TriangleNCT03685591 · OUTCOME
Number of Participants With Treatment-Emergent Adverse Events (Treatment Related)
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 28 days after last dose of study treatment ( up to approximately 2 years)
What was measured
Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of death; inpatient hospitalization; life-threatening experience; disability; congenital anomaly or deemed significant for any other reason. Symptoms of infusion-related reactions (IRRs) may include, but were not limited to, fever, chills, flushing, hypotension, dyspnea, wheezing, back pain, abdominal pain, and urticaria. Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE.
Analysis population: Population included all enrolled participants who received at least one dose of investigational product.
Groups in this outcome
Part 1A: PF-06952229 20mg Monotherapy
PF-06952229 was administered at a dose of 20 mg orally twice daily (BID) for 7 days on, 7 days off for each Cycle (one cycle = 28 days).
Part 1A: PF-06952229 40mg Monotherapy
PF-06952229 was administered at a dose of 40 mg orally BID for 7 days on, 7 days off for each Cycle (one cycle = 28 days).
Part 1A: PF-06952229 80mg Monotherapy
PF-06952229 was administered at a dose of 80 mg orally BID for 7 days on, 7 days off for each Cycle (one cycle = 28 days).
Part 1A: PF-06952229 150mg Monotherapy
PF-06952229 was administered at a dose of 150 mg orally BID for 7 days on, 7 days off for each Cycle (one cycle = 28 days).
Part 1A: PF-06952229 250mg Monotherapy
PF-06952229 was administered at a dose of 250 mg orally BID for 7 days on, 7 days off for each Cycle (one cycle = 28 days).
Part 1A: PF-06952229 375mg Monotherapy
PF-06952229 was administered at a dose of 375 mg orally BID for 7 days on, 7 days off for each Cycle (one cycle = 28 days).
Part 1A: PF-06952229 500mg Monotherapy
PF-06952229 was administered at a dose of 500 mg orally BID for 7 days on, 7 days off for each Cycle (one cycle = 28 days).
Part 1B: PF-06952229 250mg + Enzalutamide
PF-06952229 was administered at a dose of 250 mg orally twice daily (BID) for 7 days on, 7 days off for each Cycle (one cycle = 28 days) in combination with enzalutamide at 160 mg orally once a day (QD) as continuous daily dosing.
Part 1B: PF-06952229 375mg + Enzalutamide
PF-06952229 was administered at a dose of 375 mg orally twice daily (BID) for 7 days on, 7 days off for each Cycle (one cycle = 28 days) in combination with enzalutamide at 160 mg orally QD as continuous daily dosing.
| Group | Source count |
|---|---|
| Part 1A: PF-06952229 20mg Monotherapy | 1 |
| Part 1A: PF-06952229 40mg Monotherapy | 1 |
| Part 1A: PF-06952229 80mg Monotherapy | 1 |
| Part 1A: PF-06952229 150mg Monotherapy | 5 |
| Part 1A: PF-06952229 250mg Monotherapy | 13 |
| Part 1A: PF-06952229 375mg Monotherapy | 17 |
| Part 1A: PF-06952229 500mg Monotherapy | 4 |
| Part 1B: PF-06952229 250mg + Enzalutamide | 4 |
| Part 1B: PF-06952229 375mg + Enzalutamide | 3 |
Reported measurements
Participants with adverse events
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1A: PF-06952229 20mg Monotherapy | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 40mg Monotherapy | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 80mg Monotherapy | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 150mg Monotherapy | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 250mg Monotherapy | 9 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 375mg Monotherapy | 13 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 500mg Monotherapy | 4 | Not reported | Not reported | Not reported | Not reported |
| Part 1B: PF-06952229 250mg + Enzalutamide | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1B: PF-06952229 375mg + Enzalutamide | 1 | Not reported | Not reported | Not reported | Not reported |
Participants with serious adverse events
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1A: PF-06952229 20mg Monotherapy | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 40mg Monotherapy | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 80mg Monotherapy | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 150mg Monotherapy | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 250mg Monotherapy | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 375mg Monotherapy | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 500mg Monotherapy | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1B: PF-06952229 250mg + Enzalutamide | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1B: PF-06952229 375mg + Enzalutamide | 0 | Not reported | Not reported | Not reported | Not reported |
Participants with Maximum Grade 3 or 4 adverse events
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1A: PF-06952229 20mg Monotherapy | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 40mg Monotherapy | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 80mg Monotherapy | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 150mg Monotherapy | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 250mg Monotherapy | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 375mg Monotherapy | 6 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 500mg Monotherapy | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 1B: PF-06952229 250mg + Enzalutamide | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1B: PF-06952229 375mg + Enzalutamide | 0 | Not reported | Not reported | Not reported | Not reported |
Participants with Maximum Grade 5 adverse events
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1A: PF-06952229 20mg Monotherapy | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 40mg Monotherapy | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 80mg Monotherapy | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 150mg Monotherapy | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 250mg Monotherapy | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 375mg Monotherapy | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 500mg Monotherapy | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1B: PF-06952229 250mg + Enzalutamide | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1B: PF-06952229 375mg + Enzalutamide | 0 | Not reported | Not reported | Not reported | Not reported |
Participants discontinued from study due to adverse events
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1A: PF-06952229 20mg Monotherapy | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 40mg Monotherapy | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 80mg Monotherapy | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 150mg Monotherapy | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 250mg Monotherapy | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 375mg Monotherapy | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 500mg Monotherapy | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1B: PF-06952229 250mg + Enzalutamide | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1B: PF-06952229 375mg + Enzalutamide | 1 | Not reported | Not reported | Not reported | Not reported |
Participants discontinued study drug due to AE and continue Study
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1A: PF-06952229 20mg Monotherapy | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 40mg Monotherapy | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 80mg Monotherapy | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 150mg Monotherapy | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 250mg Monotherapy | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 375mg Monotherapy | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 500mg Monotherapy | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1B: PF-06952229 250mg + Enzalutamide | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1B: PF-06952229 375mg + Enzalutamide | 0 | Not reported | Not reported | Not reported | Not reported |
Participants with dose reduced or temporary discontinuation due to adverse events
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1A: PF-06952229 20mg Monotherapy | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 40mg Monotherapy | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 80mg Monotherapy | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 150mg Monotherapy | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 250mg Monotherapy | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 375mg Monotherapy | 6 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: PF-06952229 500mg Monotherapy | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 1B: PF-06952229 250mg + Enzalutamide | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1B: PF-06952229 375mg + Enzalutamide | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 9
- group Id
- OG005
- value
- 13
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 1
- title
- Participants with adverse events
- 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
- 1
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- title
- Participants with serious adverse events
- 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
- 2
- group Id
- OG005
- value
- 6
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 0
- title
- Participants with Maximum Grade 3 or 4 adverse events
- 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
- title
- Participants with Maximum Grade 5 adverse events
- 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
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 1
- title
- Participants discontinued from study due to adverse events
- 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
- title
- Participants discontinued study drug due to AE and continue Study
- 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
- 3
- group Id
- OG005
- value
- 6
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 0
- title
- Participants with dose reduced or temporary discontinuation due to adverse events
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 13
- group Id
- OG005
- value
- 17
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 4
- group Id
- OG008
- value
- 3
- units
- Participants
- description
- Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of death; inpatient hospitalization; life-threatening experience; disability; congenital anomaly or deemed significant for any other reason. Symptoms of infusion-related reactions (IRRs) may include, but were not limited to, fever, chills, flushing, hypotension, dyspnea, wheezing, back pain, abdominal pain, and urticaria. Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE.
- groups
- description
- PF-06952229 was administered at a dose of 20 mg orally twice daily (BID) for 7 days on, 7 days off for each Cycle (one cycle = 28 days).
- id
- OG000
- title
- Part 1A: PF-06952229 20mg Monotherapy
- description
- PF-06952229 was administered at a dose of 40 mg orally BID for 7 days on, 7 days off for each Cycle (one cycle = 28 days).
- id
- OG001
- title
- Part 1A: PF-06952229 40mg Monotherapy
- description
- PF-06952229 was administered at a dose of 80 mg orally BID for 7 days on, 7 days off for each Cycle (one cycle = 28 days).
- id
- OG002
- title
- Part 1A: PF-06952229 80mg Monotherapy
- description
- PF-06952229 was administered at a dose of 150 mg orally BID for 7 days on, 7 days off for each Cycle (one cycle = 28 days).
- id
- OG003
- title
- Part 1A: PF-06952229 150mg Monotherapy
- description
- PF-06952229 was administered at a dose of 250 mg orally BID for 7 days on, 7 days off for each Cycle (one cycle = 28 days).
- id
- OG004
- title
- Part 1A: PF-06952229 250mg Monotherapy
- description
- PF-06952229 was administered at a dose of 375 mg orally BID for 7 days on, 7 days off for each Cycle (one cycle = 28 days).
- id
- OG005
- title
- Part 1A: PF-06952229 375mg Monotherapy
- description
- PF-06952229 was administered at a dose of 500 mg orally BID for 7 days on, 7 days off for each Cycle (one cycle = 28 days).
- id
- OG006
- title
- Part 1A: PF-06952229 500mg Monotherapy
- description
- PF-06952229 was administered at a dose of 250 mg orally twice daily (BID) for 7 days on, 7 days off for each Cycle (one cycle = 28 days) in combination with enzalutamide at 160 mg orally once a day (QD) as continuous daily dosing.
- id
- OG007
- title
- Part 1B: PF-06952229 250mg + Enzalutamide
- description
- PF-06952229 was administered at a dose of 375 mg orally twice daily (BID) for 7 days on, 7 days off for each Cycle (one cycle = 28 days) in combination with enzalutamide at 160 mg orally QD as continuous daily dosing.
- id
- OG008
- title
- Part 1B: PF-06952229 375mg + Enzalutamide
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Population included all enrolled participants who received at least one dose of investigational product.
- reporting Status
- POSTED
- time Frame
- Baseline up to 28 days after last dose of study treatment ( up to approximately 2 years)
- title
- Number of Participants With Treatment-Emergent Adverse Events (Treatment Related)
- type
- PRIMARY
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice