further [1:10 mg daily prednisone equivalent) or other immunosuppressive medications, a positive test for hepatitis B or C, and a history of HIV. The trial population characteristics in the Opdivo group and the chemotherapy group were similar: 66% male, median age 59.5 years, 98% white, baseline Eastern Cooperative Oncology Group (ECOG) performance status 0 (59%) or 1 (41%), 74% with M1c stage disease, 73% with cutaneous melanoma, 11% with mucosal melanoma, 73% received two or more prior therapies for advanced or metastatic disease, and 18% had brain metastasis. There were more patients in the Opdivo group with elevated LDH at baseline (51% vs. 38%). Opdivo was discontinued for adverse reactions in 9% of patients. Twenty-six percent of patients receiving Opdivo had a drug delay for an adverse reaction. Serious adverse reactions occurred in 41% of patients receiving Opdivo. Grade 3 and 4 adverse reactions occurred in 42% of patients receiving Opdivo. The most frequent Grade 3 and 4 adverse reactions reported in 2% to less than 5% of patients receiving Opdivo were abdominal pain, hyponatremia, increased aspartate aminotransferase, and increased lipase. Table 2 summarizes the adverse reactions that occurred in at least 10% of Opdivo-treated patients in CHECKMATE-037. The most common adverse reaction (reported in at least 20% of patients) was rash. Table 2: Adverse Reactions Occurring in 10% of Opdivo-Treated Patients and at a Higher Incidence than in the Chemotherapy Arm (Between Arm Difference of 5% [All Grades] or 2% [Grades 3-4]) (CHECKMATE-037) Adverse Reaction Opdivo (n=268) Chemotherapy (n=102) All Grades Grades 3-4 All Grades Grades 3-4 Percentage (%) of Patients Toxicity was graded per NCI CTCAE v4. a Rash is a composite term which includes maculopapular rash, erythematous rash, pruritic rash, follicular rash, macular rash, papular rash, pustular rash, vesicular rash, and acneiform dermatitis. b Upper respiratory tract infection is a composite term which includes rhinitis, pharyngitis, and nasopharyngitis. Skin and Subcutaneous Tissue Disorders Rash a 21 0.4 7 0 Pruritus 19 0 3.9 0 Respiratory, Thoracic, and Mediastinal Disorders Cough 17 0 6 0 Infections Upper respiratory tract infection b 11 0 2.0 0 General Disorders and Administration Site Conditions Peripheral edema 10 0 5 0 Other clinically important adverse reactions in less than 10% of patients treated with Opdivo in CHECKMATE-037 were: Cardiac Disorders: ventricular arrhythmia Eye Disorders: iridocyclitis General Disorders and Administration Site Conditions: infusion-related reactions Investigations: increased amylase, increased lipase Nervous System Disorders: dizziness, peripheral and sensory neuropathy Skin and Subcutaneous Tissue Disorders: exfoliative dermatitis, erythema multiforme, vitiligo, psoriasis Table 3: Laboratory Abnormalities Worsening from Baseline Occurring in 10% of Opdivo-Treated Patients and at a Higher Incidence than in the Chemotherapy Arm (Between Arm Difference of 5% [All Grades] or 2% [Grades 3-4]) (CHECKMATE-037) a Each test incidence is based on the number of patients who had both baseline and at least one on-study laboratory measurement available: Opdivo group (range: 252 to 256 patients) and chemotherapy group (range: 94 to 96 patients). Laboratory Abnormality Percentage of Patients with Worsening Laboratory Test from Baseline a Opdivo Chemotherapy All Grades Grades 3-4 All Grades Grades 3-4 Increased AST 28 2.4 12 1.0 Increased alkaline phosphatase 22 2.4 13 1.1 Hyponatremia 25 5 18 1.1 Increased ALT 16 1.6 5 0 Hyperkalemia 15 2.0 6 0 Previously Untreated Metastatic Melanoma CHECKMATE-066 The safety of Opdivo was also evaluated in CHECKMATE-066, a randomized, double-blind, active-controlled trial in which 411 previously untreated patients with BRAF V600 wild-type unresectable or metastatic melanoma received Opdivo 3 mg/kg every 2 weeks (n=206) or dacarbazine 1000 mg/m 2 every 3 weeks (n=205) [see Clinical Studies (14.1) ] . The median duration of exposure was 6.5 months (range: 1 day to 16.6 months) in Opdivo-treated patients. In this trial, 47% of patients received Opdivo for greater than 6 months and 12% of patients received Opdivo for greater than 1 year. The trial excluded patients with autoimmune disease and patients requiring chronic systemic treatment with corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications. The trial population characteristics in the Opdivo group and dacarbazine group: 59% male, median age 65 years, 99.5% white, 61% with M1c stage disease, 74% with cutaneous melanoma, 11% with mucosal melanoma, 4% with brain metastasis, and 37% with elevated LDH at baseline. There were more patients in the Opdivo group with ECOG performance status 0 (71% vs. 59%). Adverse reactions led to permanent discontinuation of Opdivo in 7% of patients and dose interruption in 26% of patients; no single type of adverse reaction accounted for the majority of Opdivo discontinuations. Serious adverse reactions occurred in 36% of patients receiving Opdivo. Grade 3 and 4 adverse reactions occurred in 41% of patients receiving Opdivo. The most frequent Grade 3 and 4 adverse reactions reported in at least 2% of patients receiving Opdivo were gamma-glutamyltransferase increase (3.9%) and diarrhea (3.4%). Table 4 summarizes selected adverse reactions that occurred in at least 10% of Opdivo-treated patients. The most common adverse reactions (reported in at least 20% of patients and at a higher incidence than in the dacarbazine arm) were fatigue, musculoskeletal pain, rash, and pruritus. Table 4: Adverse Reactions Occurring in 10% of Opdivo-Treated Patients and at a Higher Incidence than in the Dacarbazine Arm (Between Arm Difference of 5% [All Grades] or 2% [Grades 3-4]) (CHECKMATE-066) Adverse Reaction Opdivo (n=206) Dacarbazine (n=205) All Grades Grades 3-4 All Grades Grades 3-4 Percentage (%) of Patients Toxicity was graded per NCI CTCAE v4. a Includes periorbital edema, face edema, generalized edema, gravitational edema, localized edema, peripheral edema, pulmonary edema, and lymphedema. b Includes back pain, bone pain, musculoskeletal chest pain, musculoskeletal discomfort, myalgia, neck pain, pain in extremity, pain in jaw, and spinal pain. c Includes maculopapular rash, erythematous rash, pruritic rash, follicular rash, macular rash, papular rash, pustular rash, vesicular rash, dermatitis, allergic dermatitis, exfoliative dermatitis, acneiform dermatitis, drug eruption, and skin reaction. d Includes rhinitis, viral rhinitis, pharyngitis, and nasopharyngitis. General Disorders and Administration Site Conditions Fatigue 49 1.9 39 3.4 Edema a 12 1.5 4.9 0 Musculoskeletal and Connective Tissue Disorders Musculoskeletal pain b 32 2.9 25 2.4 Skin and Subcutaneous Tissue Disorders Rash c 28 1.5 12 0 Pruritus 23 0.5 12 0 Erythema 10 0 2.9 0 Vitiligo 11 0 0.5 0 Infections Upper respiratory tract infection d 17 0 6 0 Other clinically important adverse reactions in less than 10% of patients treated with Opdivo in CHECKMATE-066 were: Nervous System Disorders: peripheral neuropathy Table 5: Laboratory Abnormalities Worsening from Baseline Occurring in 10% of Opdivo-Treated Patients and at a Higher Incidence than in the Dacarbazine Arm (Between Arm Difference of 5% [All Grades] or 2% [Grades 3-4]) (CHECKMATE-066) a Each test incidence is based on the number of patients who had both baseline and at least one on-study laboratory measurement available: Opdivo group (range: 194 to 197 patients) and dacarbazine group (range: 186 to 193 patients). Laboratory Abnormality Percentage of Patients with Worsening Laboratory Test from Baseline a Opdivo Dacarbazine All Grades Grades 3-4 All Grades Grades 3-4 Increased ALT 25 3.0 19 0.5 Increased AST 24 3.6 19 0.5 Increased alkaline phosphatase 21 2.6 14 1.6 Increased bilirubin 13 3.1 6 0 CHECKMATE-067 The safety of Opdivo, administered with ipilimumab or as a single agent, was evaluated in CHECKMATE-067 [see Clinical Studies (14.1) ] , a randomized (1:1:1), a double-blind trial in which 937 patients with previously untreated, unresectable or metastatic melanoma received: Opdivo 1 mg/kg with ipilimumab 3 mg/kg every 3 weeks for 4 doses followed by Opdivo 3 mg/kg as a single agent every 2 weeks (Opdivo plus ipilimumab arm; n=313), Opdivo 3 mg/kg every 2 weeks (Opdivo arm; n=313), or Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses (ipilimumab arm; n=311). The median duration of exposure to Opdivo was 2.8 months (range: 1 day to 18.8 months) for the Opdivo plus ipilimumab arm and 6.6 months (range: 1 day to 17.3 months) for the Opdivo arm. In the Opdivo plus ipilimumab arm, 39% were exposed to Opdivo for 6 months and 24% exposed for >1 year. In the Opdivo arm, 53% were exposed for 6 months and 32% for >1 year. CHECKMATE-067 excluded patients with autoimmune disease, a medical condition requiring systemic treatment with corticosteroids (more than 10 mg daily prednisone equivalent) or other immunosuppressive medication within 14 days of the start of study therapy, a positive test result for hepatitis B or C, or a history of HIV. The trial population characteristics were: 65% male, median age 61 years, 97% White, baseline ECOG performance status 0 (73%) or 1 (27%), 93% with AJCC Stage IV disease, 58% with M1c stage disease; 36% with elevated LDH at baseline, 4% with a history of brain metastasis, and 22% had received adjuvant therapy. In CHECKMATE-067, serious adverse reactions (73% and 37%), adverse reactions leading to permanent discontinuation (43% and 14%) or to dosing delays (55% and 28%), and Grade 3 or 4 adverse reactions (72% and 44%) all occurred more frequently in the Opdivo plus ipilimumab arm relative to the Opdivo arm. The most frequent ( 10%) serious adverse reactions in the Opdivo plus ipilimumab arm and the Opdivo arm, respectively, were diarrhea (13% and 2.6%), colitis (10% and 1.6%), and pyrexia (10% and 0.6%). The most frequent adverse reactions leading to discontinuation of both drugs in the Opdivo plus ipilimumab arm and of Opdivo in the Opdivo arm, respectively, were diarrhea (8% and 1.9%), colitis (8% and 0.6%), increased ALT (4.8% and 1.3%), increased AST (4.5% and 0.6%), and pneumonitis (1.9% and 0.3%). The most common ( 20%) adverse reactions in the Opdivo plus ipilimumab arm were fatigue, rash, diarrhea, nausea, pyrexia, vomiting, and dyspnea. The most common ( 20%) adverse reactions in the Opdivo arm were fatigue, rash, diarrhea, and nausea. Table 6 summarizes the incidence of adverse reactions occurring in at least 10% of patients in either Opdivo-containing arm in CHECKMATE-067. Table 6: Adverse Reactions Occurring in 10% of Patients on the Opdivo plus Ipilimumab Arm or the Opdivo Arm and at a Higher Incidence than in the Ipilimumab Arm (Between Arm Difference of 5% [All Grades] or 2% [Grades 3-4]) (CHECKMATE-067) Adverse Reaction Percentage (%) of Patients Opdivo plus Ipilimumab (n=313) Opdivo (n=313) Ipilimumab (n=311) All Grades Grades 3-4 All Grades Grades 3-4 All Grades Grades 3-4 Toxicity was graded per NCI CTCAE v4. a Fatigue is a composite term which includes asthenia and fatigue. b Rash is a composite term which includes pustular rash, dermatitis, acneiform dermatitis, allergic dermatitis, atopic dermatitis, bullous dermatitis, exfoliative dermatitis, psoriasiform dermatitis, drug eruption, erythema, exfoliative rash, erythematous rash, generalized rash, macular rash, maculopapular rash, morbilliform rash, papular rash, papulosquamous rash, pruritic rash, and seborrheic dermatitis. General Disorders and Administration Site Conditions Fatigue a 59 6 53 1.9 50 3.9 Pyrexia 37 1.6 14 0 17 0.6 Skin and Subcutaneous Tissue Disorders Rash b 53 5 40 1.6 42 3.9 Gastrointestinal Disorders Diarrhea 52 11 31 3.8 46 8 Nausea 40 3.5 28 0.6 29 1.9 Vomiting 28 3.5 17 1.0 16 1.6 Respiratory, Thoracic, and Mediastinal Disorders Dyspnea 20 2.2 12 1.3 13 0.6 Other clinically important adverse reactions in less than 10% of patients treated with either Opdivo with ipilimumab or single-agent Opdivo in CHECKMATE-067 were: Gastrointestinal Disorders: stomatitis, intestinal perforation Skin and Subcutaneous Tissue Disorders: vitiligo Musculoskeletal and Connective Tissue Disorders: myopathy, Sjogren s syndrome, spondyloarthropathy Nervous System Disorders: neuritis, peroneal nerve palsy Table 7: Laboratory Abnormalities Worsening from Baseline Occurring in 20% of Patients Treated with Opdivo with Ipilimumab or Single-Agent Opdivo and at a Higher Incidence than in the Ipilimumab Arm (Between Arm Difference of 5% [All Grades] or 2% [Grades 3-4]) (CHECKMATE-067) Laboratory Abnormality Percentage (%) of Patients a Opdivo plus Ipilimumab Opdivo Ipilimumab Any Grade Grade 3-4 Any Grade Grade 3-4 Any Grade Grade 3-4 a Each test incidence is based on the number of patients who had both baseline and at least one on-study laboratory measurement available: Opdivo plus ipilimumab (range: 241 to 297); Opdivo (range: 260 to 306); ipilimumab (range: 253 to 304). Chemistry Increased ALT 53 15 23 3.0 28 2.7 Increased AST 47 13 27 3.7 27 1.7 Hyponatremia 42 9 20 3.3 25 7 Increased lipase 41 20 29 9 23 7 Increased alkaline phosphatase 40 6 24 2.0 22 2.0 Hypocalcemia 29 1.1 13 0.7 21 0.7 Increased amylase 25 9.1 15 1.9 14 1.6 Increased creatinine 23 2.7 16 0.3 16 1.3 Hematology Anemia 50 2.7 39 2.6 40 6 Lymphopenia 35 4.8 39 4.3 27 3.4 Metastatic Non-Small Cell Lung Cancer The safety of Opdivo in metastatic NSCLC was evaluated in CHECKMATE-017, a randomized open-label, multicenter trial in patients with metastatic squamous NSCLC and progression on or after one prior platinum doublet-based chemotherapy regimen and in CHECKMATE-057, a randomized, open-label, multicenter trial in patients with metastatic non-squamous NSCLC and progression on or after one prior platinum doublet-based chemotherapy regimen [see Clinical Studies (14.2) ] . Patients received 3 mg/kg of Opdivo administered intravenously over 60 minutes every 2 weeks or docetaxel administered intravenously at 75 mg/m 2 every 3 weeks. The median duration of therapy in Opdivo-treated patients in CHECKMATE-017 was 3.3 months (range: 1 day to 21.7+ months) and in CHECKMATE-057 was 2.6 months (range: 0 to 24.0+ months). In CHECKMATE-017, 36% of patients received Opdivo for at least 6 months and 18% of patients received Opdivo for at least 1 year and in CHECKMATE-057, 30% of patients received Opdivo for greater than 6 months and 20% of patients received Opdivo for greater than 1 year. CHECKMATE-017 and CHECKMATE-057 excluded patients with active autoimmune disease, medical conditions requiring systemic immunosuppression, or with symptomatic interstitial lung disease. Across both trials, the median age of Opdivo-treated patients was 61 years (range: 37 to 85); 38% were 65 years of age, 61% were male, and 91% were white. Ten percent of patients had brain metastases and ECOG performance status was 0 (26%) or 1 (74%). Opdivo was discontinued in 11% of patients, and was delayed in 28% of patients for an adverse reaction. Serious adverse reactions occurred in 46% of patients receiving Opdivo. The most frequent serious adverse reactions reported in at least 2% of patients receiving Opdivo were pneumonia, pulmonary embolism, dyspnea, pyrexia, pleural effusion, pneumonitis, and respiratory failure. In CHECKMATE-057, in the Opdivo arm, seven deaths were due to infection including one case of Pneumocystis jirovecii pneumonia, four were due to pulmonary embolism, and one death was due to limbic encephalitis. Across both trials, the most common adverse reactions (reported in at least 20% of patients) were fatigue, musculoskeletal pain, cough, dyspnea, and decreased appetite. Table 8 summarizes selected adverse reactions occurring more frequently in at least 10% of Opdivo-treated patients. Table 8: Adverse Reactions Occurring in 10% of Opdivo-Treated Patients and at a Higher Incidence than Docetaxel (Between Arm Difference of 5% [All Grades] or 2% [Grades 3-4]) (CHECKMATE-017 and CHECKMATE-057) Adverse Reaction Opdivo (n=418) Docetaxel (n=397) All Grades Grades 3-4 All Grades Grades 3-4 Percentage (%) of Patients Toxicity was graded per NCI CTCAE v4. Respiratory, Thoracic, and Mediastinal Disorders Cough 31 0.7 24 0 Metabolism and Nutrition Disorders Decreased appetite 28 1.4 23 1.5 Skin and Subcutaneous Tissue Disorders Pruritus 10 0.2 2.0 0 Other clinically important adverse reactions observed in patients treated with Opdivo and which occurred at a similar incidence in docetaxel-treated patients and not listed elsewhere in section 6 include: fatigue/asthenia (48% Grade 1-4, 5% Grade 3-4), musculoskeletal pain (33%), pleural effusion (4.5%), pulmonary embolism (3.3%). Table 9: Laboratory Abnormalities Worsening from Baseline Occurring in 10% of Opdivo-Treated Patients for all NCI CTCAE Grades and at a Higher Incidence than Docetaxel (Between Arm Difference of 5% [All Grades] or 2% [Grades 3-4]) (CHECKMATE-017 and CHECKMATE-057) a Each test incidence is based on the number of patients who had both baseline and at least one on-study laboratory measurement available: Opdivo group (range: 405 to 417 patients) and docetaxel group (range: 372 to 390 patients); TSH: Opdivo group n=314 and docetaxel group n=297. b Not graded per NCI CTCAE v4. Laboratory Abnormality Percentage of Patients with Worsening Laboratory Test from Baseline a Opdivo Docetaxel All Grades Grades 3-4 All Grades Grades 3-4 Chemistry Hyponatremia 35 7 34 4.9 Increased AST 27 1.9 13 0.8 Increased alkaline phosphatase 26 0.7 18 0.8 Increased ALT 22 1.7 17 0.5 Increased creatinine 18 0 12 0.5 Increased TSH b 14 N/A 6 N/A Renal Cell Carcinoma The safety of Opdivo was evaluated in CHECKMATE-025, a randomized open-label trial in which 803 patients with advanced RCC who had experienced disease progression during or after at least one anti-angiogenic treatment regimens received Opdivo 3 mg/kg every 2 weeks (n=406) or everolimus 10 mg daily (n=397) [see Clinical Studies (14.3) ] . The median duration of treatment was 5.5 months (range: 1 day to 29.6+ months) in Opdivo-treated patients and 3.7 months (range: 6 days to 25.7+ months) in everolimus-treated patients. Study therapy was discontinued for adverse reactions in 16% of Opdivo patients and 19% of everolimus patients. Forty-four percent (44%) of patients receiving Opdivo had a drug delay for an adverse reaction. Serious adverse reactions occurred in 47% of patients receiving Opdivo. The most frequent serious adverse reactions reported in at least 2% of patients were acute kidney injury, pleural