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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
In a study of 71 patients, four patients including a 39-year-old man [not all ages and sexes stated] received off-label SC cladribine [Litak] and developed lymphopenia. In addition to this, one patient developed nausea during treatment with famciclovir, and one patient developed headache on famciclovir and vertigo during treatment with valaciclovir [durations of treatments to reactions onsets not stated; not all routes, dosages and outcomes stated].
Patient 1: The patient who had progressive multiple sclerosis, started receiving off-label treatment with SC cladribine. During the first week of treatment, the patient received SC cladribine 10mg on day 1, 2 and 3. Four weeks later, differential white cell counts were obtained, and depending upon the total lymphocyte count,another...