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| 25 PROPERTY OF VERASTEM, INC. – NOT FOR DISTRIBUTION OR DISSEMINATION 25 † Grouped term for reactions with multiple preferred terms a Diarrhea or colitis includes the preferred terms: colitis, enterocolitis, colitis microscopic, colitis ulcerative, diarrhea, diarrhea hemorrhagic b Pneumonia includes the preferred terms: All preferred terms containing "pneumonia" except for "pneumonia aspiration"; bronchopneumonia, bronchopulmonary aspergillosis c Rash includes the preferred terms: dermatitis (including allergic, exfoliative, perivascular), erythema (including multiforme), rash (including exfoliative, erythematous, follicular, generalized, macular & papular, pruritic, pustular), toxic epidermal necrolysis and toxic skin eruption, drug reaction with eosinophilia and systemic symptoms, drug eruption, Stevens- Johnson syndrome Pooled Analysis of Safety Supporting Approval Adverse Reactions COPIKTRA 25 mg BID (N = 442) Grade ≥ 3 n (%) Any Grade n (%) Neutropenia † 132 (30%) 151 (34%) Diarrhea or colitis †a 101 (23%) 222 (50%) Pneumonia †b 67 (15%) 91 (21%) Anemia † 48 (11%) 90 (20%) Rash †c 41 (9%) 136 (31%) Fatigue † 22 (5%) 126 (29%) Pyrexia 7 (2%) 115 (26%) Musculoskeletal pain † 6 (1%) 90 (20%) Nausea † 4 (<1%) 104 (24%) Cough † 2 (<1%) 111 (25%) Upper respiratory tract infection † 2 (<1%) 94 (21%) 442 Patients with Previously Treated Hematologic Malignancies Most Common Adverse Reactions (≥ 10% Grade ≥ 3 or ≥ 20% Any Grade) in Patients with B-cell Malignancies Receiving COPIKTRA® Serious adverse reactions were reported in 289 patients (65%). The most frequent serious adverse reactions that occurred were: ▪ infection (31%) † ▪ diarrhea or colitis (18%) † ▪ pneumonia (17%) † ▪ rash (5%) † ▪ pneumonitis (5%) † Sources Copiktra USPI, 2018 COPIKTRA is approved for the treatment of adult patients with relapsed or refractory CLL or SLL after at least two prior therapies. For full prescribing and safety information, please refer to the Package Insert and Important Safety Information available at www.COPIKTRA.com. |