TriangleNCT04744831 · OUTCOME
Percentage of Participants Reporting Treatment-emergent Adverse Events Following Intravenous Administration of T-DXd in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Overexpressing Metastatic Colorectal Cancer
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- Not reported
- Time frame
- From first dose administration to data cut off, up to approximately 19 months.
What was measured
A Treatment-emergent Adverse Events (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug or has worsened in severity or seriousness after initiating the study drug until 47 days after the last dose of the study drug. Serious AEs with an onset or worsening 48 days or more after the last dose of study drug, if considered related to study treatment. are also TEAEs. TEAEs were assessed in the Safety Analysis Set at data cut-off date of 01 Nov 2022.
Analysis population: The Safety Analysis Set (SAS) included all randomized/registered subjects who received at least 1 dose of study treatment. Subjects were summarized according to treatment received.
Groups in this outcome
T-DXd 5.4 mg/kg Q3W
Participants were randomized to receive intravenous T-DXd administered at a dose of 5.4 mg/kg every 3 weeks (Q3W).
T-DXd 6.4 mg/kg Q3W
Participants were randomized to receive intravenous T-DXd administered at a dose of 6.4 mg/kg every 3 weeks (Q3W).
| Group | Source count |
|---|---|
| T-DXd 5.4 mg/kg Q3W | 83 |
| T-DXd 6.4 mg/kg Q3W | 39 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| T-DXd 5.4 mg/kg Q3W | 98.8 | Not reported | Not reported | Not reported | Not reported |
| T-DXd 6.4 mg/kg Q3W | 100 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 98.8
- group Id
- OG001
- value
- 100
- denoms
- counts
- group Id
- OG000
- value
- 83
- group Id
- OG001
- value
- 39
- units
- Participants
- description
- A Treatment-emergent Adverse Events (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug or has worsened in severity or seriousness after initiating the study drug until 47 days after the last dose of the study drug. Serious AEs with an onset or worsening 48 days or more after the last dose of study drug, if considered related to study treatment. are also TEAEs. TEAEs were assessed in the Safety Analysis Set at data cut-off date of 01 Nov 2022.
- groups
- description
- Participants were randomized to receive intravenous T-DXd administered at a dose of 5.4 mg/kg every 3 weeks (Q3W).
- id
- OG000
- title
- T-DXd 5.4 mg/kg Q3W
- description
- Participants were randomized to receive intravenous T-DXd administered at a dose of 6.4 mg/kg every 3 weeks (Q3W).
- id
- OG001
- title
- T-DXd 6.4 mg/kg Q3W
- param Type
- NUMBER
- population Description
- The Safety Analysis Set (SAS) included all randomized/registered subjects who received at least 1 dose of study treatment. Subjects were summarized according to treatment received.
- reporting Status
- POSTED
- time Frame
- From first dose administration to data cut off, up to approximately 19 months.
- title
- Percentage of Participants Reporting Treatment-emergent Adverse Events Following Intravenous Administration of T-DXd in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Overexpressing Metastatic Colorectal Cancer
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice