Select serious adverse events (AEs)

*  TRANSFORM was a Phase 3 open-label, randomized, parallel-group, multicentre trial in adult patients with large B-cell lymphoma primary refractory to or relapsed within 12 months from a complete response to initial chemoimmunotherapy, who were candidates for autologous hemopoietic stem cell transplant. 92 patients underwent leukapheresis and 89 patients received a single intravenous infusion of BREYANZI.
†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
‡  National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria for grading neurologic toxicities.¹

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CLINICAL TRIAL ADVERSE EVENTS

TRANSFORM trial adverse events¹

Adapted from the BREYANZI Product Monograph

The Preferred Term of cytokine release syndrome (CRS) is summarized as well as the individual symptoms of CRS. These include: chills, dizziness, fatigue, headache, hypotension, nausea, pyrexia, tachycardia, vomiting.

• *  Includes sinus tachycardia, and tachycardia.
• †  Includes abdominal pain, abdominal pain lower, abdominal pain upper, abdominal tenderness.
• ‡  Includes fatigue, malaise.
• §  Includes localized edema, edema peripheral, peripheral swelling.
• ¶  Infections and infestations are grouped per MedDRA high level group term.
• **  Includes headache, migraine, migraine with aura.
• ††  Includes dizziness, dizziness postural, presyncope, syncope.
• ‡‡  Includes resting tremor, tremor.
• §§  Includes insomnia, sleep disorder.
• ¶¶  Includes cough, productive cough.
• ***  Includes dermatitis acneiform, erythema, erythema multiforme, erythema nodosum, rash, rash maculo-papular, rash pruritic.
• †††  Includes hypotension, orthostatic hypotension.

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