NCT02393859 · OUTCOME
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs)
Phase 3 Trial of Blinatumomab vs Standard Chemotherapy in Pediatric Subjects With HIgh-Risk (HR) First Relapse B-precursor Acute Lymphoblastic Leukemia (ALL) · Source last updated 2026-06-26
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- From first dose of IP through the last dose of IP (up to Day 29) plus 30 days.
What was measured
Adverse event (AE): any untoward medical occurrence. Serious AE: an AE meeting at least 1 of the following serious criteria: fatal; life-threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; congenital anomaly/birth defect; other medically important serious event. Severity was graded according to the Common Terminology Criteria for AEs (CTCAE) version 4.03: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death. Investigational product (IP) in the HC3 arm refers to dexamethasone, methotrexate, daunorubicin, erwinase, ifosfamide, asparaginase, and vincristine, and in the blinatumomab arm refers to blinatumomab. Treatment-related refers to the assessment of a relationship between IP and the event.
Analysis population: Safety Analysis Set: participants who received protocol-specified therapy analyzed according to the treatment they received.
Groups in this outcome
HC3 Chemotherapy
One week of treatment with HC3 followed by 3 weeks of no treatment. The standard intensive consolidation chemotherapy course HC3 includes dexamethasone (10 mg/m\^2/day IV on Days 1-6), vincrisitne (1.5 mg/m\^2/day IV on Days 1 and 6), daunorubicin (30 mg/m\^2 IV over 24 hours on Day 5), methotrexate (1 g/m\^2 IV over 36 hours on Day 1), ifosfamide (800 mg/m\^2 IV for 1 hour on Days 2-4), and pegylated \[PEG\]-asparaginase (1000 U/m\^2 IV for 2 hours or IM on Day 6) or, if allergic, erwinia-asparaginase (20,000 units/m\^2 IV or IM every 48 hours for a total of 6 doses).
Blinatumomab
One 4-week cycle of blinatumomab 15 μg/m\^2/day as a continuous intravenous infusion (CIVI).
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 |
|---|
| HC3 Chemotherapy | 52 |
|---|
| Blinatumomab | 54 |
|---|
Reported measurements
TEAEs
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| HC3 Chemotherapy | 50 | Not reported | Not reported | Not reported | Not reported |
|---|
| Blinatumomab | 54 | Not reported | Not reported | Not reported | Not reported |
|---|
TEAEs Grade ≥ 3
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| HC3 Chemotherapy | 43 | Not reported | Not reported | Not reported | Not reported |
|---|
| Blinatumomab | 33 | Not reported | Not reported | Not reported | Not reported |
|---|
Serious TEAEs
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| HC3 Chemotherapy | 24 | Not reported | Not reported | Not reported | Not reported |
|---|
| Blinatumomab | 15 | Not reported | Not reported | Not reported | Not reported |
|---|
Fatal TEAEs
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| HC3 Chemotherapy | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Blinatumomab | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
TEAEs Leading to Discontinuation of IP
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| HC3 Chemotherapy | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Blinatumomab | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
TEAEs Leading to Interruption of IP
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| HC3 Chemotherapy | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Blinatumomab | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
TRAEs
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| HC3 Chemotherapy | 41 | Not reported | Not reported | Not reported | Not reported |
|---|
| Blinatumomab | 45 | Not reported | Not reported | Not reported | Not reported |
|---|
TRAEs Grade ≥ 3
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| HC3 Chemotherapy | 33 | Not reported | Not reported | Not reported | Not reported |
|---|
| Blinatumomab | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
Serious TRAEs
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| HC3 Chemotherapy | 15 | Not reported | Not reported | Not reported | Not reported |
|---|
| Blinatumomab | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
Fatal TRAEs
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| HC3 Chemotherapy | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Blinatumomab | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
TRAEs Leading to Discontinuation of IP
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| HC3 Chemotherapy | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Blinatumomab | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
TRAEs Leading to Interruption of IP
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| HC3 Chemotherapy | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Blinatumomab | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 50
- group Id
- OG001
- value
- 54
- title
- TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 43
- group Id
- OG001
- value
- 33
- title
- TEAEs Grade ≥ 3
- categories
- measurements
- group Id
- OG000
- value
- 24
- group Id
- OG001
- value
- 15
- title
- Serious TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Fatal TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- title
- TEAEs Leading to Discontinuation of IP
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 6
- title
- TEAEs Leading to Interruption of IP
- categories
- measurements
- group Id
- OG000
- value
- 41
- group Id
- OG001
- value
- 45
- title
- TRAEs
- categories
- measurements
- group Id
- OG000
- value
- 33
- group Id
- OG001
- value
- 9
- title
- TRAEs Grade ≥ 3
- categories
- measurements
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 9
- title
- Serious TRAEs
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Fatal TRAEs
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- title
- TRAEs Leading to Discontinuation of IP
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 5
- title
- TRAEs Leading to Interruption of IP
- denoms
- counts
- group Id
- OG000
- value
- 52
- group Id
- OG001
- value
- 54
- units
- Participants
- description
- Adverse event (AE): any untoward medical occurrence. Serious AE: an AE meeting at least 1 of the following serious criteria: fatal; life-threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; congenital anomaly/birth defect; other medically important serious event. Severity was graded according to the Common Terminology Criteria for AEs (CTCAE) version 4.03: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death. Investigational product (IP) in the HC3 arm refers to dexamethasone, methotrexate, daunorubicin, erwinase, ifosfamide, asparaginase, and vincristine, and in the blinatumomab arm refers to blinatumomab. Treatment-related refers to the assessment of a relationship between IP and the event.
- groups
- description
- One week of treatment with HC3 followed by 3 weeks of no treatment. The standard intensive consolidation chemotherapy course HC3 includes dexamethasone (10 mg/m\^2/day IV on Days 1-6), vincrisitne (1.5 mg/m\^2/day IV on Days 1 and 6), daunorubicin (30 mg/m\^2 IV over 24 hours on Day 5), methotrexate (1 g/m\^2 IV over 36 hours on Day 1), ifosfamide (800 mg/m\^2 IV for 1 hour on Days 2-4), and pegylated \[PEG\]-asparaginase (1000 U/m\^2 IV for 2 hours or IM on Day 6) or, if allergic, erwinia-asparaginase (20,000 units/m\^2 IV or IM every 48 hours for a total of 6 doses).
- id
- OG000
- title
- HC3 Chemotherapy
- description
- One 4-week cycle of blinatumomab 15 μg/m\^2/day as a continuous intravenous infusion (CIVI).
- id
- OG001
- title
- Blinatumomab
- param Type
- NUMBER
- population Description
- Safety Analysis Set: participants who received protocol-specified therapy analyzed according to the treatment they received.
- reporting Status
- POSTED
- time Frame
- From first dose of IP through the last dose of IP (up to Day 29) plus 30 days.
- title
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs)
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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