effusion, pneumonia, diarrhea, and hypercalcemia. Rate of death on treatment or within 30 days of the last dose of study drug was 4.7% on the Opdivo arm versus 8.6% on the everolimus arm. The most common adverse reactions (reported in at least 20% of patients) were asthenic conditions, cough, nausea, rash, dyspnea, diarrhea, constipation, decreased appetite, back pain, and arthralgia. Table 10 summarizes adverse reactions that occurred in greater than 15% of Opdivo-treated patients. Table 10: Grade 1-4 Adverse Reactions in >15% of Patients Receiving Opdivo (CHECKMATE-025) Toxicity was graded per NCI CTCAE v4. a Asthenic conditions covering PTs asthenia, decreased activity, fatigue, and malaise. b Includes nasopharyngitis, pharyngitis, rhinitis, and viral URI. c Includes colitis, enterocolitis, and gastroenteritis. d Includes dermatitis, acneiform dermatitis, erythematous rash, generalized rash, macular rash, maculopapular rash, papular rash, pruritic rash, erythema multiforme, and erythema. Opdivo (n=406) Everolimus (n=397) Percentage (%) of Patients Grades 1-4 Grades 3-4 Grades 1-4 Grades 3-4 Adverse Reaction 98 56 96 62 General Disorders and Administration Site Conditions Asthenic conditions a 56 6 57 7 Pyrexia 17 0.7 20 0.8 Respiratory, Thoracic and Mediastinal Disorders Cough/productive cough 34 0 38 0.5 Dyspnea/exertional dyspnea 27 3.0 31 2.0 Upper respiratory infection b 18 0 11 0 Gastrointestinal Disorders Nausea 28 0.5 29 1 Diarrhea c 25 2.2 32 1.8 Constipation 23 0.5 18 0.5 Vomiting 16 0.5 16 0.5 Skin and Subcutaneous Tissue Disorders Rash d 28 1.5 36 1.0 Pruritus/generalized pruritus 19 0 14 0 Metabolism and Nutrition Disorders Decreased appetite 23 1.2 30 1.5 Musculoskeletal and Connective Tissue Disorders Arthralgia 20 1.0 14 0.5 Back pain 21 3.4 16 2.8 Other clinically important adverse reactions in CHECKMATE-025 were: General Disorders and Administration Site Conditions: peripheral edema/edema Gastrointestinal Disorders: abdominal pain/discomfort Musculoskeletal and Connective Tissue Disorders: extremity pain, musculoskeletal pain Nervous System Disorders: headache/migraine, peripheral neuropathy Investigations: weight decreased Skin Disorders: Palmar-plantar erythrodysesthesia The most common laboratory abnormalities which have worsened compared to baseline in 30% of patients include increased creatinine, lymphopenia, anemia, increased AST, increased alkaline phosphatase, hyponatremia, elevated triglycerides, and hyperkalemia. Table 11 summarizes the laboratory abnormalities that occurred in greater than 15% of Opdivo-treated patients. Table 11: Grade 1-4 Laboratory Values Worsening from Baseline Occurring in >15% of Patients on Opdivo (CHECKMATE-025) a Each test incidence is based on the number of patients who had both baseline and at least one on-study laboratory measurement available: Opdivo group (range: 259 to 401 patients) and everolimus group (range: 257 to 376 patients). Laboratory Abnormality Percentage of Patients with Worsening Laboratory Test from Baseline a Opdivo Everolimus Grades 1-4 Grades 3-4 Grades 1-4 Grades 3-4 Hematology Lymphopenia 42 6 53 11 Anemia 39 8 69 16 Chemistry Increased creatinine 42 2.0 45 1.6 Increased AST 33 2.8 39 1.6 Increased alkaline phosphatase 32 2.3 32 0.8 Hyponatremia 32 7 26 6 Hyperkalemia 30 4.0 20 2.1 Hypocalcemia 23 0.9 26 1.3 Increased ALT 22 3.2 31 0.8 Hypercalcemia 19 3.2 6 0.3 Lipids Increased triglycerides 32 1.5 67 11 Increased cholesterol 21 0.3 55 1.4 In addition, among patients with TSH less than ULN at baseline, a greater proportion of patients experienced a treatment-emergent elevation of TSH greater than ULN in the Opdivo group compared to the everolimus group (26% and 