TriangleNCT01248949 · OUTCOME
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
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
- From start of study drug administration up to 90 days after the last dose of MEDI3617
What was measured
An adverse event (AE) was any untoward medical occurrence in a participant administered investigational product and which does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) was an AE resulting in any of 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. Treatment-emergent AEs were events occurring after administration of investigational product.
Analysis population: Safety population included all participants who received treatment with MEDI3617.
Groups in this outcome
MEDI3617 SINGLE AGENT TOTAL
Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL
Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
MEDI3617 + BEVACIZUMAB Q2W TOTAL
Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
MEDI3617 + PACLITAXEL TOTAL
Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL
Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
| Group | Source count |
|---|---|
| MEDI3617 SINGLE AGENT TOTAL | 42 |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | 16 |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | 38 |
| MEDI3617 + PACLITAXEL TOTAL | 13 |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | 7 |
Reported measurements
TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MEDI3617 SINGLE AGENT TOTAL | 42 | Not reported | Not reported | Not reported | Not reported |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | 16 | Not reported | Not reported | Not reported | Not reported |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | 38 | Not reported | Not reported | Not reported | Not reported |
| MEDI3617 + PACLITAXEL TOTAL | 13 | Not reported | Not reported | Not reported | Not reported |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | 7 | Not reported | Not reported | Not reported | Not reported |
TESAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MEDI3617 SINGLE AGENT TOTAL | 18 | Not reported | Not reported | Not reported | Not reported |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | 4 | Not reported | Not reported | Not reported | Not reported |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | 18 | Not reported | Not reported | Not reported | Not reported |
| MEDI3617 + PACLITAXEL TOTAL | 7 | Not reported | Not reported | Not reported | Not reported |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | 4 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 42
- group Id
- OG001
- value
- 16
- group Id
- OG002
- value
- 38
- group Id
- OG003
- value
- 13
- group Id
- OG004
- value
- 7
- title
- TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 18
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 18
- group Id
- OG003
- value
- 7
- group Id
- OG004
- value
- 4
- title
- TESAEs
- denoms
- counts
- group Id
- OG000
- value
- 42
- group Id
- OG001
- value
- 16
- group Id
- OG002
- value
- 38
- group Id
- OG003
- value
- 13
- group Id
- OG004
- value
- 7
- units
- Participants
- description
- An adverse event (AE) was any untoward medical occurrence in a participant administered investigational product and which does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) was an AE resulting in any of 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. Treatment-emergent AEs were events occurring after administration of investigational product.
- groups
- description
- Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
- id
- OG000
- title
- MEDI3617 SINGLE AGENT TOTAL
- description
- Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
- id
- OG001
- title
- MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL
- description
- Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
- id
- OG002
- title
- MEDI3617 + BEVACIZUMAB Q2W TOTAL
- description
- Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
- id
- OG003
- title
- MEDI3617 + PACLITAXEL TOTAL
- description
- Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
- id
- OG004
- title
- MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL
- param Type
- NUMBER
- population Description
- Safety population included all participants who received treatment with MEDI3617.
- reporting Status
- POSTED
- time Frame
- From start of study drug administration up to 90 days after the last dose of MEDI3617
- title
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice