Trial Outcomes & Findings for Non-Interventional Study to Examine Rituximab Treatment in Follicular Lymphoma Participants (NCT NCT02536664)
NCT ID: NCT02536664
Last Updated: 2023-04-18
Results Overview
Progressive Disease is defined as at least a 20 percent (%) increase in the sum of the longest diameter of target lesions, taking) as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and non-target lesions) or the unequivocal progression of existing non-target lesions.
Recruitment status
COMPLETED
Target enrollment
505 participants
Primary outcome timeframe
2 years
Results posted on
2023-04-18
Participant Flow
Fifteen out of 505 participants were screen failure and excluded from the baseline and safety data sets. Safety Set Overall (SSO) included 490 participants who received at least 1 dose of study drug in/during the maintenance period. Therapy line was not reported for 1 participant and participant flow was reported for 489 participants.
Participant milestones
| Measure |
First-line Stratum
Participants who were untreated and decided by the treating physician to be treated with Rituximab for the cluster of differentiation (CD) 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
|
Relapsed/Refractory Stratum
Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
|
|---|---|---|
|
Overall Study
STARTED
|
312
|
177
|
|
Overall Study
COMPLETED
|
205
|
97
|
|
Overall Study
NOT COMPLETED
|
107
|
80
|
Reasons for withdrawal
| Measure |
First-line Stratum
Participants who were untreated and decided by the treating physician to be treated with Rituximab for the cluster of differentiation (CD) 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
|
Relapsed/Refractory Stratum
Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
|
|---|---|---|
|
Overall Study
Inadequate completion of documentation
|
2
|
4
|
|
Overall Study
Progression
|
13
|
18
|
|
Overall Study
Death due to lymphoma
|
2
|
1
|
|
Overall Study
Death due to other reason
|
3
|
2
|
|
Overall Study
Intolerability
|
8
|
6
|
|
Overall Study
Withdrawal by Subject
|
8
|
5
|
|
Overall Study
Other
|
18
|
24
|
|
Overall Study
Missing
|
53
|
20
|
Baseline Characteristics
Non-Interventional Study to Examine Rituximab Treatment in Follicular Lymphoma Participants
Baseline characteristics by cohort
| Measure |
First-line Stratum
n=310 Participants
Participants who were untreated and decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
|
Relapsed/Refractory Stratum
n=173 Participants
Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
|
Total
n=483 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.7 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
64.0 years
STANDARD_DEVIATION 11.0 • n=7 Participants
|
63.1 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
171 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
265 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
139 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
218 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Included participants who were considered for the efficacy analysis after 2 years of Rituximab maintenance therapy.
Progressive Disease is defined as at least a 20 percent (%) increase in the sum of the longest diameter of target lesions, taking) as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and non-target lesions) or the unequivocal progression of existing non-target lesions.
Outcome measures
| Measure |
First-line Stratum
n=305 Participants
Participants who were untreated and decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
|
Relapsed/Refractory Stratum
n=172 Participants
Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
|
|---|---|---|
|
Percentage of Participants Who Were Alive and Free From Progressive Disease
|
88.28 percentage of participants
Interval 83.97 to 92.59
|
76.03 percentage of participants
Interval 68.79 to 83.28
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Included participants who were considered for the efficacy analysis after 2 years of Rituximab maintenance therapy.
PFS was defined as the time from the date of the first cycle to the first occurrence of progression of tumor or death from any reason (whichever occurred first). If progression or death was not observed during the study, progression-free survival time was censored by the last documented tumor assessment during the maintenance therapy (latest at the end of study after two years). Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and non-target lesions) or the unequivocal progression of existing non-target lesions. PFS was assessed using Kaplan-Meier estimate.
Outcome measures
| Measure |
First-line Stratum
n=305 Participants
Participants who were untreated and decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
|
Relapsed/Refractory Stratum
n=172 Participants
Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
|
|---|---|---|
|
Median Progression Free Survival (PFS) Time
|
NA months
The median PFS time and 95% Confidence Interval (CI) could not be estimated due to low number of events (disease progression or death)
|
NA months
The median PFS time and 95% Confidence Interval (CI) could not be estimated due to low number of events (disease progression or death)
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Included participants who were considered for the efficacy analysis after 2 years of Rituximab maintenance therapy.
Death for any reason was regarded as an event. Percentage of participants who were alive after 2 years of maintenance therapy with Rituximab was reported.
Outcome measures
| Measure |
First-line Stratum
n=305 Participants
Participants who were untreated and decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
|
Relapsed/Refractory Stratum
n=172 Participants
Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
|
|---|---|---|
|
Percentage of Participants Who Were Alive
|
96.89 percentage of participants
Interval 94.69 to 99.09
|
95.44 percentage of participants
Interval 91.81 to 99.07
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Included participants who were considered for the efficacy analysis after 2 years of Rituximab maintenance therapy.
Survival was the interval of time from date of first dose of study medication to date of death at any time. Participants who had not died were censored at the date of last contact when they were known to be alive. OS was assessed using Kaplan-Meier estimate.
Outcome measures
| Measure |
First-line Stratum
n=305 Participants
Participants who were untreated and decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
|
Relapsed/Refractory Stratum
n=172 Participants
Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
|
|---|---|---|
|
Median Overall Survival (OS) Time
|
NA months
The median OS and 95% confidence interval (CI) were not estimated due to low number of deaths during the study
|
NA months
The median OS and 95% CI were not estimated due to low number of deaths during the study
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Included participants who were considered for the efficacy analysis after 2 years of Rituximab maintenance therapy.
CR is defined as the disappearance of all target and non-target lesions and normalization of tumor marker level; PR is defined as at least a 30 percentage (%) decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter; SD for target lesions is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started and SD for non-target lesions defined as persistence of 1 or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. PD is defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and non-target lesions) or the unequivocal progression of existing non-target lesions.
Outcome measures
| Measure |
First-line Stratum
n=305 Participants
Participants who were untreated and decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
|
Relapsed/Refractory Stratum
n=172 Participants
Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
|
|---|---|---|
|
Percentage of Participants With Response (Complete Response [CR], Partial Response [PR], Stable Disease [SD] or Progressive Disease [PD] at the End of Maintenance Therapy
SD
|
12.1 percentage of participants
|
9.3 percentage of participants
|
|
Percentage of Participants With Response (Complete Response [CR], Partial Response [PR], Stable Disease [SD] or Progressive Disease [PD] at the End of Maintenance Therapy
CR
|
58.4 percentage of participants
|
51.2 percentage of participants
|
|
Percentage of Participants With Response (Complete Response [CR], Partial Response [PR], Stable Disease [SD] or Progressive Disease [PD] at the End of Maintenance Therapy
PR
|
21.0 percentage of participants
|
20.9 percentage of participants
|
|
Percentage of Participants With Response (Complete Response [CR], Partial Response [PR], Stable Disease [SD] or Progressive Disease [PD] at the End of Maintenance Therapy
PD
|
8.5 percentage of participants
|
18.6 percentage of participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Included participants who were considered for the efficacy analysis after 2 years of Rituximab maintenance therapy.
The percentage of participants was presented with respect to the best overall response (CR, PR, SD). CR is defined as the disappearance of all target and non-target lesions and normalization of tumor marker level; PR is defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter; SD for target lesions is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started and SD for non-target lesions defined as persistence of 1 or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.
Outcome measures
| Measure |
First-line Stratum
n=305 Participants
Participants who were untreated and decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
|
Relapsed/Refractory Stratum
n=172 Participants
Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
|
|---|---|---|
|
Percentage of Participants With Best Overall Response
|
98.4 percentage of participants
Interval 96.9 to 99.8
|
96.5 percentage of participants
Interval 93.8 to 99.3
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Included participants who were considered for the efficacy analysis after 2 years of Rituximab maintenance therapy.
Percentage of participants for whom new therapy was initiated at the end of maintenance therapy was reported.
Outcome measures
| Measure |
First-line Stratum
n=305 Participants
Participants who were untreated and decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
|
Relapsed/Refractory Stratum
n=172 Participants
Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
|
|---|---|---|
|
Percentage of Participants With Initiation of New Therapy
No data
|
16.7 percentage of participants
|
11.6 percentage of participants
|
|
Percentage of Participants With Initiation of New Therapy
No
|
75.7 percentage of participants
|
69.2 percentage of participants
|
|
Percentage of Participants With Initiation of New Therapy
Yes
|
7.5 percentage of participants
|
19.2 percentage of participants
|
Adverse Events
First-line Stratum
Serious events: 35 serious events
Other events: 0 other events
Deaths: 0 deaths
Relapsed/Refractory Stratum
Serious events: 39 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
First-line Stratum
n=310 participants at risk；n=312 participants at risk
Participants who were untreated and decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
|
Relapsed/Refractory Stratum
n=173 participants at risk；n=177 participants at risk
Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
|
|---|---|---|
|
Blood and lymphatic system disorders
Agranulocytosis
|
0.32%
1/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.00%
0/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.6%
5/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
4.5%
8/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.32%
1/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
1.1%
2/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.56%
1/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.00%
0/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.56%
1/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.56%
1/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.56%
1/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
2.8%
5/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.56%
1/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Cardiac disorders
Arrhythmia
|
0.32%
1/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.00%
0/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Cardiac disorders
Atrioventricular block
|
0.32%
1/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.00%
0/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Cardiac disorders
Cardiac failure
|
0.32%
1/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.00%
0/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Cardiac disorders
Cardiovascular disorder
|
0.32%
1/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.00%
0/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Cardiac disorders
Coronary artery disease
|
0.32%
1/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.00%
0/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.32%
1/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.56%
1/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Gastrointestinal disorders
Colitis microscopic
|
0.32%
1/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.00%
0/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.32%
1/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.00%
0/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Gastrointestinal disorders
Tongue coated
|
0.32%
1/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.00%
0/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.56%
1/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.56%
1/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
1.7%
3/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.56%
1/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.56%
1/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.56%
1/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.56%
1/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
General disorders
Chest discomfort
|
0.32%
1/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.00%
0/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
General disorders
Chills
|
0.32%
1/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.00%
0/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
General disorders
Death
|
0.96%
3/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.56%
1/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
General disorders
General physical health deterioration
|
0.32%
1/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.00%
0/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
General disorders
Pain
|
0.32%
1/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
2.8%
5/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
General disorders
Pyrexia
|
0.96%
3/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
1.1%
2/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
General disorders
Fatigue
|
0.00%
0/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.56%
1/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
General disorders
Ill-defined disorder
|
0.00%
0/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.56%
1/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
General disorders
Performance status disorder
|
0.00%
0/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.56%
1/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.32%
1/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.00%
0/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.32%
1/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.00%
0/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.32%
1/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.00%
0/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Hepatobiliary disorders
Liver injury
|
0.32%
1/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.00%
0/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.56%
1/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.56%
1/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Immune system disorders
Immunodeficiency
|
0.00%
0/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.56%
1/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Infections and infestations
Bacterial infection
|
0.64%
2/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
2.3%
4/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Infections and infestations
Bronchiolitis
|
0.32%
1/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.00%
0/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Infections and infestations
Fungal infection
|
0.32%
1/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.00%
0/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Infections and infestations
Haemophilus sepsis
|
0.32%
1/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.00%
0/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Infections and infestations
Herpes zoster
|
0.32%
1/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.56%
1/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Infections and infestations
Infection
|
0.32%
1/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.56%
1/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Infections and infestations
Lung infection
|
0.64%
2/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.00%
0/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Infections and infestations
Pneumonia
|
0.96%
3/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
4.0%
7/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Infections and infestations
Viral infection
|
0.64%
2/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.56%
1/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.56%
1/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.56%
1/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Infections and infestations
Bronchitis bacterial
|
0.00%
0/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.56%
1/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.56%
1/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.56%
1/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Infections and infestations
Infectious colitis
|
0.00%
0/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.56%
1/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Infections and infestations
Rotavirus infection
|
0.00%
0/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.56%
1/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Infections and infestations
Sepsis
|
0.00%
0/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
2.3%
4/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.56%
1/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.32%
1/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.00%
0/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Investigations
Alanine aminotransferase increased
|
0.32%
1/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.56%
1/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Investigations
Aspartate aminotransferase increased
|
0.32%
1/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.00%
0/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Investigations
B-lymphocyte count decreased
|
0.64%
2/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.56%
1/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.64%
2/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.00%
0/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Investigations
Hepatic enzyme increased
|
0.32%
1/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.00%
0/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Investigations
Blast cells present
|
0.00%
0/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.56%
1/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Investigations
Carbohydrate antigen 15-3 increased
|
0.00%
0/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.56%
1/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.56%
1/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.56%
1/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma recurrent
|
0.32%
1/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.00%
0/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.32%
1/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.00%
0/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.32%
1/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.00%
0/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.32%
1/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.00%
0/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
1.3%
4/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
2.3%
4/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.32%
1/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.00%
0/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.32%
1/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.00%
0/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.56%
1/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.00%
0/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
1.1%
2/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.00%
0/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.56%
1/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis
|
0.00%
0/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.56%
1/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.56%
1/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.56%
1/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.56%
1/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.32%
1/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.00%
0/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Psychiatric disorders
Depression
|
0.32%
1/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.56%
1/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Alveolitis
|
0.32%
1/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.00%
0/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.96%
3/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
2.3%
4/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.32%
1/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.00%
0/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.96%
3/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.00%
0/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural fibrosis
|
0.32%
1/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.56%
1/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.56%
1/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.56%
1/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.56%
1/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.56%
1/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Surgical and medical procedures
Hospitalisation
|
0.00%
0/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.56%
1/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Vascular disorders
Haematoma
|
0.32%
1/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.00%
0/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Vascular disorders
Shock haemorrhagic
|
0.32%
1/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.00%
0/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.56%
1/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Vascular disorders
Hypotension
|
0.00%
0/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.56%
1/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Vascular disorders
Shock
|
0.00%
0/312 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
0.56%
1/177 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
Other adverse events
| Measure |
First-line Stratum
n=310 participants at risk；n=312 participants at risk
Participants who were untreated and decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
|
Relapsed/Refractory Stratum
n=173 participants at risk；n=177 participants at risk
Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/310 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
12.1%
21/173 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
|
Infections and infestations
Bacterial Infection
|
0.00%
0/310 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
8.1%
14/173 • 2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
|
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