{"description":"All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.","eventGroups":[{"deathsNumAffected":56,"deathsNumAtRisk":75,"description":"Arm A Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion) d 1 Cytarabine 2 g/m2 1 hr infusion, twice a day (every 12 hs.) d 2 - 3\n\nMethotrexate: Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion) on day 1, every 3 weeks for a maximum of 4 courses.\n\nAra-C: Cytarabine 2 g/m2 (1 hr infusion, twice a day every 12 hours), on d 2 - 3 every 3 weeks for a maximum of 4 courses","id":"EG000","otherNumAffected":75,"otherNumAtRisk":75,"seriousNumAffected":39,"seriousNumAtRisk":75,"title":"Arm A / MTX + AraC"},{"deathsNumAffected":41,"deathsNumAtRisk":69,"description":"Arm B Rituximab 375 mg/m2 conventional infusion d -5 \\& 0 Methotrexate 3.5 g/m2 0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion d 1 Cytarabine 2 g/m2 1 hr infusion, twice a day (every 12 hs.) d 2 - 3\n\nMethotrexate: Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion) on day 1, every 3 weeks for a maximum of 4 courses.\n\nAra-C: Cytarabine 2 g/m2 (1 hr infusion, twice a day every 12 hours), on d 2 - 3 every 3 weeks for a maximum of 4 courses\n\nRituximab: Rituximab 375 mg/m2 conventional infusion on day - 5 \\& 0 every 3 weeks for a maximum of 4 cycles","id":"EG001","otherNumAffected":68,"otherNumAtRisk":69,"seriousNumAffected":38,"seriousNumAtRisk":69,"title":"Arm B / MTX + Ara-C + Rituximab"},{"deathsNumAffected":33,"deathsNumAtRisk":75,"description":"Arm C Rituximab 375 mg/m2 conventional infusion d -5 \\& 0 Methotrexate 3.5 g/m2 0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion d 1 Cytarabine 2 g/m2 1 hr infusion, twice a day (every 12 hs.) d 2 - 3 Thiotepa 30 mg/m2 30 min. Infusion d 4\n\nMethotrexate: Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion) on day 1, every 3 weeks for a maximum of 4 courses.\n\nAra-C: Cytarabine 2 g/m2 (1 hr infusion, twice a day every 12 hours), on d 2 - 3 every 3 weeks for a maximum of 4 courses\n\nRituximab: Rituximab 375 mg/m2 conventional infusion on day - 5 \\& 0 every 3 weeks for a maximum of 4 cycles\n\nThiotepa: ARM C: Thiotepa 30 mg/m2 (30 min. Infusion) on day 4 every 3 weeks for a maximum of 4 courses ARM E: Thiotepa 5 mg/kg in 250 ml saline sol 2-hr inf. every 12 hrs days -5 \\& -4","id":"EG002","otherNumAffected":74,"otherNumAtRisk":75,"seriousNumAffected":39,"seriousNumAtRisk":75,"title":"Arm C / MTX + Ara-C + Rituximab+Thiotepa"},{"deathsNumAffected":30,"deathsNumAtRisk":55,"description":"ARM D: WBRT with 36 Gy in the case of CR to primary chemotherapy or the same WBRT dose followed by a tumor-bed boost of 9 Gy with 1-2 cm of margin surrounding enhanced residual lesion (total tumor-bed dose 45 Gy) in patients who achieved a PR or SD after primary chemotherapy. Photons of 4-10 Mev, 180 cGy per day, 5 weekly fractions.\n\nradiotherapy: Photons of 4-10 Mev, 180 cGy per day, 5 weekly fractions. Whole-brain will be irradiated by two opposite lateral fields including the first two cervical vertebras and the posterior two thirds of the orbits, which must be shielded after 30 Gy (after 36 Gy in the case of evident intraocular disease at diagnosis). Tumor-bed (boost or partial-brain RT) will be irradiated by 2 to 4 isocentric treatment fields based on tumor location, with all portals treated per each RT session.","id":"EG003","otherNumAffected":38,"otherNumAtRisk":55,"seriousNumAffected":5,"seriousNumAtRisk":55,"title":"Arm D / WBRT 36 Gy +/- Boost 9 Gy"},{"deathsNumAffected":23,"deathsNumAtRisk":58,"description":"Arm E BCNU 400 mg/m2 in 500 ml saline sol 1-hr inf. day -6 Thiotepa 5 mg/kg in 250 ml saline sol 2-hr inf. every 12 hrs days -5 \\& -4 Reinfusion of PBSC ≥5 x 106 CD34+ cells/kg day 0\n\nThiotepa: ARM C: Thiotepa 30 mg/m2 (30 min. Infusion) on day 4 every 3 weeks for a maximum of 4 courses ARM E: Thiotepa 5 mg/kg in 250 ml saline sol 2-hr inf. every 12 hrs days -5 \\& -4\n\nBCNU: BCNU 400 mg/m2 in 500 ml saline sol 1-hr inf. day -6\n\nAPBSCT: Autologous peripheral blood stem cell transplant (APBSCT)","id":"EG004","otherNumAffected":49,"otherNumAtRisk":58,"seriousNumAffected":10,"seriousNumAtRisk":58,"title":"Arm E / BCNU + Thiotepa + APBSCT"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 5.1","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":75,"numEvents":16},{"groupId":"EG001","numAffected":11,"numAtRisk":69,"numEvents":18},{"groupId":"EG002","numAffected":7,"numAtRisk":75,"numEvents":11},{"groupId":"EG003","numAffected":5,"numAtRisk":55,"numEvents":5},{"groupId":"EG004","numAffected":7,"numAtRisk":58,"numEvents":7}],"term":"Coagulation disorders"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 5.1","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":75,"numEvents":34},{"groupId":"EG001","numAffected":18,"numAtRisk":69,"numEvents":38},{"groupId":"EG002","numAffected":13,"numAtRisk":75,"numEvents":27},{"groupId":"EG003","numAffected":10,"numAtRisk":55,"numEvents":10},{"groupId":"EG004","numAffected":4,"numAtRisk":58,"numEvents":4}],"term":"Neurological toxicity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 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