Trial Outcomes & Findings for Cluster of Differentiation Antigen 19/22(CD19/22) CAR T Cells (AUTO3) for the Treatment of Diffuse Large B Cell Lymphoma (NCT NCT03287817)
NCT ID: NCT03287817
Last Updated: 2025-07-14
Results Overview
Number of patients with Grade 3-5 toxicities during escalation part of Phase I (Cohorts: 50x10\^6 CD19/22 CAR+ T Cells; 50x10\^6 CD19/22 CAR+ T Cells+Pembrolizumab \[Pem\] Day 14; 150-450x10\^6 CD19/22 CAR+ T Cells+Pem Day 14; 150-450x10\^6 CD19/22 CAR+ T Cells+Pem Day -1 in Inpatient Setting) Dose-limiting toxicity defined as: * New non-hematological AE Grade \>=3 using NCI CTCAE (5.0), probably/definitely related to AUTO3, occurring in DLT evaluation period, which did not resolve to Grade 2 or better in 14 days, despite supportive measures. * Grade 4 CRS, neurotoxicity (NT), or cerebral edema, or Grade 3 NT that lasted \>72 hrs * Grade \>3 Disseminated Intravascular Coagulation * Grade \>2 Infusion Reaction with AUTO3 * Grade 4 or 5 event not managed with conventional supportive measures or necessitating dose reduction or modification to trial therapy * Any event that in opinion of Investigator and/or medical monitor put patient at undue risk could also have been considered DLT
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
52 participants
Primary outcome timeframe
Within 75 days of AUTO3 infusion
Results posted on
2025-07-14
Participant Flow
A total of 73 adult patients with r/r DLBCL were screened and 62 patients were enrolled. For these 62 patients AUTO3 was manufactured using leukapheresed autologous peripheral blood mononuclear cells, modified with a bicistronic transgene. Ten patients did not receive AUTO3 infusion, in 6 patients this was due to death, in 3 patients due to progressive disease (without death), and in 1 patient due to failed eligibility.
Participant milestones
| Measure |
50 x 10^6 Cluster of Differentiation Antigen 19/22 (CD19/CD22) CAR+ T Cells
Patients in this cohort received actual doses of 50 to 150 x 10\^6 CD19/CD22 CAR+ T cells
|
50 x 10^6 CD19/CD22 CAR+ T Cells + Pembrolizumab at Day 14
Patients in this cohort received actual dose of 50 x 10\^6 CD19/CD22 CAR+ T cells
|
150 to 450 x 10^6 CD19/CD22 CAR+ T Cells + Pembrolizumab at Day 14
Patients in this cohort received actual doses of 150 to 495 x 10\^6 CD19/CD22 CAR+ T cells
|
150 to 450 x 10^6 CD19/CD22 CAR+ T Cells + Pembrolizumab at Day -1 in an Inpatient Setting
Patients in this cohort received actual doses of 125 to 450 x 10\^6 CD19/CD22 CAR+ T cells + pembrolizumab at Day -1 in an inpatient setting
|
150 to 450 x 10^6 CD19/CD22 CAR+ T Cells + Pembrolizumab at Day -1 in an Outpatient Setting
Patients in this cohort received actual doses of 129 to 450 x 10\^6 CD19/CD22 CAR+ T cells + pembrolizumab at Day -1 in an outpatient setting
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
8
|
17
|
20
|
|
Overall Study
COMPLETED
|
0
|
1
|
3
|
3
|
4
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
5
|
14
|
16
|
Reasons for withdrawal
| Measure |
50 x 10^6 Cluster of Differentiation Antigen 19/22 (CD19/CD22) CAR+ T Cells
Patients in this cohort received actual doses of 50 to 150 x 10\^6 CD19/CD22 CAR+ T cells
|
50 x 10^6 CD19/CD22 CAR+ T Cells + Pembrolizumab at Day 14
Patients in this cohort received actual dose of 50 x 10\^6 CD19/CD22 CAR+ T cells
|
150 to 450 x 10^6 CD19/CD22 CAR+ T Cells + Pembrolizumab at Day 14
Patients in this cohort received actual doses of 150 to 495 x 10\^6 CD19/CD22 CAR+ T cells
|
150 to 450 x 10^6 CD19/CD22 CAR+ T Cells + Pembrolizumab at Day -1 in an Inpatient Setting
Patients in this cohort received actual doses of 125 to 450 x 10\^6 CD19/CD22 CAR+ T cells + pembrolizumab at Day -1 in an inpatient setting
|
150 to 450 x 10^6 CD19/CD22 CAR+ T Cells + Pembrolizumab at Day -1 in an Outpatient Setting
Patients in this cohort received actual doses of 129 to 450 x 10\^6 CD19/CD22 CAR+ T cells + pembrolizumab at Day -1 in an outpatient setting
|
|---|---|---|---|---|---|
|
Overall Study
Progressive disease
|
4
|
2
|
3
|
10
|
8
|
|
Overall Study
Death
|
0
|
0
|
2
|
3
|
4
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
4
|
Baseline Characteristics
Data were missing for 3 patients
Baseline characteristics by cohort
| Measure |
50 x 10^6 Cluster of Differentiation (CD) 19/CD22 CAR-positive T Cells
n=4 Participants
Patients in this cohort received actual doses of 50 to 150 x 10\^6 CD19/CD22 CAR-positive T cells
|
50 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day 14
n=3 Participants
All patients in this cohort received actual dose of 50 x 10\^6 CD19/CD22 CAR-positive T cells + pembrolizumab at Day 14
|
150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day 14
n=8 Participants
Patients in this cohort received actual doses of 150 to 495 x 10\^6 CD19/CD22 CAR-positive T cells + pembrolizumab at Day 14
|
150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day -1 in an Inpatient Setting
n=17 Participants
Patients in this cohort received actual doses of 125 to 450 x 10\^6 CD19/CD22 CAR-positive T cells + pembrolizumab at Day -1 in an inpatient setting
|
150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day -1 in an Outpatient Setting
n=20 Participants
Patients in this cohort received actual doses of 129 to 450 x 10\^6 CD19/CD22 CAR-positive T cells + pembrolizumab at Day -1 in an outpatient setting
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=52 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=4 Participants
|
3 Participants
n=3 Participants
|
7 Participants
n=8 Participants
|
7 Participants
n=17 Participants
|
16 Participants
n=20 Participants
|
37 Participants
n=52 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=8 Participants
|
10 Participants
n=17 Participants
|
4 Participants
n=20 Participants
|
15 Participants
n=52 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=4 Participants
|
3 Participants
n=3 Participants
|
7 Participants
n=8 Participants
|
7 Participants
n=17 Participants
|
16 Participants
n=20 Participants
|
35 Participants
n=52 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=8 Participants
|
10 Participants
n=17 Participants
|
4 Participants
n=20 Participants
|
17 Participants
n=52 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=17 Participants
|
5 Participants
n=20 Participants
|
6 Participants
n=52 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=4 Participants
|
3 Participants
n=3 Participants
|
8 Participants
n=8 Participants
|
16 Participants
n=17 Participants
|
9 Participants
n=20 Participants
|
40 Participants
n=52 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=17 Participants
|
6 Participants
n=20 Participants
|
6 Participants
n=52 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=52 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=17 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=52 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=52 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=17 Participants
|
3 Participants
n=20 Participants
|
4 Participants
n=52 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=4 Participants
|
3 Participants
n=3 Participants
|
8 Participants
n=8 Participants
|
15 Participants
n=17 Participants
|
14 Participants
n=20 Participants
|
44 Participants
n=52 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=52 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=17 Participants
|
3 Participants
n=20 Participants
|
3 Participants
n=52 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) score
ECOG = 0
|
1 Participants
n=4 Participants
|
1 Participants
n=3 Participants
|
7 Participants
n=8 Participants
|
9 Participants
n=17 Participants
|
8 Participants
n=20 Participants
|
26 Participants
n=52 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) score
ECOG = 1
|
3 Participants
n=4 Participants
|
2 Participants
n=3 Participants
|
1 Participants
n=8 Participants
|
8 Participants
n=17 Participants
|
12 Participants
n=20 Participants
|
26 Participants
n=52 Participants
|
|
Disease stage
Stage II
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=17 Participants
|
3 Participants
n=20 Participants
|
6 Participants
n=52 Participants
|
|
Disease stage
Stage III
|
0 Participants
n=4 Participants
|
2 Participants
n=3 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=17 Participants
|
4 Participants
n=20 Participants
|
11 Participants
n=52 Participants
|
|
Disease stage
Stage IV
|
4 Participants
n=4 Participants
|
1 Participants
n=3 Participants
|
5 Participants
n=8 Participants
|
12 Participants
n=17 Participants
|
13 Participants
n=20 Participants
|
35 Participants
n=52 Participants
|
|
Relapsed/Refractory disease
Relapsed
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=17 Participants
|
11 Participants
n=20 Participants
|
16 Participants
n=52 Participants
|
|
Relapsed/Refractory disease
Refractory
|
0 Participants
n=4 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=8 Participants
|
6 Participants
n=17 Participants
|
3 Participants
n=20 Participants
|
12 Participants
n=52 Participants
|
|
Relapsed/Refractory disease
Relapsed and Refractory
|
4 Participants
n=4 Participants
|
2 Participants
n=3 Participants
|
5 Participants
n=8 Participants
|
7 Participants
n=17 Participants
|
6 Participants
n=20 Participants
|
24 Participants
n=52 Participants
|
|
Extranodal disease present
No
|
2 Participants
n=4 Participants
|
2 Participants
n=3 Participants
|
3 Participants
n=8 Participants
|
6 Participants
n=17 Participants
|
7 Participants
n=20 Participants
|
20 Participants
n=52 Participants
|
|
Extranodal disease present
Yes
|
2 Participants
n=4 Participants
|
1 Participants
n=3 Participants
|
5 Participants
n=8 Participants
|
11 Participants
n=17 Participants
|
13 Participants
n=20 Participants
|
32 Participants
n=52 Participants
|
|
Current lymphoma subtype
Non-Germinal center B cell type
|
1 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=17 Participants
|
3 Participants
n=20 Participants
|
7 Participants
n=52 Participants
|
|
Current lymphoma subtype
Germinal center B cell type
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
4 Participants
n=8 Participants
|
11 Participants
n=17 Participants
|
9 Participants
n=20 Participants
|
24 Participants
n=52 Participants
|
|
Current lymphoma subtype
Activated B cell type
|
2 Participants
n=4 Participants
|
2 Participants
n=3 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=20 Participants
|
5 Participants
n=52 Participants
|
|
Current lymphoma subtype
High Grade B Cell Lymphoma
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=17 Participants
|
1 Participants
n=20 Participants
|
3 Participants
n=52 Participants
|
|
Current lymphoma subtype
Primary Mediastinal Large B Cell Lymphoma
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=17 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=52 Participants
|
|
Current lymphoma subtype
Nodal marginal zone lymphoma
|
1 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=52 Participants
|
|
Current lymphoma subtype
Follicular lymphoma
|
0 Participants
n=4 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=17 Participants
|
5 Participants
n=20 Participants
|
10 Participants
n=52 Participants
|
|
Current lymphoma subtype
Missing
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=17 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=52 Participants
|
|
International Prognostic Index
Low risk
|
1 Participants
n=4 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=17 Participants
|
3 Participants
n=20 Participants
|
8 Participants
n=52 Participants
|
|
International Prognostic Index
Low-intermediate risk
|
1 Participants
n=4 Participants
|
2 Participants
n=3 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=17 Participants
|
9 Participants
n=20 Participants
|
16 Participants
n=52 Participants
|
|
International Prognostic Index
High-intermediate risk
|
2 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
3 Participants
n=8 Participants
|
6 Participants
n=17 Participants
|
2 Participants
n=20 Participants
|
13 Participants
n=52 Participants
|
|
International Prognostic Index
High risk
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
5 Participants
n=17 Participants
|
5 Participants
n=20 Participants
|
10 Participants
n=52 Participants
|
|
International Prognostic Index
Not done/Unknown
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=17 Participants
|
1 Participants
n=20 Participants
|
5 Participants
n=52 Participants
|
|
Molecular Subtype
No High Risk Molecular Features
|
2 Participants
n=4 Participants
|
2 Participants
n=3 Participants
|
2 Participants
n=8 Participants
|
6 Participants
n=17 Participants
|
3 Participants
n=20 Participants
|
15 Participants
n=52 Participants
|
|
Molecular Subtype
ouble Hit (myc/bcl2 or myc/bcl6 rearrangement)
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
4 Participants
n=8 Participants
|
4 Participants
n=17 Participants
|
6 Participants
n=20 Participants
|
14 Participants
n=52 Participants
|
|
Molecular Subtype
Triple Hit (myc/bcl2/bcl6 rearrangement)
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
4 Participants
n=17 Participants
|
1 Participants
n=20 Participants
|
5 Participants
n=52 Participants
|
|
Molecular Subtype
Double Expressor (myc and bcl2 overexpression)
|
0 Participants
n=4 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=17 Participants
|
3 Participants
n=20 Participants
|
8 Participants
n=52 Participants
|
|
Molecular Subtype
Not done/Unknown
|
2 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=17 Participants
|
7 Participants
n=20 Participants
|
10 Participants
n=52 Participants
|
|
Sum of Product of Perpendicular Diameters
|
17.91 cm
n=3 Participants • Data were missing for 3 patients
|
19.31 cm
n=3 Participants • Data were missing for 3 patients
|
28.55 cm
n=7 Participants • Data were missing for 3 patients
|
21.54 cm
n=16 Participants • Data were missing for 3 patients
|
13.19 cm
n=20 Participants • Data were missing for 3 patients
|
18.69 cm
n=49 Participants • Data were missing for 3 patients
|
|
Lactate Dehydrogenase
|
331.50 U/L
n=4 Participants
|
403.00 U/L
n=3 Participants
|
262.00 U/L
n=8 Participants
|
231.00 U/L
n=17 Participants
|
235.00 U/L
n=20 Participants
|
243.50 U/L
n=52 Participants
|
|
Lines of therapy
|
2.5 Lines of therapy
n=4 Participants
|
3.0 Lines of therapy
n=3 Participants
|
3.0 Lines of therapy
n=8 Participants
|
3.0 Lines of therapy
n=17 Participants
|
3.0 Lines of therapy
n=20 Participants
|
3.0 Lines of therapy
n=52 Participants
|
|
Prior stem cell transplantation
|
0 Participants
n=4 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=17 Participants
|
10 Participants
n=20 Participants
|
16 Participants
n=52 Participants
|
PRIMARY outcome
Timeframe: Within 75 days of AUTO3 infusionPopulation: Patients who received at least 1 (complete or partial) dose of AUTO3 (infused set)
Number of patients with Grade 3-5 toxicities during escalation part of Phase I (Cohorts: 50x10\^6 CD19/22 CAR+ T Cells; 50x10\^6 CD19/22 CAR+ T Cells+Pembrolizumab \[Pem\] Day 14; 150-450x10\^6 CD19/22 CAR+ T Cells+Pem Day 14; 150-450x10\^6 CD19/22 CAR+ T Cells+Pem Day -1 in Inpatient Setting) Dose-limiting toxicity defined as: * New non-hematological AE Grade \>=3 using NCI CTCAE (5.0), probably/definitely related to AUTO3, occurring in DLT evaluation period, which did not resolve to Grade 2 or better in 14 days, despite supportive measures. * Grade 4 CRS, neurotoxicity (NT), or cerebral edema, or Grade 3 NT that lasted \>72 hrs * Grade \>3 Disseminated Intravascular Coagulation * Grade \>2 Infusion Reaction with AUTO3 * Grade 4 or 5 event not managed with conventional supportive measures or necessitating dose reduction or modification to trial therapy * Any event that in opinion of Investigator and/or medical monitor put patient at undue risk could also have been considered DLT
Outcome measures
| Measure |
150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day 14
n=8 Participants
Patients in this cohort received actual doses of 150 to 495 x 10\^6 CD19/CD22 CAR-positive T cells + pembrolizumab at Day 14
|
150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day -1 in an Inpatient Setting
n=17 Participants
Patients in this cohort received actual doses of 125 to 450 x 10\^6 CD19/CD22 CAR-positive T cells + pembrolizumab at Day -1 in an inpatient setting
|
150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day -1 in an Outpatient Setting
Patients in this cohort received actual doses of 129 to 450 x 10\^6 CD19/CD22 CAR-positive T cells + pembrolizumab at Day -1 in an outpatient setting
|
50 x 10^6 CD19/CD22 CAR-positive T Cells
n=4 Participants
Patients in this cohort received actual doses of 50 to 150 x 10\^6 CD19/CD22 CAR-positive T cells
|
50 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day 14
n=3 Participants
All patients in this cohort received actual dose of 50 x 10\^6 CD19/CD22 CAR-positive T cells + pembrolizumab at Day 14
|
|---|---|---|---|---|---|
|
Phase I Escalation - Safety (Number of Participants With Grade 3-5 Toxicities) and Identification of Recommended Phase II Dose and Schedule (RP2D).
Patients with Grade 3-5 toxicity
|
7 participants
|
13 participants
|
—
|
4 participants
|
3 participants
|
|
Phase I Escalation - Safety (Number of Participants With Grade 3-5 Toxicities) and Identification of Recommended Phase II Dose and Schedule (RP2D).
Patients with dose-limiting toxicity
|
0 participants
|
0 participants
|
—
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Within 75 days of AUTO3 infusionPopulation: Patients who received at least 1 (complete or partial) dose of AUTO3 (infused set)
The incidence of Grade 3-5 toxicities during the expansion part of Phase I (Dose cohort: 150 to 450 x 10\^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day -1 in an Outpatient Setting)
Outcome measures
| Measure |
150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day 14
Patients in this cohort received actual doses of 150 to 495 x 10\^6 CD19/CD22 CAR-positive T cells + pembrolizumab at Day 14
|
150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day -1 in an Inpatient Setting
Patients in this cohort received actual doses of 125 to 450 x 10\^6 CD19/CD22 CAR-positive T cells + pembrolizumab at Day -1 in an inpatient setting
|
150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day -1 in an Outpatient Setting
n=20 Participants
Patients in this cohort received actual doses of 129 to 450 x 10\^6 CD19/CD22 CAR-positive T cells + pembrolizumab at Day -1 in an outpatient setting
|
50 x 10^6 CD19/CD22 CAR-positive T Cells
Patients in this cohort received actual doses of 50 to 150 x 10\^6 CD19/CD22 CAR-positive T cells
|
50 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day 14
All patients in this cohort received actual dose of 50 x 10\^6 CD19/CD22 CAR-positive T cells + pembrolizumab at Day 14
|
|---|---|---|---|---|---|
|
Phase I Expansion - Safety (Incidence of Grade 3-5 Toxicities) in the Outpatient / Ambulatory Care Setting
|
0 Participants
|
0 Participants
|
13 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: This was not evaluated because no dose-limiting toxicities occurred in the Phase 1 part of the study to identify the recommended dose
This was not analysed due to study termination prior to initiation of Phase II. End of study notification submitted to Medicines and Healthcare products Regulatory Agency (MHRA) (reference 46113/0003/001-0016) - The Last patient last visit was 19 October 2023 (at end of Phase 1) and the study is considered completed (End of study). As per protocol v10.0, end of study is defined as 36 months after the last patient has received AUTO3 infusion or earlier in the event of death or consent withdrawal. Fifty-two patients received AUTO3 in the Phase I part of the study. After reviewing the data and taking into consideration the available treatment landscape in r/r DLBCL, Autolus didn't progress AUTO3-DB1 into the Phase II part of the study. Autolus notified MHRA on 08 November 2021 about enrolment to Phase II of the study (Autolus has decided not to progress AUTO3-DB1 into the Phase II part of the study), and MHRA acknowledged it on 09 November 2021.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 8 weeks post leukapheresis.Population: Patients who underwent leukapheresis. This outcome is measured before patients received infusion with AUTO3. Therefore, no split by dose cohort can be provided.
Feasibility of product generation was examined by assessing the number of AUTO3 successfully manufactured as a fraction of the number of patients undergoing leukapheresis (all patients enrolled).
Outcome measures
| Measure |
150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day 14
Patients in this cohort received actual doses of 150 to 495 x 10\^6 CD19/CD22 CAR-positive T cells + pembrolizumab at Day 14
|
150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day -1 in an Inpatient Setting
Patients in this cohort received actual doses of 125 to 450 x 10\^6 CD19/CD22 CAR-positive T cells + pembrolizumab at Day -1 in an inpatient setting
|
150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day -1 in an Outpatient Setting
Patients in this cohort received actual doses of 129 to 450 x 10\^6 CD19/CD22 CAR-positive T cells + pembrolizumab at Day -1 in an outpatient setting
|
50 x 10^6 CD19/CD22 CAR-positive T Cells
n=62 Participants
Patients in this cohort received actual doses of 50 to 150 x 10\^6 CD19/CD22 CAR-positive T cells
|
50 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day 14
All patients in this cohort received actual dose of 50 x 10\^6 CD19/CD22 CAR-positive T cells + pembrolizumab at Day 14
|
|---|---|---|---|---|---|
|
Feasibility of Generating AUTO3: Number of Patients' Cells Successfully Manufactured as a Proportion of the Number of Patients Undergoing Leukapheresis.
|
—
|
—
|
—
|
52 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: All participants who received at least one dose of AUTO3. Five patients had no positive disease by FDG PET scan prior to pre-conditioning (1 in the 50 x 10\^6 group, 1 in the 150-450 x 10\^6 inpatient group, and 3 in the 15-450 x 10\^6 outpatient group). Hence, they were not evaluable for best overall response.
Participants achieving objective response per Lugano criteria based on independent central radiology review. The Lugano classification of response by 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (FDG) PET-CT: 1. no uptake or no residual uptake (when used interim) 2. slight uptake, but below blood pool (mediastinum) 3. uptake above mediastinal, but below or equal to uptake in the liver 4. uptake slightly to moderately higher than liver 5. markedly increased uptake or any new lesion (on response evaluation) Non-progressive disease * complete metabolic response - score of 1, 2 or 3 in nodal or extranodal sites with or without a residual mass * partial metabolic response - score of 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size * stable disease or no metabolic response - score of 4 or 5 with no obvious change in FDG uptake Progressive disease score 4 or 5 in any lesion with an increase in intensity of FDG uptake from baseline (and/or
Outcome measures
| Measure |
150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day 14
n=8 Participants
Patients in this cohort received actual doses of 150 to 495 x 10\^6 CD19/CD22 CAR-positive T cells + pembrolizumab at Day 14
|
150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day -1 in an Inpatient Setting
n=16 Participants
Patients in this cohort received actual doses of 125 to 450 x 10\^6 CD19/CD22 CAR-positive T cells + pembrolizumab at Day -1 in an inpatient setting
|
150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day -1 in an Outpatient Setting
n=17 Participants
Patients in this cohort received actual doses of 129 to 450 x 10\^6 CD19/CD22 CAR-positive T cells + pembrolizumab at Day -1 in an outpatient setting
|
50 x 10^6 CD19/CD22 CAR-positive T Cells
n=4 Participants
Patients in this cohort received actual doses of 50 to 150 x 10\^6 CD19/CD22 CAR-positive T cells
|
50 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day 14
n=2 Participants
All patients in this cohort received actual dose of 50 x 10\^6 CD19/CD22 CAR-positive T cells + pembrolizumab at Day 14
|
|---|---|---|---|---|---|
|
Determine the Complete Response Rate Following Treatment With AUTO3, as Per Lugano Criteria.
|
4 Participants
|
8 Participants
|
8 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Patients who received at least 1 (complete or partial) dose of AUTO3 (infused set). Patients with death not due to underling cancer or who received new anti-cancer therapy other than SCT or discontinued from the study for other reason than progressive disease (PD) or who were lost to follow-up or reached the time point of analysis without a known record of progression or death had the duration of response censored at the date of last adequate disease assessment for response.
Duration of response was defined as the time from the first observed complete response or partial response \[from the first post-baseline response assessment\] until the date of first progressive disease or death due to underlying cancer (primary reason for death=progressive disease), whichever occurred first. Only responders (patients with complete response \[CR\] or partial response \[PR\]) were included in the analysis of duration of response. Response defined by Lugano classification (see Outcome Measure 5). Patients with death not due to underling cancer (primary reason for death=adverse event \[AE\] or Other or Unknown) or who received new anti-cancer therapy other than SCT or discontinued from the study for other reason than progressive disease (PD) or who were lost to follow-up or reached the time point of analysis without a known record of progression or death had the duration of response censored at the date of last adequate disease assessment for response.
Outcome measures
| Measure |
150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day 14
n=5 Participants
Patients in this cohort received actual doses of 150 to 495 x 10\^6 CD19/CD22 CAR-positive T cells + pembrolizumab at Day 14
|
150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day -1 in an Inpatient Setting
n=11 Participants
Patients in this cohort received actual doses of 125 to 450 x 10\^6 CD19/CD22 CAR-positive T cells + pembrolizumab at Day -1 in an inpatient setting
|
150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day -1 in an Outpatient Setting
n=15 Participants
Patients in this cohort received actual doses of 129 to 450 x 10\^6 CD19/CD22 CAR-positive T cells + pembrolizumab at Day -1 in an outpatient setting
|
50 x 10^6 CD19/CD22 CAR-positive T Cells
n=2 Participants
Patients in this cohort received actual doses of 50 to 150 x 10\^6 CD19/CD22 CAR-positive T cells
|
50 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day 14
n=2 Participants
All patients in this cohort received actual dose of 50 x 10\^6 CD19/CD22 CAR-positive T cells + pembrolizumab at Day 14
|
|---|---|---|---|---|---|
|
Duration of Response (DOR).
|
NA months
Median estimates and corresponding 95% confidence intervals are not available due to limited number of events and/or insufficient follow-up, which precludes reliable estimation of survival probabilities or confidence intervals using the Kaplan-Meier method.
|
4.96 months
Interval 1.91 to
Upper limit of the confidence interval was not reached due to insufficient number of events.
|
NA months
Median estimates and corresponding 95% confidence intervals are not available due to limited number of events and/or insufficient follow-up, which precludes reliable estimation of survival probabilities or confidence intervals using the Kaplan-Meier method.
|
6.31 months
Interval 1.97 to
Upper limit of the confidence interval was not reached due to insufficient number of events.
|
NA months
Median estimates and corresponding 95% confidence intervals are not available due to limited number of events and/or insufficient follow-up, which precludes reliable estimation of survival probabilities or confidence intervals using the Kaplan-Meier method.
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Patients who received at least 1 (complete or partial) dose of AUTO3 (infused set) and were not censored.
The progression-free survival was defined as the time from first AUTO3 treatment until the first progression of disease or death from any cause, whichever occurred first. Patients who reached the time point of analysis without a known record of progression had the PFS censored at the date of last adequate disease assessment. Patients who received a new stem cell transplantation (SCT) were censored at the start date of this new SCT. Patients who received a new anti-cancer therapy or discontinued from the study for other reason than disease progression and who were lost to follow-up were censored at the date of last adequate disease assessment. Response defined by Lugano classification (see Outcome Measure 5).
Outcome measures
| Measure |
150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day 14
n=8 Participants
Patients in this cohort received actual doses of 150 to 495 x 10\^6 CD19/CD22 CAR-positive T cells + pembrolizumab at Day 14
|
150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day -1 in an Inpatient Setting
n=17 Participants
Patients in this cohort received actual doses of 125 to 450 x 10\^6 CD19/CD22 CAR-positive T cells + pembrolizumab at Day -1 in an inpatient setting
|
150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day -1 in an Outpatient Setting
n=20 Participants
Patients in this cohort received actual doses of 129 to 450 x 10\^6 CD19/CD22 CAR-positive T cells + pembrolizumab at Day -1 in an outpatient setting
|
50 x 10^6 CD19/CD22 CAR-positive T Cells
n=4 Participants
Patients in this cohort received actual doses of 50 to 150 x 10\^6 CD19/CD22 CAR-positive T cells
|
50 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day 14
n=3 Participants
All patients in this cohort received actual dose of 50 x 10\^6 CD19/CD22 CAR-positive T cells + pembrolizumab at Day 14
|
|---|---|---|---|---|---|
|
Progression-free Survival (PFS).
|
5.67 months
Interval 0.95 to
Upper limit of the confidence interval was not reached due to insufficient number of events.
|
3.22 months
Interval 1.87 to
Upper limit of the confidence interval was not reached due to insufficient number of events.
|
3.22 months
Interval 1.94 to 5.88
|
2.14 months
Interval 0.76 to
Upper limit of the confidence interval was not reached due to insufficient number of events.
|
2.43 months
Interval 2.4 to
Upper limit of the confidence interval was not reached due to insufficient number of events.
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Patients who received at least 1 (complete or partial) dose of AUTO3 (infused set) and were not censored.
Overall survival (OS) was defined as the time from the date of first AUTO3 treatment up to the date of death, regardless of cause of death. Patients alive at the time of the analysis had the OS censored at the date of last assessment when the patient was known alive.
Outcome measures
| Measure |
150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day 14
n=8 Participants
Patients in this cohort received actual doses of 150 to 495 x 10\^6 CD19/CD22 CAR-positive T cells + pembrolizumab at Day 14
|
150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day -1 in an Inpatient Setting
n=17 Participants
Patients in this cohort received actual doses of 125 to 450 x 10\^6 CD19/CD22 CAR-positive T cells + pembrolizumab at Day -1 in an inpatient setting
|
150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day -1 in an Outpatient Setting
n=20 Participants
Patients in this cohort received actual doses of 129 to 450 x 10\^6 CD19/CD22 CAR-positive T cells + pembrolizumab at Day -1 in an outpatient setting
|
50 x 10^6 CD19/CD22 CAR-positive T Cells
n=4 Participants
Patients in this cohort received actual doses of 50 to 150 x 10\^6 CD19/CD22 CAR-positive T cells
|
50 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day 14
n=3 Participants
All patients in this cohort received actual dose of 50 x 10\^6 CD19/CD22 CAR-positive T cells + pembrolizumab at Day 14
|
|---|---|---|---|---|---|
|
Overall Survival (OS).
|
5.67 months
Interval 1.77 to
Upper limit of the confidence interval was not reached due to insufficient number of events.
|
9.17 months
Interval 3.32 to
Upper limit of the confidence interval was not reached due to insufficient number of events.
|
NA months
Median estimates and corresponding 95% confidence intervals are not available due to limited number of events and/or insufficient follow-up, which precludes reliable estimation of survival probabilities or confidence intervals using the Kaplan-Meier method.
|
10.04 months
Interval 0.95 to
Upper limit of the confidence interval was not reached due to insufficient number of events.
|
6.67 months
Interval 4.93 to
Upper limit of the confidence interval was not reached due to insufficient number of events.
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 2 yearsPopulation: Patients who received at least 1 (complete or partial) dose of AUTO3 (infused set).
Analysis of cells in peripheral blood by polymerase chain reaction and/or flow cytometry at a range of time points in the peripheral blood.
Outcome measures
| Measure |
150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day 14
n=7 Participants
Patients in this cohort received actual doses of 150 to 495 x 10\^6 CD19/CD22 CAR-positive T cells + pembrolizumab at Day 14
|
150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day -1 in an Inpatient Setting
n=17 Participants
Patients in this cohort received actual doses of 125 to 450 x 10\^6 CD19/CD22 CAR-positive T cells + pembrolizumab at Day -1 in an inpatient setting
|
150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day -1 in an Outpatient Setting
n=20 Participants
Patients in this cohort received actual doses of 129 to 450 x 10\^6 CD19/CD22 CAR-positive T cells + pembrolizumab at Day -1 in an outpatient setting
|
50 x 10^6 CD19/CD22 CAR-positive T Cells
n=4 Participants
Patients in this cohort received actual doses of 50 to 150 x 10\^6 CD19/CD22 CAR-positive T cells
|
50 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day 14
n=3 Participants
All patients in this cohort received actual dose of 50 x 10\^6 CD19/CD22 CAR-positive T cells + pembrolizumab at Day 14
|
|---|---|---|---|---|---|
|
To Determine the Expansion and Persistence of AUTO3 Following Adoptive Transfer in Different Lymphoma Subtypes (Maximum Concentration)
|
5726.1 copies/microgram DNA
Interval 1420.0 to 11600.0
|
4121.4 copies/microgram DNA
Interval 174.0 to 416000.0
|
3195.6 copies/microgram DNA
Interval 241.0 to 131000.0
|
7979.7 copies/microgram DNA
Interval 155.0 to 213000.0
|
13157.4 copies/microgram DNA
Interval 3900.0 to 47100.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 2 yearsPopulation: Patients who received at least 1 (complete or partial) dose of AUTO3 (infused set).
Analysis of cells in peripheral blood by polymerase chain reaction and/or flow cytometry at a range of time points in the peripheral blood.
Outcome measures
| Measure |
150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day 14
n=7 Participants
Patients in this cohort received actual doses of 150 to 495 x 10\^6 CD19/CD22 CAR-positive T cells + pembrolizumab at Day 14
|
150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day -1 in an Inpatient Setting
n=17 Participants
Patients in this cohort received actual doses of 125 to 450 x 10\^6 CD19/CD22 CAR-positive T cells + pembrolizumab at Day -1 in an inpatient setting
|
150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day -1 in an Outpatient Setting
n=20 Participants
Patients in this cohort received actual doses of 129 to 450 x 10\^6 CD19/CD22 CAR-positive T cells + pembrolizumab at Day -1 in an outpatient setting
|
50 x 10^6 CD19/CD22 CAR-positive T Cells
n=4 Participants
Patients in this cohort received actual doses of 50 to 150 x 10\^6 CD19/CD22 CAR-positive T cells
|
50 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day 14
n=3 Participants
All patients in this cohort received actual dose of 50 x 10\^6 CD19/CD22 CAR-positive T cells + pembrolizumab at Day 14
|
|---|---|---|---|---|---|
|
To Determine the Expansion and Persistence of AUTO3 Following Adoptive Transfer in Different Lymphoma Subtypes (Area Under the Curve From Day 0 to Day 28)
|
38397.9 day*copies/microgram DNA
Interval 3510.0 to 135000.0
|
37722.7 day*copies/microgram DNA
Interval 948.0 to 571000.0
|
32152.1 day*copies/microgram DNA
Interval 1060.0 to 1930000.0
|
41511.0 day*copies/microgram DNA
Interval 912.0 to 2370000.0
|
109945.2 day*copies/microgram DNA
Interval 35600.0 to 478000.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 2 yearsPopulation: Patients who received at least 1 (complete or partial) dose of AUTO3 (infused set).
Analysis of cells in peripheral blood by polymerase chain reaction and/or flow cytometry at a range of time points in the peripheral blood.
Outcome measures
| Measure |
150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day 14
n=7 Participants
Patients in this cohort received actual doses of 150 to 495 x 10\^6 CD19/CD22 CAR-positive T cells + pembrolizumab at Day 14
|
150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day -1 in an Inpatient Setting
n=17 Participants
Patients in this cohort received actual doses of 125 to 450 x 10\^6 CD19/CD22 CAR-positive T cells + pembrolizumab at Day -1 in an inpatient setting
|
150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day -1 in an Outpatient Setting
n=20 Participants
Patients in this cohort received actual doses of 129 to 450 x 10\^6 CD19/CD22 CAR-positive T cells + pembrolizumab at Day -1 in an outpatient setting
|
50 x 10^6 CD19/CD22 CAR-positive T Cells
n=4 Participants
Patients in this cohort received actual doses of 50 to 150 x 10\^6 CD19/CD22 CAR-positive T cells
|
50 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day 14
n=3 Participants
All patients in this cohort received actual dose of 50 x 10\^6 CD19/CD22 CAR-positive T cells + pembrolizumab at Day 14
|
|---|---|---|---|---|---|
|
To Determine the Expansion and Persistence of AUTO3 Following Adoptive Transfer in Different Lymphoma Subtypes (Time to Maximum Concentration)
|
9.7 Days
Interval 9.0 to 35.0
|
10.0 Days
Interval 7.0 to 28.0
|
13.1 Days
Interval 7.0 to 58.0
|
16.4 Days
Interval 12.0 to 22.0
|
13.9 Days
Interval 11.0 to 14.0
|
Adverse Events
50 x 10^6 CD19/CD22 CAR+ T Cells
Serious events: 2 serious events
Other events: 4 other events
Deaths: 3 deaths
50 x 10^6 CD19/CD22 CAR+ T Cells + Pembrolizumab at Day 14
Serious events: 0 serious events
Other events: 3 other events
Deaths: 2 deaths
150 to 450 x 10^6 CD19/CD22 CAR+ T Cells + Pembrolizumab at Day 14
Serious events: 3 serious events
Other events: 8 other events
Deaths: 5 deaths
150 to 450 x 10^6 CD19/CD22 CAR+ T Cells + Pembrolizumab at Day -1 in an Inpatient Setting
Serious events: 10 serious events
Other events: 15 other events
Deaths: 11 deaths
150 to 450 x 10^6 CD19/CD22 CAR+ T Cells + Pembrolizumab at Day -1 in an Outpatient Setting
Serious events: 14 serious events
Other events: 19 other events
Deaths: 6 deaths
Treatment Not Received
Serious events: 0 serious events
Other events: 1 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
50 x 10^6 CD19/CD22 CAR+ T Cells
n=4 participants at risk
Patients in this cohort received actual doses of 50 to 150 x 10\^6 CD19/CD22 CAR-positive T cells
|
50 x 10^6 CD19/CD22 CAR+ T Cells + Pembrolizumab at Day 14
n=3 participants at risk
Patients in this cohort received actual dose of 50 x 10\^6 CD19/CD22 CAR-positive T cells + pembrolizumab at Day 14
|
150 to 450 x 10^6 CD19/CD22 CAR+ T Cells + Pembrolizumab at Day 14
n=8 participants at risk
Patients in this cohort received actual doses of 150 to 495 x 10\^6 CD19/CD22 CAR-positive T cells + pembrolizumab at Day 14
|
150 to 450 x 10^6 CD19/CD22 CAR+ T Cells + Pembrolizumab at Day -1 in an Inpatient Setting
n=17 participants at risk
Patients in this cohort received actual doses of 125 to 450 x 10\^6 CD19/CD22 CAR-positive T cells + pembrolizumab at Day -1 in an inpatient setting
|
150 to 450 x 10^6 CD19/CD22 CAR+ T Cells + Pembrolizumab at Day -1 in an Outpatient Setting
n=20 participants at risk
Patients in this cohort received actual doses of 129 to 450 x 10\^6 CD19/CD22 CAR-positive T cells + pembrolizumab at Day -1 in an outpatient setting
|
Treatment Not Received
n=10 participants at risk
Patients enrolled who did not receive study medication
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Abdominal infection
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.0%
1/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.0%
1/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Blood and lymphatic system disorders
Anaemia
|
25.0%
1/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.0%
1/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Immune system disorders
Cytokine release syndrome
|
25.0%
1/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
12.5%
1/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
25.0%
5/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.0%
1/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Nervous system disorders
Depressed level of consciousness
|
25.0%
1/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.0%
1/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Infections and infestations
Enterobacter infection
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.0%
1/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Nervous system disorders
Facial paresis
|
25.0%
1/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
12.5%
1/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
11.8%
2/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
15.0%
3/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Infections and infestations
Gallbladder abscess
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Nervous system disorders
Hemiparesis
|
25.0%
1/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.0%
1/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.0%
1/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Nervous system disorders
Immune effector cell-associated neurotoxicity syndrome
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.0%
1/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.0%
1/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.0%
1/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.0%
1/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Nervous system disorders
Nystagmus
|
25.0%
1/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.0%
1/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
12.5%
1/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
General disorders
Pyrexia
|
50.0%
2/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
11.8%
2/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
15.0%
3/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Infections and infestations
Sepsis
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
12.5%
1/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.0%
1/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Infections and infestations
Actinomycotic pulmonary infection
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.0%
1/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Infections and infestations
Colitis
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
12.5%
1/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Infections and infestations
COVID-19
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
10.0%
2/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Infections and infestations
Device related infection
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
12.5%
1/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Immune system disorders
Haemophagocytic lymphohistiocytosis
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
12.5%
1/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
12.5%
1/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
25.0%
1/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
12.5%
1/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
12.5%
1/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Nervous system disorders
Syncope
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.0%
1/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
Other adverse events
| Measure |
50 x 10^6 CD19/CD22 CAR+ T Cells
n=4 participants at risk
Patients in this cohort received actual doses of 50 to 150 x 10\^6 CD19/CD22 CAR-positive T cells
|
50 x 10^6 CD19/CD22 CAR+ T Cells + Pembrolizumab at Day 14
n=3 participants at risk
Patients in this cohort received actual dose of 50 x 10\^6 CD19/CD22 CAR-positive T cells + pembrolizumab at Day 14
|
150 to 450 x 10^6 CD19/CD22 CAR+ T Cells + Pembrolizumab at Day 14
n=8 participants at risk
Patients in this cohort received actual doses of 150 to 495 x 10\^6 CD19/CD22 CAR-positive T cells + pembrolizumab at Day 14
|
150 to 450 x 10^6 CD19/CD22 CAR+ T Cells + Pembrolizumab at Day -1 in an Inpatient Setting
n=17 participants at risk
Patients in this cohort received actual doses of 125 to 450 x 10\^6 CD19/CD22 CAR-positive T cells + pembrolizumab at Day -1 in an inpatient setting
|
150 to 450 x 10^6 CD19/CD22 CAR+ T Cells + Pembrolizumab at Day -1 in an Outpatient Setting
n=20 participants at risk
Patients in this cohort received actual doses of 129 to 450 x 10\^6 CD19/CD22 CAR-positive T cells + pembrolizumab at Day -1 in an outpatient setting
|
Treatment Not Received
n=10 participants at risk
Patients enrolled who did not receive study medication
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.0%
1/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Gastrointestinal disorders
Abdominal pain
|
50.0%
2/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
33.3%
1/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.0%
1/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Renal and urinary disorders
Acute kidney injury
|
25.0%
1/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
12.5%
1/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.0%
1/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
33.3%
1/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
12.5%
1/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Blood and lymphatic system disorders
Anaemia
|
50.0%
2/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
66.7%
2/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
75.0%
6/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
52.9%
9/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
40.0%
8/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Infections and infestations
Anal infection
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
12.5%
1/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.0%
1/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
General disorders
Application site vesicles
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.0%
1/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.0%
1/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.0%
1/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
General disorders
Asthenia
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.0%
1/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.0%
1/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
12.5%
1/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Nervous system disorders
Autonomic nervous system imbalance
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.0%
1/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Investigations
Blood creatine phosphokinase increased
|
25.0%
1/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
15.0%
3/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Investigations
Blood fibrinogen decreased
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.0%
1/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.0%
1/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Investigations
Blood lactic acid increased
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
12.5%
1/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Investigations
Blood uric acid decreased
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Injury, poisoning and procedural complications
Burn oral cavity
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
12.5%
1/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
General disorders
Catheter site inflammation
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
12.5%
1/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
General disorders
Chills
|
25.0%
1/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
20.0%
4/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Gastrointestinal disorders
Constipation
|
50.0%
2/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
66.7%
2/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
25.0%
2/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
29.4%
5/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
33.3%
1/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
12.5%
1/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Infections and infestations
COVID-19
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
10.0%
2/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Immune system disorders
Cytokine release syndrome
|
50.0%
2/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
37.5%
3/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
23.5%
4/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
25.0%
5/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Investigations
Cytomegalovirus test positive
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
12.5%
1/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
12.5%
1/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
10.0%
2/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
33.3%
1/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.0%
1/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Skin and subcutaneous tissue disorders
Dermatitis psoriasiform
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
12.5%
1/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
General disorders
Device related thrombosis
|
25.0%
1/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
1/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
25.0%
2/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
11.8%
2/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
20.0%
4/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
29.4%
5/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.0%
1/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
10.0%
2/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
25.0%
1/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Nervous system disorders
Dysmetria
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.0%
1/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.0%
1/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
33.3%
1/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
25.0%
2/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
17.6%
3/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.0%
1/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Ear and labyrinth disorders
Ear discomfort
|
25.0%
1/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Vascular disorders
Embolism
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.0%
1/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Infections and infestations
Enterococcal infection
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
12.5%
1/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
25.0%
1/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
11.8%
2/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.0%
1/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
15.0%
3/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
General disorders
Fatigue
|
25.0%
1/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
33.3%
1/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
50.0%
4/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
11.8%
2/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
40.0%
8/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
25.0%
1/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
12.5%
1/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
11.8%
2/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.0%
1/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Vascular disorders
Flushing
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Hepatobiliary disorders
Gallbladder enlargement
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.0%
1/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
33.3%
1/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.0%
1/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Psychiatric disorders
Hallucination, visual
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Nervous system disorders
Headache
|
50.0%
2/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
29.4%
5/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
10.0%
2/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Metabolism and nutrition disorders
Hyperferritinaemia
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
12.5%
1/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.0%
1/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
33.3%
1/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.0%
1/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
12.5%
1/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
12.5%
1/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.0%
1/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Immune system disorders
Hypogammaglobulinaemia
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
12.5%
1/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
10.0%
2/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
10.0%
2/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
50.0%
2/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
33.3%
1/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
12.5%
1/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
10.0%
2/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Vascular disorders
Hypotension
|
25.0%
1/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
50.0%
4/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
10.0%
2/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.0%
1/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.0%
1/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
25.0%
1/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
12.5%
1/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
17.6%
3/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Nervous system disorders
Lethargy
|
25.0%
1/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
12.5%
1/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
25.0%
1/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
33.3%
1/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
15.0%
3/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
General disorders
Malaise
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
11.8%
2/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
33.3%
1/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
25.0%
1/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
12.5%
1/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.0%
1/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.0%
1/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
33.3%
1/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
12.5%
1/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
11.8%
2/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.0%
1/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Blood and lymphatic system disorders
Neutropenia
|
50.0%
2/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
50.0%
4/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
52.9%
9/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
25.0%
5/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
12.5%
1/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Investigations
Neutrophil count decreased
|
100.0%
4/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
100.0%
3/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
37.5%
3/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
17.6%
3/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
10.0%
2/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.0%
1/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
General disorders
Non-cardiac chest pain
|
25.0%
1/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Hepatobiliary disorders
Ocular icterus
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
General disorders
Oedema peripheral
|
25.0%
1/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
12.5%
1/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
23.5%
4/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.0%
1/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
12.5%
1/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
25.0%
1/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
10.0%
2/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Musculoskeletal and connective tissue disorders
Osteosclerosis
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
General disorders
Pain
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
11.8%
2/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.0%
1/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
25.0%
1/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.0%
1/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Gastrointestinal disorders
Pancreatic mass
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
25.0%
2/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Infections and infestations
Parvovirus infection
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
33.3%
1/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
12.5%
1/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
General disorders
Physical deconditioning
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Investigations
Platelet count decreased
|
100.0%
4/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
100.0%
3/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
37.5%
3/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
11.8%
2/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
20.0%
4/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
25.0%
1/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
12.5%
1/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.0%
1/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
12.5%
1/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
12.5%
1/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.0%
1/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
General disorders
Pyrexia
|
25.0%
1/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
66.7%
2/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
50.0%
4/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
25.0%
5/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.0%
1/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
33.3%
1/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
12.5%
1/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Rash maculo-papular
|
25.0%
1/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
10.0%
2/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Skin and subcutaneous tissue disorders
Rash pustular
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.0%
1/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory alkalosis
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Investigations
Serum ferritin increased
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Cardiac disorders
Sinus tachycardia
|
25.0%
1/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
25.0%
1/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.0%
1/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Infections and infestations
Staphylococcal abscess
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
12.5%
1/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Skin and subcutaneous tissue disorders
Staphylococcal infection
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
25.0%
2/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
10.0%
2/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Infections and infestations
Superinfection
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Nervous system disorders
Syncope
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
12.5%
1/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
33.3%
1/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.0%
1/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.0%
1/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.0%
1/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Gastrointestinal disorders
Terminal ileitis
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.0%
1/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
25.0%
2/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
41.2%
7/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
15.0%
3/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Product Issues
Thrombosis in device
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Nervous system disorders
Tremor
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.0%
1/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.0%
1/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.0%
1/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.0%
1/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Reproductive system and breast disorders
Vaginal fistula
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
12.5%
1/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
General disorders
Vascular device occlusion
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Eye disorders
Vision blurred
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
12.5%
1/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.0%
1/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
33.3%
1/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
25.0%
2/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
10.0%
2/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Investigations
Weight decreased
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
12.5%
1/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.0%
1/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Investigations
Weight increased
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
12.5%
1/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
25.0%
2/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
20.0%
4/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
12.5%
1/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
10.0%
1/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.0%
1/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Musculoskeletal and connective tissue disorders
back pain
|
25.0%
1/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
11.8%
2/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
12.5%
1/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Gastrointestinal disorders
Dyspepsia
|
25.0%
1/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
25.0%
1/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Infections and infestations
Hepatitis B reactivation
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.0%
1/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
25.0%
1/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
12.5%
1/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.9%
1/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Infections and infestations
Pharyngitis bacterial
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
12.5%
1/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
25.0%
1/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/3 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/8 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/17 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
5.0%
1/20 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
0.00%
0/10 • From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).
All adverse events (AEs)/serious adverse events (SAEs) were recorded from admission for pre-conditioning chemotherapy (Day -7 relative to AUTO3). Due to the long period between consent and AUTO3 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60