NCT01803282 · OUTCOME
Percentage of Participants Experiencing Treatment-Emergent Adverse Events
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
- Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days
Analysis population: The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Groups in this outcome
Part A: ADX 200 mg
Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 200 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part A: ADX 600 mg
Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 600 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part A: ADX 1800 mg
Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 1800 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: PAC, ADX 800 mg
Participants with PAC received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (gemcitabine and nab paclitaxel, on Days 1, 8, and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: LAC, ADX 1200 mg
Participants with LAC received ADX 1200 mg every 3 weeks via IV infusion in addition to the 21-day cycle chemotherapy (carboplatin and pemetrexed, on Day 1) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: LSC, ADX 1200 mg
Participants with LSC received ADX 1200 mg every 3 weeks via IV infusion in addition to the 21-day cycle chemotherapy (carboplatin and paclitaxel, on Day 1) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: EGC, ADX 800 mg
Participants with EGC received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: FL CRC, ADX 800 mg+BEV 5 mg/kg
Participants with CRC received FL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6 and bevacizumab 5 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: FL CRC, ADX 800 mg+BEV 10 mg/kg
Participants with CRC received FL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6 and bevacizumab 10 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: SL CRC, ADX 800 mg+BEV 5 mg/kg
Participants with CRC received SL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (FOLFIRI and bevacizumab 5 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: SL CRC, ADX 800 mg+BEV 10 mg/kg
Participants with CRC received SL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (FOLFIRI and bevacizumab 10 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: BRCA, ADX 800 mg
Participants with BRCA received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (paclitaxel, on Days 1, 8, and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
| Group | Source count |
|---|---|
| Part A: ADX 200 mg | 4 |
| Part A: ADX 600 mg | 3 |
| Part A: ADX 1800 mg | 6 |
| Part B: PAC, ADX 800 mg | 36 |
| Part B: LAC, ADX 1200 mg | 10 |
| Part B: LSC, ADX 1200 mg | 10 |
| Part B: EGC, ADX 800 mg | 40 |
| Part B: FL CRC, ADX 800 mg+BEV 5 mg/kg | 45 |
| Part B: FL CRC, ADX 800 mg+BEV 10 mg/kg | 11 |
| Part B: SL CRC, ADX 800 mg+BEV 5 mg/kg | 44 |
| Part B: SL CRC, ADX 800 mg+BEV 10 mg/kg | 8 |
| Part B: BRCA, ADX 800 mg | 15 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A: ADX 200 mg | 100.0 | Not reported | Not reported | Not reported | Not reported |
| Part A: ADX 600 mg | 100.0 | Not reported | Not reported | Not reported | Not reported |
| Part A: ADX 1800 mg | 83.3 | Not reported | Not reported | Not reported | Not reported |
| Part B: PAC, ADX 800 mg | 100.0 | Not reported | Not reported | Not reported | Not reported |
| Part B: LAC, ADX 1200 mg | 100.0 | Not reported | Not reported | Not reported | Not reported |
| Part B: LSC, ADX 1200 mg | 100.0 | Not reported | Not reported | Not reported | Not reported |
| Part B: EGC, ADX 800 mg | 100.0 | Not reported | Not reported | Not reported | Not reported |
| Part B: FL CRC, ADX 800 mg+BEV 5 mg/kg | 100.0 | Not reported | Not reported | Not reported | Not reported |
| Part B: FL CRC, ADX 800 mg+BEV 10 mg/kg | 100.0 | Not reported | Not reported | Not reported | Not reported |
| Part B: SL CRC, ADX 800 mg+BEV 5 mg/kg | 100.0 | Not reported | Not reported | Not reported | Not reported |
| Part B: SL CRC, ADX 800 mg+BEV 10 mg/kg | 100.0 | Not reported | Not reported | Not reported | Not reported |
| Part B: BRCA, ADX 800 mg | 100.0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 100.0
- group Id
- OG001
- value
- 100.0
- group Id
- OG002
- value
- 83.3
- group Id
- OG003
- value
- 100.0
- group Id
- OG004
- value
- 100.0
- group Id
- OG005
- value
- 100.0
- group Id
- OG006
- value
- 100.0
- group Id
- OG007
- value
- 100.0
- group Id
- OG008
- value
- 100.0
- group Id
- OG009
- value
- 100.0
- group Id
- OG010
- value
- 100.0
- group Id
- OG011
- value
- 100.0
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 36
- group Id
- OG004
- value
- 10
- group Id
- OG005
- value
- 10
- group Id
- OG006
- value
- 40
- group Id
- OG007
- value
- 45
- group Id
- OG008
- value
- 11
- group Id
- OG009
- value
- 44
- group Id
- OG010
- value
- 8
- group Id
- OG011
- value
- 15
- units
- Participants
- groups
- description
- Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 200 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
- id
- OG000
- title
- Part A: ADX 200 mg
- description
- Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 600 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
- id
- OG001
- title
- Part A: ADX 600 mg
- description
- Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 1800 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
- id
- OG002
- title
- Part A: ADX 1800 mg
- description
- Participants with PAC received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (gemcitabine and nab paclitaxel, on Days 1, 8, and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
- id
- OG003
- title
- Part B: PAC, ADX 800 mg
- description
- Participants with LAC received ADX 1200 mg every 3 weeks via IV infusion in addition to the 21-day cycle chemotherapy (carboplatin and pemetrexed, on Day 1) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
- id
- OG004
- title
- Part B: LAC, ADX 1200 mg
- description
- Participants with LSC received ADX 1200 mg every 3 weeks via IV infusion in addition to the 21-day cycle chemotherapy (carboplatin and paclitaxel, on Day 1) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
- id
- OG005
- title
- Part B: LSC, ADX 1200 mg
- description
- Participants with EGC received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
- id
- OG006
- title
- Part B: EGC, ADX 800 mg
- description
- Participants with CRC received FL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6 and bevacizumab 5 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
- id
- OG007
- title
- Part B: FL CRC, ADX 800 mg+BEV 5 mg/kg
- description
- Participants with CRC received FL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6 and bevacizumab 10 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
- id
- OG008
- title
- Part B: FL CRC, ADX 800 mg+BEV 10 mg/kg
- description
- Participants with CRC received SL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (FOLFIRI and bevacizumab 5 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
- id
- OG009
- title
- Part B: SL CRC, ADX 800 mg+BEV 5 mg/kg
- description
- Participants with CRC received SL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (FOLFIRI and bevacizumab 10 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
- id
- OG010
- title
- Part B: SL CRC, ADX 800 mg+BEV 10 mg/kg
- description
- Participants with BRCA received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (paclitaxel, on Days 1, 8, and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
- id
- OG011
- title
- Part B: BRCA, ADX 800 mg
- param Type
- NUMBER
- population Description
- The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
- reporting Status
- POSTED
- time Frame
- Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days
- title
- Percentage of Participants Experiencing Treatment-Emergent Adverse Events
- type
- PRIMARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice
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