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ADVERSE EVENTS BY CHOICE OF TAXANE:
ABRAXANE GROUP13

FROM THE NEW ENGLAND JOURNAL OF MEDICINE

Data cutoff April 3, 2018

Adverse events occurring in ≥15% of patients who received ABRAXANE in either group*
Adverse reactions in the pembrolizumab combination arm (n=109) vs the placebo combination arm (n=113): anemia (80 [73.4%] vs 82 [72.6%], any grade; 26 [23.9%] vs 36 [31.9%], Grade 3, 4, or 5), neutropenia (59 [54.1%] vs 55 [48.7%], any grade; 37 [33.9%] vs 40 [35.4%], Grade 3, 4, or 5), thrombocytopenia (41 [37.6%] vs 33 [29.2%], any grade; 10 [9.2%] vs 9 [8.0%], Grade 3, 4, or 5; alopecia (38 [34.9%] vs 27 [23.9%], any grade; 0 vs 0, Grade 3, 4, or 5), diarrhea (38 [34.9%] vs 36 [31.9%], any grade; 4 [3.7%] vs 1 [0.9%], Grade 3, 4, or 5], nausea (38 [34.9%] vs 44 [38.9%], any grade;
1 [0.9%] vs 3 [2.7%], Grade 3, 4, or 5), decreased appetite (30 [27.5%] vs 40 [35.4%], any grade; 1 [0.9%] vs 4 [3.5%], Grade 3, 4, or 5), fatigue (28
[25.7%] vs 35 [31.0%], any grade; 2 [1.8%] vs 5 [4.4%], Grade 3, 4, or 5), constipation (25 [22.9%] vs 27 [23.9%], any grade; 1 [0.9%] vs 1 [0.9%], Grade 3, 4, or 5), asthenia (23 [21.1%] vs 25 [22.1%], any grade; 1 [0.9%] vs 3 [2.7%], Grade 3, 4, or 5), vomiting (21 [19.3%] vs 18 [15.9%], any grade; 1 [0.9%] vs 3 [2.7%], Grade 3, 4, or 5), epistaxis (20 [18.3%] vs 13
[11.5%], any grade; 0 vs 0, Grade 3, 4, or 5), arthralgia (17 [15.6%] vs 15 [13.3%], any grade; 1 [0.9%] vs 1 [0.9%], Grade 3, 4, or 5), rash (17 [15.6%]
vs 12 [10.6%], any grade; 0 vs 0, Grade 3, 4, or 5), white blood cell count decreased (17 [15.6%] vs 17 [15.0%], any grade; 7 [6.4%] vs 7 [6.2%], Grade 3, 4, or 5), cough (16 [14.7%] vs 24 [21.2%], any grade; 2 [1.8%] vs 2 [1.8%], Grade 3, 4, or 5), pyrexia (13 [11.9%] vs 22 (19.5%], any grade; 2 [1.8%] vs 2 [1.8%], Grade 3, 4, or 5), neutrophil count decreased (12 [11.0%] vs 20 [17.7%], any grade; 8 [7.3%] vs 17 [15.0%], Grade 3, 4, or 5).

*Includes adverse events that occurred during randomly allocated study treatment or within the 30 days thereafter (within 90 days for serious events), regardless of attribution to study treatment by the investigator. Adverse events that occurred during in-study crossover are excluded. The as-treated population included all patients who underwent randomization and received ≥1 dose of study treatment.13


ADVERSE EVENTS BY CHOICE OF TAXANE:
PACLITAXEL GROUP13

FROM THE NEW ENGLAND JOURNAL OF MEDICINE

Data cutoff April 3, 2018

Adverse events occurring in ≥15% of patients who received paclitaxel in either group*
Adverse reactions in the pembrolizumab combination arm (n=169) vs the placebo combination arm (n=167): alopecia (90 [53.3%] vs 75 [44.9%], any grade; 1 [0.6%] vs 3 [1.8%], Grade 3, 4, or 5), anemia (68 [40.2%] vs 63 [37.7%], any grade; 17 [10.1%] vs 21 [12.6%], Grade 3, 4, or 5), nausea (61 [36.1%] vs 46 [27.5%], any grade; 2 [1.2%] vs 1 [0.6%], Grade 3, 4, or 5), neutropenia (46 [27.2%] vs 37 [22.2%], any grade; 26 [15.4%] vs 29 [17.4%], Grade 3, 4, or 5), diarrhea (45 [26.6%] vs 29 [17.4%], any grade; 7 [4.1%] vs 5 [3.0%], Grade 3, 4, or 5), thrombocytopenia (44 [26.0%] vs 32 [19.2%], any grade; 9 [5.3%] vs 9 [5.4%], Grade 3, 4, or 5), neuropathy peripheral (42 [24.9%] vs 33 [19.8%], any grade; 2 [1.2%] vs 2 [1.2%], Grade 3, 4, or 5), arthralgia (40 [23.7%] vs 25 [15.0%], any grade; 3 [1.8%] vs 1 [0.6%], Grade 3, 4, or 5), constipation (39 [23.1%] vs 34 [20.4%], any grade; 1 [0.6%] vs 2 [1.2%], Grade 3, 4, or 5), decreased appetite (38 [22.5%] vs 42 [25.1%], any grade; 5 [3.0%] vs 1 [0.6%], Grade 3, 4, or 5), asthenia (37 [21.9%] vs 34 [20.4%], any grade; 5 [3.0%] vs 7 [4.2%], Grade 3, 4, or 5), fatigue (35 [20.7%] vs 37 [22.2%], any grade; 7 [4.1%] vs 6 [3.6%], Grade 3, 4, or 5), myalgia (28 [16.6%] vs 23 [13.8%], any grade; 2 [1.2%] vs 1 [0.6%], Grade 3, 4, or 5), and dyspnea (23 [13.6%] vs 29 [17.4%], any grade; 3 [1.8%] vs 1 [0.6%], Grade 3, 4, or 5).

*Includes adverse events that occurred during randomly allocated study treatment or within the 30 days thereafter (within 90 days for serious events), regardless of attribution to study treatment by the investigator. Adverse events that occurred during in-study crossover are excluded. The as-treated population included all patients who underwent randomization and received ≥1 dose of study treatment.13

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