TriangleNCT04844073 · OUTCOME
Number of Participants With Cytokine Release Syndrome (CRS) According to American Society for Transplantation and Cellular Therapy (ASTCT) CRS Consensus Grading
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
- From start of study drug up to 90 days after last dose of the study drug (up to 22 months)
What was measured
CRS was defined as a systemic inflammatory response caused by the rapid and excessive release of pro-inflammatory cytokines from activated immune cells. Grade 1=temperature greater than or equal to (\>=) 38°C; Grade 2= temperature \>= 38°C, hypotension not requiring vasopressors, and/or hypoxia requiring low-flow nasal cannula or blow-by oxygen; Grade 3=temperature \>= 38°C, hypotension requiring one vasopressor with or without vasopressin, and/or hypoxia requiring high-flow nasal cannula facemask, nonrebreather mask, or venturi mask; Grade 4=temperature \>= 38°C, hypotension requiring multiple vasopressors (excluding vasopressin), and/or hypoxia requiring positive pressure (eg, continuous positive airway pressure \[CPAP\], bilevel positive airway pressure \[BiPAP\], intubation, and mechanical ventilation). Grade 5= Death due to CRS (if directly attributable). Number of participants with CRS according to ASTCT CRS consensus grading were reported.
Analysis population: Safety population included all participants who received at least 1 dose of TAK-186.
Groups in this outcome
Dose Escalation Phase: TAK-186 - Dose A + Dexamethasone
Participants received TAK-186, Dose A as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose A is the lowest dose.
Dose Escalation Phase: TAK-186 -Dose B + Dexamethasone
Participants received TAK-186, Dose B as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose B is higher than Dose A.
Dose Escalation Phase: TAK-186 -Dose B → Dose C + Dexamethasone
Participants received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose C is higher than Dose B.
Dose Escalation Phase: TAK-186 - Dose B → Dose D + Dexamethasone
Participants received TAK-186, Dose B on Day 1 followed by Dose D on Day 8 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose D is higher than Dose B.
Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose E + Dexamethasone
Participants received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and Dose E on Day 15 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose E is higher than Dose C and B.
Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose E + Double Dexamethasone
Participants received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and Dose E on Day 15 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion and post-infusion. Dose E is higher than Dose C and B.
Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose F + Dexamethasone
Participants received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and Dose F on Day 15 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose F is highest dose and is higher than Dose B and C.
Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone
Participants received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and Dose D on Day 15 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose D is higher than Dose B and C.
Dose Escalation Phase:TAK-186 - Dose B → Dose C→ Dose D + Double Dexamethasone
Participants received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and Dose D on Day 15 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion and post-infusion. Dose D is higher than Dose B and C.
Cohort Expansion Phase: NSCLC
Participants with NSCLC received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and Dose E on Day 15 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion and post-infusion. Dose E is higher than Dose C and B.
| Group | Source count |
|---|---|
| Dose Escalation Phase: TAK-186 - Dose A + Dexamethasone | 1 |
| Dose Escalation Phase: TAK-186 -Dose B + Dexamethasone | 1 |
| Dose Escalation Phase: TAK-186 -Dose B → Dose C + Dexamethasone | 5 |
| Dose Escalation Phase: TAK-186 - Dose B → Dose D + Dexamethasone | 10 |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose E + Dexamethasone | 17 |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose E + Double Dexamethasone | 13 |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose F + Dexamethasone | 5 |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone | 4 |
| Dose Escalation Phase:TAK-186 - Dose B → Dose C→ Dose D + Double Dexamethasone | 8 |
| Cohort Expansion Phase: NSCLC | 31 |
Reported measurements
Grade 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Phase: TAK-186 - Dose A + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 -Dose B + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 -Dose B → Dose C + Dexamethasone | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 - Dose B → Dose D + Dexamethasone | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose E + Dexamethasone | 5 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose E + Double Dexamethasone | 7 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose F + Dexamethasone | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase:TAK-186 - Dose B → Dose C→ Dose D + Double Dexamethasone | 4 | Not reported | Not reported | Not reported | Not reported |
| Cohort Expansion Phase: NSCLC | 5 | Not reported | Not reported | Not reported | Not reported |
Grade 2
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Phase: TAK-186 - Dose A + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 -Dose B + Dexamethasone | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 -Dose B → Dose C + Dexamethasone | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 - Dose B → Dose D + Dexamethasone | 4 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose E + Dexamethasone | 8 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose E + Double Dexamethasone | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose F + Dexamethasone | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase:TAK-186 - Dose B → Dose C→ Dose D + Double Dexamethasone | 2 | Not reported | Not reported | Not reported | Not reported |
| Cohort Expansion Phase: NSCLC | 16 | Not reported | Not reported | Not reported | Not reported |
Grade 3
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Phase: TAK-186 - Dose A + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 -Dose B + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 -Dose B → Dose C + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 - Dose B → Dose D + Dexamethasone | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose E + Dexamethasone | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose E + Double Dexamethasone | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose F + Dexamethasone | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase:TAK-186 - Dose B → Dose C→ Dose D + Double Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort Expansion Phase: NSCLC | 3 | Not reported | Not reported | Not reported | Not reported |
Grade 4
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Phase: TAK-186 - Dose A + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 -Dose B + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 -Dose B → Dose C + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 - Dose B → Dose D + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose E + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose E + Double Dexamethasone | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose F + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase:TAK-186 - Dose B → Dose C→ Dose D + Double Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort Expansion Phase: NSCLC | 0 | Not reported | Not reported | Not reported | Not reported |
Grade 5
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Phase: TAK-186 - Dose A + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 -Dose B + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 -Dose B → Dose C + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 - Dose B → Dose D + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose E + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose E + Double Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose F + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase:TAK-186 - Dose B → Dose C→ Dose D + Double Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort Expansion Phase: NSCLC | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
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- 2
- group Id
- OG003
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- 5
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- 7
- group Id
- OG006
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- 1
- group Id
- OG007
- value
- 1
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- value
- 4
- group Id
- OG009
- value
- 5
- title
- Grade 1
- categories
- measurements
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- OG000
- value
- 0
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- OG001
- value
- 1
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- value
- 2
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- value
- 4
- group Id
- OG004
- value
- 8
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 2
- group Id
- OG009
- value
- 16
- title
- Grade 2
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 3
- title
- Grade 3
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- title
- Grade 4
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- 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
- title
- Grade 5
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 10
- group Id
- OG004
- value
- 17
- group Id
- OG005
- value
- 13
- group Id
- OG006
- value
- 5
- group Id
- OG007
- value
- 4
- group Id
- OG008
- value
- 8
- group Id
- OG009
- value
- 31
- units
- Participants
- description
- CRS was defined as a systemic inflammatory response caused by the rapid and excessive release of pro-inflammatory cytokines from activated immune cells. Grade 1=temperature greater than or equal to (\>=) 38°C; Grade 2= temperature \>= 38°C, hypotension not requiring vasopressors, and/or hypoxia requiring low-flow nasal cannula or blow-by oxygen; Grade 3=temperature \>= 38°C, hypotension requiring one vasopressor with or without vasopressin, and/or hypoxia requiring high-flow nasal cannula facemask, nonrebreather mask, or venturi mask; Grade 4=temperature \>= 38°C, hypotension requiring multiple vasopressors (excluding vasopressin), and/or hypoxia requiring positive pressure (eg, continuous positive airway pressure \[CPAP\], bilevel positive airway pressure \[BiPAP\], intubation, and mechanical ventilation). Grade 5= Death due to CRS (if directly attributable). Number of participants with CRS according to ASTCT CRS consensus grading were reported.
- groups
- description
- Participants received TAK-186, Dose A as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose A is the lowest dose.
- id
- OG000
- title
- Dose Escalation Phase: TAK-186 - Dose A + Dexamethasone
- description
- Participants received TAK-186, Dose B as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose B is higher than Dose A.
- id
- OG001
- title
- Dose Escalation Phase: TAK-186 -Dose B + Dexamethasone
- description
- Participants received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose C is higher than Dose B.
- id
- OG002
- title
- Dose Escalation Phase: TAK-186 -Dose B → Dose C + Dexamethasone
- description
- Participants received TAK-186, Dose B on Day 1 followed by Dose D on Day 8 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose D is higher than Dose B.
- id
- OG003
- title
- Dose Escalation Phase: TAK-186 - Dose B → Dose D + Dexamethasone
- description
- Participants received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and Dose E on Day 15 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose E is higher than Dose C and B.
- id
- OG004
- title
- Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose E + Dexamethasone
- description
- Participants received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and Dose E on Day 15 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion and post-infusion. Dose E is higher than Dose C and B.
- id
- OG005
- title
- Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose E + Double Dexamethasone
- description
- Participants received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and Dose F on Day 15 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose F is highest dose and is higher than Dose B and C.
- id
- OG006
- title
- Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose F + Dexamethasone
- description
- Participants received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and Dose D on Day 15 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose D is higher than Dose B and C.
- id
- OG007
- title
- Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone
- description
- Participants received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and Dose D on Day 15 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion and post-infusion. Dose D is higher than Dose B and C.
- id
- OG008
- title
- Dose Escalation Phase:TAK-186 - Dose B → Dose C→ Dose D + Double Dexamethasone
- description
- Participants with NSCLC received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and Dose E on Day 15 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion and post-infusion. Dose E is higher than Dose C and B.
- id
- OG009
- title
- Cohort Expansion Phase: NSCLC
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety population included all participants who received at least 1 dose of TAK-186.
- reporting Status
- POSTED
- time Frame
- From start of study drug up to 90 days after last dose of the study drug (up to 22 months)
- title
- Number of Participants With Cytokine Release Syndrome (CRS) According to American Society for Transplantation and Cellular Therapy (ASTCT) CRS Consensus Grading
- type
- PRIMARY
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice