TriangleNCT02001623 · OUTCOME
Dose Escalation Part: Evaluation of Treatment-Emergent 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
- Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the dose escalation part.
What was measured
Evaluation of treatment-emergent adverse events (TEAEs) includes number of participants with at least one: TEAE Serious TEAE Infusion-related TEAE Common Terminology Criteria for Adverse Events (CTCAE) grade \>=3 Treatment-related TEAE A CTCAE TEAE was determined using the CTCAE grading systems based on National Cancer Institute (NCI)-CTCAE version 4.03 assessed by the investigator per the below definitions. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE.
Groups in this outcome
Dose Escalation Part: 0.3 mg/kg
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an intravenous (IV) infusion at a dose of 0.3 mg/kg of body weight.
Dose Escalation Part: 0.6 mg/kg
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.6 mg/kg of body weight.
Dose Escalation Part: 0.9 mg/kg
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.9 mg/kg of body weight.
Dose Escalation Part: 1.2 mg/kg
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.2 mg/kg of body weight.
Dose Escalation Part: 1.5 mg/kg
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.5 mg/kg of body weight.
Dose Escalation Part: 1.8 mg/kg
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.8 mg/kg of body weight.
Dose Escalation Part: 2.0 mg/kg
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
Dose Escalation Part: 2.2 mg/kg
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.2 mg/kg of body weight.
| Group | Source count |
|---|---|
| Dose Escalation Part: 0.3 mg/kg | 3 |
| Dose Escalation Part: 0.6 mg/kg | 3 |
| Dose Escalation Part: 0.9 mg/kg | 3 |
| Dose Escalation Part: 1.2 mg/kg | 3 |
| Dose Escalation Part: 1.5 mg/kg | 3 |
| Dose Escalation Part: 1.8 mg/kg | 3 |
| Dose Escalation Part: 2.0 mg/kg | 3 |
| Dose Escalation Part: 2.2 mg/kg | 6 |
Reported measurements
TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Part: 0.3 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Part: 0.6 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Part: 0.9 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.2 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.5 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.8 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Part: 2.0 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Part: 2.2 mg/kg | 6 | Not reported | Not reported | Not reported | Not reported |
Serious TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Part: 0.3 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Part: 0.6 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Part: 0.9 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.2 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.5 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.8 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Part: 2.0 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Part: 2.2 mg/kg | 4 | Not reported | Not reported | Not reported | Not reported |
Infusion-Related TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Part: 0.3 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Part: 0.6 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Part: 0.9 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.2 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.5 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.8 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Part: 2.0 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Part: 2.2 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
CTCAE Grade >=3 TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Part: 0.3 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Part: 0.6 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Part: 0.9 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.2 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.5 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.8 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Part: 2.0 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Part: 2.2 mg/kg | 4 | Not reported | Not reported | Not reported | Not reported |
TEAEs Related to Study Drug
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Part: 0.3 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Part: 0.6 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Part: 0.9 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.2 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.5 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.8 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Part: 2.0 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Part: 2.2 mg/kg | 6 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 6
- title
- TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 4
- title
- Serious TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- title
- Infusion-Related TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 4
- title
- CTCAE Grade >=3 TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 6
- title
- TEAEs Related to Study Drug
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 6
- units
- Participants
- description
- Evaluation of treatment-emergent adverse events (TEAEs) includes number of participants with at least one: TEAE Serious TEAE Infusion-related TEAE Common Terminology Criteria for Adverse Events (CTCAE) grade \>=3 Treatment-related TEAE A CTCAE TEAE was determined using the CTCAE grading systems based on National Cancer Institute (NCI)-CTCAE version 4.03 assessed by the investigator per the below definitions. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE.
- groups
- description
- Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an intravenous (IV) infusion at a dose of 0.3 mg/kg of body weight.
- id
- OG000
- title
- Dose Escalation Part: 0.3 mg/kg
- description
- Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.6 mg/kg of body weight.
- id
- OG001
- title
- Dose Escalation Part: 0.6 mg/kg
- description
- Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.9 mg/kg of body weight.
- id
- OG002
- title
- Dose Escalation Part: 0.9 mg/kg
- description
- Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.2 mg/kg of body weight.
- id
- OG003
- title
- Dose Escalation Part: 1.2 mg/kg
- description
- Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.5 mg/kg of body weight.
- id
- OG004
- title
- Dose Escalation Part: 1.5 mg/kg
- description
- Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.8 mg/kg of body weight.
- id
- OG005
- title
- Dose Escalation Part: 1.8 mg/kg
- description
- Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
- id
- OG006
- title
- Dose Escalation Part: 2.0 mg/kg
- description
- Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.2 mg/kg of body weight.
- id
- OG007
- title
- Dose Escalation Part: 2.2 mg/kg
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the dose escalation part.
- title
- Dose Escalation Part: Evaluation of Treatment-Emergent Adverse Events
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice