TriangleNCT01011920 · STUDY IN CONTEXT
Trial for Patients With Newly Diagnosed Primary Central Nervous System (CNS) Lymphoma
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
Percentage of patients with complete remission after 3 month of treatment. Percentage values are rounded to whole numbers.
Percentage of patients alive and free from disease progression, relapse, need for new treatment, after 2 years from study entry. Percentage values are rounded to whole numbers.
Percentage of patients alive and free from disease progression, relapse, need for new treatment, after 2 years from study entry any cause. Percentage values are rounded to whole numbers.
Percentage of patients alive after 2 years from study entry. Percentage values are rounded to whole numbers.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-central-nervous-system-lymphoma
- nct id
- NCT01011920
- trial label
- Trial for Patients With Newly Diagnosed Primary Central Nervous System (CNS) Lymphoma
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 4
- harms Count
- 5
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-central-nervous-system-lymphoma
- nct id
- NCT01011920
- outcome key
- om-0000
- source section id
- NCT01011920-om-0000
- source outcome index
- 0
- endpoint
- Complete Remission Rate After Primary Chemotherapy
- endpoint definition
- Percentage of patients with complete remission after 3 month of treatment. Percentage values are rounded to whole numbers.
- time origin
- 3 months after treatment start
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-central-nervous-system-lymphoma
- nct id
- NCT01011920
- outcome key
- om-0001
- source section id
- NCT01011920-om-0001
- source outcome index
- 1
- endpoint
- 2 Years Failure Free Survival (FFS) After Second Randomization
- endpoint definition
- Percentage of patients alive and free from disease progression, relapse, need for new treatment, after 2 years from study entry. Percentage values are rounded to whole numbers.
- time origin
- Every 3 weeks during treatment and every 3 months thereafter up to 2 years from study entry
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-central-nervous-system-lymphoma
- nct id
- NCT01011920
- outcome key
- om-0002
- source section id
- NCT01011920-om-0002
- source outcome index
- 2
- endpoint
- 2 Years Failure Free Survival (FFS)
- endpoint definition
- Percentage of patients alive and free from disease progression, relapse, need for new treatment, after 2 years from study entry any cause. Percentage values are rounded to whole numbers.
- time origin
- Every 3 weeks during treatment and every 3 months thereafter up to 2 years from study entry
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-central-nervous-system-lymphoma
- nct id
- NCT01011920
- outcome key
- om-0003
- source section id
- NCT01011920-om-0003
- source outcome index
- 3
- endpoint
- 2 Year Overall Survival (OS)
- endpoint definition
- Percentage of patients alive after 2 years from study entry. Percentage values are rounded to whole numbers.
- time origin
- From study entry until 2 years after
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-central-nervous-system-lymphoma
- nct id
- NCT01011920
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Arm A / MTX + AraC
- regimen
- 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 Methotrexate: 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. Ara-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
- analyzed count
- 75
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01011920-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-central-nervous-system-lymphoma
- nct id
- NCT01011920
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Arm B / MTX + Ara-C + Rituximab
- regimen
- 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 Methotrexate: 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. Ara-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 Rituximab: Rituximab 375 mg/m2 conventional infusion on day - 5 \& 0 every 3 weeks for a maximum of 4 cycles
- analyzed count
- 69
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01011920-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-central-nervous-system-lymphoma
- nct id
- NCT01011920
- outcome key
- om-0000
- arm key
- OG002
- arm label
- Arm C / MTX + Ara-C + Rituximab+Thiotepa
- regimen
- 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 Methotrexate: 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. Ara-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 Rituximab: Rituximab 375 mg/m2 conventional infusion on day - 5 \& 0 every 3 weeks for a maximum of 4 cycles Thiotepa: 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
- analyzed count
- 75
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01011920-om-0000#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-central-nervous-system-lymphoma
- nct id
- NCT01011920
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Arm D / WBRT 36 Gy +/- Boost 9 Gy
- regimen
- 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. radiotherapy: 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.
- analyzed count
- 55
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01011920-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-central-nervous-system-lymphoma
- nct id
- NCT01011920
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Arm E / BCNU + Thiotepa + APBSCT
- regimen
- 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 Thiotepa: 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 BCNU: BCNU 400 mg/m2 in 500 ml saline sol 1-hr inf. day -6 APBSCT: Autologous peripheral blood stem cell transplant (APBSCT)
- analyzed count
- 58
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01011920-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-central-nervous-system-lymphoma
- nct id
- NCT01011920
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Arm A / MTX + AraC
- regimen
- 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 Methotrexate: 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. Ara-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
- analyzed count
- 75
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01011920-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-central-nervous-system-lymphoma
- nct id
- NCT01011920
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Arm B / MTX + Ara-C + Rituximab
- regimen
- 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 Methotrexate: 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. Ara-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 Rituximab: Rituximab 375 mg/m2 conventional infusion on day - 5 \& 0 every 3 weeks for a maximum of 4 cycles
- analyzed count
- 69
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01011920-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-central-nervous-system-lymphoma
- nct id
- NCT01011920
- outcome key
- om-0002
- arm key
- OG002
- arm label
- Arm C / MTX + Ara-C + Rituximab+Thiotepa
- regimen
- 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 Methotrexate: 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. Ara-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 Rituximab: Rituximab 375 mg/m2 conventional infusion on day - 5 \& 0 every 3 weeks for a maximum of 4 cycles Thiotepa: 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
- analyzed count
- 75
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01011920-om-0002#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-central-nervous-system-lymphoma
- nct id
- NCT01011920
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Arm A / MTX + AraC
- regimen
- 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 Methotrexate: 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. Ara-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
- analyzed count
- 75
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01011920-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-central-nervous-system-lymphoma
- nct id
- NCT01011920
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Arm B / MTX + Ara-C + Rituximab
- regimen
- 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 Methotrexate: 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. Ara-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 Rituximab: Rituximab 375 mg/m2 conventional infusion on day - 5 \& 0 every 3 weeks for a maximum of 4 cycles
- analyzed count
- 69
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01011920-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-central-nervous-system-lymphoma
- nct id
- NCT01011920
- outcome key
- om-0003
- arm key
- OG002
- arm label
- Arm C / MTX + Ara-C + Rituximab+Thiotepa
- regimen
- 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 Methotrexate: 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. Ara-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 Rituximab: Rituximab 375 mg/m2 conventional infusion on day - 5 \& 0 every 3 weeks for a maximum of 4 cycles Thiotepa: 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
- analyzed count
- 75
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01011920-om-0003#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-central-nervous-system-lymphoma
- nct id
- NCT01011920
- outcome key
- om-0003
- arm key
- OG003
- arm label
- Arm D / WBRT 36 Gy +/- Boost 9 Gy
- regimen
- 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. radiotherapy: 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.
- analyzed count
- 55
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01011920-om-0003#groups/OG003
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-central-nervous-system-lymphoma
- nct id
- NCT01011920
- harm key
- EG000
- source section id
- NCT01011920-ae
- event group key
- EG000
- event group label
- Arm A / MTX + AraC
- serious affected
- 39
- serious at risk
- 75
- other affected
- 75
- other at risk
- 75
- frequency threshold
- 5
- collection period
- The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
- event definition
- 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.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-central-nervous-system-lymphoma
- nct id
- NCT01011920
- harm key
- EG001
- source section id
- NCT01011920-ae
- event group key
- EG001
- event group label
- Arm B / MTX + Ara-C + Rituximab
- serious affected
- 38
- serious at risk
- 69
- other affected
- 68
- other at risk
- 69
- frequency threshold
- 5
- collection period
- The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
- event definition
- 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.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-central-nervous-system-lymphoma
- nct id
- NCT01011920
- harm key
- EG002
- source section id
- NCT01011920-ae
- event group key
- EG002
- event group label
- Arm C / MTX + Ara-C + Rituximab+Thiotepa
- serious affected
- 39
- serious at risk
- 75
- other affected
- 74
- other at risk
- 75
- frequency threshold
- 5
- collection period
- The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
- event definition
- 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.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-central-nervous-system-lymphoma
- nct id
- NCT01011920
- harm key
- EG003
- source section id
- NCT01011920-ae
- event group key
- EG003
- event group label
- Arm D / WBRT 36 Gy +/- Boost 9 Gy
- serious affected
- 5
- serious at risk
- 55
- other affected
- 38
- other at risk
- 55
- frequency threshold
- 5
- collection period
- The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
- event definition
- 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.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-central-nervous-system-lymphoma
- nct id
- NCT01011920
- harm key
- EG004
- source section id
- NCT01011920-ae
- event group key
- EG004
- event group label
- Arm E / BCNU + Thiotepa + APBSCT
- serious affected
- 10
- serious at risk
- 58
- other affected
- 49
- other at risk
- 58
- frequency threshold
- 5
- collection period
- The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
- event definition
- 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.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice