Stopping Rules and Discontinuation Criteria Sample Clauses

Stopping Rules and Discontinuation Criteria. During the conduct of the study, SAEs will be reviewed (see Section 8.1.4) as they are reported from the study sites to identify safety concerns. The sponsor may terminate this study at any time. Reasons for termination include but are not limited to: • The incidence or severity of AEs in this or other studies point to a potential health hazard for study subjects • Insufficient subject enrolment • Any information becoming available that substantially changes the expected benefit/risk profile of the study treatments. A subject may discontinue participation in the study at any time for any reason (e.g. lack of efficacy, withdrawal of consent, AE) (see Section 4.4). The investigator and/or sponsor can withdraw a subject from the study at any time for any reason (e.g. protocol deviation as defined in Section 11.1.2, noncompliance with the protocol conditions or AE).
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Stopping Rules and Discontinuation Criteria. A patient may discontinue participation in the study at any time for any reason (eg, lack of efficacy, consent withdrawn, or adverse event). The investigator and/or sponsor can withdraw a patient from the study at any time for any reason (eg, protocol violation or deviation as defined in section 11.1.2, noncompliance, or adverse event). An independent, external DSMB will oversee the safety of the patients enrolled in the study and monitor the occurrence of flare throughout the study. The DSMB will meet as specified in its charter. The DSMB may recommend stopping the study for safety concerns. Toxicity will be monitored using the Modified World Health Organization (WHO) Toxicity Criteria, which includes graded adverse events on a scale from 0 to 4 (see Appendix A).Individual patients will be withdrawn from the study if any of the following occur: Event Rule for withdrawing patient Grade 2 event The patient will be treated according to the investigator’s usual standard of care (SOC). If the event does not improve to grade 1 or less within 4 weeks from the onset of grade 2 severity, the medical monitor should be contacted to determine if the patient should be withdrawn from the study. Grade 3 event (one grade 3 event not related to treatment) The patient will be treated according to the investigator’s usual SOC. If the event does not improve to grade 1 or less within 4 weeks from the onset of grade 3 severity, the medical monitor should be contacted to determine if the patient should be withdrawn from the study. Grade 3 event (one grade 3 event related to treatment or two grade 3 events not related to treatment) The patient will be withdrawn from the study. Grade 4 event (any grade 4 event, related or not related to treatment) The patient will be withdrawn from the study. Pregnancy The patient will be withdrawn from the study. Serious intercurrent illness or significant worsening of intercurrent illness (eg, diagnosis of any cancer, lymphoma or leukemia, anaphylaxis, severe infections) The patient will be withdrawn from the study. Severe flare The patient will be withdrawn from the study. This study may be prematurely terminated if, in the opinion of the DSMB or the sponsor, there is sufficient and reasonable cause. Written notification documenting the reason for study termination will be provided by the terminating party to all involved. In order to ensure patient safety, patients who are determined to be treatment failures will be withdrawn from the study. ...
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