14%, respectively). Classical Hodgkin Lymphoma The safety of Opdivo 3 mg/kg every 2 weeks was evaluated in 266 adult patients with cHL (243 patients in the CHECKMATE-205 and 23 patients in the CHECKMATE-039 trials). Treatment could continue until disease progression, maximal clinical benefit, or unacceptable toxicity. The median age was 34 years (range: 18 to 72), 98% of patients had received autologous HSCT, none had received allogeneic HSCT, and 74% had received brentuximab vedotin. The median number of prior systemic regimens was 4 (range: 2 to 15). Patients received a median of 23 doses (cycles) of Opdivo (range: 1 to 48), with a median duration of therapy of 11 months (range: 0 to 23 months). Opdivo was discontinued due to adverse reactions in 7% of patients. Dose delay for an adverse reaction occurred in 34% of patients. Serious adverse reactions occurred in 26% of patients. The most frequent serious adverse reactions reported in at least 1% of patients were pneumonia, infusion-related reaction, pyrexia, colitis or diarrhea, pleural effusion, pneumonitis, and rash. Eleven patients died from causes other than disease progression: 3 from adverse reactions within 30 days of the last nivolumab dose, 2 from infection 8 to 9 months after completing nivolumab, and 6 from complications of allogeneic HSCT. The most common adverse reactions (reported in at least 20%) among all patients were upper respiratory tract infection, fatigue, cough, diarrhea, pyrexia, musculoskeletal pain, rash, nausea, and pruritus. Table 12 summarizes the adverse reactions, excluding laboratory terms, that occurred in at least 10% of patients in the safety population. Table 12: Non-Laboratory Adverse Reactions Occurring in 10% of Patients with cHL(CHECKMATE-205 and CHECKMATE-039) Toxicity was graded per NCI CTCAE v4. a Includes events occurring up to 30 days after last nivolumab dose, regardless of causality. After an immune-mediated adverse reaction, reactions following nivolumab rechallenge were included if they occurred up to 30 days after completing the initial nivolumab course. b Includes asthenia. c Includes colitis. d Includes abdominal discomfort and upper abdominal pain. e Includes nasopharyngitis, pharyngitis, rhinitis, and sinusitis. f Includes pneumonia bacterial, pneumonia mycoplasmal, pneumocystis jirovecii pneumonia. g Includes dermatitis, dermatitis acneiform, dermatitis exfoliative, and rash described as macular, papular, maculopapular, pruritic, exfoliative, or acneiform. h Includes back pain, bone pain, musculoskeletal chest pain, musculoskeletal discomfort, myalgia, neck pain, and pain in extremity. i Includes hyperesthesia, hypoesthesia, paresthesia, dysesthesia, peripheral motor neuropathy, peripheral sensory neuropathy, and polyneuropathy. These numbers are specific to treatment-emergent events. Opdivo cHL Safety Population (n=266) Adverse Reaction a Percentage (%) All Grades Grades 3-4 General Disorders and Administration Site Conditions Fatigue b 39 1.9 Pyrexia 29]} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Manufacturer Bristol-Myers Squibb Company Drug Class Anti-PD-1 monoclonal antibodies Related Drugs Anti-PD-1 monoclonal antibodies Keytruda , nivolumab , pembrolizumab , Tecentriq , atezolizumab , Imfinzi Non-Small Cell Lung Cancer Avastin , methotrexate , Taxol , cisplatin , Taxotere , Tarceva , More... Renal Cell Carcinoma Avastin , nivolumab , Nexavar , Afinitor , Sutent , bevacizumab , More... Melanoma, Metastatic Keytruda , nivolumab , pembrolizumab , Yervoy , ipilimumab , Tafinlar , More... 6 more conditions... Opdivo Rating 17 User Reviews 3.6 /10 17 User Reviews 3.6 Rate it!} } diagnosed
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