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Discountinuation across trails

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5.spravato

* Patients in the TRANSFORM-1,1 TRANSFORM-22 and SUSTAIN-14 trials were adults aged 18 to 64. Patients in the TRANSFORM-3 trial were elderly (aged ≥ 65). Patients in the SUSTAIN-2 trial were adults (aged 18 to 64) and elderly (aged ≥ 65). 5
* Combined data across 56 mg and 84 mg dose groups. Single event of depression in the 56 mg group. In the 84 mg, AEs leading to discontinuation were single events of anxiety, disturbance in attention, extrasystoles, headache, mania, motion sickness, panic attack, and tachycardia; and two events each of dizziness, nausea and vomiting. 1
** Single events of erectile dysfunction, and worsening insomnia. 4

Single events of anxiety, depression, depressive symptoms, panic attack, drug intolerance, feeling drunk, dizziness, headache, vertigo, nausea, road traffic accident, and multiple injuries.2
Single event of generalised rash.2

§AE that started in the double-blind phase and resulted in discontinuation in the follow-up phase is counted as treatment-emergent in the doubleblind phase. Incidence is based on the number of patients experiencing at least one AE, not the number of events.3

#Worsening depression (3 patients) 8, anxiety and confusional state (transient) 1 patient.4
In the active comparator group, the placebo nasal spray was discontinued in 2.1% of patients (n=3/145; worsening depression for each).4

Reference:
1- Fedgchin M, Trivedi M, Daly EJ, Melkote R, et al. Efficacy and Safety of Fixed-Dose Esketamine
Nasal Spray Combined With a New Oral Antidepressant in Treatment- Resistant Depression: Results of a Randomized, Double-Blind, Active- Controlled Study (TRANSFORM-1). Int J Neuropsychopharmacol. 2019; 22 (10) :616-630.
2- Popova V, Daly EJ, Trivedi M, et al. Efficacy and Safety of Flexibly Dosed Esketamine Nasal
Spray Combined With a Newly Initiated Oral Antidepressant in Treatment- Resistant Depression: A
Randomized Double-Blind Active-Controlled Study Am J Psychiatry 2019; 176: 428-438.
3- Ochs-Ross R, Daly EJ, Zhang Y, Lane R, Lim P, et al. Efficacy and Safety of Esketamine Nasal Spray Plus an Oral Antidepressant in Elderly Patients With Treatment-Resistant Depression-TRANSFORM-3. Am J Geriatr Psychiatry. 2020; 28 (2) :121-141.
4- Daly EJ, Trivedi MH, Janik A, et al. Efficacy of Esketamine Nasal Spray Plus Oral Antidepressant
Treatment for Relapse Prevention in Patients With Treatment-Resistant Depression: A Randomized
Clinical Trial. JAMA Psychiatry 2019; 76 (9) : 893–903.
5- Wajs E, Aluisio L, Holder R,et al . Esketamine Nasal Spray Plus Oral Antidepressant in Patients With Treatment-Resistant Depression: Assessment of Long-Term Safety in a Phase 3, Open-Label Study (SUSTAIN-2). J Clin Psychiatry. 2020; 81 (3) :19m12891.

CP-233066