Skin and subcutaneous tissue |
||
Rash†† | 16 | 7 |
Pruritus | 11 | 3.6 |
Alopecia | 10 | 11 |
Respiratory, thoracic and mediastinal |
||
Cough‡‡ | 16 | 13 |
Infections and infestations |
||
Pneumonia§§ | 13 | 10 |
Musculoskeletal and connective tissue |
||
Musculoskeletal pain|||| | 11 | 8 |
Adverse reaction | OPDIVO + cisplatin and 5-FU (n=310) |
Cisplatin and 5-FU (n=304) |
---|---|---|
Grade 3-4 (%) |
Grade 3-4 (%) |
|
Adverse reactions |
70 | 54 |
Gastrointestinal | ||
Nausea | 4.2 | 2.6 |
Constipation | 1.0 | 1.0 |
Stomatitis* | 0 | 3.0 |
Diarrhea | 2.9 | 2.0 |
Vomiting | 2.3 | 3.0 |
Dysphagia | 7 | 4.9 |
Abdominal pain† | 1.9 | 0.7 |
Metabolism and nutrition |
||
Decreased appetite | 7 | 6 |
Hyponatremia | 8 | 3.9 |
Hypokalemia‡ | 7 | 3.9 |
General | ||
Fatigue§ | 3.2 | 4.9 |
Pyrexia|| | 0.3 | 0.3 |
Malaise | 0.3 | 0 |
Edema¶ | 0 | 0 |
Nervous system | ||
Peripheral neuropathy# |
1.3 | 1.0 |
Psychiatric | ||
Insomnia | 0 | 0.3 |
Investigations | ||
White blood cell count decreased |
4.8 | 2.6 |
Blood creatine increased |
0.6 | 0.5 |
Weight decreased | 0.6 | 0.1 |
Transaminases increased** | 1.9 | 1.3 |
Skin and subcutaneous tissue |
||
Rash†† | 0.6 | 0 |
Pruritus | 0 | 0 |
Alopecia | 0 | 0 |
Respiratory, thoracic and mediastinal |
||
Cough‡‡ | 0.3 | 0.3 |
Infections and infestations |
||
Pneumonia§§ | 5 | 2.6 |
Musculoskeletal and connective tissue |
||
Musculoskeletal pain|||| | 0.3 | 0.3 |
Toxicity was graded per NCI CTCAE v4.1
Includes aphthous ulcer, mouth ulceration, and mucosal inflammation.
Includes abdominal discomfort, abdominal pain lower, and abdominal pain upper.
Includes asthenia and malaise.
Includes swelling, generalized edema, edema peripheral, and peripheral swelling.
Includes hyperaesthesia, hypoaesthesia, peripheral motor neuropathy, peripheral sensorimotor neuropathy, and peripheral sensory neuropathy.
Includes dermatitis, dermatitis acneiform, dermatitis allergic, dermatitis bullous, drug eruption, exfoliative rash, rash erythematous, rash follicular, rash macular, rash maculopapular, rash papular, and rash pruritic.
Includes productive cough.
Includes organizing pneumonia, pneumonia bacterial, and pneumonia pseudomonal.
Includes back pain, bone pain, musculoskeletal chest pain, myalgia, neck pain, pain in extremity, and spinal pain.
Among patients who received
OPDIVO + chemotherapy:
- Fatal adverse reactions occurred in 5 (1.6%) patients who received OPDIVO in combination with chemotherapy; these included pneumonitis, pneumonitis intestinal, pneumonia, and acute kidney injury1
- Serious adverse reactions occurred in 62% of patients receiving OPDIVO in combination with chemotherapy1
- OPDIVO and/or chemotherapy were discontinued in 39% of patients and were delayed in 71% of patients for an adverse reaction1
- The most frequent serious adverse reactions reported in ≥2% of patients who received OPDIVO with chemotherapy were pneumonia (11%), dysphagia (7%), esophageal stenosis (2.9%), acute kidney injury (2.9%), and pyrexia (2.3%)1
- The most common adverse reactions reported in ≥20% of patients treated with OPDIVO in combination with chemotherapy were nausea (65%), decreased appetite (51%), fatigue (47%), constipation (44%), stomatitis (44%), diarrhea (29%), and vomiting (23%)1
1L=first-line; 5-FU=5-fluorouracil; NCI CTACAE v4=National Caner Institute Common Terminology Criteria for Adverse Events Version 4;
UGI=upper gastrointestinal.