TriangleNCT02365597 · OUTCOME
Main Study: Percentage of Participants With Treatment-emergent Adverse Event (TEAEs)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of Participants
- Interval / dispersion
- Not reported
- Time frame
- From Day 1 up to 6 years 2 months
What was measured
Percentage of participants with TEAEs were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are those events that occurred from first dose date through 30 days after last dose date, or day before subsequent anticancer therapy, whichever occurs first.
Analysis population: The population included participants who received at least 1 dose of study drug.
Groups in this outcome
Main Study: Regimen 1: Erdafitinib 10 Milligrams (mg)/ 12 mg
Participants received single dose of erdafitinib 10 mg tablet, orally, once daily, starting from Day 1 through Day 7 and from Day 15 through Day 21 and so on, that is 7-day on and off in each subsequent 28-day cycles starting from Cycle 1. Based on serum phosphate (PO4) levels, there was an option to up-titrate erdafitinib dose to 12 mg, orally, once daily starting from Cycle 2 Day 1 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation.
Main Study: Regimen 2: Erdafitinib 6 mg/ 8 mg
Participants received single dose of erdafitinib 6 mg tablet, orally, once daily, starting from Day 1 through Day 28 in each subsequent 28-day cycles starting from Cycle 1. Based on serum PO4 levels, there was an option to up-titrate erdafitinib dose to 8 mg, orally, once daily starting from Cycle 2 Day 1 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation.
Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg
Participants received single dose of erdafitinib 8 mg tablet, orally, once daily, starting from Day 1 through Day 28 in each subsequent 28-day cycles starting from Cycle 1. Based on serum PO4 levels, there was an option to up-titrate erdafitinib dose to 9 mg, orally, once daily starting from Cycle 1 Day 15 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation.
| Group | Source count |
|---|---|
| Main Study: Regimen 1: Erdafitinib 10 Milligrams (mg)/ 12 mg | 33 |
| Main Study: Regimen 2: Erdafitinib 6 mg/ 8 mg | 78 |
| Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg | 101 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study: Regimen 1: Erdafitinib 10 Milligrams (mg)/ 12 mg | 100 | Not reported | Not reported | Not reported | Not reported |
| Main Study: Regimen 2: Erdafitinib 6 mg/ 8 mg | 100 | Not reported | Not reported | Not reported | Not reported |
| Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg | 100 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 100
- group Id
- OG001
- value
- 100
- group Id
- OG002
- value
- 100
- denoms
- counts
- group Id
- OG000
- value
- 33
- group Id
- OG001
- value
- 78
- group Id
- OG002
- value
- 101
- units
- Participants
- description
- Percentage of participants with TEAEs were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are those events that occurred from first dose date through 30 days after last dose date, or day before subsequent anticancer therapy, whichever occurs first.
- groups
- description
- Participants received single dose of erdafitinib 10 mg tablet, orally, once daily, starting from Day 1 through Day 7 and from Day 15 through Day 21 and so on, that is 7-day on and off in each subsequent 28-day cycles starting from Cycle 1. Based on serum phosphate (PO4) levels, there was an option to up-titrate erdafitinib dose to 12 mg, orally, once daily starting from Cycle 2 Day 1 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation.
- id
- OG000
- title
- Main Study: Regimen 1: Erdafitinib 10 Milligrams (mg)/ 12 mg
- description
- Participants received single dose of erdafitinib 6 mg tablet, orally, once daily, starting from Day 1 through Day 28 in each subsequent 28-day cycles starting from Cycle 1. Based on serum PO4 levels, there was an option to up-titrate erdafitinib dose to 8 mg, orally, once daily starting from Cycle 2 Day 1 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation.
- id
- OG001
- title
- Main Study: Regimen 2: Erdafitinib 6 mg/ 8 mg
- description
- Participants received single dose of erdafitinib 8 mg tablet, orally, once daily, starting from Day 1 through Day 28 in each subsequent 28-day cycles starting from Cycle 1. Based on serum PO4 levels, there was an option to up-titrate erdafitinib dose to 9 mg, orally, once daily starting from Cycle 1 Day 15 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation.
- id
- OG002
- title
- Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg
- param Type
- NUMBER
- population Description
- The population included participants who received at least 1 dose of study drug.
- reporting Status
- POSTED
- time Frame
- From Day 1 up to 6 years 2 months
- title
- Main Study: Percentage of Participants With Treatment-emergent Adverse Event (TEAEs)
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice