NCT02552121 · OUTCOME
Part 1: Number of Participants Who Experienced Disease Control
Tisotumab Vedotin (HuMax®-TF-ADC) Safety Study in Patients With Solid Tumors · Source last updated 2021-04-08
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
- 6, 12, 24 and 36 weeks post first infusion (Part 1)
What was measured
Participants were defined as having disease control at a specific time point if they had an evaluation of complete response (CR) or partial response (PR) at the time point (with a window of +/- 7 days) or had an evaluation of stable disease (SD), PR or CR at any point from the time point minus 7 days or later.
Groups in this outcome
Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg
Tisotumab vedotin 0.9 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
Tisotumab vedotin 1.2 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg | 3 |
|---|
| Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg | 6 |
|---|
Reported measurements
6 Weeks
Disease Control - Yes
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
Disease Control - No
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
12 Weeks
Disease Control - Yes
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Disease Control - No
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
24 Weeks
Disease Control - Yes
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Disease Control - No
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
36 Weeks
Disease Control - Yes
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Disease Control - No
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- title
- Disease Control - Yes
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 3
- title
- Disease Control - No
- title
- 6 Weeks
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Disease Control - Yes
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 6
- title
- Disease Control - No
- title
- 12 Weeks
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Disease Control - Yes
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 6
- title
- Disease Control - No
- title
- 24 Weeks
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Disease Control - Yes
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 6
- title
- Disease Control - No
- title
- 36 Weeks
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 6
- units
- Participants
- description
- Participants were defined as having disease control at a specific time point if they had an evaluation of complete response (CR) or partial response (PR) at the time point (with a window of +/- 7 days) or had an evaluation of stable disease (SD), PR or CR at any point from the time point minus 7 days or later.
- groups
- description
- Tisotumab vedotin 0.9 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
- id
- OG000
- title
- Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg
- description
- Tisotumab vedotin 1.2 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
- id
- OG001
- title
- Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- 6, 12, 24 and 36 weeks post first infusion (Part 1)
- title
- Part 1: Number of Participants Who Experienced Disease Control
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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