TriangleNCT05070247 · OUTCOME
Dose Escalation: Number of Participants With One or More TEAEs Leading to Dose Modifications and Treatment Discontinuations
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
- Up to approximately 32.8 months
What was measured
AE means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. A TEAE was reported as an AE for which the date of onset was on or after the first dose of any study drug and on or before the 30 days after the last dose of any study drug (or 90 days after the last dose of study drug for immune-mediated AEs).
Analysis population: Safety analysis set included participants who had received at least 1 dose, even if incomplete, of any study drug (i.e., TAK-500 or pembrolizumab).
Groups in this outcome
Single Agent Dose Escalation: TAK-500 8 µg/kg
Participants received TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (once every 3 weeks, Q3W) for up to 1 year.
Single Agent Dose Escalation: 1 TOCI + TAK-500 8 µg/kg
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab (TOCI) followed by TAK-500, 8 µg/kg IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
Single Agent Dose Escalation: TAK-500 16 µg/kg
Participants received TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg
Participants received premedication with dexamethasone (DEX) as a single 10 mg IV bolus 1 hour before the administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 16 µg/kg, IV infusion, intravenously, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
Single Agent Dose Escalation: 2 DEX + TAK-500 24 µg/kg
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
Single Agent Dose Escalation: 1 TOCI + TAK-500 24 µg/kg
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 60 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle or on Days 1 and 22 in a 42-day cycle (Q3W) for up to 1 year, along with TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year.
Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year.
Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK 500 24 µg/kg
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK-500 40 µg/kg
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
| Group | Source count |
|---|---|
| Single Agent Dose Escalation: TAK-500 8 µg/kg | 3 |
| Single Agent Dose Escalation: 1 TOCI + TAK-500 8 µg/kg | 3 |
| Single Agent Dose Escalation: TAK-500 16 µg/kg | 5 |
| Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg | 3 |
| Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg | 3 |
| Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg | 7 |
| Single Agent Dose Escalation: 2 DEX + TAK-500 24 µg/kg | 3 |
| Single Agent Dose Escalation: 1 TOCI + TAK-500 24 µg/kg | 2 |
| Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg | 6 |
| Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg | 4 |
| Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg | 5 |
| Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg | 5 |
| Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK 500 24 µg/kg | 7 |
| Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK-500 40 µg/kg | 5 |
Reported measurements
TEAEs Leading to Dose Modifications
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Single Agent Dose Escalation: TAK-500 8 µg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| Single Agent Dose Escalation: 1 TOCI + TAK-500 8 µg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Single Agent Dose Escalation: TAK-500 16 µg/kg | 4 | Not reported | Not reported | Not reported | Not reported |
| Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Single Agent Dose Escalation: 2 DEX + TAK-500 24 µg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Single Agent Dose Escalation: 1 TOCI + TAK-500 24 µg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK 500 24 µg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK-500 40 µg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
TEAEs Leading to Treatment Discontinuations
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Single Agent Dose Escalation: TAK-500 8 µg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Single Agent Dose Escalation: 1 TOCI + TAK-500 8 µg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Single Agent Dose Escalation: TAK-500 16 µg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Single Agent Dose Escalation: 2 DEX + TAK-500 24 µg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Single Agent Dose Escalation: 1 TOCI + TAK-500 24 µg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
| Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
| Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK 500 24 µg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK-500 40 µg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 1
- title
- TEAEs Leading to Dose Modifications
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 2
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- title
- TEAEs Leading to Treatment Discontinuations
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 7
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 6
- group Id
- OG009
- value
- 4
- group Id
- OG010
- value
- 5
- group Id
- OG011
- value
- 5
- units
- Participants
- description
- AE means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. A TEAE was reported as an AE for which the date of onset was on or after the first dose of any study drug and on or before the 30 days after the last dose of any study drug (or 90 days after the last dose of study drug for immune-mediated AEs).
- groups
- description
- Participants received TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (once every 3 weeks, Q3W) for up to 1 year.
- id
- OG000
- title
- Single Agent Dose Escalation: TAK-500 8 µg/kg
- description
- Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab (TOCI) followed by TAK-500, 8 µg/kg IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
- id
- OG001
- title
- Single Agent Dose Escalation: 1 TOCI + TAK-500 8 µg/kg
- description
- Participants received TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
- id
- OG002
- title
- Single Agent Dose Escalation: TAK-500 16 µg/kg
- description
- Participants received premedication with dexamethasone (DEX) as a single 10 mg IV bolus 1 hour before the administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
- id
- OG003
- title
- Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg
- description
- Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
- id
- OG004
- title
- Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg
- description
- Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 16 µg/kg, IV infusion, intravenously, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
- id
- OG005
- title
- Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg
- description
- Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
- id
- OG006
- title
- Single Agent Dose Escalation: 2 DEX + TAK-500 24 µg/kg
- description
- Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
- id
- OG007
- title
- Single Agent Dose Escalation: 1 TOCI + TAK-500 24 µg/kg
- description
- Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
- id
- OG008
- title
- Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg
- description
- Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 60 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
- id
- OG009
- title
- Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg
- description
- Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle or on Days 1 and 22 in a 42-day cycle (Q3W) for up to 1 year, along with TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year.
- id
- OG010
- title
- Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg
- description
- Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year.
- id
- OG011
- title
- Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety analysis set included participants who had received at least 1 dose, even if incomplete, of any study drug (i.e., TAK-500 or pembrolizumab).
- reporting Status
- POSTED
- time Frame
- Up to approximately 32.8 months
- title
- Dose Escalation: Number of Participants With One or More TEAEs Leading to Dose Modifications and Treatment Discontinuations
- type
- PRIMARY
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice