Trial Outcomes & Findings for Study of Efficacy and Safety of CTL019 in Adult DLBCL Patients (NCT NCT02445248)
NCT ID: NCT02445248
Last Updated: 2024-04-18
Results Overview
ORR, which includes complete response (CR) and partial response (PR) in the Main cohort as determined by IRC assessment. ORR is the percentage of participants with a best overall disease response of CR or PR, where the best overall disease response is defined as the best disease response recorded from CTL019 infusion until progressive disease or start of new anticancer therapy (including ASCT), whichever comes first. Response was assessed according to Evaluation Criteria in diffuse large B cell lymphoma studies (based on Cheson Response criteria and the Lugano Classification (2014))
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
115 participants
Primary outcome timeframe
60 months
Results posted on
2024-04-18
Participant Flow
115 participants were infused in this study: 99 in the Main Cohort and 16 in Cohort A.
After informed consent/assent was obtained, and prior to infusion, participants underwent a routine lymphodepleting therapy, 14 to 5 days before CTL019 infusion. There were 27 centers across 10 countries for this trial.
Participant milestones
| Measure |
Tisagenlecleucel - Main Cohort
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US.
|
Tisagenlecleucel Cohort A
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
|
|---|---|---|
|
Overall Study
STARTED
|
99
|
16
|
|
Overall Study
COMPLETED
|
26
|
3
|
|
Overall Study
NOT COMPLETED
|
73
|
13
|
Reasons for withdrawal
| Measure |
Tisagenlecleucel - Main Cohort
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US.
|
Tisagenlecleucel Cohort A
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
|
|---|---|---|
|
Overall Study
Death
|
45
|
12
|
|
Overall Study
Progressive disease
|
13
|
1
|
|
Overall Study
Subject decision
|
8
|
0
|
|
Overall Study
Physician Decision
|
5
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Study of Efficacy and Safety of CTL019 in Adult DLBCL Patients
Baseline characteristics by cohort
| Measure |
Tisagenlecleucel - Main Cohort
n=99 Participants
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US.
|
Tisagenlecleucel Cohort A
n=16 Participants
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
|
Total
n=115 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.3 years
STANDARD_DEVIATION 13.09 • n=5 Participants
|
51.1 years
STANDARD_DEVIATION 12.98 • n=7 Participants
|
53.8 years
STANDARD_DEVIATION 13.07 • n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
63 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
83 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
10 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
ECOG performance status
ECOG status of 0
|
54 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
ECOG performance status
ECOG status of 1
|
45 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 60 monthsPopulation: Full Analysis Set (FAS): Comprised of all patients in the Main cohort who received infusion of tisagenlecleucel.
ORR, which includes complete response (CR) and partial response (PR) in the Main cohort as determined by IRC assessment. ORR is the percentage of participants with a best overall disease response of CR or PR, where the best overall disease response is defined as the best disease response recorded from CTL019 infusion until progressive disease or start of new anticancer therapy (including ASCT), whichever comes first. Response was assessed according to Evaluation Criteria in diffuse large B cell lymphoma studies (based on Cheson Response criteria and the Lugano Classification (2014))
Outcome measures
| Measure |
Tisagenlecleucel - Main Cohort
n=99 Participants
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US.
|
Tisagenlecleucel - All Patients
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US and at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
|
Tisagenlecleucel - All Patients
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US and at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
|
Tisagenlecleucel - Cohort A: SD/PD/UNK
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
|
|---|---|---|---|---|
|
Overall Response Rate (ORR) Per Independent Review Committee (IRC) in Main Cohort
|
54.5 Percentage of participants
Interval 44.2 to 64.6
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: Full Analysis Set (FAS): Comprised all patients who received infusion of tisagenlecleucel.
ORR, which includes complete response (CR) and partial response (PR) in the Main cohort as determined by IRC assessment. ORR is the percentage of participants with a best overall disease response of CR or PR, where the best overall disease response is defined as the best disease response recorded from CTL019 infusion until progressive disease or start of new anticancer therapy (including ASCT), whichever comes first.
Outcome measures
| Measure |
Tisagenlecleucel - Main Cohort
n=16 Participants
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US.
|
Tisagenlecleucel - All Patients
n=115 Participants
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US and at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
|
Tisagenlecleucel - All Patients
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US and at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
|
Tisagenlecleucel - Cohort A: SD/PD/UNK
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
|
|---|---|---|---|---|
|
Overall Response Rate (ORR) Per Independent Review Committee (IRC) in Cohort A & in All Patients
|
43.8 Percentage of participants
Interval 19.8 to 70.1
|
53.0 Percentage of participants
Interval 43.5 to 62.4
|
—
|
—
|
SECONDARY outcome
Timeframe: up to approx. 3.3 monthsPopulation: Full Analysis Set (FAS): Comprised all patients in the Main cohort who received infusion of tisagenlecleucel.
TTR is the time between date of CTL019 infusion until first documented response (CR or PR).
Outcome measures
| Measure |
Tisagenlecleucel - Main Cohort
n=99 Participants
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US.
|
Tisagenlecleucel - All Patients
n=115 Participants
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US and at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
|
Tisagenlecleucel - All Patients
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US and at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
|
Tisagenlecleucel - Cohort A: SD/PD/UNK
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
|
|---|---|---|---|---|
|
Time to Response (TTR) as Assessed by Independent Review Committee (Main Cohort & All Patients)
|
1.0 Months
Interval 0.9 to 1.0
|
1.0 Months
Interval 0.9 to 1.0
|
—
|
—
|
SECONDARY outcome
Timeframe: up to approx. 60.1 monthsPopulation: Full Analysis Set (FAS): Comprised all patients who received infusion of tisagenlecleucel and who achieved a completer response (CR) or a partial response (PR).
DOR is the time from achievement of CR or PR, whichever occurs first, to relapse or death due to diffuse large B-cell lymphoma (DLBCL).
Outcome measures
| Measure |
Tisagenlecleucel - Main Cohort
n=54 Participants
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US.
|
Tisagenlecleucel - All Patients
n=7 Participants
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US and at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
|
Tisagenlecleucel - All Patients
n=61 Participants
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US and at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
|
Tisagenlecleucel - Cohort A: SD/PD/UNK
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
|
|---|---|---|---|---|
|
Duration of Overall Response (DOR) Per IRC
|
NA Months
Interval 10.0 to
NA: The Median and the upper limit of Confidence Interval could not be reached because fewer than half of the patients experienced an event
|
NA Months
Interval 1.2 to
NA: The Median and the upper limit of Confidence Interval could not be reached because fewer than half of the patients experienced an event
|
NA Months
Interval 10.0 to
NA: The Median and the upper limit of Confidence Interval could not be reached because fewer than half of the patients experienced an event
|
—
|
SECONDARY outcome
Timeframe: up to approx. 61 monthsPopulation: Full Analysis Set (FAS): Comprised all patients who received infusion of tisagenlecleucel.
EFS is the time from date of CTL019 infusion to the date of first documented disease progression or relapse, new treatment for lymphoma or death due to any cause.
Outcome measures
| Measure |
Tisagenlecleucel - Main Cohort
n=99 Participants
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US.
|
Tisagenlecleucel - All Patients
n=16 Participants
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US and at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
|
Tisagenlecleucel - All Patients
n=115 Participants
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US and at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
|
Tisagenlecleucel - Cohort A: SD/PD/UNK
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
|
|---|---|---|---|---|
|
Event Free Survival (EFS) Per Independent Review Committee
|
2.8 Months
Interval 2.2 to 3.5
|
2.1 Months
Interval 1.0 to 3.1
|
2.8 Months
Interval 2.1 to 3.1
|
—
|
SECONDARY outcome
Timeframe: up to approx. 61 monthsPopulation: Full Analysis Set (FAS): Comprised all patients who received infusion of tisagenlecleucel.
PFS is the time from date of CTL019 infusion to the date of first documented disease progression or death due to any cause.
Outcome measures
| Measure |
Tisagenlecleucel - Main Cohort
n=99 Participants
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US.
|
Tisagenlecleucel - All Patients
n=16 Participants
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US and at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
|
Tisagenlecleucel - All Patients
n=115 Participants
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US and at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
|
Tisagenlecleucel - Cohort A: SD/PD/UNK
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
|
|---|---|---|---|---|
|
Progression Free Survival (PFS) Per Independent Review Committee
|
3.0 Months
Interval 2.4 to 6.2
|
2.9 Months
Interval 1.0 to
NA: The upper limit of the Confidence Interval could ne be reached because there were not enough events to estimate the time to the later events.
|
2.9 Months
Interval 2.3 to 5.2
|
—
|
SECONDARY outcome
Timeframe: 60 monthsPopulation: Full Analysis Set (FAS): Comprised all patients who received infusion of tisagenlecleucel.
OS is the time from date of CTL019 infusion to the date of death due to any cause.
Outcome measures
| Measure |
Tisagenlecleucel - Main Cohort
n=99 Participants
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US.
|
Tisagenlecleucel - All Patients
n=16 Participants
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US and at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
|
Tisagenlecleucel - All Patients
n=115 Participants
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US and at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
|
Tisagenlecleucel - Cohort A: SD/PD/UNK
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
|
|---|---|---|---|---|
|
Overall Survival (OS) Per Independent Review Committee
|
12.5 Months
Interval 7.2 to 34.2
|
5.9 Months
Interval 3.1 to 19.2
|
11.1 Months
Interval 6.6 to 23.9
|
—
|
SECONDARY outcome
Timeframe: 60 monthsPopulation: Full Analysis Set (FAS): Comprised all patients who received infusion of tisagenlecleucel with valid PK assessments.
Cmax is the maximum (peak) observed in peripheral blood or other body fluid drug concentration after single dose administration. Cmax, based on the transgene level data by qPCR, was summarized by Month 3 response, per Independent Review Committee assessment. The reported Cmax is the summary of maximum level observed based on the data from each patient and based on all the data that's been collected for up to 60 months in a patient.
Outcome measures
| Measure |
Tisagenlecleucel - Main Cohort
n=40 Participants
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US.
|
Tisagenlecleucel - All Patients
n=56 Participants
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US and at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
|
Tisagenlecleucel - All Patients
n=4 Participants
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US and at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
|
Tisagenlecleucel - Cohort A: SD/PD/UNK
n=11 Participants
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
|
|---|---|---|---|---|
|
Pharmacokinetics (Pk): Cmax
|
5570 copies/ug
Geometric Coefficient of Variation 271.3
|
4690 copies/ug
Geometric Coefficient of Variation 481.1
|
14300 copies/ug
Geometric Coefficient of Variation 67.5
|
6950 copies/ug
Geometric Coefficient of Variation 109.3
|
SECONDARY outcome
Timeframe: 60 monthsPopulation: Full Analysis Set (FAS): Comprised all patients who received infusion of tisagenlecleucel with valid PK assessments.
Tmax is the time to reach maximum (peak) peripheral blood or other body fluid drug concentration after single dose administration (days). Tmax, based on the transgene level data by qPCR, was summarized by Month 3 response, per Independent Review Committee assessment. The time frame of 60 months refers to the duration for which the data were reviewed to identify the time of Cmax for this measure.
Outcome measures
| Measure |
Tisagenlecleucel - Main Cohort
n=40 Participants
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US.
|
Tisagenlecleucel - All Patients
n=56 Participants
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US and at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
|
Tisagenlecleucel - All Patients
n=4 Participants
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US and at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
|
Tisagenlecleucel - Cohort A: SD/PD/UNK
n=11 Participants
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
|
|---|---|---|---|---|
|
Pharmacokinetics (Pk): Tmax
|
9.84 days
Interval 5.78 to 27.7
|
8.95 days
Interval 0.994 to 26.7
|
6.95 days
Interval 5.94 to 8.96
|
6.93 days
Interval 6.67 to 10.9
|
SECONDARY outcome
Timeframe: 0 - 28 days after infusion for AUC0-28d, 0 - 84 days after infusion for AUC0-84dPopulation: Full Analysis Set (FAS): Comprised all patients who received infusion of tisagenlecleucel with valid PK assessments.
The AUC from time zero to day 28 and 84 or other disease assessment days, in peripheral blood. AUC0-28d and AUC0-84d, based on the transgene level data by qPCR, were summarized by Month 3 response, per Independent Review Committee assessment.
Outcome measures
| Measure |
Tisagenlecleucel - Main Cohort
n=40 Participants
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US.
|
Tisagenlecleucel - All Patients
n=59 Participants
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US and at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
|
Tisagenlecleucel - All Patients
n=4 Participants
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US and at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
|
Tisagenlecleucel - Cohort A: SD/PD/UNK
n=12 Participants
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
|
|---|---|---|---|---|
|
Pharmacokinetics (Pk): AUC0-28d and AUC0-84d
AUC0-28d
|
58000 copies/ug*days
Geometric Coefficient of Variation 182.1
|
49900 copies/ug*days
Geometric Coefficient of Variation 388.5
|
141000 copies/ug*days
Geometric Coefficient of Variation 78.2
|
63700 copies/ug*days
Geometric Coefficient of Variation 134.2
|
|
Pharmacokinetics (Pk): AUC0-28d and AUC0-84d
AUC0-84d
|
102000 copies/ug*days
Geometric Coefficient of Variation 171.7
|
92900 copies/ug*days
Geometric Coefficient of Variation 165.4
|
206000 copies/ug*days
Geometric Coefficient of Variation 76.7
|
142000 copies/ug*days
Geometric Coefficient of Variation 61.3
|
SECONDARY outcome
Timeframe: 60 monthsPopulation: Full Analysis Set (FAS): Comprised all patients who received infusion of tisagenlecleucel with valid PK assessments.
T1/2 is the half-life associated with the disposition phase slopes (alpha, beta, gamma etc.) of a semi logarithmic concentration-time curve in peripheral blood. T1/2, based on the transgene level data by qPCR, was summarized by Month 3 response, per Independent Review Committee assessment. This time frame of 60 months reflects the maximum duration up to which the transgene levels were collected to measure the half life.
Outcome measures
| Measure |
Tisagenlecleucel - Main Cohort
n=28 Participants
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US.
|
Tisagenlecleucel - All Patients
n=40 Participants
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US and at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
|
Tisagenlecleucel - All Patients
n=3 Participants
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US and at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
|
Tisagenlecleucel - Cohort A: SD/PD/UNK
n=9 Participants
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
|
|---|---|---|---|---|
|
Pharmacokinetics (Pk): T1/2
|
167 days
Geometric Coefficient of Variation 355.3
|
10.9 days
Geometric Coefficient of Variation 205.4
|
59.4 days
Geometric Coefficient of Variation 30402.1
|
15.6 days
Geometric Coefficient of Variation 163.5
|
SECONDARY outcome
Timeframe: 60 monthsPopulation: Full Analysis Set (FAS): Comprised all patients who received infusion of tisagenlecleucel with valid PK assessments.
Clast is the last observed quantifiable concentration in peripheral blood. Clast, based on the transgene level data by qPCR, was summarized by Month 3 response, per Independent Review Committee assessment. This time frame reflects maximum duration of 60 months up to which the transgene levels were collected.
Outcome measures
| Measure |
Tisagenlecleucel - Main Cohort
n=40 Participants
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US.
|
Tisagenlecleucel - All Patients
n=55 Participants
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US and at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
|
Tisagenlecleucel - All Patients
n=4 Participants
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US and at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
|
Tisagenlecleucel - Cohort A: SD/PD/UNK
n=12 Participants
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
|
|---|---|---|---|---|
|
Pharmacokinetics (Pk): Clast
|
181 copies/ug
Geometric Coefficient of Variation 114.4
|
332 copies/ug
Geometric Coefficient of Variation 430.9
|
272 copies/ug
Geometric Coefficient of Variation 30.6
|
386 copies/ug
Geometric Coefficient of Variation 540.9
|
SECONDARY outcome
Timeframe: 60 monthsPopulation: Full Analysis Set (FAS): Comprised all patients who received infusion of tisagenlecleucel with valid PK assessments.
Tlast is the time of last observed quantifiable concentration in peripheral blood. Tlast, based on the transgene level data by qPCR, was summarized by Month 3 response, per Independent Review Committee assessment. This time frame reflects maximum duration of 60 months up to which the transgene levels were collected.
Outcome measures
| Measure |
Tisagenlecleucel - Main Cohort
n=40 Participants
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US.
|
Tisagenlecleucel - All Patients
n=55 Participants
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US and at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
|
Tisagenlecleucel - All Patients
n=4 Participants
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US and at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
|
Tisagenlecleucel - Cohort A: SD/PD/UNK
n=12 Participants
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
|
|---|---|---|---|---|
|
Pharmacokinetics (Pk): Tlast
|
930 days
Interval 18.0 to 1830.0
|
41.9 days
Interval 0.994 to 1480.0
|
1040 days
Interval 17.1 to 1830.0
|
59.4 days
Interval 26.8 to 126.0
|
SECONDARY outcome
Timeframe: pre-infusion and at any time point post-baseline, up to duration of the study, up to 5 yearsPopulation: Full Analysis Set (FAS): Comprised all patients who received infusion of tisagenlecleucel.
This is defined as the percentage of participants who tested positive for anti-mCAR19 antibodies at any time post-baseline, reported by complete response (CR), partial response (PR), Stable disease (SD), progressive disease (SD), Unknown for all participants who received with tisagenlecleucel.
Outcome measures
| Measure |
Tisagenlecleucel - Main Cohort
n=115 Participants
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US.
|
Tisagenlecleucel - All Patients
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US and at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
|
Tisagenlecleucel - All Patients
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US and at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
|
Tisagenlecleucel - Cohort A: SD/PD/UNK
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
|
|---|---|---|---|---|
|
Incidence of Immunogenicity to CTL019
Complete response
|
36 Participants
|
—
|
—
|
—
|
|
Incidence of Immunogenicity to CTL019
Partial response
|
6 Participants
|
—
|
—
|
—
|
|
Incidence of Immunogenicity to CTL019
Stable disease
|
1 Participants
|
—
|
—
|
—
|
|
Incidence of Immunogenicity to CTL019
Progressive disease
|
50 Participants
|
—
|
—
|
—
|
|
Incidence of Immunogenicity to CTL019
Unknown
|
14 Participants
|
—
|
—
|
—
|
|
Incidence of Immunogenicity to CTL019
All Participants
|
107 Participants
|
—
|
—
|
—
|
POST_HOC outcome
Timeframe: On-treatment deaths: Up to 61 months; Post-treatment survival follow-up deaths: Up to approx. 61 monthsPopulation: Clinical Database Population: all infused participants in the Study.
On-treatment deaths, which include post-treatment survival follow-up deaths, were collected during the post-infusion period (starting at the day of first infusion) until the end of the study, approx. 61 months. All deaths refers to the sum of on-treatment deaths and post-treatment survival follow-up deaths up to approx. 61 months.
Outcome measures
| Measure |
Tisagenlecleucel - Main Cohort
n=115 Participants
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US.
|
Tisagenlecleucel - All Patients
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US and at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
|
Tisagenlecleucel - All Patients
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US and at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
|
Tisagenlecleucel - Cohort A: SD/PD/UNK
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
|
|---|---|---|---|---|
|
All Collected Deaths
On-treatment deaths include post-treatment survival follow-up deaths
|
76 Participants
|
—
|
—
|
—
|
|
All Collected Deaths
All deaths
|
76 Participants
|
—
|
—
|
—
|
Adverse Events
Tisagenlecleucel - All Patients
Serious events: 84 serious events
Other events: 113 other events
Deaths: 76 deaths
Serious adverse events
| Measure |
Tisagenlecleucel - All Patients
n=115 participants at risk
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US and at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
|
|---|---|
|
Blood and lymphatic system disorders
Bone marrow failure
|
1.7%
2/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
8.7%
10/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.7%
2/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
2.6%
3/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Cardiac disorders
Atrial fibrillation
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Cardiac disorders
Cardiac arrest
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Ear and labyrinth disorders
Vertigo
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Gastrointestinal disorders
Anal fissure
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.7%
2/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Gastrointestinal disorders
Haematemesis
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Gastrointestinal disorders
Melaena
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Gastrointestinal disorders
Vomiting
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
General disorders
Face oedema
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
General disorders
Fatigue
|
3.5%
4/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
General disorders
Influenza like illness
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
General disorders
Multiple organ dysfunction syndrome
|
2.6%
3/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
General disorders
Pyrexia
|
7.8%
9/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Immune system disorders
Cytokine release syndrome
|
27.0%
31/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Immune system disorders
Haemophagocytic lymphohistiocytosis
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Infections and infestations
Atypical pneumonia
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Infections and infestations
Bronchitis
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Infections and infestations
Candida infection
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Infections and infestations
Cerebral toxoplasmosis
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Infections and infestations
Clostridium difficile infection
|
2.6%
3/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Infections and infestations
Corynebacterium infection
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Infections and infestations
Escherichia infection
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Infections and infestations
Infection
|
1.7%
2/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Infections and infestations
Influenza
|
1.7%
2/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
1.7%
2/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Infections and infestations
Pneumonia
|
7.8%
9/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Infections and infestations
Pneumonia aspiration
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Infections and infestations
Pseudomonas infection
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Infections and infestations
Respiratory tract infection
|
1.7%
2/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Infections and infestations
Sepsis
|
2.6%
3/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Infections and infestations
Sinusitis
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Infections and infestations
Staphylococcal infection
|
1.7%
2/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Infections and infestations
Systemic infection
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Infections and infestations
Urinary tract infection
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Infections and infestations
Urosepsis
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Infections and infestations
Vaginal infection
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Investigations
Blood bilirubin increased
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Investigations
C-reactive protein increased
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Investigations
Liver function test increased
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Investigations
Neutrophil count decreased
|
2.6%
3/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Investigations
Platelet count decreased
|
1.7%
