Trial Outcomes & Findings for Prospective Observational Study on the Management of Patients With Relapsed or Refractory Follicular Lymphoma (OLYMPE) (NCT NCT02316613)

NCT ID: NCT02316613

Last Updated: 2016-02-25

Results Overview

At study inclusion, the therapeutic management of participants was decided by either "pluri-disciplinary consultation meeting," "Only the physician in charge of the participant," "Discussion between physicians," or "Punctual consultation of an external physician." Percentage of participants with each of these modalities of therapeutic decision was reported.

• Recruitment status: COMPLETED
• Target enrollment: 260 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2016-02-25

Participant Flow

Of 260 participants, 5 were excluded as no data available and duplicate cases (N=255; safety population) and 14 were excluded as other selection criteria not met (N=241; overall population).

Participant milestones

Measure	All Participants Participants with histologically confirmed, refractory/relapsed cluster of differentiation-20 (CD20) positive follicular non-Hodgkin's lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
Overall Study STARTED	260
Overall Study Safety Population	255
Overall Study Overall Population	241
Overall Study COMPLETED	156
Overall Study NOT COMPLETED	104

Reasons for withdrawal

Measure	All Participants Participants with histologically confirmed, refractory/relapsed cluster of differentiation-20 (CD20) positive follicular non-Hodgkin's lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
Overall Study Death	63
Overall Study Lost to Follow-up	9
Overall Study Lymphoma transformation	2
Overall Study Participant moved/changed medical team	11
Overall Study No data and duplicate cases	5
Overall Study Did not met selection criteria	14

Baseline Characteristics

Prospective Observational Study on the Management of Patients With Relapsed or Refractory Follicular Lymphoma (OLYMPE)

Baseline characteristics by cohort

Measure	All Participants n=241 Participants Participants with histologically confirmed, refractory/relapsed CD2 0-positive follicular non-Hodgkin's lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
Age, Continuous	61.6 years STANDARD_DEVIATION 11.2 • n=5 Participants
Sex: Female, Male Female	110 Participants n=5 Participants
Sex: Female, Male Male	131 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Population: Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed = participants who were evaluable for this outcome measure.

At study inclusion, the therapeutic management of participants was decided by either "pluri-disciplinary consultation meeting," "Only the physician in charge of the participant," "Discussion between physicians," or "Punctual consultation of an external physician." Percentage of participants with each of these modalities of therapeutic decision was reported.

Outcome measures

Measure	MabThera as Maintenance Therapy Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period. Participants who received treatment with MabThera after the first study induction period was reported.	All Participants n=238 Participants Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin's lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years. Participants who received treatment with MabThera over the first study induction period was reported.
Percentage of Participants With Modalities of the Therapeutic Decision Before First Study Induction Treatment Phase Pluri-disciplinary consultation meeting	—	81.9 percentage of participants
Percentage of Participants With Modalities of the Therapeutic Decision Before First Study Induction Treatment Phase Only the physician in charge of the participants	—	8.4 percentage of participants
Percentage of Participants With Modalities of the Therapeutic Decision Before First Study Induction Treatment Phase Discussion between physicians	—	6.3 percentage of participants
Percentage of Participants With Modalities of the Therapeutic Decision Before First Study Induction Treatment Phase Punctual consultation of an external physician	—	3.4 percentage of participants

PRIMARY outcome

Timeframe: Induction Phase: 18.7 months

Population: Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included.

Over the first treatment induction period, participants received following therapies for the treatment of refractory/relapsed follicular non-Hodgkin's lymphoma: chemotherapy combined with MabThera, chemotherapy alone, MabThera monotherapy, and stem cell transplantation, radio-immunotherapy, or radiation therapy combined with any other treatment. Study induction treatment phase consists total of three visits (one before the first cycle, one halfway through therapy and one after the last cycle to evaluate response). Induction treatment duration ranged between <3 months to >6 months. Each participants may received more than one therapy.

Outcome measures

Measure	MabThera as Maintenance Therapy Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period. Participants who received treatment with MabThera after the first study induction period was reported.	All Participants n=241 Participants Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin's lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years. Participants who received treatment with MabThera over the first study induction period was reported.
Percentage of Participants With Treatments Prescribed Over the First Study Induction Phase Chemotherapy plus MabThera	—	47.7 percentage of participants
Percentage of Participants With Treatments Prescribed Over the First Study Induction Phase MabThera as monotherapy	—	21.2 percentage of participants
Percentage of Participants With Treatments Prescribed Over the First Study Induction Phase Stem Cells Transplantation	—	19.5 percentage of participants
Percentage of Participants With Treatments Prescribed Over the First Study Induction Phase Radio-immunotherapy	—	11.2 percentage of participants
Percentage of Participants With Treatments Prescribed Over the First Study Induction Phase Chemotherapy alone	—	2.9 percentage of participants
Percentage of Participants With Treatments Prescribed Over the First Study Induction Phase Radiation therapy	—	2.5 percentage of participants

PRIMARY outcome

Timeframe: Induction Phase: 18.7 months

Population: Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included.

Over the first study induction phase, participants received the following chemotherapy: regimen including fludarabine; regimen including aracytine - platinum salts; cyclophosphamide/hydroxydaunorubicin/oncovin/prednisone (CHOP-like); cyclophosphamide/vincristine/prednisone (CVP); regimen including ifosfamide - etoposide; and other chemotherapy. One participant could receive more than one type of chemotherapy over the first treatment induction period.

Outcome measures

Measure	MabThera as Maintenance Therapy Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period. Participants who received treatment with MabThera after the first study induction period was reported.	All Participants n=122 Participants Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin's lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years. Participants who received treatment with MabThera over the first study induction period was reported.
Percentage of Participants With Chemotherapies Prescribed Over the First Study Induction Phase Regimen including fludarabine	—	45.9 percentage of participants
Percentage of Participants With Chemotherapies Prescribed Over the First Study Induction Phase Regimen including aracytine - platinum salts	—	44.3 percentage of participants
Percentage of Participants With Chemotherapies Prescribed Over the First Study Induction Phase CHOP-like	—	32.0 percentage of participants
Percentage of Participants With Chemotherapies Prescribed Over the First Study Induction Phase CVP	—	13.1 percentage of participants
Percentage of Participants With Chemotherapies Prescribed Over the First Study Induction Phase Regimen including ifosfamide - etoposide	—	10.7 percentage of participants
Percentage of Participants With Chemotherapies Prescribed Over the First Study Induction Phase Other chemotherapy	—	23.8 percentage of participants

PRIMARY outcome

Timeframe: Maintenance/observation Phase: 67.8 months

Population: Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed= those who entered in maintenance/observation after the first induction and before the first disease progression over the study.

During the maintenance period participants received four weekly infusion of MabThera.

Outcome measures

Measure	MabThera as Maintenance Therapy Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period. Participants who received treatment with MabThera after the first study induction period was reported.	All Participants n=201 Participants Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin's lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years. Participants who received treatment with MabThera over the first study induction period was reported.
Percentage of Participants With MabThera as Maintenance Therapy	—	63.2 percentage of participants Interval 56.5 to 69.9

PRIMARY outcome

Timeframe: Maintenance/observation Phase: 67.8 months

Population: Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed = those who received at least one MabThera infusion over the maintenance therapy period.

After study induction period (three visits) participants entered into either of two periods: 1. period of maintenance with MabThera followed by observation or 2. period of observation/maintenance without MabThera, followed by maintenance with MabThera.

Outcome measures

Measure	MabThera as Maintenance Therapy Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period. Participants who received treatment with MabThera after the first study induction period was reported.	All Participants n=127 Participants Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin's lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years. Participants who received treatment with MabThera over the first study induction period was reported.
Percentage of Participants With MabThera Maintenance Therapy and at Least One Observation Phase Maintenance with MabThera followed by observation	—	70.9 percentage of participants
Percentage of Participants With MabThera Maintenance Therapy and at Least One Observation Phase Observation followed by maintenance with MabThera	—	1.6 percentage of participants
Percentage of Participants With MabThera Maintenance Therapy and at Least One Observation Phase Only maintenance therapy	—	27.6 percentage of participants

PRIMARY outcome

Timeframe: Maintenance/observation Phase: 67.8 months

Population: Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed = those who received at least one infusion of MabThera and completed maintenance therapy with MabThera when associated with observation period.

Duration of MabThera maintenance therapy was calculated from the end of induction period to the day before the first disease progression over the study (or to the date of last participant information if no disease progression until the end of the participant follow-up). Disease progression was based on the followings: Eastern Cooperative Oncology Group performance status; presence of B symptoms (fever 38°C in absence of infection for more than 8 days, night sweats, weight loss exceeding 10% in 6 months); evaluation of tumor mass (Groupe d'Etudes des Lymphomes Folliculaires criteria); number of nodal sites; number and location of extranodal sites; Ann-Arbor stage (I to IV); any histological documentation: type of biopsy (nodal, extranodal, bone marrow); histological type (progression of follicular non-Hodgkin's lymphomas or transformation); latest available hemoglobin, neutrophils, normal or leukemic lymphocytes, platelets, lactate dehydrogenase, and total gamma globulins level.

Outcome measures

Measure	MabThera as Maintenance Therapy Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period. Participants who received treatment with MabThera after the first study induction period was reported.	All Participants n=92 Participants Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin's lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years. Participants who received treatment with MabThera over the first study induction period was reported.
Duration of MabThera Maintenance Therapy When Associated With Observation	—	24.5 months Interval 3.2 to 37.7

PRIMARY outcome

Timeframe: Maintenance/observation Phase: 67.8 months

Population: Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed=all participants having had maintenance/observation period before the first study disease progression.

Participants was prescribed with either of the following infection prophylaxis treatment: anti-pneumocystosis agents, antiviral agents, or immunoglobulins.

Outcome measures

Measure	MabThera as Maintenance Therapy Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period. Participants who received treatment with MabThera after the first study induction period was reported.	All Participants n=201 Participants Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin's lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years. Participants who received treatment with MabThera over the first study induction period was reported.
Percentage of Participants With Prescription of Injection Prophylaxis	—	39.3 percentage of participants

PRIMARY outcome

Timeframe: Maintenance/observation Phase: 67.8 months

Population: Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number participants analyzed= all participants having had maintenance/observation period before the first study disease progression and received infection prophylaxis treatment.

Participants received anti-pneumocystosis agents, antiviral agents, or immunoglobulins as infection prophylaxis. One participant could receive more than one infection prophylaxis treatment.

Outcome measures

Measure	MabThera as Maintenance Therapy Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period. Participants who received treatment with MabThera after the first study induction period was reported.	All Participants n=79 Participants Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin's lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years. Participants who received treatment with MabThera over the first study induction period was reported.
Percentage of Participants With Injection Prophylaxis Treatment Anti-pneumocystosis agent	—	65.8 percentage of participants
Percentage of Participants With Injection Prophylaxis Treatment Antiviral agents	—	83.5 percentage of participants
Percentage of Participants With Injection Prophylaxis Treatment Immunoglobulins	—	26.9 percentage of participants

PRIMARY outcome

Timeframe: Up to 6 years

Population: Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed= participants with at least one disease progression over the study period.

The therapeutic management of participants was decided by either "pluri-disciplinary consultation meeting," "Only the physician in charge of the participant," "Discussion between physicians," or "Punctual consultation of an external physician." Percentage of participants with each of these modalities of therapeutic decision was reported.

Outcome measures

Measure	MabThera as Maintenance Therapy n=40 Participants Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period. Participants who received treatment with MabThera after the first study induction period was reported.	All Participants n=35 Participants Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin's lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years. Participants who received treatment with MabThera over the first study induction period was reported.
Percentage of Participants With Modalities of the Therapeutic Decision at First Study Disease Progression Pluri-disciplinary consultation meeting	67.5 percentage of participants	80.0 percentage of participants
Percentage of Participants With Modalities of the Therapeutic Decision at First Study Disease Progression Only physician in charge of the participant	20.0 percentage of participants	17.1 percentage of participants
Percentage of Participants With Modalities of the Therapeutic Decision at First Study Disease Progression Discussion between physicians	10.0 percentage of participants	2.9 percentage of participants
Percentage of Participants With Modalities of the Therapeutic Decision at First Study Disease Progression Punctual consultation with an external physician	2.5 percentage of participants	0.0 percentage of participants

PRIMARY outcome

Timeframe: Up to 6 years

Population: Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed= participants with at least one disease progression over the study period.

After the first disease progression the participants received chemotherapy, immunotherapy, radio immunotherapy, stem cell transplantation, or radiation therapy for therapeutic management of the refractory/relapsed follicular non-Hodgkin's lymphoma. One participant could receive more than one type of treatment after the first study disease progression.

Outcome measures

Measure	MabThera as Maintenance Therapy n=40 Participants Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period. Participants who received treatment with MabThera after the first study induction period was reported.	All Participants n=35 Participants Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin's lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years. Participants who received treatment with MabThera over the first study induction period was reported.
Number of Participants With Therapeutic Management After the First Study Disease Progression Missing	4 participants	2 participants
Number of Participants With Therapeutic Management After the First Study Disease Progression Chemotherapy	29 participants	24 participants
Number of Participants With Therapeutic Management After the First Study Disease Progression Immunotherapy	27 participants	24 participants
Number of Participants With Therapeutic Management After the First Study Disease Progression Radio immunotherapy	4 participants	0 participants
Number of Participants With Therapeutic Management After the First Study Disease Progression Stem cell transplantation	7 participants	7 participants
Number of Participants With Therapeutic Management After the First Study Disease Progression Radiation therapy	5 participants	6 participants

SECONDARY outcome

Timeframe: Induction Phase: 18.7 months

Population: Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed (N)=number of participants evaluable for this outcome measure.

Last Induction treatment response: the last response assessment over the first study induction treatment (complete response [CR]: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CR unconfirmed: CR along with regression in lymph node mass by more than [>]75% in the sum of the products of greatest diameters [SPD]; Partial Response [PR]: greater than or equal to [>=] 50% decrease in SPD of 6 largest dominant nodes or nodal masses; Progression was 1 of the following: 1) lymphadenopathy; 2) a >=50% increase in previously noted or new appearance of hepato/splenomegaly; 3) >=50% increase in blood lymphocyte count with at least 5000 B lymphocytes/μL; 4) transformation to Richter's syndrome; or 5) occurrence of cytopenia; Stable disease [SD]: absence of necessary criteria to achieve CR or PR, but no advancement to progression) was described at the end of first study induction.

Outcome measures

Measure	MabThera as Maintenance Therapy Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period. Participants who received treatment with MabThera after the first study induction period was reported.	All Participants n=227 Participants Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin's lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years. Participants who received treatment with MabThera over the first study induction period was reported.
Percentage of Participants With Last Induction Treatment Response Complete response	—	38.3 percentage of participants
Percentage of Participants With Last Induction Treatment Response Complete response not confirmed	—	11.5 percentage of participants
Percentage of Participants With Last Induction Treatment Response Partial response >=50%	—	31.7 percentage of participants
Percentage of Participants With Last Induction Treatment Response Partial response <50%	—	6.2 percentage of participants
Percentage of Participants With Last Induction Treatment Response Stability	—	5.3 percentage of participants
Percentage of Participants With Last Induction Treatment Response Progression	—	7.0 percentage of participants

SECONDARY outcome

Timeframe: Up to 6 years

Population: Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed= those participants who entered in maintenance/observation after the first induction and before the first disease progression over the study.

Participants with at least one disease progression after the first study induction period were reported.

Outcome measures

Measure	MabThera as Maintenance Therapy n=127 Participants Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period. Participants who received treatment with MabThera after the first study induction period was reported.	All Participants n=74 Participants Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin's lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years. Participants who received treatment with MabThera over the first study induction period was reported.
Percentage of Participants With Number of Disease Progressions Number of disease progressions: 0	68.5 percentage of participants	52.7 percentage of participants
Percentage of Participants With Number of Disease Progressions Number of disease progressions: 1	22.0 percentage of participants	39.22 percentage of participants
Percentage of Participants With Number of Disease Progressions Number of disease progressions: 2	6.3 percentage of participants	6.8 percentage of participants
Percentage of Participants With Number of Disease Progressions Number of disease progressions: 3	2.4 percentage of participants	1.4 percentage of participants
Percentage of Participants With Number of Disease Progressions Number of disease progressions: 4	0.8 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: Up to 6 years

Population: Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed= participants with at least one disease progression over the study period. n=number of evaluable participant for each disease characteristics.

Disease characteristics included (tumor burden, measured from whole body computed tomography (CT) scan. Groupe d'Etudes des Lymphomes Folliculaires (GELF) criteria defined as parameters to initiate treatment in participants with untreated follicular lymphoma, grade 1,2,or 3A; having just one of the criteria justified treatment: 1. involvement of >=3 nodal sites, each with diameter of >=3 centimeter(cm); 2. any nodal/extranodal tumor mass with diameter of >=7cm; 3. B symptoms (temperature >=38 degrees celsius or night sweats or weight loss >10% over past 6 months); 4. splenomegaly; 5. pleural effusion/peritoneal ascites; 6. cytopenia (leukocytes <1×10^9 and/or platelets <100×10^9/L. One participant could present with more than 1 GELF criterion. Ann Arbor staging was used as staging system for lymphomas (Stage I to IV); stage depended upon the place where malignant tissue was located (through biopsy, CT scan, or positron emission tomography) and on systemic symptoms due to lymphoma).

Outcome measures

Measure	MabThera as Maintenance Therapy n=39 Participants Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period. Participants who received treatment with MabThera after the first study induction period was reported.	All Participants n=35 Participants Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin's lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years. Participants who received treatment with MabThera over the first study induction period was reported.
Percentage of Participants With Disease Characteristics at First Study Disease Progression Tumor burden: Data not available (n=32, 38)	5.3 percentage of participants	3.1 percentage of participants
Percentage of Participants With Disease Characteristics at First Study Disease Progression Tumor burden: High (n=32, 38)	42.1 percentage of participants	50.0 percentage of participants
Percentage of Participants With Disease Characteristics at First Study Disease Progression Tumor burden: Low (n=32, 38)	52.6 percentage of participants	46.9 percentage of participants
Percentage of Participants With Disease Characteristics at First Study Disease Progression GELF criteria: at least 3 nodal sites (n=32, 38)	21.1 percentage of participants	12.5 percentage of participants
Percentage of Participants With Disease Characteristics at First Study Disease Progression GELF criteria: Any nodal/extra-nodal mass(n=32,38)	18.4 percentage of participants	12.5 percentage of participants
Percentage of Participants With Disease Characteristics at First Study Disease Progression GELF criteria: B symptoms (n=32, 38)	0.0 percentage of participants	12.5 percentage of participants
Percentage of Participants With Disease Characteristics at First Study Disease Progression GELF criteria: Splenomegaly (n=32, 38)	2.6 percentage of participants	9.4 percentage of participants
Percentage of Participants With Disease Characteristics at First Study Disease Progression GELF criteria: Pleural/ascites effusion (n=32, 38)	7.9 percentage of participants	6.3 percentage of participants
Percentage of Participants With Disease Characteristics at First Study Disease Progression GELF criteria: Cytopenia (n=32, 38)	0.0 percentage of participants	6.3 percentage of participants
Percentage of Participants With Disease Characteristics at First Study Disease Progression GELF criteria: None (n=32, 38)	52.6 percentage of participants	46.9 percentage of participants
Percentage of Participants With Disease Characteristics at First Study Disease Progression GELF criteria: Not available (n=32, 38)	5.3 percentage of participants	3.1 percentage of participants
Percentage of Participants With Disease Characteristics at First Study Disease Progression Ann-Arbor stage I (n=35, 39)	15.4 percentage of participants	11.4 percentage of participants
Percentage of Participants With Disease Characteristics at First Study Disease Progression Ann-Arbor stage II (n=35, 39)	10.3 percentage of participants	14.3 percentage of participants
Percentage of Participants With Disease Characteristics at First Study Disease Progression Ann-Arbor stage III (n=35, 39)	15.4 percentage of participants	14.3 percentage of participants
Percentage of Participants With Disease Characteristics at First Study Disease Progression Ann-Arbor stage IV (n=35, 39)	33.3 percentage of participants	37.1 percentage of participants
Percentage of Participants With Disease Characteristics at First Study Disease Progression Ann-Arbor stage data not available (n=35, 39)	23.1 percentage of participants	17.1 percentage of participants
Percentage of Participants With Disease Characteristics at First Study Disease Progression Ann-Arbor stage not assessable (n=35, 39)	2.6 percentage of participants	5.7 percentage of participants

SECONDARY outcome

Timeframe: Up to 6 years

Population: Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included.

The PFS was defined as the time from the date of first induction treatment over the study (first treatment administration of first cycle) to the date of first disease progression or participants death or date of lymphoma transformation diagnosis.

Outcome measures

Measure	MabThera as Maintenance Therapy Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period. Participants who received treatment with MabThera after the first study induction period was reported.	All Participants n=241 Participants Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin's lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years. Participants who received treatment with MabThera over the first study induction period was reported.
Progression Free Survival (PFS)	—	44.4 months Interval 33.9 to 54.7

SECONDARY outcome

Timeframe: Up to 6 years

Population: Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included.

Time to next treatment was calculated from the date of the end of first induction treatment administration over the study to the date of the start of next treatment after disease progression.

Outcome measures

Measure	MabThera as Maintenance Therapy Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period. Participants who received treatment with MabThera after the first study induction period was reported.	All Participants n=241 Participants Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin's lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years. Participants who received treatment with MabThera over the first study induction period was reported.
Time to Next Treatment	—	NA months Median time to next treatment and 95% confidence interval (CI) were not estimated due to insufficient (\<50%) participants with the event of interest.

SECONDARY outcome

Timeframe: Up to 6 years

Population: Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included.

The overall survival was defined as the time from the date of first induction treatment administration over the study to the date of participants' death or early study withdrawal. OS was calculated using Kaplan-Meier method.

Outcome measures

Measure	MabThera as Maintenance Therapy Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period. Participants who received treatment with MabThera after the first study induction period was reported.	All Participants n=241 Participants Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin's lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years. Participants who received treatment with MabThera over the first study induction period was reported.
Overall Survival (OS)	—	NA months Median time to next treatment and 95% CI were not estimated due to insufficient (\<50%) participants with the event of interest.

SECONDARY outcome

Timeframe: Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)

Population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included.

Outcome measures

Measure	MabThera as Maintenance Therapy n=127 Participants Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period. Participants who received treatment with MabThera after the first study induction period was reported.	All Participants n=241 Participants Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin's lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years. Participants who received treatment with MabThera over the first study induction period was reported.
Number of Participants Who Used MabThera At least one cycle of MabThera	127 participants	230 participants
Number of Participants Who Used MabThera All cycles with MabThera (monotherapy/combination)	127 participants	205 participants
Number of Participants Who Used MabThera At least one cycle of MabThera as monotherapy	125 participants	89 participants
Number of Participants Who Used MabThera All cycles with MabThera as monotherapy	124 participants	51 participants
Number of Participants Who Used MabThera At least one cycle of MabThera in combination	2 participants	178 participants
Number of Participants Who Used MabThera All cycles with MabThera in combination	1 participants	119 participants

SECONDARY outcome

Timeframe: Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)

Population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed= participants who received at least one cycle of MabThera and available with valid data for this outcome.

All participants who received MabThera treatment before the first disease progression were reported.

Outcome measures

Measure	MabThera as Maintenance Therapy n=125 Participants Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period. Participants who received treatment with MabThera after the first study induction period was reported.	All Participants n=216 Participants Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin's lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years. Participants who received treatment with MabThera over the first study induction period was reported.
MabThera Regimen: Dose of MabThera	671.15 milligram (mg) Standard Deviation 111.05	661.25 milligram (mg) Standard Deviation 92.94

SECONDARY outcome

Timeframe: Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)

Population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed= participants who received at least one cycle of MabThera and available with valid data.

Outcome measures

Measure	MabThera as Maintenance Therapy n=103 Participants Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period. Participants who received treatment with MabThera after the first study induction period was reported.	All Participants n=199 Participants Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin's lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years. Participants who received treatment with MabThera over the first study induction period was reported.
MabThera Regimen: Infusion Duration	150.25 minutes (mn) Standard Deviation 60.09	168.60 minutes (mn) Standard Deviation 64.74

SECONDARY outcome

Timeframe: Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)

Population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed= participants who received at least one cycle of MabThera and available with valid data for this outcome.

Outcome measures

Measure	MabThera as Maintenance Therapy n=125 Participants Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period. Participants who received treatment with MabThera after the first study induction period was reported.	All Participants n=230 Participants Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin's lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years. Participants who received treatment with MabThera over the first study induction period was reported.
MabThera Regimen: Number of Cycles of MabThera	7.6 number of cycles Standard Deviation 3.2	4.8 number of cycles Standard Deviation 1.9

SECONDARY outcome

Timeframe: Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)

Population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed= participants who received at least one cycle of MabThera and available with valid data.

Outcome measures

Measure	MabThera as Maintenance Therapy n=119 Participants Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period. Participants who received treatment with MabThera after the first study induction period was reported.	All Participants n=222 Participants Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin's lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years. Participants who received treatment with MabThera over the first study induction period was reported.
MabThera Regimen: Time Between Cycles	80.60 days Standard Deviation 20.69	23.79 days Standard Deviation 12.04

SECONDARY outcome

Timeframe: Maintenance phase : 67.8 months

Population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed= participants who received at least one MabThera infusion over the maintenance therapy period. n=number of evaluable participants for each category.

Outcome measures

Measure	MabThera as Maintenance Therapy Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period. Participants who received treatment with MabThera after the first study induction period was reported.	All Participants n=123 Participants Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin's lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years. Participants who received treatment with MabThera over the first study induction period was reported.
Percentage of Participants With Discontinuations and Modifications of MabThera During Maintenance Phase Treatment discontinuation: Yes (n=123)	—	6.5 percentage of participants
Percentage of Participants With Discontinuations and Modifications of MabThera During Maintenance Phase Treatment discontinuation: No (n=123)	—	93.5 percentage of participants
Percentage of Participants With Discontinuations and Modifications of MabThera During Maintenance Phase At least 1 dose modification: Yes (n=121)	—	41.3 percentage of participants
Percentage of Participants With Discontinuations and Modifications of MabThera During Maintenance Phase At least 1 dose modification: No (n=121)	—	58.7 percentage of participants
Percentage of Participants With Discontinuations and Modifications of MabThera During Maintenance Phase At least 1 duration modification: Yes (n=121)	—	36.4 percentage of participants
Percentage of Participants With Discontinuations and Modifications of MabThera During Maintenance Phase At least 1 duration modification: No (n=121)	—	63.6 percentage of participants
Percentage of Participants With Discontinuations and Modifications of MabThera During Maintenance Phase Number (No.) of dose modifications: 0 (n=121)	—	58.7 percentage of participants
Percentage of Participants With Discontinuations and Modifications of MabThera During Maintenance Phase No. of dose modifications: 1 (n=121)	—	17.4 percentage of participants
Percentage of Participants With Discontinuations and Modifications of MabThera During Maintenance Phase No. of dose modifications: 2 (n=121)	—	10.7 percentage of participants
Percentage of Participants With Discontinuations and Modifications of MabThera During Maintenance Phase No. of dose modifications: 3 (n=121)	—	5.8 percentage of participants
Percentage of Participants With Discontinuations and Modifications of MabThera During Maintenance Phase No. of dose modifications: 4 (n=121)	—	4.1 percentage of participants
Percentage of Participants With Discontinuations and Modifications of MabThera During Maintenance Phase No. of dose modifications: 5 (n=121)	—	2.5 percentage of participants
Percentage of Participants With Discontinuations and Modifications of MabThera During Maintenance Phase No. of dose modifications: 6 (n=121)	—	0.8 percentage of participants
Percentage of Participants With Discontinuations and Modifications of MabThera During Maintenance Phase No. of infusion duration modifications: 0 (n=121)	—	63.6 percentage of participants
Percentage of Participants With Discontinuations and Modifications of MabThera During Maintenance Phase No. of infusion duration modifications: 1 (n=121)	—	10.7 percentage of participants
Percentage of Participants With Discontinuations and Modifications of MabThera During Maintenance Phase No. of infusion duration modifications: 2 (n=121)	—	5.8 percentage of participants
Percentage of Participants With Discontinuations and Modifications of MabThera During Maintenance Phase No. of infusion duration modifications: 3 (n=121)	—	4.1 percentage of participants
Percentage of Participants With Discontinuations and Modifications of MabThera During Maintenance Phase No of infusion duration modifications: 4 (n=121)	—	3.3 percentage of participants
Percentage of Participants With Discontinuations and Modifications of MabThera During Maintenance Phase No. of infusion duration modifications: 5 (n=121)	—	5.0 percentage of participants
Percentage of Participants With Discontinuations and Modifications of MabThera During Maintenance Phase No. of infusion duration modifications: 6 (n=121)	—	1.7 percentage of participants
Percentage of Participants With Discontinuations and Modifications of MabThera During Maintenance Phase No. of infusion duration modifications: 7 (n=121)	—	2.5 percentage of participants
Percentage of Participants With Discontinuations and Modifications of MabThera During Maintenance Phase No. of infusion duration modifications: 8 (n=121)	—	2.5 percentage of participants
Percentage of Participants With Discontinuations and Modifications of MabThera During Maintenance Phase No. of infusion duration modifications: 9 (n=121)	—	0.8 percentage of participants

SECONDARY outcome

Timeframe: Up to 6 years (assessed at start, mid and end of induction [induction: 18.7 months], at each infusion during maintenance [maintenance phase: 67.8 months], and at disease progression [maximum up to 6 years])

Population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. n=number of evaluable questionnaires for each category.

The FACT-G with Lymphoma-Specific Additional Concerns Subscale (Lym) total score was calculated by adding the score obtained on the FACT-G (physical well-being, scored 0-28; social well-being, scored 0-28; functional well-being, scored 0-28; emotional well-being, scored 0-24), to the score obtained on the LYM subscale (15 items; responses to each item range from 0, "Not at all" to 4, "Very much"). Total score ranges from 0 to 168. Higher scores indicated a better participant-reported outcome/quality of life over the past week when responding to the items.

Outcome measures

Measure	MabThera as Maintenance Therapy Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period. Participants who received treatment with MabThera after the first study induction period was reported.	All Participants n=666 Total number of assessable questionnaire Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin's lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years. Participants who received treatment with MabThera over the first study induction period was reported.
Function Assessment of Chronic Illness Therapy-General (FACT-G) With Lymphoma-Specific Additional Concerns Subscale (Lym) Total Score Physical well-being (n=661)	—	22.14 score on scale Standard Deviation 4.99
Function Assessment of Chronic Illness Therapy-General (FACT-G) With Lymphoma-Specific Additional Concerns Subscale (Lym) Total Score Social well-being (n=660)	—	17.67 score on scale Standard Deviation 5.31
Function Assessment of Chronic Illness Therapy-General (FACT-G) With Lymphoma-Specific Additional Concerns Subscale (Lym) Total Score Emotional well-being (n=664)	—	17.30 score on scale Standard Deviation 4.46
Function Assessment of Chronic Illness Therapy-General (FACT-G) With Lymphoma-Specific Additional Concerns Subscale (Lym) Total Score Functional well-being (n=659)	—	15.32 score on scale Standard Deviation 5.69
Function Assessment of Chronic Illness Therapy-General (FACT-G) With Lymphoma-Specific Additional Concerns Subscale (Lym) Total Score Other worrying participants (n=662)	—	45.92 score on scale Standard Deviation 8.88
Function Assessment of Chronic Illness Therapy-General (FACT-G) With Lymphoma-Specific Additional Concerns Subscale (Lym) Total Score Global score (n=663)	—	118.11 score on scale Standard Deviation 23.09

SECONDARY outcome

Timeframe: Up to 6 years

Population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included.

Number and type of hospitalization (a day hospitalization, short-lasting hospitalization, and short-stay hospitalization) was reported.

Outcome measures

Measure	MabThera as Maintenance Therapy n=951 cycles with MabThera Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period. Participants who received treatment with MabThera after the first study induction period was reported.	All Participants n=1035 cycles with MabThera Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin's lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years. Participants who received treatment with MabThera over the first study induction period was reported.
Number and Type of Hospitalization Associated With MabThera Perfusion A day hospitalization	934 hospitalizations	727 hospitalizations
Number and Type of Hospitalization Associated With MabThera Perfusion Short-lasting hospitalization	15 hospitalizations	308 hospitalizations
Number and Type of Hospitalization Associated With MabThera Perfusion Short-stay hospitalization	2 hospitalizations	0 hospitalizations

Adverse Events

All Participants

Serious events: 94 serious events

Other events: 134 other events

Deaths: 0 deaths

Serious adverse events

Measure	All Participants n=243 participants at risk Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin's lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
Infections and infestations Lung infection	6.2% 15/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Infections and infestations Urinary tract infection	2.1% 5/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Infections and infestations Bacteraemia	1.6% 4/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Infections and infestations Bronchopulmonary aspergillosis	1.2% 3/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Infections and infestations Pneumocystis jiroveci pneumonia	1.2% 3/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Infections and infestations Septic shock	1.2% 3/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Infections and infestations Herpes zoster	0.82% 2/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Infections and infestations Abdominal infection	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Infections and infestations Anal abscess	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Infections and infestations Aspergillosis	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Infections and infestations Bronchitis	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Infections and infestations Bronchopneumonia	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Infections and infestations Conjunctivitis infective	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Infections and infestations Haemophilus infection	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Infections and infestations Hepatitis B	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Infections and infestations Onychomycosis	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Infections and infestations Oropharyngeal candidiasis	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Infections and infestations Pharyngitis	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Infections and infestations Pneumonia	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Infections and infestations Pneumonia cytomegaloviral	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Infections and infestations Progressive multifocal leukoencephalopathy	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Infections and infestations Pyelonephritis acuts	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Infections and infestations Reiter's syndrome	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Infections and infestations Tooth abscess	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Infections and infestations Ureapasma infection	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Infections and infestations Varicella	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	1.6% 4/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	1.6% 4/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.82% 2/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.82% 2/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial carcinoma	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer metastic	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hair follicle tumour benign	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal cancer	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic bronchial carcinoma	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastic malignant melanoma	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm skin	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.82% 2/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Refractory cytopenia with multilineage dysplasia	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin cancer	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
General disorders Pyrexia	2.9% 7/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
General disorders Disease progression	2.5% 6/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
General disorders Death	1.2% 3/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
General disorders General physical health deterioration	1.2% 3/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
General disorders Chest pain	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
General disorders Fatigue	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
General disorders Hypothermia	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
General disorders Multi-organ failure	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Blood and lymphatic system disorders Neutropenia	2.1% 5/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Blood and lymphatic system disorders Anaemia	1.6% 4/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Blood and lymphatic system disorders Thrombocytopenia	1.6% 4/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Blood and lymphatic system disorders Febrile bone marrow aplasia	1.2% 3/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Blood and lymphatic system disorders Febrile neutropenia	0.82% 2/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Blood and lymphatic system disorders Agranulocytosis	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Blood and lymphatic system disorders Haemolytic anaemia	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Blood and lymphatic system disorders Leukopenia	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Blood and lymphatic system disorders Pancytopenia	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Respiratory, thoracic and mediastinal disorders Lung disorder	1.2% 3/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Respiratory, thoracic and mediastinal disorders Sinus polyp	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Cardiac disorders Myocardial infarction	1.2% 3/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Cardiac disorders Cardiac disorder	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Cardiac disorders Cardiac failure	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Cardiac disorders Cardio-respiratory arrest	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Cardiac disorders Coronary artery disease	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Gastrointestinal disorders Dyspepsia	0.82% 2/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Gastrointestinal disorders Abdominal adhesions	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Gastrointestinal disorders Colitits ulcerative	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Gastrointestinal disorders Gastrointestinal haemorrhage	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Gastrointestinal disorders Pancreatitis acute	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Gastrointestinal disorders Peritonitis	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Gastrointestinal disorders Small intestinal perforation	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Vascular disorders Aneurysm	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Vascular disorders Arterial stenosis	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Vascular disorders Cerebrovascular accident	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Vascular disorders Ischaemic stroke	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Vascular disorders Jugular vein thrombosis	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Immune system disorders Hypogammaglobulinaemia	1.2% 3/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Injury, poisoning and procedural complications Fall	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Injury, poisoning and procedural complications Gastroenteritis radiation	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Injury, poisoning and procedural complications Spinal compression fracture	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Nervous system disorders Encephalopathy	0.82% 2/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Nervous system disorders Balance disorder	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Nervous system disorders VIIth nerve paralysis	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Hepatobiliary disorders Cholecystitis acute	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Hepatobiliary disorders Jaundice	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Musculoskeletal and connective tissue disorders Back pain	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Musculoskeletal and connective tissue disorders Bone pain	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Renal and urinary disorders Renal colic	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Renal and urinary disorders Renal failure acute	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Eye disorders Blindness	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Eye disorders Optic neuropathy	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Investigations CD4 lymphocytes decreased	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Surgical and medical procedures Inguinal hernia repair	0.41% 1/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).

Other adverse events

Measure	All Participants n=243 participants at risk Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin's lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
Infections and infestations Bronchitis	19.3% 47/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Infections and infestations Herpes zoster	5.8% 14/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Infections and infestations Pharyngitis	4.9% 12/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
Infections and infestations Sinusitis	4.9% 12/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
General disorders Pyrexia	20.2% 49/243 • Up to 6 years Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).

Additional Information

Medical Communications

Hoffmann-LaRoche

Phone: 800-821-8590

Email: genentech@druginfo.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
• Publication restrictions are in place

Restriction type: OTHER