NCT01492088 · OUTCOME
Number of Participants With Abnormal Clinical Laboratory Values Reported as AEs (Phase 1 and 2)
Study of Brentuximab Vedotin (SGN-35) in Pediatric Participants With Relapsed or Refractory (r/r) Systemic Anaplastic Large-Cell Lymphoma or Hodgkin Lymphoma · Source last updated 2024-05-30
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From the first dose through 30 days after the last dose of study medication (Up to 15 months)
What was measured
Abnormal clinical laboratory values (serum chemistry and hematology) were reported as AEs if they were considered by the investigator to be a clinically significant change from Baseline or led to premature discontinuation of study treatment, dose modification, or other therapeutic intervention.
Analysis population: Safety population is defined as all participants who received at least 1 dose of study drug. Data was summarized together for Phase 1 and 2 participants in brentuximab 1.8 mg/kg arm group.
Groups in this outcome
Brentuximab Vedotin 1.4 mg/kg: Phase 1
Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only
Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only
Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
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 |
|---|
| Brentuximab Vedotin 1.4 mg/kg: Phase 1 | 3 |
|---|
| Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only | 16 |
|---|
| Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only | 17 |
|---|
Reported measurements
Gamma-glutamyltransferase increased
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Brentuximab Vedotin 1.4 mg/kg: Phase 1 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Alanine aminotransferase increased
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Brentuximab Vedotin 1.4 mg/kg: Phase 1 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Aspartate aminotransferase increased
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Brentuximab Vedotin 1.4 mg/kg: Phase 1 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Transaminases increased
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Brentuximab Vedotin 1.4 mg/kg: Phase 1 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Lymphocyte count decreased
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Brentuximab Vedotin 1.4 mg/kg: Phase 1 | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Neutrophil count decreased
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Brentuximab Vedotin 1.4 mg/kg: Phase 1 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
White blood cell count decreased
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Brentuximab Vedotin 1.4 mg/kg: Phase 1 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Blood bicarbonate decreased
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Brentuximab Vedotin 1.4 mg/kg: Phase 1 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Weight decreased
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Brentuximab Vedotin 1.4 mg/kg: Phase 1 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
C-reactive protein increased
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Brentuximab Vedotin 1.4 mg/kg: Phase 1 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Blood alkaline phosphatase increased
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Brentuximab Vedotin 1.4 mg/kg: Phase 1 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 0
- title
- Gamma-glutamyltransferase increased
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- title
- Alanine aminotransferase increased
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- title
- Aspartate aminotransferase increased
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- title
- Transaminases increased
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 2
- title
- Lymphocyte count decreased
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 2
- title
- Neutrophil count decreased
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- title
- White blood cell count decreased
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- title
- Blood bicarbonate decreased
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- title
- Weight decreased
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- title
- C-reactive protein increased
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- title
- Blood alkaline phosphatase increased
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 16
- group Id
- OG002
- value
- 17
- units
- Participants
- description
- Abnormal clinical laboratory values (serum chemistry and hematology) were reported as AEs if they were considered by the investigator to be a clinically significant change from Baseline or led to premature discontinuation of study treatment, dose modification, or other therapeutic intervention.
- groups
- description
- Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
- id
- OG000
- title
- Brentuximab Vedotin 1.4 mg/kg: Phase 1
- description
- Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
- id
- OG001
- title
- Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only
- description
- Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
- id
- OG002
- title
- Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety population is defined as all participants who received at least 1 dose of study drug. Data was summarized together for Phase 1 and 2 participants in brentuximab 1.8 mg/kg arm group.
- reporting Status
- POSTED
- time Frame
- From the first dose through 30 days after the last dose of study medication (Up to 15 months)
- title
- Number of Participants With Abnormal Clinical Laboratory Values Reported as AEs (Phase 1 and 2)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
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