2/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Investigations
White blood cell count decreased
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.7%
2/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
3.5%
4/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
2.6%
3/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Refractory cytopenia with multilineage dysplasia
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Nervous system disorders
Acute polyneuropathy
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Nervous system disorders
Demyelinating polyneuropathy
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Nervous system disorders
Encephalopathy
|
3.5%
4/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Nervous system disorders
Somnolence
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Nervous system disorders
Status epilepticus
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Nervous system disorders
Syncope
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Psychiatric disorders
Anxiety
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Psychiatric disorders
Confusional state
|
2.6%
3/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Psychiatric disorders
Mental status changes
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Renal and urinary disorders
Acute kidney injury
|
3.5%
4/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic bronchitis
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.6%
3/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal haemorrhage
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.7%
2/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.7%
2/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Vascular disorders
Deep vein thrombosis
|
0.87%
1/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Vascular disorders
Hypotension
|
1.7%
2/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
Other adverse events
| Measure |
Tisagenlecleucel - All Patients
n=115 participants at risk
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US and at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
47.8%
55/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
9.6%
11/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Blood and lymphatic system disorders
Neutropenia
|
18.3%
21/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
13.0%
15/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Cardiac disorders
Tachycardia
|
10.4%
12/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.8%
9/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Gastrointestinal disorders
Constipation
|
16.5%
19/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Gastrointestinal disorders
Diarrhoea
|
31.3%
36/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Gastrointestinal disorders
Dry mouth
|
5.2%
6/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Gastrointestinal disorders
Nausea
|
28.7%
33/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Gastrointestinal disorders
Stomatitis
|
6.1%
7/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Gastrointestinal disorders
Vomiting
|
7.8%
9/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
General disorders
Asthenia
|
7.0%
8/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
General disorders
Chills
|
12.2%
14/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
General disorders
Fatigue
|
24.3%
28/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
General disorders
Influenza like illness
|
7.8%
9/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
General disorders
Oedema peripheral
|
14.8%
17/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
General disorders
Pain
|
5.2%
6/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
General disorders
Pyrexia
|
30.4%
35/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Immune system disorders
Cytokine release syndrome
|
40.9%
47/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Immune system disorders
Hypogammaglobulinaemia
|
8.7%
10/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Infections and infestations
Influenza
|
6.1%
7/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Infections and infestations
Nasopharyngitis
|
7.8%
9/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Infections and infestations
Pneumonia
|
7.0%
8/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Infections and infestations
Sinusitis
|
7.0%
8/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Infections and infestations
Upper respiratory tract infection
|
13.0%
15/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Infections and infestations
Urinary tract infection
|
8.7%
10/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Investigations
Blood creatinine increased
|
10.4%
12/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Investigations
Blood immunoglobulin G decreased
|
6.1%
7/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Investigations
Lymphocyte count decreased
|
6.1%
7/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Investigations
Neutrophil count decreased
|
34.8%
40/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Investigations
Platelet count decreased
|
33.0%
38/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Investigations
Weight decreased
|
12.2%
14/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Investigations
White blood cell count decreased
|
35.7%
41/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
13.0%
15/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
5.2%
6/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
22.6%
26/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
16.5%
19/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
7.8%
9/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
16.5%
19/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.9%
16/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.1%
7/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.1%
7/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.7%
10/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Nervous system disorders
Dizziness
|
12.2%
14/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Nervous system disorders
Headache
|
20.9%
24/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Psychiatric disorders
Anxiety
|
9.6%
11/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Psychiatric disorders
Confusional state
|
7.0%
8/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Psychiatric disorders
Insomnia
|
7.0%
8/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Renal and urinary disorders
Acute kidney injury
|
5.2%
6/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.5%
19/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
13.9%
16/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
7.0%
8/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.2%
6/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.2%
6/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
5.2%
6/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.2%
6/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
|
Vascular disorders
Hypotension
|
24.3%
28/115 • Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e., data from all sites) in clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER