NCT01466179 · OUTCOME
Number of Participants With Treatment-emergent Adverse Events
Clinical Study With Blinatumomab in Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) · Source last updated 2017-08-18
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 42.2 days.
What was measured
Adverse events (AEs) were evaluated for severity according to the the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4, as follows: Grade 1 - Mild AE; Grade 2 - Moderate AE; Grade 3 - Severe AE; Grade 4 - Life-threatening or disabling AE; 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.
An AE was considered "serious" if it resulted in death, was life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant incapacity or substantial disruption to conduct normal life functions, is a congenital anomaly or birth defect or is a medically important condition.
Progressive disease was not an adverse event, per the protocol, unless it was more severe than expected for the patient. Therefore, many deaths due to progressive disease were not counted as adverse events.
Analysis population: Full analysis set (FAS), defined as all patients who received any infusion of blinatumomab.
Groups in this outcome
Blinatumomab
Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 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 |
|---|
| Blinatumomab | 189 |
|---|
Reported measurements
Any adverse event (AE)
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Blinatumomab | 188 | Not reported | Not reported | Not reported | Not reported |
|---|
Adverse events of at least CTC grade 3
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Blinatumomab | 155 | Not reported | Not reported | Not reported | Not reported |
|---|
Treatment-related adverse events
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Blinatumomab | 166 | Not reported | Not reported | Not reported | Not reported |
|---|
Related adverse events of at least CTC grade 3
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Blinatumomab | 105 | Not reported | Not reported | Not reported | Not reported |
|---|
Serious adverse events
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Blinatumomab | 121 | Not reported | Not reported | Not reported | Not reported |
|---|
Serious adverse events of at least CTC grade 3
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Blinatumomab | 105 | Not reported | Not reported | Not reported | Not reported |
|---|
Related serious adverse events
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Blinatumomab | 69 | Not reported | Not reported | Not reported | Not reported |
|---|
AEs leading to interruption of blinatumomab
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Blinatumomab | 63 | Not reported | Not reported | Not reported | Not reported |
|---|
AEs leading to discontinuation of blinatumomab
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Blinatumomab | 34 | Not reported | Not reported | Not reported | Not reported |
|---|
Related AE leading to treatment discontinuation
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Blinatumomab | 18 | Not reported | Not reported | Not reported | Not reported |
|---|
AEs leading to death
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Blinatumomab | 28 | Not reported | Not reported | Not reported | Not reported |
|---|
Related AEs leading to death
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Blinatumomab | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- title
- Any adverse event (AE)
- title
- Adverse events of at least CTC grade 3
- title
- Treatment-related adverse events
- title
- Related adverse events of at least CTC grade 3
- title
- Serious adverse events
- title
- Serious adverse events of at least CTC grade 3
- title
- Related serious adverse events
- title
- AEs leading to interruption of blinatumomab
- title
- AEs leading to discontinuation of blinatumomab
- title
- Related AE leading to treatment discontinuation
- title
- AEs leading to death
- title
- Related AEs leading to death
- description
- Adverse events (AEs) were evaluated for severity according to the the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4, as follows: Grade 1 - Mild AE; Grade 2 - Moderate AE; Grade 3 - Severe AE; Grade 4 - Life-threatening or disabling AE; 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.
An AE was considered "serious" if it resulted in death, was life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant incapacity or substantial disruption to conduct normal life functions, is a congenital anomaly or birth defect or is a medically important condition.
Progressive disease was not an adverse event, per the protocol, unless it was more severe than expected for the patient. Therefore, many deaths due to progressive disease were not counted as adverse events.
- groups
- description
- Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
- id
- OG000
- title
- Blinatumomab
- param Type
- NUMBER
- population Description
- Full analysis set (FAS), defined as all patients who received any infusion of blinatumomab.
- 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 42.2 days.
- title
- Number of Participants With Treatment-emergent 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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