TriangleNCT01693562 · OUTCOME
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) in the Dose-escalation, Dose-exploration, and Dose-expansion Phase
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 Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
What was measured
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Analysis population: As-treated population included all participants who received any dose of study drug. Participants enrolled in the 10 mg/kg Q2W Expansion and Escalation Cohort have been summarized as a total only. This is because the safety profile of durvalumab monotherapy 10 mg/kg Q2W was manageable and generally consistent with the known safety profile of the anti-programmed cell death ligand (PD-L1/PD-1) drug class.
Groups in this outcome
Escalation Cohort (MEDI4736 0.1 mg/kg Q2W)
Participants received intravenous (IV) infusion of MEDI4736 (durvalumab) 0.1 mg/kg every 2 weeks (Q2W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
Escalation Cohort (MEDI4736 0.3 mg/kg Q2W)
Participants received IV infusion of MEDI4736 0.3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first
Escalation Cohort (MEDI4736 1 mg/kg Q2W)
Participants received IV infusion of MEDI4736 1 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
Escalation Cohort (MEDI4736 3 mg/kg Q2W)
Participants received IV infusion of MEDI4736 3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.
Escalation Cohort (MEDI4736 15 mg/kg Q3W)
Participants received IV infusion of MEDI4736 15 mg/kg every 3 weeks (Q3W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
Exploration Cohort (MEDI4736 20 mg/kg Q4W)
Participants received IV infusion of MEDI4736 20 mg/kg every 4 weeks (Q4W) in the dose-exploration phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W)
Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation or dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.
| Group | Source count |
|---|---|
| Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) | 4 |
| Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) | 4 |
| Escalation Cohort (MEDI4736 1 mg/kg Q2W) | 3 |
| Escalation Cohort (MEDI4736 3 mg/kg Q2W) | 3 |
| Escalation Cohort (MEDI4736 15 mg/kg Q3W) | 7 |
| Exploration Cohort (MEDI4736 20 mg/kg Q4W) | 21 |
| Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) | 980 |
Reported measurements
Any TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) | 3 | Not reported | Not reported | Not reported | Not reported |
| Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) | 4 | Not reported | Not reported | Not reported | Not reported |
| Escalation Cohort (MEDI4736 1 mg/kg Q2W) | 3 | Not reported | Not reported | Not reported | Not reported |
| Escalation Cohort (MEDI4736 3 mg/kg Q2W) | 3 | Not reported | Not reported | Not reported | Not reported |
| Escalation Cohort (MEDI4736 15 mg/kg Q3W) | 7 | Not reported | Not reported | Not reported | Not reported |
| Exploration Cohort (MEDI4736 20 mg/kg Q4W) | 21 | Not reported | Not reported | Not reported | Not reported |
| Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) | 963 | Not reported | Not reported | Not reported | Not reported |
Any TESAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) | 1 | Not reported | Not reported | Not reported | Not reported |
| Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) | 2 | Not reported | Not reported | Not reported | Not reported |
| Escalation Cohort (MEDI4736 1 mg/kg Q2W) | 1 | Not reported | Not reported | Not reported | Not reported |
| Escalation Cohort (MEDI4736 3 mg/kg Q2W) | 1 | Not reported | Not reported | Not reported | Not reported |
| Escalation Cohort (MEDI4736 15 mg/kg Q3W) | 3 | Not reported | Not reported | Not reported | Not reported |
| Exploration Cohort (MEDI4736 20 mg/kg Q4W) | 13 | Not reported | Not reported | Not reported | Not reported |
| Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W) | 536 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 7
- group Id
- OG005
- value
- 21
- group Id
- OG006
- value
- 963
- title
- Any TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 13
- group Id
- OG006
- value
- 536
- title
- Any TESAEs
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 7
- group Id
- OG005
- value
- 21
- group Id
- OG006
- value
- 980
- units
- Participants
- description
- An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
- groups
- description
- Participants received intravenous (IV) infusion of MEDI4736 (durvalumab) 0.1 mg/kg every 2 weeks (Q2W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
- id
- OG000
- title
- Escalation Cohort (MEDI4736 0.1 mg/kg Q2W)
- description
- Participants received IV infusion of MEDI4736 0.3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first
- id
- OG001
- title
- Escalation Cohort (MEDI4736 0.3 mg/kg Q2W)
- description
- Participants received IV infusion of MEDI4736 1 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
- id
- OG002
- title
- Escalation Cohort (MEDI4736 1 mg/kg Q2W)
- description
- Participants received IV infusion of MEDI4736 3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.
- id
- OG003
- title
- Escalation Cohort (MEDI4736 3 mg/kg Q2W)
- description
- Participants received IV infusion of MEDI4736 15 mg/kg every 3 weeks (Q3W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
- id
- OG004
- title
- Escalation Cohort (MEDI4736 15 mg/kg Q3W)
- description
- Participants received IV infusion of MEDI4736 20 mg/kg every 4 weeks (Q4W) in the dose-exploration phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
- id
- OG005
- title
- Exploration Cohort (MEDI4736 20 mg/kg Q4W)
- description
- Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation or dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.
- id
- OG006
- title
- Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- As-treated population included all participants who received any dose of study drug. Participants enrolled in the 10 mg/kg Q2W Expansion and Escalation Cohort have been summarized as a total only. This is because the safety profile of durvalumab monotherapy 10 mg/kg Q2W was manageable and generally consistent with the known safety profile of the anti-programmed cell death ligand (PD-L1/PD-1) drug class.
- reporting Status
- POSTED
- time Frame
- From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
- title
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) in the Dose-escalation, Dose-exploration, and Dose-expansion Phase
- type
- PRIMARY
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice