NCT03105336 · OUTCOME

Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher

A Study of Axicabtagene Ciloleucel in Participants With Relapsed/Refractory Indolent Non-Hodgkin Lymphoma · Source last updated 2025-12-23

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: NUMBER
Unit: percentage of participants
Interval / dispersion: Not reported
Time frame: Up to 85.6 months

What was measured

Percentages were rounded-off.

Analysis population: Participants in the Safety Analysis Set were analyzed.

Groups in this outcome

Axicabtagene Ciloleucel (Follicular Lymphoma)

Participants with r/r B-cell iNHL subtype of FL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.

Axicabtagene Ciloleucel (Marginal Zone Lymphoma)

Participants with r/r B-cell iNHL subtype of MZL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)	124
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	28

Reported measurements

Grade 3 or Higher Increase in Hemoglobin (mmol/L)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	0	Not reported	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	0	Not reported	Not reported	Not reported	Not reported

Grade 3 or Higher Increase in Leukocytes (10^9/L)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	1	Not reported	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	0	Not reported	Not reported	Not reported	Not reported

Grade 3 or Higher Increase in Lymphocytes (10^9/L)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	0	Not reported	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	0	Not reported	Not reported	Not reported	Not reported

Grade 3 or Higher Increase in Alanine Aminotransferase (U/L)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	6	Not reported	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	21	Not reported	Not reported	Not reported	Not reported

Grade 3 or Higher Increase in Alkaline Phosphatase (U/L)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	0	Not reported	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	4	Not reported	Not reported	Not reported	Not reported

Grade 3 or Higher Increase in Aspartate Aminotransferase (U/L)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	4	Not reported	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	11	Not reported	Not reported	Not reported	Not reported

Grade 3 or Higher Increase in Bilirubin (umol/L)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	4	Not reported	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	11	Not reported	Not reported	Not reported	Not reported

Grade 3 or Higher Increase in Calcium (mmol/L)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	1	Not reported	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	0	Not reported	Not reported	Not reported	Not reported

Grade 3 or Higher Increase in Creatinine (umol/L)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	1	Not reported	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	0	Not reported	Not reported	Not reported	Not reported

Grade 3 or Higher Increase in Direct Bilirubin (umol/L)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	2	Not reported	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	11	Not reported	Not reported	Not reported	Not reported

Grade 3 or Higher Increase in Glucose (mmol/L)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	9	Not reported	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	21	Not reported	Not reported	Not reported	Not reported

Grade 3 or Higher Increase in Magnesium (mmol/L)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	3	Not reported	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	4	Not reported	Not reported	Not reported	Not reported

Grade 3 or Higher Increase in Potassium (mmol/L)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	1	Not reported	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	0	Not reported	Not reported	Not reported	Not reported

Grade 3 or Higher Increase in Sodium (mmol/L)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	0	Not reported	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	0	Not reported	Not reported	Not reported	Not reported

Grade 3 or Higher Increase in Urate (mmol/L)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	13	Not reported	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	25	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
title
Grade 3 or Higher Increase in Hemoglobin (mmol/L)
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
title
Grade 3 or Higher Increase in Leukocytes (10^9/L)
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
title
Grade 3 or Higher Increase in Lymphocytes (10^9/L)
categories
measurements
group Id
OG000
value
6
group Id
OG001
value
21
title
Grade 3 or Higher Increase in Alanine Aminotransferase (U/L)
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
4
title
Grade 3 or Higher Increase in Alkaline Phosphatase (U/L)
categories
measurements
group Id
OG000
value
4
group Id
OG001
value
11
title
Grade 3 or Higher Increase in Aspartate Aminotransferase (U/L)
categories
measurements
group Id
OG000
value
4
group Id
OG001
value
11
title
Grade 3 or Higher Increase in Bilirubin (umol/L)
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
title
Grade 3 or Higher Increase in Calcium (mmol/L)
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
title
Grade 3 or Higher Increase in Creatinine (umol/L)
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
11
title
Grade 3 or Higher Increase in Direct Bilirubin (umol/L)
categories
measurements
group Id
OG000
value
9
group Id
OG001
value
21
title
Grade 3 or Higher Increase in Glucose (mmol/L)
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
4
title
Grade 3 or Higher Increase in Magnesium (mmol/L)

denoms

counts
group Id
OG000
value
124
group Id
OG001
value
28
units
Participants

description

Percentages were rounded-off.

groups

description
Participants with r/r B-cell iNHL subtype of FL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
id
OG000
title
Axicabtagene Ciloleucel (Follicular Lymphoma)
description
Participants with r/r B-cell iNHL subtype of MZL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
id
OG001
title
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)

param Type

NUMBER

population Description

Participants in the Safety Analysis Set were analyzed.

reporting Status

POSTED

time Frame

Up to 85.6 months

title

Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher

type

SECONDARY

unit Of Measure

percentage of participants

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Preserved source evidence · Not medical advice