Select serious adverse events¹*

Pooled safety data from the TRANSCEND and TRANSCEND WORLD studies (N=213)

*  Pooled results from two studies (TRANSCEND [017001] and TRANSCEND WORLD [JCAR017-BCM-001]) in 213 adult patients within the dose range of 60 x 10⁶ to 120 x 10⁶ CAR+ viable T cells with R/R large B-cell lymphoma who received a flat dose of BREYANZI.¹
†  Lee criteria for grading CRS (Lee DW. Blood. 2014;124(2):188-95. Errata in Blood. 2015;126(8):1048 and 2016;128(11):1533).¹
‡  NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) criteria for grading neurologic toxicities.^1
§  3 patients who received BREYANZI had ongoing CRS at the time of death.¹
¶  Ongoing.

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CLINICAL TRIAL ADVERSE EVENTS

Pooled safety data from the TRANSCEND and TRANSCEND WORLD studies¹

The Preferred Term of CRS is summarized as well as the individual symptoms of CRS. These include chills, decreased appetite, dizziness, dyspnea, fatigue, headache, hypotension, hypoxia, nausea, pain, pyrexia, tachycardia, tremor.

• *  Includes heart rate increased, sinus tachycardia, tachycardia.
• †  Includes abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper, abdominal rigidity, abdominal tenderness, gastrointestinal pain.
• ‡  Includes fatigue, malaise.
• §  Includes edema, edema genital, edema peripheral, generalized edema, localized edema, scrotal edema, peripheral swelling, swelling.
• ¶  Includes hypogammaglobulinemia, immunoglobulins decreased.
• **  Infections and infestations are grouped per MedDRA high level group term.
• ††  Includes headache, head discomfort, migraine, sinus headache.
• ‡‡  Includes amnesia, cognitive disorder, confusional state, depersonalization/derealization disorder, depressed level of consciousness, disturbance in attention, flat affect, hypersomnia, incoherent, lethargy, leukoencephalopathy, loss of consciousness, memory impairment, mental impairment, mental status changes, paranoia, somnolence, stupor.
• §§  Includes dizziness, presyncope, syncope.
• ¶¶  Includes tremor, essential tremor, resting tremor.
• ***  Includes acute kidney injury, blood creatinine increased, renal failure, renal impairment, renal injury.
• †††  Includes cough, productive cough, upper-airway cough syndrome.
• ‡‡‡  Includes acute respiratory failure, dyspnea, dyspnea exertional, respiratory failure.
• §§§  Includes dermatitis acneiform, erythema, rash, rash maculo-papular, rash pruritic.
• ¶¶¶  Includes hypotension, orthostatic hypotension.

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