TriangleNCT02001623 · OUTCOME
Dose Expansion 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 325 days in the dose expansion 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 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 Expansion Part: Bladder Cancer
Participants with bladder cancer 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 Expansion Part: Cervical Cancer
Participants with cervical cancer 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 Expansion Part: Endometrial Cancer
Participants with endometrial cancer 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 Expansion Part: Esophageal Cancer
Participants with esophageal cancer 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 Expansion Part: Non-Small Cell Lung Cancer (NSCLC)
Participants with NSCLC 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 Expansion Part: Ovarian Cancer
Participants with ovarian cancer 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 Expansion Part: Prostate Cancer
Participants with prostate cancer 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.
| Group | Source count |
|---|---|
| Dose Expansion Part: Bladder Cancer | 15 |
| Dose Expansion Part: Cervical Cancer | 55 |
| Dose Expansion Part: Endometrial Cancer | 14 |
| Dose Expansion Part: Esophageal Cancer | 15 |
| Dose Expansion Part: Non-Small Cell Lung Cancer (NSCLC) | 15 |
| Dose Expansion Part: Ovarian Cancer | 36 |
| Dose Expansion Part: Prostate Cancer | 18 |
Reported measurements
TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Expansion Part: Bladder Cancer | 15 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Part: Cervical Cancer | 55 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Part: Endometrial Cancer | 14 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Part: Esophageal Cancer | 15 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Part: Non-Small Cell Lung Cancer (NSCLC) | 15 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Part: Ovarian Cancer | 36 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Part: Prostate Cancer | 18 | Not reported | Not reported | Not reported | Not reported |
Serious TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Expansion Part: Bladder Cancer | 7 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Part: Cervical Cancer | 26 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Part: Endometrial Cancer | 5 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Part: Esophageal Cancer | 8 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Part: Non-Small Cell Lung Cancer (NSCLC) | 6 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Part: Ovarian Cancer | 13 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Part: Prostate Cancer | 6 | Not reported | Not reported | Not reported | Not reported |
Infusion-Related TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Expansion Part: Bladder Cancer | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Part: Cervical Cancer | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Part: Endometrial Cancer | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Part: Esophageal Cancer | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Part: Non-Small Cell Lung Cancer (NSCLC) | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Part: Ovarian Cancer | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Part: Prostate Cancer | 0 | Not reported | Not reported | Not reported | Not reported |
CTCAE Grade >=3 TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Expansion Part: Bladder Cancer | 9 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Part: Cervical Cancer | 30 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Part: Endometrial Cancer | 8 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Part: Esophageal Cancer | 8 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Part: Non-Small Cell Lung Cancer (NSCLC) | 10 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Part: Ovarian Cancer | 16 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Part: Prostate Cancer | 11 | Not reported | Not reported | Not reported | Not reported |
TEAEs Related to Study Drug
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Expansion Part: Bladder Cancer | 15 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Part: Cervical Cancer | 54 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Part: Endometrial Cancer | 13 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Part: Esophageal Cancer | 14 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Part: Non-Small Cell Lung Cancer (NSCLC) | 14 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Part: Ovarian Cancer | 36 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Part: Prostate Cancer | 18 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 55
- group Id
- OG002
- value
- 14
- group Id
- OG003
- value
- 15
- group Id
- OG004
- value
- 15
- group Id
- OG005
- value
- 36
- group Id
- OG006
- value
- 18
- title
- TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 26
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 8
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 13
- group Id
- OG006
- value
- 6
- title
- Serious TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- title
- Infusion-Related TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 30
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 8
- group Id
- OG004
- value
- 10
- group Id
- OG005
- value
- 16
- group Id
- OG006
- value
- 11
- title
- CTCAE Grade >=3 TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 54
- group Id
- OG002
- value
- 13
- group Id
- OG003
- value
- 14
- group Id
- OG004
- value
- 14
- group Id
- OG005
- value
- 36
- group Id
- OG006
- value
- 18
- title
- TEAEs Related to Study Drug
- denoms
- counts
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 55
- group Id
- OG002
- value
- 14
- group Id
- OG003
- value
- 15
- group Id
- OG004
- value
- 15
- group Id
- OG005
- value
- 36
- group Id
- OG006
- value
- 18
- 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 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 with bladder cancer 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
- OG000
- title
- Dose Expansion Part: Bladder Cancer
- description
- Participants with cervical cancer 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
- OG001
- title
- Dose Expansion Part: Cervical Cancer
- description
- Participants with endometrial cancer 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
- OG002
- title
- Dose Expansion Part: Endometrial Cancer
- description
- Participants with esophageal cancer 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
- OG003
- title
- Dose Expansion Part: Esophageal Cancer
- description
- Participants with NSCLC 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
- OG004
- title
- Dose Expansion Part: Non-Small Cell Lung Cancer (NSCLC)
- description
- Participants with ovarian cancer 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
- OG005
- title
- Dose Expansion Part: Ovarian Cancer
- description
- Participants with prostate cancer 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 Expansion Part: Prostate Cancer
- 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 325 days in the dose expansion part.
- title
- Dose Expansion 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