Criteria for discontinuing allocated interventions
toxicity, agentAny, intercurrent illness
ADVERSE EVENTS, DISEASE
An individual participant may stop treatment early for any of the following reasons:Disease progressionUnacceptable toxicity, intercurrent illness or change in patient's condition that justifies discontinuationInadequate compliance with the protocol treatment, in the judgement of the treating physicianPregnancy or intent to become pregnantGrade ≥ 3 infusion reactionInitiation of alternative anticancer therapy including another investigational agentAny dosing interruption lasting >6 weeks although dosing delays or interruptions to allow for prolonged steroid tapers to manage drug-related adverse events are allowed.Withdrawal of consent for treatment by the patient