TriangleNCT02552121 · OUTCOME
Part 2: Number of Participants Reporting One or More Infusion-related Adverse Events
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
- Day 1, Day 8 & Day 15 (+1 day) until end of trial (Part 2), up to 36 weeks
What was measured
An infusion-related adverse event (AE) was defined as an AE occurring during infusion where the onset date and time of the event occurred within infusion time (+24 hours), and the event was judged as related to tisotumab vedotin by the investigator.
Groups in this outcome
Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials \[RP2D\] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials \[RP2D\] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical
Participants with the indication of cervical cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
Part 2: Cohort Expansion: Cohort 6 1q3w Cervical
Participants with the indication of cervical cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
| Group | Source count |
|---|---|
| Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian | 11 |
| Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical | 3 |
| Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian | 1 |
| Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical | 5 |
| Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian | 1 |
| Part 2: Cohort Expansion: Cohort 6 1q3w Cervical | 3 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian | 4 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Cohort Expansion: Cohort 6 1q3w Cervical | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 3
- units
- Participants
- description
- An infusion-related adverse event (AE) was defined as an AE occurring during infusion where the onset date and time of the event occurred within infusion time (+24 hours), and the event was judged as related to tisotumab vedotin by the investigator.
- groups
- description
- Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials \[RP2D\] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
- id
- OG000
- title
- Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian
- description
- Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials \[RP2D\] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
- id
- OG001
- title
- Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical
- description
- Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
- id
- OG002
- title
- Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian
- description
- Participants with the indication of cervical cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
- id
- OG003
- title
- Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical
- description
- Participants with the indication of ovarian cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
- id
- OG004
- title
- Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian
- description
- Participants with the indication of cervical cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
- id
- OG005
- title
- Part 2: Cohort Expansion: Cohort 6 1q3w Cervical
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- Day 1, Day 8 & Day 15 (+1 day) until end of trial (Part 2), up to 36 weeks
- title
- Part 2: Number of Participants Reporting One or More Infusion-related Adverse Events
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice