TriangleNCT02554812 · OUTCOME
Number of Participants With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination B
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
- Baseline up to end of treatment/withdrawal (maximum of 3.5 years)
What was measured
The laboratory results were graded according to the NCI CTCAE v4.03 severity grade. Grade 1=mild AE. Grade 2=moderate AE. Grade 3=severe AE. Grade 4=life-threatening consequences; urgent intervention indicated. Number of participants with new abnormal or worsening chemistry laboratory test is presented." Participants with any grade \>=3 is presented for following parameters: Alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, creatinine increased, hyperglycemia, lipase increased and serum amylase increased. Baseline is defined as the last assessment prior to the date/time of the first dose of study treatment.
Analysis population: All participants who received at least one dose of study drug and who could be evaluated for CTCAE criteria for each parameter in each treatment group. Participants were classified according to study treatment actually received. If participant received more than one study treatment, participant was classified according to first treatment received. Here, "N''=number of participants evaluable for this outcome measure.
Groups in this outcome
Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab
During Phase 1b participants received PF-04518600 0.3 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W. Phase 2 in the melanoma cohort was not planned.
Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received PF-04518600 1.0 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W. Phase 2 in the melanoma cohort was not planned.
Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab
During Phase 1b participants received PF-04518600 3.0 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W. Phase 2 in the melanoma cohort was not planned.
Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab
During Phase 2 participants with NSCLC received PF-04518600 0.3 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W.
Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab
During Phase 2 participants with SCCHN received PF-04518600 0.3 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W.
| Group | Source count |
|---|---|
| Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab | 12 |
| Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab | 12 |
| Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab | 8 |
| Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab | 14 |
| Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab | 24 |
Reported measurements
Participants with any grade >= 3 Alanine Aminotransferase Increased
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab | 0 | Not reported | Not reported | Not reported | Not reported |
Participants with any grade >= 3 Alkaline Phosphatase Increased
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab | 1 | Not reported | Not reported | Not reported | Not reported |
| Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab | 0 | Not reported | Not reported | Not reported | Not reported |
Participants with any grade >= 3 Aspartate Aminotransferase Increased
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab | 1 | Not reported | Not reported | Not reported | Not reported |
| Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab | 0 | Not reported | Not reported | Not reported | Not reported |
Participants with any grade >= 3 Blood Bilirubin Increased
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab | 0 | Not reported | Not reported | Not reported | Not reported |
Participants with any grade >= 3 Creatinine Increased
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab | 1 | Not reported | Not reported | Not reported | Not reported |
Participants with any grade >= 3 Hyperglycemia
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab | 1 | Not reported | Not reported | Not reported | Not reported |
| Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab | 2 | Not reported | Not reported | Not reported | Not reported |
Participants with any grade >= 3 Lipase Increased
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab | 1 | Not reported | Not reported | Not reported | Not reported |
| Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab | 1 | Not reported | Not reported | Not reported | Not reported |
| Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab | 1 | Not reported | Not reported | Not reported | Not reported |
| Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab | 4 | Not reported | Not reported | Not reported | Not reported |
| Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab | 5 | Not reported | Not reported | Not reported | Not reported |
Participants with any grade >= 3 Serum Amylase Increased
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab | 1 | Not reported | Not reported | Not reported | Not reported |
| Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab | 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
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- title
- Participants with any grade >= 3 Alanine Aminotransferase Increased
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- title
- Participants with any grade >= 3 Alkaline Phosphatase Increased
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- title
- Participants with any grade >= 3 Aspartate Aminotransferase Increased
- 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
- title
- Participants with any grade >= 3 Blood Bilirubin Increased
- 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
- 1
- title
- Participants with any grade >= 3 Creatinine Increased
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 2
- title
- Participants with any grade >= 3 Hyperglycemia
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 5
- title
- Participants with any grade >= 3 Lipase Increased
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 0
- title
- Participants with any grade >= 3 Serum Amylase Increased
- denoms
- counts
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 12
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 14
- group Id
- OG004
- value
- 24
- units
- Participants
- description
- The laboratory results were graded according to the NCI CTCAE v4.03 severity grade. Grade 1=mild AE. Grade 2=moderate AE. Grade 3=severe AE. Grade 4=life-threatening consequences; urgent intervention indicated. Number of participants with new abnormal or worsening chemistry laboratory test is presented." Participants with any grade \>=3 is presented for following parameters: Alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, creatinine increased, hyperglycemia, lipase increased and serum amylase increased. Baseline is defined as the last assessment prior to the date/time of the first dose of study treatment.
- groups
- description
- During Phase 1b participants received PF-04518600 0.3 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W. Phase 2 in the melanoma cohort was not planned.
- id
- OG000
- title
- Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab
- description
- During Phase 1b participants received PF-04518600 1.0 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W. Phase 2 in the melanoma cohort was not planned.
- id
- OG001
- title
- Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab
- description
- During Phase 1b participants received PF-04518600 3.0 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W. Phase 2 in the melanoma cohort was not planned.
- id
- OG002
- title
- Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab
- description
- During Phase 2 participants with NSCLC received PF-04518600 0.3 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W.
- id
- OG003
- title
- Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab
- description
- During Phase 2 participants with SCCHN received PF-04518600 0.3 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W.
- id
- OG004
- title
- Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All participants who received at least one dose of study drug and who could be evaluated for CTCAE criteria for each parameter in each treatment group. Participants were classified according to study treatment actually received. If participant received more than one study treatment, participant was classified according to first treatment received. Here, "N''=number of participants evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Baseline up to end of treatment/withdrawal (maximum of 3.5 years)
- title
- Number of Participants With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination B
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice