TriangleNCT04697628 · OUTCOME
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
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 start of treatment up to 30 days after last dose of study treatment (up to 25 months)
What was measured
An AE was any untoward medical occurrence in a clinical study participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.. TEAE was defined as a newly occurring or worsening AE after the first dose of study treatment and with onset date on or before 30 days after the last dose of study treatment.
Analysis population: Safety analysis set included all randomized participants who received at least 1 dose of study treatment (tisotumab vedotin or chemotherapy).
Groups in this outcome
Tisotumab Vedotin
Participants with rCC/mCC were administered tisotumab vedotin 2.0 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once every 3 weeks (Q3W).
Chemotherapy
Participants with rCC/mCC were treated with investigator's choice of chemotherapy which included either topotecan 1 or 1.25 milligram per meter square \[mg/m\^2\] IV on Days 1 to 5, every 21 days or vinorelbine 30 mg/m\^2 IV on Days 1 and 8, every 21 days or gemcitabine 1000 mg/m\^2 IV on Days 1 and 8, every 21 days or irinotecan 100 or 125 mg/m\^2 IV weekly for 28 days, every 42 days or pemetrexed 500 mg/m\^2 on Day 1, every 21 days.
| Group | Source count |
|---|---|
| Tisotumab Vedotin | 250 |
| Chemotherapy | 239 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Tisotumab Vedotin | 246 | Not reported | Not reported | Not reported | Not reported |
| Chemotherapy | 237 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 246
- group Id
- OG001
- value
- 237
- denoms
- counts
- group Id
- OG000
- value
- 250
- group Id
- OG001
- value
- 239
- units
- Participants
- description
- An AE was any untoward medical occurrence in a clinical study participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.. TEAE was defined as a newly occurring or worsening AE after the first dose of study treatment and with onset date on or before 30 days after the last dose of study treatment.
- groups
- description
- Participants with rCC/mCC were administered tisotumab vedotin 2.0 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once every 3 weeks (Q3W).
- id
- OG000
- title
- Tisotumab Vedotin
- description
- Participants with rCC/mCC were treated with investigator's choice of chemotherapy which included either topotecan 1 or 1.25 milligram per meter square \[mg/m\^2\] IV on Days 1 to 5, every 21 days or vinorelbine 30 mg/m\^2 IV on Days 1 and 8, every 21 days or gemcitabine 1000 mg/m\^2 IV on Days 1 and 8, every 21 days or irinotecan 100 or 125 mg/m\^2 IV weekly for 28 days, every 42 days or pemetrexed 500 mg/m\^2 on Day 1, every 21 days.
- id
- OG001
- title
- Chemotherapy
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety analysis set included all randomized participants who received at least 1 dose of study treatment (tisotumab vedotin or chemotherapy).
- reporting Status
- POSTED
- time Frame
- From start of treatment up to 30 days after last dose of study treatment (up to 25 months)
- title
- Number of Participants With Treatment Emergent Adverse Events (TEAEs)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice