NCT01471782 · OUTCOME
Number of Participants With Adverse Events
Clinical Study With Blinatumomab in Pediatric and Adolescent Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia · Source last updated 2017-02-08
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 the start of the first infusion to 30 days after the end of the last infusion in the core study or from the start of the first retreatment cycle infusion to 30 days after the end of the last retreatment cycle, median treatment duration was 28 days
What was measured
The severity (or intensity) of adverse events (AEs) was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), v4.03 and according to the following:
Grade 1 - Mild adverse event; Grade 2 - Moderate adverse event; Grade 3 - Severe and undesirable adverse event; Grade 4 - Life-threatening or disabling adverse event; Grade 5 - Death. The investigator used medical judgment to determine if there was a causal relationship (ie, related, unrelated) between an adverse event and blinatumomab.
Analysis population: Full analysis set
Groups in this outcome
Phase 1: Blinatumomab 5 µg/m²/Day
Blinatumomab was administered as a continuous intravenous (cIV) infusion at a constant daily flow rate of 5 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
Phase 1: Blinatumomab 15 µg/m²/Day
Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
Phase 1+2: Blinatumomab 5/15 µg/m²/Day
Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
Phase 1: Blinatumomab 15/30 µg/m²/Day
Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day for the first week of cycle 1 and then at 30 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 30 µg/m²/day for up to five cycles of treatment.
Phase 1: Blinatumomab 30 µg/m²/Day
Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
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 |
|---|
| Phase 1: Blinatumomab 5 µg/m²/Day | 5 |
|---|
| Phase 1: Blinatumomab 15 µg/m²/Day | 7 |
|---|
| Phase 1+2: Blinatumomab 5/15 µg/m²/Day | 70 |
|---|
| Phase 1: Blinatumomab 15/30 µg/m²/Day | 6 |
|---|
| Phase 1: Blinatumomab 30 µg/m²/Day | 5 |
|---|
Reported measurements
Any adverse event (AE)
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 1: Blinatumomab 5 µg/m²/Day | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 1: Blinatumomab 15 µg/m²/Day | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 1+2: Blinatumomab 5/15 µg/m²/Day | 70 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 1: Blinatumomab 15/30 µg/m²/Day | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 1: Blinatumomab 30 µg/m²/Day | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
Adverse event of at least CTC grade 3
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 1: Blinatumomab 5 µg/m²/Day | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 1: Blinatumomab 15 µg/m²/Day | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 1+2: Blinatumomab 5/15 µg/m²/Day | 61 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 1: Blinatumomab 15/30 µg/m²/Day | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 1: Blinatumomab 30 µg/m²/Day | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
Serious adverse event (SAEs)
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 1: Blinatumomab 5 µg/m²/Day | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 1: Blinatumomab 15 µg/m²/Day | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 1+2: Blinatumomab 5/15 µg/m²/Day | 39 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 1: Blinatumomab 15/30 µg/m²/Day | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 1: Blinatumomab 30 µg/m²/Day | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
SAE of at least grade 3
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 1: Blinatumomab 5 µg/m²/Day | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 1: Blinatumomab 15 µg/m²/Day | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 1+2: Blinatumomab 5/15 µg/m²/Day | 28 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 1: Blinatumomab 15/30 µg/m²/Day | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 1: Blinatumomab 30 µg/m²/Day | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
AE leading to interruption of study drug
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 1: Blinatumomab 5 µg/m²/Day | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 1: Blinatumomab 15 µg/m²/Day | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 1+2: Blinatumomab 5/15 µg/m²/Day | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 1: Blinatumomab 15/30 µg/m²/Day | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 1: Blinatumomab 30 µg/m²/Day | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
AE leading to discontinuation of study drug
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 1: Blinatumomab 5 µg/m²/Day | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 1: Blinatumomab 15 µg/m²/Day | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 1+2: Blinatumomab 5/15 µg/m²/Day | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 1: Blinatumomab 15/30 µg/m²/Day | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 1: Blinatumomab 30 µg/m²/Day | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Adverse event leading to death
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 1: Blinatumomab 5 µg/m²/Day | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 1: Blinatumomab 15 µg/m²/Day | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 1+2: Blinatumomab 5/15 µg/m²/Day | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 1: Blinatumomab 15/30 µg/m²/Day | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 1: Blinatumomab 30 µg/m²/Day | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Treatment-related adverse event (TRAE)
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 1: Blinatumomab 5 µg/m²/Day | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 1: Blinatumomab 15 µg/m²/Day | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 1+2: Blinatumomab 5/15 µg/m²/Day | 59 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 1: Blinatumomab 15/30 µg/m²/Day | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 1: Blinatumomab 30 µg/m²/Day | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
TRAE of at least CTC grade 3
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 1: Blinatumomab 5 µg/m²/Day | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 1: Blinatumomab 15 µg/m²/Day | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 1+2: Blinatumomab 5/15 µg/m²/Day | 38 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 1: Blinatumomab 15/30 µg/m²/Day | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 1: Blinatumomab 30 µg/m²/Day | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
Treatment-related serious adverse event
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 1: Blinatumomab 5 µg/m²/Day | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 1: Blinatumomab 15 µg/m²/Day | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 1+2: Blinatumomab 5/15 µg/m²/Day | 15 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 1: Blinatumomab 15/30 µg/m²/Day | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 1: Blinatumomab 30 µg/m²/Day | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
TRAE leading to discontinuation of study drug
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 1: Blinatumomab 5 µg/m²/Day | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 1: Blinatumomab 15 µg/m²/Day | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 1+2: Blinatumomab 5/15 µg/m²/Day | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 1: Blinatumomab 15/30 µg/m²/Day | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 1: Blinatumomab 30 µg/m²/Day | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
TRAE leading to death
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 1: Blinatumomab 5 µg/m²/Day | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 1: Blinatumomab 15 µg/m²/Day | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 1+2: Blinatumomab 5/15 µg/m²/Day | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 1: Blinatumomab 15/30 µg/m²/Day | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 1: Blinatumomab 30 µg/m²/Day | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 70
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 5
- title
- Any adverse event (AE)
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 61
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 5
- title
- Adverse event of at least CTC grade 3
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 39
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 3
- title
- Serious adverse event (SAEs)
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 28
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 3
- title
- SAE of at least grade 3
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 10
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 2
- title
- AE leading to interruption of study drug
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 2
- title
- AE leading to discontinuation of study drug
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 1
- title
- Adverse event leading to death
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 59
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 5
- title
- Treatment-related adverse event (TRAE)
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 38
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 5
- title
- TRAE of at least CTC grade 3
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 15
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 2
- title
- Treatment-related serious adverse event
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 2
- title
- TRAE leading to discontinuation of study drug
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 0
- title
- TRAE leading to death
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 70
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 5
- units
- Participants
- description
- The severity (or intensity) of adverse events (AEs) was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), v4.03 and according to the following:
Grade 1 - Mild adverse event; Grade 2 - Moderate adverse event; Grade 3 - Severe and undesirable adverse event; Grade 4 - Life-threatening or disabling adverse event; Grade 5 - Death. The investigator used medical judgment to determine if there was a causal relationship (ie, related, unrelated) between an adverse event and blinatumomab.
- groups
- description
- Blinatumomab was administered as a continuous intravenous (cIV) infusion at a constant daily flow rate of 5 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
- id
- OG000
- title
- Phase 1: Blinatumomab 5 µg/m²/Day
- description
- Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
- id
- OG001
- title
- Phase 1: Blinatumomab 15 µg/m²/Day
- description
- Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
- id
- OG002
- title
- Phase 1+2: Blinatumomab 5/15 µg/m²/Day
- description
- Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day for the first week of cycle 1 and then at 30 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 30 µg/m²/day for up to five cycles of treatment.
- id
- OG003
- title
- Phase 1: Blinatumomab 15/30 µg/m²/Day
- description
- Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
- id
- OG004
- title
- Phase 1: Blinatumomab 30 µg/m²/Day
- param Type
- NUMBER
- population Description
- Full analysis set
- reporting Status
- POSTED
- time Frame
- From the start of the first infusion to 30 days after the end of the last infusion in the core study or from the start of the first retreatment cycle infusion to 30 days after the end of the last retreatment cycle, median treatment duration was 28 days
- title
- Number of Participants With Adverse Events
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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