Trial Outcomes & Findings for Safety and Feasibility Study of Combination of State of Art Chemoimmunotherapy, Intensive Central Nervous System Prophylaxis and Scrotal Irradiation to Treat Primary Diffuse Large B-cell Lymphoma of Testis (NCT NCT00945724)
NCT ID: NCT00945724
Last Updated: 2025-05-30
Results Overview
Number of patients who withdrew the treatment due to adverse event
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
54 participants
Primary outcome timeframe
From treatment start until the last drug administration, up to week 22 for the 'R-CHOP, Depocyte, Methotrexate' Group, up to 15 weeks (Weeks 1-15) for the 'R-CHOP + Lyposomal Cytarabine' Group, and from week 18-22 for the 'HD-MTX' Group
Results posted on
2025-05-30
Participant Flow
Recruitment lasted from 27 September 2009 to 13 July 2017
Participant milestones
| Measure |
R-CHOP, Depocyte, Methotrexate
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone, liposomal cytarabine, methotrexate: Weeks 1-15:
* 6 cycles of CHOP on Days 1 to 5, to be repeated q21 Days
* Rituximab 375 mg/m2 on Day 0 or Day 1 of every CHOP cycle
* IT chemoth:Depocyte 50 mg on Day 0 of cycles 2,3,4\&5 of R-CHOP
Weeks 18-22:
• Methotrexate 1.5 g/m2 q14 Days x 2
From Week 24:
• Scrotal prophylactic radiotherapy or involved field radiotherapy(but can be planned concomitantly to R-CHOP in pts with bilateral disease)
|
|---|---|
|
Overall Study
STARTED
|
54
|
|
Overall Study
COMPLETED
|
45
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
R-CHOP, Depocyte, Methotrexate
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone, liposomal cytarabine, methotrexate: Weeks 1-15:
* 6 cycles of CHOP on Days 1 to 5, to be repeated q21 Days
* Rituximab 375 mg/m2 on Day 0 or Day 1 of every CHOP cycle
* IT chemoth:Depocyte 50 mg on Day 0 of cycles 2,3,4\&5 of R-CHOP
Weeks 18-22:
• Methotrexate 1.5 g/m2 q14 Days x 2
From Week 24:
• Scrotal prophylactic radiotherapy or involved field radiotherapy(but can be planned concomitantly to R-CHOP in pts with bilateral disease)
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Adverse Event
|
5
|
|
Overall Study
Second malignancy
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
R-CHOP, Depocyte, Methotrexate
n=54 Participants
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone, liposomal cytarabine, methotrexate: Weeks 1-15:
* 6 cycles of CHOP on Days 1 to 5, to be repeated q21 Days
* Rituximab 375 mg/m2 on Day 0 or Day 1 of every CHOP cycle
* IT chemoth:Depocyte 50 mg on Day 0 of cycles 2,3,4\&5 of R-CHOP
Weeks 18-22:
• Methotrexate 1.5 g/m2 q14 Days x 2
From Week 24:
• Scrotal prophylactic radiotherapy or involved field radiotherapy(but can be planned concomitantly to R-CHOP in pts with bilateral disease)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=54 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=54 Participants
|
|
Age, Categorical
>=65 years
|
27 Participants
n=54 Participants
|
|
Age, Continuous
|
66 years
n=54 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=54 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=54 Participants
|
|
Region of Enrollment
Italy
|
47 participants
n=54 Participants
|
|
Region of Enrollment
Switzerland
|
7 participants
n=54 Participants
|
|
Ann Arbor stage
Stage I
|
32 Participants
n=54 Participants
|
|
Ann Arbor stage
Stage II
|
22 Participants
n=54 Participants
|
|
Bilateral testicular location
Bilateral testicular location
|
1 Participants
n=54 Participants
|
|
Bilateral testicular location
No bilateral testicular location
|
53 Participants
n=54 Participants
|
|
B symptoms
Presence of B symptoms
|
2 Participants
n=54 Participants
|
|
B symptoms
No Presence of B symptoms
|
52 Participants
n=54 Participants
|
|
Serum lactate dehydrogenase (LDH)
> normal upper value
|
7 Participants
n=54 Participants
|
|
Serum lactate dehydrogenase (LDH)
</= normal upper value
|
47 Participants
n=54 Participants
|
|
Serum Beta2-microglobulin
> normal upper value
|
8 Participants
n=54 Participants
|
|
Serum Beta2-microglobulin
</= normal upper value
|
40 Participants
n=54 Participants
|
|
Serum Beta2-microglobulin
Not recorded
|
6 Participants
n=54 Participants
|
PRIMARY outcome
Timeframe: From treatment start until the last drug administration, up to week 22 for the 'R-CHOP, Depocyte, Methotrexate' Group, up to 15 weeks (Weeks 1-15) for the 'R-CHOP + Lyposomal Cytarabine' Group, and from week 18-22 for the 'HD-MTX' GroupPopulation: Weeks 1 -15 All patients treated with 6 cycles of R-CHOP (CHOP21) on days 0/1 to 5, to be repeated every 21 days Intratecal (IT) Chemotherapy: liposomal cytarabine on day 0 of cycles 2, 3, 4 and 5 of R-CHOP Weeks 18 - 22 High Dose (HD) Methotrexate (MTX) Days 0 - 4 of two 14 days cycles From Week 25 Scrotal prophylactic radio therapy (RT) to the contralateral testis.
Number of patients who withdrew the treatment due to adverse event
Outcome measures
| Measure |
R-CHOP, Depocyte, Methotrexate
n=54 Participants
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone, liposomal cytarabine, methotrexate: Weeks 1-15:
* 6 cycles of CHOP on Days 1 to 5, to be repeated q21 Days
* Rituximab 375 mg/m2 on Day 0 or Day 1 of every CHOP cycle
* IT chemoth:Depocyte 50 mg on Day 0 of cycles 2,3,4\&5 of R-CHOP
Weeks 18-22:
• Methotrexate 1.5 g/m2 q14 Days x 2
From Week 24:
• Scrotal prophylactic radiotherapy or involved field radiotherapy(but can be planned concomitantly to R-CHOP in pts with bilateral disease)
|
R-CHOP + Lyposomal Cytarabine
n=54 Participants
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone, liposomal cytarabine, methotrexate: Weeks 1-15:
* 6 cycles of CHOP on Days 1 to 5, to be repeated q21 Days
* Rituximab 375 mg/m2 on Day 0 or Day 1 of every CHOP cycle
* IT chemoth:Depocyte 50 mg on Day 0 of cycles 2,3,4\&5 of R-CHOP
|
HD-MTX
n=48 Participants
Weeks 18-22:
• Methotrexate 1.5 g/m2 q14 Days x 2
|
|---|---|---|---|
|
Adverse Events Assessment
|
6 Participants
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: From the first documented response to relapse until 5 years from study entryPercentage of patients with disease progression after achieving a remission
Outcome measures
| Measure |
R-CHOP, Depocyte, Methotrexate
n=54 Participants
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone, liposomal cytarabine, methotrexate: Weeks 1-15:
* 6 cycles of CHOP on Days 1 to 5, to be repeated q21 Days
* Rituximab 375 mg/m2 on Day 0 or Day 1 of every CHOP cycle
* IT chemoth:Depocyte 50 mg on Day 0 of cycles 2,3,4\&5 of R-CHOP
Weeks 18-22:
• Methotrexate 1.5 g/m2 q14 Days x 2
From Week 24:
• Scrotal prophylactic radiotherapy or involved field radiotherapy(but can be planned concomitantly to R-CHOP in pts with bilateral disease)
|
R-CHOP + Lyposomal Cytarabine
