Trial Outcomes & Findings for MabRella Study: A Study to Evaluate the Safety of Switching From Intravenous to Subcutaneous Administration of Rituximab During First-Line Treatment for Lymphoma (NCT NCT01987505)
NCT ID: NCT01987505
Last Updated: 2018-12-26
Results Overview
AARs were defined as all adverse events (AEs) occurring within 24 hours of rituximab SC administration and which were considered related to study drug. AARs included infusion/injection-related reactions (IIRRs), injection-site reactions, administration site conditions and all symptoms thereof. Grading was completed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
140 participants
Primary outcome timeframe
From start of treatment to end of treatment (up to 32 months)
Results posted on
2018-12-26
Participant Flow
Participant milestones
| Measure |
Subcutaneous Rituximab
Participants with CD20+ non-Hodgkin's follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab during first-line treatment. Participants with FL were administered 1400 mg rituximab during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). Participants with DLBCL were administered 1400 mg SC of rituximab once monthly for 4-7 cycles. Treatment duration was expected to last up to 7 months for participants with DLBCL and up to 32 months for participants with FL.
|
|---|---|
|
Overall Study
STARTED
|
140
|
|
Overall Study
COMPLETED
|
106
|
|
Overall Study
NOT COMPLETED
|
34
|
Reasons for withdrawal
| Measure |
Subcutaneous Rituximab
Participants with CD20+ non-Hodgkin's follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab during first-line treatment. Participants with FL were administered 1400 mg rituximab during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). Participants with DLBCL were administered 1400 mg SC of rituximab once monthly for 4-7 cycles. Treatment duration was expected to last up to 7 months for participants with DLBCL and up to 32 months for participants with FL.
|
|---|---|
|
Overall Study
Other
|
9
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Other Reason
|
2
|
|
Overall Study
Lost to Follow-up
|
15
|
|
Overall Study
Investigator Decision
|
2
|
|
Overall Study
Death
|
4
|
Baseline Characteristics
MabRella Study: A Study to Evaluate the Safety of Switching From Intravenous to Subcutaneous Administration of Rituximab During First-Line Treatment for Lymphoma
Baseline characteristics by cohort
| Measure |
Diffuse Large B-Cell Lymphoma
n=29 Participants
Participants with diffuse large B-cell lymphoma (DLBCL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab. Participants with DLBCL were administered 1400 mg SC of rituximab once monthly for 4-7 cycles. Treatment duration was expected to last up to 7 months for participants with DLBCL.
|
Follicular Lymphoma
n=111 Participants
Participants with CD20+ non-Hodgkin's follicular lymphoma (FL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab. Participants with FL were administered 1400 mg rituximab during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). Treatment duration was expected to last to 32 months for participants with FL.
|
Total
n=140 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.5 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
59.6 years
STANDARD_DEVIATION 12.5 • n=7 Participants
|
60.2 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
29 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From start of treatment to end of treatment (up to 32 months)Population: Safety Population included all enrolled participants who received at least one dose of study medication.
AARs were defined as all adverse events (AEs) occurring within 24 hours of rituximab SC administration and which were considered related to study drug. AARs included infusion/injection-related reactions (IIRRs), injection-site reactions, administration site conditions and all symptoms thereof. Grading was completed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.
Outcome measures
| Measure |
Diffuse Large B-Cell Lymphoma (DLBCL)
n=29 Participants
Participants with diffuse large B-cell lymphoma (DLBCL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab. Participants with DLBCL were administered 1400 mg SC of rituximab once monthly for 4-7 cycles. Treatment duration was expected to last up to 7 months for participants with DLBCL.
|
Follicular Lymphoma (FL)
n=111 Participants
Participants with CD20+ non-Hodgkin's follicular lymphoma (FL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab. Participants with FL were administered 1400 mg rituximab during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). Treatment duration was expected to last to 32 months for participants with FL.
|
Subcutaneous Rituximab
n=140 Participants
Participants with CD20+ non-Hodgkin's follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab during first-line treatment. Participants with FL were administered 1400 mg rituximab during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). Participants with DLBCL were administered 1400 mg SC of rituximab once monthly for 4-7 cycles. Treatment duration was expected to last up to 7 months for participants with DLBCL and up to 32 months for participants with FL.
|
|---|---|---|---|
|
Percentage of Participants With Administration-Associated Reactions (AARs)
At Least One AAR Grade ≥ 3
|
0 percentage of participants
|
2.7 percentage of participants
|
2.1 percentage of participants
|
|
Percentage of Participants With Administration-Associated Reactions (AARs)
At Least One Serious AARs
|
0 percentage of participants
|
1.8 percentage of participants
|
1.4 percentage of participants
|
|
Percentage of Participants With Administration-Associated Reactions (AARs)
Generalised or Remote from the Injection Site AARs
|
57.9 percentage of participants
|
11.1 percentage of participants
|
15.1 percentage of participants
|
|
Percentage of Participants With Administration-Associated Reactions (AARs)
At Least One AAR
|
34.5 percentage of participants
|
52.3 percentage of participants
|
48.6 percentage of participants
|
|
Percentage of Participants With Administration-Associated Reactions (AARs)
Localised at the injection site AARs
|
42.1 percentage of participants
|
88.9 percentage of participants
|
84.9 percentage of participants
|
SECONDARY outcome
Timeframe: From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)Population: Safety Population included all enrolled participants who received at least one dose of study medication.
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsen during a study are also considered as adverse events. Grading was completed according to the CTCAE, version 4.0.
Outcome measures
| Measure |
Diffuse Large B-Cell Lymphoma (DLBCL)
n=29 Participants
Participants with diffuse large B-cell lymphoma (DLBCL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab. Participants with DLBCL were administered 1400 mg SC of rituximab once monthly for 4-7 cycles. Treatment duration was expected to last up to 7 months for participants with DLBCL.
|
Follicular Lymphoma (FL)
n=111 Participants
Participants with CD20+ non-Hodgkin's follicular lymphoma (FL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab. Participants with FL were administered 1400 mg rituximab during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). Treatment duration was expected to last to 32 months for participants with FL.
|
Subcutaneous Rituximab
n=140 Participants
Participants with CD20+ non-Hodgkin's follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab during first-line treatment. Participants with FL were administered 1400 mg rituximab during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). Participants with DLBCL were administered 1400 mg SC of rituximab once monthly for 4-7 cycles. Treatment duration was expected to last up to 7 months for participants with DLBCL and up to 32 months for participants with FL.
|
|---|---|---|---|
|
Percentage of Participants With At Least One Grade >/= 3 Adverse Events (AEs)
|
48.3 percentage of participants
|
36.0 percentage of participants
|
38.6 percentage of participants
|
SECONDARY outcome
Timeframe: From start of treatment to end of treatment (up to 32 months)Population: Safety Population included all enrolled participants who received at least one dose of study medication.
Grading of IIRRs was completed according to the CTCAE, version 4.0.
Outcome measures
| Measure |
Diffuse Large B-Cell Lymphoma (DLBCL)
n=29 Participants
Participants with diffuse large B-cell lymphoma (DLBCL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab. Participants with DLBCL were administered 1400 mg SC of rituximab once monthly for 4-7 cycles. Treatment duration was expected to last up to 7 months for participants with DLBCL.
|
Follicular Lymphoma (FL)
n=111 Participants
Participants with CD20+ non-Hodgkin's follicular lymphoma (FL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab. Participants with FL were administered 1400 mg rituximab during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). Treatment duration was expected to last to 32 months for participants with FL.
|
Subcutaneous Rituximab
n=140 Participants
Participants with CD20+ non-Hodgkin's follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab during first-line treatment. Participants with FL were administered 1400 mg rituximab during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). Participants with DLBCL were administered 1400 mg SC of rituximab once monthly for 4-7 cycles. Treatment duration was expected to last up to 7 months for participants with DLBCL and up to 32 months for participants with FL.
|
|---|---|---|---|
|
Percentage of Participants With At Least One Grade >/= 3 Infusion/ Injection Related Reactions (IIRRs)
|
0.0 percentage of participants
|
2.7 percentage of participants
|
2.1 percentage of participants
|
SECONDARY outcome
Timeframe: From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)Population: Safety Population included all enrolled participants who received at least one dose of study medication.
SAE was defined as any experience that suggested a significant hazard, contraindication, side effect, or precaution, and fulfilled any of the following criteria: fatal (resulted in death), life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/ birth defect, was medically significant or required intervention to prevent any of the other outcomes listed here.
Outcome measures
| Measure |
Diffuse Large B-Cell Lymphoma (DLBCL)
n=29 Participants
Participants with diffuse large B-cell lymphoma (DLBCL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab. Participants with DLBCL were administered 1400 mg SC of rituximab once monthly for 4-7 cycles. Treatment duration was expected to last up to 7 months for participants with DLBCL.
|
Follicular Lymphoma (FL)
n=111 Participants
Participants with CD20+ non-Hodgkin's follicular lymphoma (FL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab. Participants with FL were administered 1400 mg rituximab during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). Treatment duration was expected to last to 32 months for participants with FL.
|
Subcutaneous Rituximab
n=140 Participants
Participants with CD20+ non-Hodgkin's follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab during first-line treatment. Participants with FL were administered 1400 mg rituximab during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). Participants with DLBCL were administered 1400 mg SC of rituximab once monthly for 4-7 cycles. Treatment duration was expected to last up to 7 months for participants with DLBCL and up to 32 months for participants with FL.
|
|---|---|---|---|
|
Percentage of Participants With At Least One Serious Adverse Event (SAE)
|
37.9 percentage of participants
|
27.9 percentage of participants
|
30.0 percentage of participants
|
SECONDARY outcome
Timeframe: From time of first dose of rituximab IV before study enrollment up to end of study (up to approximately 62 months)Population: Intent-to-Treat (ITT) population included all enrolled participants.
EFS was defined as the time from first dose of rituximab IV to first occurrence of progressive disease (PD) or relapse, according to the International Working Group (IWG) response criteria or initiation of a non-protocol-specified anti-lymphoma therapy or death, whichever occurs first. PD: \>/= 50% increase lymph nodes and nodal mass size, any new lesion, enlarged liver/spleen, reappearance bone marrow abnormalities.
Outcome measures
| Measure |
Diffuse Large B-Cell Lymphoma (DLBCL)
n=29 Participants
Participants with diffuse large B-cell lymphoma (DLBCL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab. Participants with DLBCL were administered 1400 mg SC of rituximab once monthly for 4-7 cycles. Treatment duration was expected to last up to 7 months for participants with DLBCL.
|
Follicular Lymphoma (FL)
n=111 Participants
Participants with CD20+ non-Hodgkin's follicular lymphoma (FL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab. Participants with FL were administered 1400 mg rituximab during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). Treatment duration was expected to last to 32 months for participants with FL.
|
Subcutaneous Rituximab
n=140 Participants
Participants with CD20+ non-Hodgkin's follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab during first-line treatment. Participants with FL were administered 1400 mg rituximab during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). Participants with DLBCL were administered 1400 mg SC of rituximab once monthly for 4-7 cycles. Treatment duration was expected to last up to 7 months for participants with DLBCL and up to 32 months for participants with FL.
|
|---|---|---|---|
|
Event-Free Survival (EFS)
|
25.79 months
Interval 20.8 to 30.776
|
54.39 months
Interval 51.416 to 57.362
|
52.314 months
Interval 49.162 to 55.466
|
SECONDARY outcome
Timeframe: From time of first dose of rituximab IV before study enrollment up to end of study (up to approximately 62 months)Population: ITT population included all enrolled participants.
PFS was defined as the time from first dose of rituximab IV to the first occurrence of progressive disease (PD) or relapse, according to the International Working Group (IWG) response criteria or death from any cause. PD: \>/= 50% increase lymph nodes and nodal mass size, any new lesion, enlarged liver/spleen, reappearance bone marrow abnormalities.
Outcome measures
| Measure |
Diffuse Large B-Cell Lymphoma (DLBCL)
n=29 Participants
Participants with diffuse large B-cell lymphoma (DLBCL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab. Participants with DLBCL were administered 1400 mg SC of rituximab once monthly for 4-7 cycles. Treatment duration was expected to last up to 7 months for participants with DLBCL.
|
Follicular Lymphoma (FL)
n=111 Participants
Participants with CD20+ non-Hodgkin's follicular lymphoma (FL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab. Participants with FL were administered 1400 mg rituximab during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). Treatment duration was expected to last to 32 months for participants with FL.
|
Subcutaneous Rituximab
n=140 Participants
Participants with CD20+ non-Hodgkin's follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab during first-line treatment. Participants with FL were administered 1400 mg rituximab during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). Participants with DLBCL were administered 1400 mg SC of rituximab once monthly for 4-7 cycles. Treatment duration was expected to last up to 7 months for participants with DLBCL and up to 32 months for participants with FL.
|
|---|---|---|---|
|
Progression-Free Survival (PFS)
|
27.952 months
Interval 23.443 to 32.46
|
54.389 months
Interval 51.416 to 57.362
|
53.118 months
Interval 50.108 to 56.127
|
SECONDARY outcome
Timeframe: From time of first dose of rituximab IV before study enrollment up to end of study (up to approximately 62 months)Population: ITT population included all enrolled participants.
OS was defined as the time from first dose of rituximab IV to death from any cause.
Outcome measures
| Measure |
Diffuse Large B-Cell Lymphoma (DLBCL)
n=29 Participants
Participants with diffuse large B-cell lymphoma (DLBCL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab. Participants with DLBCL were administered 1400 mg SC of rituximab once monthly for 4-7 cycles. Treatment duration was expected to last up to 7 months for participants with DLBCL.
|
Follicular Lymphoma (FL)
n=111 Participants
Participants with CD20+ non-Hodgkin's follicular lymphoma (FL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab. Participants with FL were administered 1400 mg rituximab during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). Treatment duration was expected to last to 32 months for participants with FL.
|
Subcutaneous Rituximab
n=140 Participants
Participants with CD20+ non-Hodgkin's follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab during first-line treatment. Participants with FL were administered 1400 mg rituximab during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). Participants with DLBCL were administered 1400 mg SC of rituximab once monthly for 4-7 cycles. Treatment duration was expected to last up to 7 months for participants with DLBCL and up to 32 months for participants with FL.
|
|---|---|---|---|
|
Overall Survival (OS)
|
37.42 months
Interval 33.354 to 41.485
|
60.61 months
Interval 59.692 to 61.535
|
59.516 months
Interval 57.999 to 61.033
|
SECONDARY outcome
Timeframe: From time of first dose of rituximab IV before study enrollment up to end of study (up to approximately 62 months)Population: ITT population included all enrolled participants.
DFS was assessed in participants achieving complete response (CR) including complete response unconfirmed (Cru) and was defined as the period from the date of the initial CR/CRu until the date of relapse or death from any cause. CR: 1) disappearance of all evidence/symptoms of disease, 2) lymph nodes and nodal masses normal size, 3) enlarged spleen must have regressed in size, 4) normal bone marrow; CRu: see 1) and 3) of CR plus \> 75% decrease in residual lymph node mass, indeterminate bone marrow. Reported here is the truncated mean estimate based on Kaplan-Meier analysis.
Outcome measures
| Measure |
Diffuse Large B-Cell Lymphoma (DLBCL)
n=29 Participants
Participants with diffuse large B-cell lymphoma (DLBCL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab. Participants with DLBCL were administered 1400 mg SC of rituximab once monthly for 4-7 cycles. Treatment duration was expected to last up to 7 months for participants with DLBCL.
|
Follicular Lymphoma (FL)
n=111 Participants
Participants with CD20+ non-Hodgkin's follicular lymphoma (FL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab. Participants with FL were administered 1400 mg rituximab during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). Treatment duration was expected to last to 32 months for participants with FL.
|
Subcutaneous Rituximab
n=140 Participants
Participants with CD20+ non-Hodgkin's follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab during first-line treatment. Participants with FL were administered 1400 mg rituximab during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). Participants with DLBCL were administered 1400 mg SC of rituximab once monthly for 4-7 cycles. Treatment duration was expected to last up to 7 months for participants with DLBCL and up to 32 months for participants with FL.
|
|---|---|---|---|
|
Disease-Free Survival (DFS)
|
26.062 months
Interval 23.51 to 28.613
|
NA months
No events in this arm, therefore mean and 95% Confidence Interval could not be calculated.
|
33.044 months
Interval 31.489 to 34.6
|
SECONDARY outcome
Timeframe: 4-6 weeks after the last dose of Induction (Up to approximately 8 months)Population: ITT population included all enrolled participants.
Treatment response rate was classified according to the International Working Group (IWG) response criteria: CR/Cru, partial response (PR), stable disease (SD) and PD. CR: 1) disappearance of all evidence/symptoms of disease, 2) lymph nodes and nodal masses normal size, 3) enlarged spleen must have regressed in size, 4) normal bone marrow; CRu: see 1) and 3) of CR plus \> 75% decrease in residual lymph node mass, indeterminate bone marrow; PR: \>/= 50% decrease lymph nodes and nodal mass size; decrease in liver/spleen size, no new sites; SD: less than a PR, but is not PD; PD: \>/= 50% increase lymph nodes and nodal mass size, any new lesion, enlarged liver/spleen, reappearance bone marrow abnormalities.
Outcome measures
| Measure |
Diffuse Large B-Cell Lymphoma (DLBCL)
n=29 Participants
Participants with diffuse large B-cell lymphoma (DLBCL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab. Participants with DLBCL were administered 1400 mg SC of rituximab once monthly for 4-7 cycles. Treatment duration was expected to last up to 7 months for participants with DLBCL.
|
Follicular Lymphoma (FL)
n=111 Participants
Participants with CD20+ non-Hodgkin's follicular lymphoma (FL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab. Participants with FL were administered 1400 mg rituximab during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). Treatment duration was expected to last to 32 months for participants with FL.
|
Subcutaneous Rituximab
n=140 Participants
Participants with CD20+ non-Hodgkin's follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab during first-line treatment. Participants with FL were administered 1400 mg rituximab during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). Participants with DLBCL were administered 1400 mg SC of rituximab once monthly for 4-7 cycles. Treatment duration was expected to last up to 7 months for participants with DLBCL and up to 32 months for participants with FL.
|
|---|---|---|---|
|
Treatment Response Rate
Complete Response (CR)
|
62.1 percentage of participants
|
66.7 percentage of participants
|
64.3 percentage of participants
|
|
Treatment Response Rate
Complete Response Unconfirmed (CRU)
|
3.4 percentage of participants
|
7.4 percentage of participants
|
5.4 percentage of participants
|
|
Treatment Response Rate
Partial Response (PR)
|
3.4 percentage of participants
|
11.1 percentage of participants
|
7.1 percentage of participants
|
|
Treatment Response Rate
Stable Disease (SD)
|
0.0 percentage of participants
|
3.7 percentage of participants
|
1.8 percentage of participants
|
|
Treatment Response Rate
Progressive disease (PD)
|
17.2 percentage of participants
|
7.4 percentage of participants
|
12.5 percentage of participants
|
|
Treatment Response Rate
Unable to Assess (UA)
|
6.9 percentage of participants
|
0.0 percentage of participants
|
3.6 percentage of participants
|
|
Treatment Response Rate
Not Evaluable
|
6.9 percentage of participants
|
3.7 percentage of participants
|
5.4 percentage of participants
|
Adverse Events
Subcutaneous Rituximab
Serious events: 42 serious events
Other events: 117 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Subcutaneous Rituximab
n=140 participants at risk
Participants with CD20+ non-Hodgkin's follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab during first-line treatment. Participants with FL were administered 1400 mg rituximab during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). Participants with DLBCL were administered 1400 mg SC of rituximab once monthly for 4-7 cycles. Treatment duration was expected to last up to 7 months for participants with DLBCL and up to 32 months for participants with FL.
|
|---|---|
|
Blood and lymphatic system disorders
Agranulocytosis
|
0.71%
1/140 • From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Safety Population included all enrolled participants who received at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
8.6%
12/140 • From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Safety Population included all enrolled participants who received at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Neutropenia
|
7.1%
10/140 • From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Safety Population included all enrolled participants who received at least one dose of study medication.
|
|
Cardiac disorders
Atrial fibrillation
|
0.71%
1/140 • From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Safety Population included all enrolled participants who received at least one dose of study medication.
|
|
Ear and labyrinth disorders
Vertigo
|
0.71%
1/140 • From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Safety Population included all enrolled participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.4%
2/140 • From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Safety Population included all enrolled participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.71%
1/140 • From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Safety Population included all enrolled participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Enteritis
|
0.71%
1/140 • From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Safety Population included all enrolled participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.71%
1/140 • From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Safety Population included all enrolled participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.71%
1/140 • From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Safety Population included all enrolled participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.71%
1/140 • From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Safety Population included all enrolled participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.71%
1/140 • From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Safety Population included all enrolled participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.71%
1/140 • From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Safety Population included all enrolled participants who received at least one dose of study medication.
|
|
General disorders
Pyrexia
|
0.71%
1/140 • From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Safety Population included all enrolled participants who received at least one dose of study medication.
|
|
Infections and infestations
Enterobacter bacteraemia
|
0.71%
1/140 • From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Safety Population included all enrolled participants who received at least one dose of study medication.
|
|
Infections and infestations
Cellulitis
|
0.71%
1/140 • From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Safety Population included all enrolled participants who received at least one dose of study medication.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.71%
1/140 • From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Safety Population included all enrolled participants who received at least one dose of study medication.
|
|
Infections and infestations
Gastroenteritis
|
2.1%
3/140 • From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Safety Population included all enrolled participants who received at least one dose of study medication.
|
|
Infections and infestations
Influenza
|
0.71%
1/140 • From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Safety Population included all enrolled participants who received at least one dose of study medication.
|
|
Infections and infestations
Lung infection
|
0.71%
1/140 • From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Safety Population included all enrolled participants who received at least one dose of study medication.
|
|
Infections and infestations
Pneumonia
|
2.9%
4/140 • From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Safety Population included all enrolled participants who received at least one dose of study medication.
|
|
Infections and infestations
Pneumonia pneumococcal
|
1.4%
2/140 • From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Safety Population included all enrolled participants who received at least one dose of study medication.
|
|
Infections and infestations
Respiratory tract infection
|
2.9%
4/140 • From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Safety Population included all enrolled participants who received at least one dose of study medication.
|
|
Infections and infestations
Sepsis
|
0.71%
1/140 • From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Safety Population included all enrolled participants who received at least one dose of study medication.
|
|
Infections and infestations
Urinary tract infection
|
0.71%
1/140 • From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Safety Population included all enrolled participants who received at least one dose of study medication.
|
|
Infections and infestations
Urosepsis
|
1.4%
2/140 • From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Safety Population included all enrolled participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.71%
1/140 • From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Safety Population included all enrolled participants who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.71%
1/140 • From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Safety Population included all enrolled participants who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.71%
1/140 • From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Safety Population included all enrolled participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.71%
1/140 • From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Safety Population included all enrolled participants who received at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.71%
1/140 • From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Safety Population included all enrolled participants who received at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric neoplasm
|
0.71%
1/140 • From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Safety Population included all enrolled participants who received at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.71%
1/140 • From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Safety Population included all enrolled participants who received at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.71%
1/140 • From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Safety Population included all enrolled participants who received at least one dose of study medication.
|
|
Nervous system disorders
Presyncope
|
0.71%
1/140 • From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Safety Population included all enrolled participants who received at least one dose of study medication.
|
|
Nervous system disorders
Syncope
|
0.71%
1/140 • From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Safety Population included all enrolled participants who received at least one dose of study medication.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.71%
1/140 • From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Safety Population included all enrolled participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.71%
1/140 • From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Safety Population included all enrolled participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.71%
1/140 • From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Safety Population included all enrolled participants who received at least one dose of study medication.
|
|
Vascular disorders
Venous thrombosis
|
0.71%
1/140 • From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Safety Population included all enrolled participants who received at least one dose of study medication.
|
Other adverse events
| Measure |
Subcutaneous Rituximab
n=140 participants at risk
Participants with CD20+ non-Hodgkin's follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab during first-line treatment. Participants with FL were administered 1400 mg rituximab during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). Participants with DLBCL were administered 1400 mg SC of rituximab once monthly for 4-7 cycles. Treatment duration was expected to last up to 7 months for participants with DLBCL and up to 32 months for participants with FL.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
9.3%
13/140 • From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Safety Population included all enrolled participants who received at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Neutropenia
|
17.1%
24/140 • From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Safety Population included all enrolled participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
9.3%
13/140 • From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Safety Population included all enrolled participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
15.7%
22/140 • From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Safety Population included all enrolled participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.7%
8/140 • From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Safety Population included all enrolled participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
8.6%
12/140 • From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Safety Population included all enrolled participants who received at least one dose of study medication.
|
|
General disorders
Asthenia
|
22.1%
31/140 • From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Safety Population included all enrolled participants who received at least one dose of study medication.
|
|
General disorders
Injection site erythema
|
8.6%
12/140 • From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Safety Population included all enrolled participants who received at least one dose of study medication.
|
|
General disorders
Pain
|
6.4%
9/140 • From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Safety Population included all enrolled participants who received at least one dose of study medication.
|
|
General disorders
Pyrexia
|
10.0%
14/140 • From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Safety Population included all enrolled participants who received at least one dose of study medication.
|
|
Infections and infestations
Respiratory tract infection
|
16.4%
23/140 • From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Safety Population included all enrolled participants who received at least one dose of study medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.6%
12/140 • From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Safety Population included all enrolled participants who received at least one dose of study medication.
|
|
Infections and infestations
Urinary tract infection
|
7.9%
11/140 • From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Safety Population included all enrolled participants who received at least one dose of study medication.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
15.0%
21/140 • From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Safety Population included all enrolled participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.3%
13/140 • From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Safety Population included all enrolled participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.7%
15/140 • From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Safety Population included all enrolled participants who received at least one dose of study medication.
|
|
Nervous system disorders
Dizziness
|
5.0%
7/140 • From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Safety Population included all enrolled participants who received at least one dose of study medication.
|
|
Nervous system disorders
Headache
|
7.9%
11/140 • From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Safety Population included all enrolled participants who received at least one dose of study medication.
|
|
Nervous system disorders
Paraesthesia
|
10.0%
14/140 • From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Safety Population included all enrolled participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
14/140 • From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Safety Population included all enrolled participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
6.4%
9/140 • From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Safety Population included all enrolled participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
25.7%
36/140 • From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Safety Population included all enrolled participants who received at least one dose of study medication.
|
Additional Information
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