TriangleNCT03474107 · OUTCOME
Number of Participants With ECOG Performance Status
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- End of treatment (EOT) (Median (range) time on study drug was 4.99 (0.5, 19.4) months in enfortumab vedotin and 3.45 (0.2, 15.0) months in chemotherapy group)
What was measured
ECOG performance status was measured on an 6 point scale. 0-Fully active, able to carry on all pre-disease performance without restriction. 1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours. 3. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5. Dead. Number of participants with ECOG PS was reported.
Analysis population: Safety population with available data.
Groups in this outcome
Enfortumab Vedotin 1.25 mg/kg
Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
Chemotherapy
Participants received either 75 mg/m\^2 docetaxel by IV infusion over approximately 1 hour or 320 mg/m\^2 vinflunine by IV infusion over approximately 20 minutes or 175 mg/m\^2 paclitaxel by IV infusion over approximately 3 hours on day 1 of every 21-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
| Group | Source count |
|---|---|
| Enfortumab Vedotin 1.25 mg/kg | 184 |
| Chemotherapy | 219 |
Reported measurements
ECOG PS = 0
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Enfortumab Vedotin 1.25 mg/kg | 34 | Not reported | Not reported | Not reported | Not reported |
| Chemotherapy | 57 | Not reported | Not reported | Not reported | Not reported |
ECOG PS = 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Enfortumab Vedotin 1.25 mg/kg | 110 | Not reported | Not reported | Not reported | Not reported |
| Chemotherapy | 118 | Not reported | Not reported | Not reported | Not reported |
ECOG PS >1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Enfortumab Vedotin 1.25 mg/kg | 40 | Not reported | Not reported | Not reported | Not reported |
| Chemotherapy | 44 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 34
- group Id
- OG001
- value
- 57
- title
- ECOG PS = 0
- categories
- measurements
- group Id
- OG000
- value
- 110
- group Id
- OG001
- value
- 118
- title
- ECOG PS = 1
- categories
- measurements
- group Id
- OG000
- value
- 40
- group Id
- OG001
- value
- 44
- title
- ECOG PS >1
- denoms
- counts
- group Id
- OG000
- value
- 184
- group Id
- OG001
- value
- 219
- units
- Participants
- description
- ECOG performance status was measured on an 6 point scale. 0-Fully active, able to carry on all pre-disease performance without restriction. 1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours. 3. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5. Dead. Number of participants with ECOG PS was reported.
- groups
- description
- Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
- id
- OG000
- title
- Enfortumab Vedotin 1.25 mg/kg
- description
- Participants received either 75 mg/m\^2 docetaxel by IV infusion over approximately 1 hour or 320 mg/m\^2 vinflunine by IV infusion over approximately 20 minutes or 175 mg/m\^2 paclitaxel by IV infusion over approximately 3 hours on day 1 of every 21-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
- id
- OG001
- title
- Chemotherapy
- param Type
- NUMBER
- population Description
- Safety population with available data.
- reporting Status
- POSTED
- time Frame
- End of treatment (EOT) (Median (range) time on study drug was 4.99 (0.5, 19.4) months in enfortumab vedotin and 3.45 (0.2, 15.0) months in chemotherapy group)
- title
- Number of Participants With ECOG Performance Status
- type
- SECONDARY
- unit Of Measure
- participants
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Preserved source evidence · Not medical advice