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone, liposomal cytarabine, methotrexate: Weeks 1-15:
* 6 cycles of CHOP on Days 1 to 5, to be repeated q21 Days
* Rituximab 375 mg/m2 on Day 0 or Day 1 of every CHOP cycle
* IT chemoth:Depocyte 50 mg on Day 0 of cycles 2,3,4\&5 of R-CHOP
|
HD-MTX
Weeks 18-22:
• Methotrexate 1.5 g/m2 q14 Days x 2
|
|---|---|---|---|
|
5 Year Cumulative Incidence of Progressions
|
6 percentage of participants
Interval 2.0 to 16.0
|
—
|
—
|
SECONDARY outcome
Timeframe: From study entry until 5 years afterPercentage of patients free from disease progression after 5 years from study entry
Outcome measures
| Measure |
R-CHOP, Depocyte, Methotrexate
n=54 Participants
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone, liposomal cytarabine, methotrexate: Weeks 1-15:
* 6 cycles of CHOP on Days 1 to 5, to be repeated q21 Days
* Rituximab 375 mg/m2 on Day 0 or Day 1 of every CHOP cycle
* IT chemoth:Depocyte 50 mg on Day 0 of cycles 2,3,4\&5 of R-CHOP
Weeks 18-22:
• Methotrexate 1.5 g/m2 q14 Days x 2
From Week 24:
• Scrotal prophylactic radiotherapy or involved field radiotherapy(but can be planned concomitantly to R-CHOP in pts with bilateral disease)
|
R-CHOP + Lyposomal Cytarabine
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone, liposomal cytarabine, methotrexate: Weeks 1-15:
* 6 cycles of CHOP on Days 1 to 5, to be repeated q21 Days
* Rituximab 375 mg/m2 on Day 0 or Day 1 of every CHOP cycle
* IT chemoth:Depocyte 50 mg on Day 0 of cycles 2,3,4\&5 of R-CHOP
|
HD-MTX
Weeks 18-22:
• Methotrexate 1.5 g/m2 q14 Days x 2
|
|---|---|---|---|
|
5 Years Progression Free Survival (PFS)
|
91 percentage of participants
Interval 79.0 to 96.0
|
—
|
—
|
SECONDARY outcome
Timeframe: From study entry until 5 years afterPercentage of patients alive after 5 years from study entry
Outcome measures
| Measure |
R-CHOP, Depocyte, Methotrexate
n=54 Participants
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone, liposomal cytarabine, methotrexate: Weeks 1-15:
* 6 cycles of CHOP on Days 1 to 5, to be repeated q21 Days
* Rituximab 375 mg/m2 on Day 0 or Day 1 of every CHOP cycle
* IT chemoth:Depocyte 50 mg on Day 0 of cycles 2,3,4\&5 of R-CHOP
Weeks 18-22:
• Methotrexate 1.5 g/m2 q14 Days x 2
From Week 24:
• Scrotal prophylactic radiotherapy or involved field radiotherapy(but can be planned concomitantly to R-CHOP in pts with bilateral disease)
|
R-CHOP + Lyposomal Cytarabine
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone, liposomal cytarabine, methotrexate: Weeks 1-15:
* 6 cycles of CHOP on Days 1 to 5, to be repeated q21 Days
* Rituximab 375 mg/m2 on Day 0 or Day 1 of every CHOP cycle
* IT chemoth:Depocyte 50 mg on Day 0 of cycles 2,3,4\&5 of R-CHOP
|
HD-MTX
Weeks 18-22:
• Methotrexate 1.5 g/m2 q14 Days x 2
|
|---|---|---|---|
|
5 Years Overall Survival (OS)
|
92 percentage of participants
Interval 81.0 to 97.0
|
—
|
—
|
Adverse Events
Safety Population
Serious events: 19 serious events
Other events: 47 other events
Deaths: 12 deaths
R-CHOP + Lyposomal Cytarabine
Serious events: 17 serious events
Other events: 47 other events
Deaths: 0 deaths
HD-MTX
Serious events: 3 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Safety Population
n=54 participants at risk
All patients who have received at least one dose of treatment will be considered as Safety Population
|
R-CHOP + Lyposomal Cytarabine
n=54 participants at risk
Subjects treated with R-CHOP (CHOP21).
|
HD-MTX
n=48 participants at risk
Subjects treated with HD-MTX.
|
|---|---|---|---|
|
Investigations
Increase of neutrophilis
|
1.9%
1/54 • Number of events 1 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
1.9%
1/54 • Number of events 1 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
0.00%
0/48 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic Cancer
|
1.9%
1/54 • Number of events 1 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
1.9%
1/54 • Number of events 1 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
0.00%
0/48 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
|
Vascular disorders
Thrombosis
|
1.9%
1/54 • Number of events 1 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
1.9%
1/54 • Number of events 1 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
0.00%
0/48 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
|
Cardiac disorders
Atrial fibrillation
|
1.9%
1/54 • Number of events 1 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
1.9%
1/54 • Number of events 1 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
0.00%
0/48 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
|
Cardiac disorders
Atrial flutter
|
1.9%
1/54 • Number of events 1 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
1.9%
1/54 • Number of events 1 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
0.00%
0/48 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
|
Cardiac disorders
Cardiac general pericardial effusion
|
1.9%
1/54 • Number of events 1 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
1.9%
1/54 • Number of events 1 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
0.00%
0/48 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
|
Nervous system disorders
Syncope
|
1.9%
1/54 • Number of events 1 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
1.9%
1/54 • Number of events 1 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
0.00%
0/48 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
|
Nervous system disorders
CNS cerebrovascular ischemia
|
1.9%
1/54 • Number of events 1 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
1.9%
1/54 • Number of events 1 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
0.00%
0/48 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
|
Nervous system disorders
Neuropathy
|
1.9%
1/54 • Number of events 1 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
1.9%
1/54 • Number of events 1 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
0.00%
0/48 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
|
Nervous system disorders
Headache
|
1.9%
1/54 • Number of events 1 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
1.9%
1/54 • Number of events 1 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
0.00%
0/48 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
|
Nervous system disorders
Intracranial hemorrhage
|
1.9%
1/54 • Number of events 1 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
0.00%
0/54 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
2.1%
1/48 • Number of events 1 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.4%
4/54 • Number of events 4 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
7.4%
4/54 • Number of events 4 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
0.00%
0/48 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
|
General disorders
Mucositis
|
1.9%
1/54 • Number of events 1 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
0.00%
0/54 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
2.1%
1/48 • Number of events 1 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
|
General disorders
Injection site reaction/extravasation changes
|
1.9%
1/54 • Number of events 1 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
1.9%
1/54 • Number of events 1 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
0.00%
0/48 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
|
General disorders
Fever
|
1.9%
1/54 • Number of events 1 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
1.9%
1/54 • Number of events 1 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
0.00%
0/48 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
|
Eye disorders
Diplopia
|
1.9%
1/54 • Number of events 1 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
1.9%
1/54 • Number of events 1 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
0.00%
0/48 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
|
Gastrointestinal disorders
Constipation
|
1.9%
1/54 • Number of events 1 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
1.9%
1/54 • Number of events 1 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
0.00%
0/48 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
1.9%
1/54 • Number of events 1 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
1.9%
1/54 • Number of events 1 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
0.00%
0/48 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
|
Renal and urinary disorders
Renal failure
|
1.9%
1/54 • Number of events 1 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
0.00%
0/54 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
2.1%
1/48 • Number of events 1 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
|
Renal and urinary disorders
Acute urinary retention
|
1.9%
1/54 • Number of events 1 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
1.9%
1/54 • Number of events 1 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
0.00%
0/48 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
|
Infections and infestations
Pneumonia
|
3.7%
2/54 • Number of events 2 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
3.7%
2/54 • Number of events 2 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
0.00%
0/48 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
Other adverse events
| Measure |
Safety Population
n=54 participants at risk
All patients who have received at least one dose of treatment will be considered as Safety Population
|
R-CHOP + Lyposomal Cytarabine
n=54 participants at risk
Subjects treated with R-CHOP (CHOP21).
|
HD-MTX
n=48 participants at risk
Subjects treated with HD-MTX.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.6%
3/54 • Number of events 5 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
5.6%
3/54 • Number of events 4 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
0.00%
0/48 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
|
Blood and lymphatic system disorders
Anemia
|
13.0%
7/54 • Number of events 13 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
14.8%
8/54 • Number of events 10 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
4.2%
2/48 • Number of events 3 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
|
Metabolism and nutrition disorders
Anorexia
|
5.6%
3/54 • Number of events 4 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
5.6%
3/54 • Number of events 4 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
0.00%
0/48 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
|
Gastrointestinal disorders
Constipation
|
22.2%
12/54 • Number of events 19 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
20.4%
11/54 • Number of events 15 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
4.2%
2/48 • Number of events 3 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
|
Gastrointestinal disorders
Diarreha
|
13.0%
7/54 • Number of events 11 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
11.1%
6/54 • Number of events 9 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
4.2%
2/48 • Number of events 2 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
11.1%
6/54 • Number of events 7 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
3.7%
2/54 • Number of events 3 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
0.00%
0/48 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
|
General disorders
Fatigue
|
16.7%
9/54 • Number of events 20 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
14.8%
8/54 • Number of events 16 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
8.3%
4/48 • Number of events 4 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.4%
4/54 • Number of events 4 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
7.4%
4/54 • Number of events 4 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
0.00%
0/48 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
|
General disorders
Fever
|
20.4%
11/54 • Number of events 17 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
16.7%
9/54 • Number of events 14 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
6.2%
3/48 • Number of events 3 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
|
General disorders
Flue-like Syndrome
|
7.4%
4/54 • Number of events 4 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
3.7%
2/54 • Number of events 2 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
2.1%
1/48 • Number of events 1 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
|
Nervous system disorders
Headache
|
25.9%
14/54 • Number of events 20 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
25.9%
14/54 • Number of events 19 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
0.00%
0/48 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
|
Blood and lymphatic system disorders
Leukopenia
|
13.0%
7/54 • Number of events 21 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
11.1%
6/54 • Number of events 17 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
6.2%
3/48 • Number of events 3 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
|
General disorders
Mucositis
|
11.1%
6/54 • Number of events 7 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
5.6%
3/54 • Number of events 3 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
8.3%
4/48 • Number of events 4 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
9/54 • Number of events 20 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
16.7%
9/54 • Number of events 17 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
4.2%
2/48 • Number of events 2 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
|
Blood and lymphatic system disorders
Neutropenia
|
38.9%
21/54 • Number of events 34 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
31.5%
17/54 • Number of events 28 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
8.3%
4/48 • Number of events 4 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
|
General disorders
Pain
|
18.5%
10/54 • Number of events 16 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
18.5%
10/54 • Number of events 12 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
4.2%
2/48 • Number of events 3 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
|
Nervous system disorders
Paresthesia
|
11.1%
6/54 • Number of events 7 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
7.4%
4/54 • Number of events 4 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
2.1%
1/48 • Number of events 1 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
|
Infections and infestations
Pneumonia
|
5.6%
3/54 • Number of events 3 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
3.7%
2/54 • Number of events 2 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
0.00%
0/48 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
|
Nervous system disorders
Sensitive/Peripheral Neuropathy
|
13.0%
7/54 • Number of events 7 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
11.1%
6/54 • Number of events 6 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
2.1%
1/48 • Number of events 1 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
|
Hepatobiliary disorders
Transaminases increase
|
13.0%
7/54 • Number of events 12 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
11.1%
6/54 • Number of events 10 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
4.2%
2/48 • Number of events 2 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
|
Blood and lymphatic system disorders
Trombocytopenia
|
5.6%
3/54 • Number of events 4 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
5.6%
3/54 • Number of events 4 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
0.00%
0/48 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
3/54 • Number of events 5 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
5.6%
3/54 • Number of events 5 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
0.00%
0/48 • All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
|
Additional Information
Scientific and Medical Director
International Extranodal Lymphoma Study Group (IELSG)
Phone: +41 58 666
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place