STUDYID,DOMAIN,USUBJID,AESEQ,AETERM,AEMODIFY,AEDECOD,AEBODSYS,AESEV,AESER,AEACN,AEREL,AESTDTC,AEENDTC,AESTDY,AEENDY,AEENRF CDISC01,AE,CDISC01.100008,1,AGITATED,AGITATION,Agitation,Psychiatric disorders,MILD,N,DOSE NOT CHANGED,POSSIBLY RELATED,2003-05,,3,.,AFTER CDISC01,AE,CDISC01.100008,2,ANXIETY,,Anxiety,Psychiatric disorders,MODERATE,N,DOSE NOT CHANGED,POSSIBLY RELATED,2003-05-13,,15,.,AFTER CDISC01,AE,CDISC01.100008,3,DECREASED APPETITE,,Decreased appetite,Metabolism and nutrition disorders,MILD,N,DOSE NOT CHANGED,POSSIBLY RELATED,2003-08-19,2003-09-15,113,140, CDISC01,AE,CDISC01.100014,1,DIARRHEA,,Diarrhoea,Gastrointestinal disorders,MILD,N,DOSE NOT CHANGED,NOT RELATED,2004-01-06,,84,.,AFTER CDISC01,AE,CDISC01.100014,2,HEMORRHOIDS,,Haemorrhoids,Gastrointestinal disorders,MODERATE,N,DOSE NOT CHANGED,NOT RELATED,2004-01-06,,84,.,AFTER CDISC01,AE,CDISC01.100014,3,HEADACHE,,Headache,Nervous system disorders,MILD,N,DOSE NOT CHANGED,NOT RELATED,2004-01-27,,105,.,AFTER CDISC01,AE,CDISC01.100014,4,VOMIT,VOMITING,Vomiting,Gastrointestinal disorders,MODERATE,N,DRUG INTERRUPTED,POSSIBLY RELATED,2004-02-03,2004-02-03,112,112, CDISC01,AE,CDISC01.100014,5,VOMIT,VOMITING,Vomiting,Gastrointestinal disorders,SEVERE,Y,DRUG INTERRUPTED,POSSIBLY RELATED,2004-02-04,2004-02-09,113,118, CDISC01,AE,CDISC01.200001,1,ANXIETY,,Anxiety,Psychiatric disorders,SEVERE,N,DOSE NOT CHANGED,POSSIBLY RELATED,2003-10-16,2003-10-20,17,21, CDISC01,AE,CDISC01.200001,2,NAUSEA INTERMITTENT,,Nausea,Gastrointestinal disorders,SEVERE,N,DOSE NOT CHANGED,POSSIBLY RELATED,2003-10-16,2003-10-20,17,21, CDISC01,AE,CDISC01.200001,3,CONSTIPATION,,Constipation,Gastrointestinal disorders,MODERATE,N,DOSE NOT CHANGED,NOT RELATED,2003-12-25,,87,.,AFTER CDISC01,AE,CDISC01.200001,4,TIREDNESS,,Fatigue,General disorders and administration site conditions,SEVERE,N,DOSE NOT CHANGED,POSSIBLY RELATED,2003-12-25,,87,.,AFTER CDISC01,AE,CDISC01.200001,5,LEFT KNEE PAIN WORSENING,,Arthralgia,Musculoskeletal and connective tissue disorders,MILD,N,DRUG WITHDRAWN,NOT RELATED,2004-02-02,,126,.,AFTER CDISC01,AE,CDISC01.200002,1,MUSCLE SPASMS,,Muscle spasms,Musculoskeletal and connective tissue disorders,MILD,N,DOSE NOT CHANGED,NOT RELATED,2004-01-05,,88,.,AFTER CDISC01,AE,CDISC01.200002,2,PALPITATIONS INTERMITTENT,,Palpitations,Cardiac disorders,MILD,N,DOSE NOT CHANGED,NOT RELATED,2004-01-05,,88,.,AFTER CDISC01,AE,CDISC01.200002,3,LIGHTHEADEDNESS,,Dizziness,Nervous system disorders,MILD,N,DOSE NOT CHANGED,NOT RELATED,2004-02-26,2004-02-26,140,140,