TriangleNCT00866047 · OUTCOME
Adverse Events by Severity, Seriousness, and Relationship to Treatment
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
- up to 12 months
What was measured
Counts of participants who had adverse events or treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death). Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an adverse event within a category are counted once within the category.
Analysis population: All participants who received treatment
Groups in this outcome
Brentuximab Vedotin
Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
| Group | Source count |
|---|---|
| Brentuximab Vedotin | 58 |
Reported measurements
Any TEAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Brentuximab Vedotin | 58 | Not reported | Not reported | Not reported | Not reported |
TEAE related to study drug
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Brentuximab Vedotin | 53 | Not reported | Not reported | Not reported | Not reported |
TEAE with CTCAE severity grade >/=3
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Brentuximab Vedotin | 36 | Not reported | Not reported | Not reported | Not reported |
Serious adverse event
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Brentuximab Vedotin | 25 | Not reported | Not reported | Not reported | Not reported |
Serious adverse event related to study drug
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Brentuximab Vedotin | 11 | Not reported | Not reported | Not reported | Not reported |
Discontinued treatment due to adverse event
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Brentuximab Vedotin | 16 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 58
- title
- Any TEAE
- categories
- measurements
- group Id
- OG000
- value
- 53
- title
- TEAE related to study drug
- categories
- measurements
- group Id
- OG000
- value
- 36
- title
- TEAE with CTCAE severity grade >/=3
- categories
- measurements
- group Id
- OG000
- value
- 25
- title
- Serious adverse event
- categories
- measurements
- group Id
- OG000
- value
- 11
- title
- Serious adverse event related to study drug
- categories
- measurements
- group Id
- OG000
- value
- 16
- title
- Discontinued treatment due to adverse event
- denoms
- counts
- group Id
- OG000
- value
- 58
- units
- Participants
- description
- Counts of participants who had adverse events or treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death). Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an adverse event within a category are counted once within the category.
- groups
- description
- Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
- id
- OG000
- title
- Brentuximab Vedotin
- param Type
- NUMBER
- population Description
- All participants who received treatment
- reporting Status
- POSTED
- time Frame
- up to 12 months
- title
- Adverse Events by Severity, Seriousness, and Relationship to Treatment
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice