NCT03105336 · OUTCOME
Percentage of Participants With Decrease 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 Decrease in Hemoglobin (mmol/L)
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Axicabtagene Ciloleucel (Follicular Lymphoma) | 33 | Not reported | Not reported | Not reported | Not reported |
|---|
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | 39 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 3 or Higher Decrease in Leukocytes (10^9/L)
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Axicabtagene Ciloleucel (Follicular Lymphoma) | 94 | Not reported | Not reported | Not reported | Not reported |
|---|
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | 93 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 3 or Higher Decrease in Lymphocytes (10^9/L)
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Axicabtagene Ciloleucel (Follicular Lymphoma) | 99 | Not reported | Not reported | Not reported | Not reported |
|---|
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | 100 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 3 or Higher Decrease in Neutrophils (10^9/L)
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Axicabtagene Ciloleucel (Follicular Lymphoma) | 92 | Not reported | Not reported | Not reported | Not reported |
|---|
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | 96 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 3 or Higher Decrease in Platelets (10^9/L)
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Axicabtagene Ciloleucel (Follicular Lymphoma) | 35 | Not reported | Not reported | Not reported | Not reported |
|---|
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | 32 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 3 or Higher Decrease in Albumin (g/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) | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 3 or Higher Decrease in Calcium (mmol/L)
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Axicabtagene Ciloleucel (Follicular Lymphoma) | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 3 or Higher Decrease in Glucose (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 Decrease in Magnesium (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 Decrease in Phosphate (mmol/L)
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Axicabtagene Ciloleucel (Follicular Lymphoma) | 23 | Not reported | Not reported | Not reported | Not reported |
|---|
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | 39 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 3 or Higher Decrease in Potassium (mmol/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) | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 3 or Higher Decrease in Sodium (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) | 18 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 33
- group Id
- OG001
- value
- 39
- title
- Grade 3 or Higher Decrease in Hemoglobin (mmol/L)
- categories
- measurements
- group Id
- OG000
- value
- 94
- group Id
- OG001
- value
- 93
- title
- Grade 3 or Higher Decrease in Leukocytes (10^9/L)
- categories
- measurements
- group Id
- OG000
- value
- 99
- group Id
- OG001
- value
- 100
- title
- Grade 3 or Higher Decrease in Lymphocytes (10^9/L)
- categories
- measurements
- group Id
- OG000
- value
- 92
- group Id
- OG001
- value
- 96
- title
- Grade 3 or Higher Decrease in Neutrophils (10^9/L)
- categories
- measurements
- group Id
- OG000
- value
- 35
- group Id
- OG001
- value
- 32
- title
- Grade 3 or Higher Decrease in Platelets (10^9/L)
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 4
- title
- Grade 3 or Higher Decrease in Albumin (g/L)
- categories
- measurements
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 7
- title
- Grade 3 or Higher Decrease in Calcium (mmol/L)
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Grade 3 or Higher Decrease in Glucose (mmol/L)
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Grade 3 or Higher Decrease in Magnesium (mmol/L)
- categories
- measurements
- group Id
- OG000
- value
- 23
- group Id
- OG001
- value
- 39
- title
- Grade 3 or Higher Decrease in Phosphate (mmol/L)
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 7
- title
- Grade 3 or Higher Decrease in Potassium (mmol/L)
- categories
- measurements
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 18
- title
- Grade 3 or Higher Decrease in Sodium (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 Decrease in Laboratory Values Reported as Grade 3 or Higher
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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