Trial Outcomes & Findings for A Study of Obinutuzumab [RO5072759 (GA101)] in Combination With CHOP Chemotherapy in Patients With Previously Untreated Advanced Diffuse Large B-Cell Lymphoma (GATHER) (NCT NCT01414855)
NCT ID: NCT01414855
Last Updated: 2018-04-25
Results Overview
Complete response rate is defined as the percentage of participants with Complete Response (CR) according to the Revised Response Criteria for Malignant Lymphoma (Cheson et al., 2007). Disease response was evaluated by the investigator using regular clinical and laboratory examinations, fluorodeoxyglucose-positron emission tomography (FDG-PET) and computed tomography (CT). CR is the disappearance of all evidence of disease.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
100 participants
Primary outcome timeframe
From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days)
Results posted on
2018-04-25
Participant Flow
Participant milestones
| Measure |
Obinutuzumab + CHOP
Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy (cyclophosphamide, doxorubicin, vincristine and prednisone) for 6 cycles.
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|---|---|
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Overall Study
STARTED
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100
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Overall Study
COMPLETED
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71
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Overall Study
NOT COMPLETED
|
29
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Reasons for withdrawal
| Measure |
Obinutuzumab + CHOP
Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy (cyclophosphamide, doxorubicin, vincristine and prednisone) for 6 cycles.
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|---|---|
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Overall Study
Death
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17
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Overall Study
Lost to Follow-up
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5
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Overall Study
Withdrawal by Subject
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7
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Baseline Characteristics
A Study of Obinutuzumab [RO5072759 (GA101)] in Combination With CHOP Chemotherapy in Patients With Previously Untreated Advanced Diffuse Large B-Cell Lymphoma (GATHER)
Baseline characteristics by cohort
| Measure |
Obinutuzumab + CHOP
n=100 Participants
Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
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|---|---|
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Age, Continuous
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57.9 years
STANDARD_DEVIATION 14.4 • n=5 Participants
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Sex: Female, Male
Female
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43 Participants
n=5 Participants
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Sex: Female, Male
Male
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57 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days)Population: All participants.
Complete response rate is defined as the percentage of participants with Complete Response (CR) according to the Revised Response Criteria for Malignant Lymphoma (Cheson et al., 2007). Disease response was evaluated by the investigator using regular clinical and laboratory examinations, fluorodeoxyglucose-positron emission tomography (FDG-PET) and computed tomography (CT). CR is the disappearance of all evidence of disease.
Outcome measures
| Measure |
Obinutuzumab + CHOP
n=100 Participants
Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
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Complete Response (CR) Rate as Assessed by the Investigator at the End of Treatment
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55.0 percentage of participants
Interval 44.73 to 64.97
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PRIMARY outcome
Timeframe: From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days)Population: All participants
Overall response rate was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) according to the Revised Response Criteria for Malignant Lymphoma (Cheson et al., 2007). Disease response was evaluated by the investigator using regular clinical and laboratory examinations, FDG-PET and computed tomography (CT). CR is the disappearance of all evidence of disease. PR is at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites.
Outcome measures
| Measure |
Obinutuzumab + CHOP
n=100 Participants
Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
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Overall Response Rate (ORR) as Assessed by the Investigator at the End of Treatment
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82.0 percentage of participants
Interval 73.05 to 88.97
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SECONDARY outcome
Timeframe: From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days)Population: All participants.
Complete response rate is defined as the percentage of participants with Complete Response (CR) according to the Revised Response Criteria for Malignant Lymphoma (Cheson et al., 2007). Disease response was evaluated by the IRF using CT scans, PET scans and pertinent clinical information. CR is the disappearance of all evidence of disease.
Outcome measures
| Measure |
Obinutuzumab + CHOP
n=100 Participants
Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
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Complete Response (CR) Rate as Assessed by the Independent Review Facility (IRF) at the End of Treatment
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58.0 percentage of participants
Interval 47.71 to 67.8
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SECONDARY outcome
Timeframe: From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days)Population: All participants
Overall response rate was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) according to the Revised Response Criteria for Malignant Lymphoma (Cheson et al., 2007). Disease response was evaluated by the IRF using CT scans, PET scans and pertinent clinical information. CR is the disappearance of all evidence of disease. PR is at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites.
Outcome measures
| Measure |
Obinutuzumab + CHOP
n=100 Participants
Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
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Overall Response Rate (ORR) as Assessed by the IRF at the End of Treatment
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75.0 percentage of participants
Interval 65.34 to 83.12
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SECONDARY outcome
Timeframe: From the first dose of study treatment to PFS assessment (up to 64 months)Population: All participants. Patients who had not progressed, relapsed or died at the time of analysis were censored on the date of last valid disease assessment. If no tumor assessments were performed after the baseline visit, the patient was censored for PFS at the date after the first dose of study treatments.
PFS was defined as the time from the date of the first dose of study treatment until the date of disease progression, relapse, or death from any cause.
Outcome measures
| Measure |
Obinutuzumab + CHOP
n=100 Participants
Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
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Progression-Free Survival (PFS) as Assessed by the Investigator
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48.3 months
Interval 46.1 to 58.2
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SECONDARY outcome
Timeframe: From the response assessment to relapse, progression, or death (up to 64 months)Population: All participants with data available. Participants who had not progressed, relapsed, or died at the time of analysis were censored for duration of response at the date of the last valid response assessment.
DOR is defined as first occurrence of documented response (CR or PR) until the first occurrence of relapse or progression or death of any cause. CR: disappearance of all evidence of disease. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites.
Outcome measures
| Measure |
Obinutuzumab + CHOP
n=96 Participants
Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
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Duration of Response (DOR)
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45.6 months
Interval 43.1 to 55.7
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SECONDARY outcome
Timeframe: From the first dose of study treatment to end of study (up to 5 years 4 months)Population: Safety population included all randomized participants who received study drug.
An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug or other protocol-imposed intervention. Preexisting conditions that worsened during the study were reported as adverse events.
Outcome measures
| Measure |
Obinutuzumab + CHOP
n=100 Participants
Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
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Percentage of Participants With Adverse Events as a Measure of Safety
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100.0 percentage of participants
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SECONDARY outcome
Timeframe: From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days)Population: Participants from the Safety population, all randomized participants who received at least 1 dose of study drug, who received shorter duration infusions.
SDI 120 is a shorter duration infusion of 120 minutes and SDI 90 is shorter duration infusion of 90 minutes. Grade 3 IRR AE: Prolonged (e.g., not rapidly responsive to symptomatic medication and/or brief interruption of infusion); recurrence of symptoms following initial improvement; hospitalization indicated for clinical sequelae. Grade 4 IRR AE: Life-threatening consequences; urgent intervention indicated.
Outcome measures
| Measure |
Obinutuzumab + CHOP
n=75 Participants
Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
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Number of Participants With Grade 3 to 4 Infusion-Related (IRR) Adverse Events (AE) in Participants Receiving Shorter Duration Infusion (SDI)
SDI 90 (n=70)
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0 participants
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Number of Participants With Grade 3 to 4 Infusion-Related (IRR) Adverse Events (AE) in Participants Receiving Shorter Duration Infusion (SDI)
SDI 120 (n=5)
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0 participants
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SECONDARY outcome
Timeframe: Cycle 1 Day 1 pre and post dose, Days 3,5, Day 8 pre and post-dose, Day 15 pre-dose. Cycle 8 Day 1 pre and post-dose, Days 5,8,12Population: PK-Evaluable included all participants with viable PK data for analysis.
Blood was collected for PK Parameters. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in micrograms per milliliter (μg/mL).
Outcome measures
| Measure |
Obinutuzumab + CHOP
n=100 Participants
Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
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Pharmacokinetics (PK): Maximum Concentration Observed (Cmax) for Obinutuzumab
Cycle 1
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297 μg/mL
Standard Deviation 110
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Pharmacokinetics (PK): Maximum Concentration Observed (Cmax) for Obinutuzumab
Cycle 8 (n = 85)
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574 μg/mL
Standard Deviation 183
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SECONDARY outcome
Timeframe: Cycle 1 Day 1 pre and post dose, Days 3,5, Day 8 pre and post-dose, Day 15 pre-dose. Cycle 8 Day 1 pre and post-dose, Days 5,8,12Population: PK-Evaluable included all participants with viable PK data for analysis.
T1/2 is the time required for the concentration of the drug to reach half of its original value. Blood was collected for PK Parameters. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in days
Outcome measures
| Measure |
Obinutuzumab + CHOP
n=100 Participants
Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
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Pharmacokinetics: Terminal Half-Life (t1/2) for Obinutuzumab
Cycle 1 (n = 37)
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6.04 days
Standard Deviation 1.54
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Pharmacokinetics: Terminal Half-Life (t1/2) for Obinutuzumab
Cycle 8 (n = 21)
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23 days
Standard Deviation 15.9
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SECONDARY outcome
Timeframe: Cycle 1 Day 1 pre and post dose, Days 3,5, Day 8 pre and post-dose, Day 15 pre-dose. Cycle 8 Day 1 pre and post-dose, Days 5,8,12Population: PK-Evaluable included all participants with viable PK data for analysis.
Cl is the volume of serum cleared of the drug per unit of time. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in milliliters/day (mL/day).
Outcome measures
| Measure |
Obinutuzumab + CHOP
n=100 Participants
Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
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Pharmacokinetics: Clearance (Cl) for Obinutuzumab
Cycle 1 (n = 54)
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456 mL/day
Standard Deviation 254
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Pharmacokinetics: Clearance (Cl) for Obinutuzumab
Cycle 8 (n = 37)
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143 mL/day
Standard Deviation 59.8
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SECONDARY outcome
Timeframe: Cycle 1 Day 1 pre and post dose, Days 3,5, Day 8 pre and post-dose, Day 15 pre-dose. Cycle 8 Day 1 pre and post-dose, Days 5,8,12Population: PK-Evaluable included all participants with viable PK data for analysis.
V is the apparent volume in which a drug is distributed in the body. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in milliliters (mL).
Outcome measures
| Measure |
Obinutuzumab + CHOP
n=100 Participants
Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
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Pharmacokinetics: Volume of Distribution (V) for Obinutuzumab
Cycle 1 (n = 54)
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4580 mL
Standard Deviation 2450
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Pharmacokinetics: Volume of Distribution (V) for Obinutuzumab
Cycle 8 (n = 37)
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9210 mL
Standard Deviation 17000
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SECONDARY outcome
Timeframe: Cycle 1 Day 1 pre and post dose, Days 3,5, Day 8 pre and post-dose, Day 15 pre-dose. Cycle 8 Day 1 pre and post-dose, Days 5,8,12Population: PK-Evaluable included all participants with viable PK data for analysis.
Blood was collected for PK parameters. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in in day times micrograms per milliliter (day\*μg/mL).
Outcome measures
| Measure |
Obinutuzumab + CHOP
n=100 Participants
Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
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|---|---|
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Pharmacokinetics: Area Under the Concentration-Time Curve 7 Day (AUC7day)
Cycle 1 (n = 59)
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1320 day*μg/mL
Standard Deviation 440
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Pharmacokinetics: Area Under the Concentration-Time Curve 7 Day (AUC7day)
Cycle 8 (n = 74)
|
3300 day*μg/mL
Standard Deviation 1130
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SECONDARY outcome
Timeframe: Up to approximately 24 monthsOutcome measures
Outcome data not reported
Adverse Events
Obinutuzumab + CHOP
Serious events: 38 serious events
Other events: 100 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Obinutuzumab + CHOP
n=100 participants at risk
Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
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Infections and infestations
Pneumonia
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6.0%
6/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
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Infections and infestations
Sepsis
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2.0%
2/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
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Infections and infestations
Catheter site cellulitis
|
1.0%
1/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
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|
Infections and infestations
Cellulitis
|
1.0%
1/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Clostridium difficile infection
|
1.0%
1/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia cytomegaloviral
|
1.0%
1/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Device related infection
|
1.0%
1/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
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|
Infections and infestations
Encephalitis
|
1.0%
1/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Enterococcal infection
|
1.0%
1/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Herpes zoster
|
1.0%
1/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Herpes zoster disseminated
|
1.0%
1/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Colonic abscess
|
1.0%
1/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Localised infection
|
1.0%
1/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia legionella
|
1.0%
1/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Septic shock
|
1.0%
1/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
1.0%
1/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
14.0%
14/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.0%
1/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.0%
1/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
1.0%
1/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
2/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.0%
1/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
1.0%
1/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Intestinal perforation
|
1.0%
1/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
1.0%
1/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
1.0%
1/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.0%
1/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
1.0%
1/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac failure congestive
|
1.0%
1/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Acute left ventricular failure
|
1.0%
1/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiovascular disorder
|
1.0%
1/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Left ventricular dysfunction
|
1.0%
1/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.0%
2/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.0%
2/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.0%
1/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.0%
1/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Hemiparesis
|
1.0%
1/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Presyncope
|
1.0%
1/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Spondylitic myelopathy
|
1.0%
1/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Syncope
|
1.0%
1/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.0%
2/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.0%
1/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Mental status changes
|
2.0%
2/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Delirium
|
1.0%
1/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Suicide attempt
|
1.0%
1/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
General disorders
Asthenia
|
1.0%
1/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
General disorders
Chest pain
|
1.0%
1/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
1.0%
1/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.0%
1/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.0%
1/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
1.0%
1/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
1.0%
1/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
General disorders
Death
|
1.0%
1/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Obinutuzumab + CHOP
n=100 participants at risk
Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
|
|---|---|
|
General disorders
Fatigue
|
48.0%
48/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
General disorders
Chills
|
41.0%
41/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
26.0%
26/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
General disorders
Mucosal inflammation
|
10.0%
10/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
General disorders
Oedema peripheral
|
9.0%
9/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
General disorders
Chest pain
|
7.0%
7/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
General disorders
Pain
|
6.0%
6/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
General disorders
Asthenia
|
5.0%
5/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
59.0%
59/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
38.0%
38/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
31.0%
31/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
29.0%
29/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
14.0%
14/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
12.0%
12/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
9.0%
9/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
8.0%
8/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.0%
5/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Oral pain
|
6.0%
6/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
56.0%
56/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
5.0%
5/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Neuropathy peripheral
|
24.0%
24/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
20.0%
20/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
17.0%
17/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
7.0%
7/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
5.0%
5/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.0%
5/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
28.0%
28/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
20/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
15.0%
15/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
6.0%
6/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
40.0%
40/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.0%
8/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.0%
7/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
6.0%
6/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
40.0%
40/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
18.0%
18/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.0%
6/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.0%
14/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
14.0%
14/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
10/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.0%
8/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.0%
5/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
19.0%
19/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
15.0%
15/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
10.0%
10/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
5.0%
5/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
9.0%
9/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Sinusitis
|
6.0%
6/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Candida infection
|
5.0%
5/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.0%
5/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
14.0%
14/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
10.0%
10/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Investigations
Weight decreased
|
12.0%
12/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Investigations
Ejection fraction decreased
|
5.0%
5/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypotension
|
15.0%
15/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Tachycardia
|
9.0%
9/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Eye disorders
Lacrimation increased
|
5.0%
5/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Eye disorders
Vision blurred
|
5.0%
5/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Dysuria
|
5.0%
5/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
5.0%
5/100 • From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
|
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