Table 13: Adverse Reactions (≥10%) in Patients with Relapsed or Refractory Multiple Myeloma Who Received TALVEY in MonumenTAL-1
	TALVEY N=339
System Organ Class Adverse Reaction	Any Grade (%)	Grade 3 or 4 (%)
Adverse reactions were graded based on CTCAE Version 4.03, with the exception of CRS, which was graded per ASTCT 2019 criteria.
* Includes other related terms. † Only grade 3 adverse reactions occurred. ‡ Dysgeusia: ageusia, dysgeusia, hypogeusia and taste disorder. § Per CTCAE v4.03, maximum toxicity grade for dysgeusia is 2 and maximum toxicity grade for dry mouth is 3. ¶ Stomatitis: cheilitis, glossitis, glossodynia, mouth ulceration, oral discomfort, oral mucosal erythema, oral pain, stomatitis, swollen tongue, tongue discomfort, tongue erythema, tongue edema and tongue ulceration. # Oral disorder: oral disorder, oral dysesthesia, oral mucosal exfoliation, oral toxicity and oropharyngeal pain. Þ Nail disorder: koilonychia, nail bed disorder, nail cuticle fissure, nail discoloration, nail disorder, nail dystrophy, nail hypertrophy, nail pitting, nail ridging, nail toxicity, onychoclasis, onycholysis and onychomadesis. ß Skin disorder: palmar-plantar erythrodysesthesia syndrome, palmoplantar keratoderma, skin discoloration, skin exfoliation and skin fissures. à Rash: dermatitis, dermatitis acneiform, dermatitis contact, dermatitis exfoliative, dermatitis exfoliative generalized, erythema, exfoliative rash, rash, rash erythematous, rash macular, rash maculo-papular, rash papular, rash pruritic, rash pustular, rash vesicular and stasis dermatitis. è Xerosis: dry eye, dry skin and xerosis. ð Bacterial infection including sepsis: bacteremia, bacterial prostatitis, carbuncle, cellulitis, citrobacter infection, clostridium difficile colitis, clostridium difficile infection, cystitis escherichia, cystitis klebsiella, diverticulitis, enterobacter bacteremia, escherichia pyelonephritis, escherichia sepsis, folliculitis, gastroenteritis escherichia coli, helicobacter gastritis, human ehrlichiosis, klebsiella bacteremia, klebsiella sepsis, moraxella infection, otitis media acute, pitted keratolysis, pneumococcal sepsis, pneumonia, pneumonia streptococcal, pseudomonal bacteremia, pyuria, renal abscess, salmonella sepsis, sepsis, septic shock, skin infection, staphylococcal bacteremia, staphylococcal infection, staphylococcal sepsis, streptococcal bacteremia, tooth abscess, tooth infection, urinary tract infection enterococcal, and urinary tract infection pseudomonal. ø Includes fatal outcome(s): COVID-19 (N=2), dyspnea (N=2), bacterial infection including sepsis (N=1), fungal infection (N=1). ý Fungal infection: body tinea, candida infection, ear infection fungal, esophageal candidiasis, fungal infection, fungal sepsis, fungal skin infection, genital candidiasis, onychomycosis, oral candidiasis, oral fungal infection, oropharyngeal candidiasis, tinea pedis, vulvovaginal candidiasis, and vulvovaginal mycotic infection. £ Encephalopathy: agitation, altered state of consciousness, amnesia, aphasia, bradyphrenia, confusional state, delirium, depressed level of consciousness, disorientation, encephalopathy, hallucination, lethargy, memory impairment, mood altered, restlessness, sleep disorder and somnolence. ¥ Sensory neuropathy: dysesthesia, hyperesthesia, hypoesthesia, hypoesthesia oral, immune-mediated neuropathy, neuralgia, neuropathy peripheral, paresthesia, peripheral sensory neuropathy, polyneuropathy, sciatica and vestibular neuronitis. Œ Motor dysfunction: dysarthria, dysgraphia, dysmetria, dysphonia, gait disturbance, muscle atrophy, muscle spasms, muscular weakness and tremor.
General disorders and administration site conditions
Pyrexia *	83	4.7 †
Fatigue *	37	3.5 †
Chills	19	0
Pain *	18	1.8 †
Edema *	14	0
Injection site reaction *	13	0
Immune system disorders
Cytokine release syndrome	76	1.5 †
Gastrointestinal disorders
Dysgeusia ‡§	70	0
Dry mouth §	34	0
Dysphagia	23	0.9 †
Diarrhea †	21	0.9
Stomatitis ¶	18	1.2 †
Nausea	18	0
Constipation	16	0
Oral disorder #	12	0
Skin and subcutaneous tissue disorders
Nail disorder Þ	50	0
Skin disorder ß	41	0.3 †
Rash à	38	3.5 †
Xerosis è	30	0
Pruritus	19	0.3 †
Musculoskeletal and connective tissue disorders
Musculoskeletal pain *	43	3.2 †
Investigations
Weight decreased	35	1.5 †
Infections and infestations
Upper respiratory tract infection *	22	2.7 †
Bacterial infection including sepsis ð ø	19	9
COVID-19 *ø	11	2.7
Fungal infection ý ø	10	0.6
Vascular disorders
Hypotension *	21	2.9
Nervous system disorders
Headache *	21	0.6 †
Encephalopathy £	15	1.8 †
Sensory neuropathy ¥	14	0
Motor dysfunction Œ	10	0.6 †
Metabolism and nutrition disorders
Decreased appetite	19	1.2 †
Respiratory, thoracic and mediastinal disorders
Cough *	17	0
Dyspnea *ø	11	1.8
Hypoxia *	10	1.5 †
Cardiac disorders
Tachycardia *	11	0.6 †

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