TriangleNCT03269136 · OUTCOME
Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03
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 first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to of 43.3 months)
What was measured
AE: any untoward medical occurrence in clinical study participant, temporally associated with use of study intervention, whether or not considered related to intervention. TEAE: any event increasing in severity from baseline or event started during PF-06863135 therapy or within 30 days of last dose of drug. SAE: any untoward medical occurrence at any dose that resulted in either: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission via Pfizer product of infectious agent, pathogenic or non-pathogenic; or considered as important event. Treatment-related AE: AEs attributed to drug in participants who received drug. Relatedness was judged by investigator. NCI CTCAE v4.03, Grade 3= severe AE, Grade 4= life-threatening, urgent intervention indicated, Grade 5= death related to AE. AEs included SAEs and all non-SAEs.
Analysis population: Safety analysis set included all participants who receive at least 1 full or partial dose of study medication.
Groups in this outcome
Part 1: PF-06863135 0.1 mcg/kg IV
Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: PF-06863135 0.3 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: PF-06863135 1 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: PF-06863135 3 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: PF-06863135 10 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: PF-06863135 30 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: PF-06863135 50 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: PF-06863135 80 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: PF-06863135 130 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: PF-06863135 215 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: PF-06863135 360 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: PF-06863135 600 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: PF-06863135 1000 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1000 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1.1: PF-06863135 Priming Cohort Q1W SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every week (Q1W) on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1.1: PF-06863135 Priming Cohort Q2W SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every 2 weeks (Q2W) on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1C: PF-06863135 + Lenalidomide SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1D: PF-06863135 + Pomalidomide SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: PF-06863135 Total IV
Participants with relapsed/refractory advanced MM received PF-06863135 as an IV infusion (any dose) for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: PF-06863135 Total SC
Participants with relapsed/refractory advanced MM received PF-06863135 as a SC injection (any dose) on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1.1: PF-06863135 Total SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection Q1W on Day 1, 8 ,15 and 22 of each 28-day cycle or Q2W on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
| Group | Source count |
|---|---|
| Part 1: PF-06863135 0.1 mcg/kg IV | 2 |
| Part 1: PF-06863135 0.3 mcg/kg IV | 3 |
| Part 1: PF-06863135 1 mcg/kg IV | 2 |
| Part 1: PF-06863135 3 mcg/kg IV | 3 |
| Part 1: PF-06863135 10 mcg/kg IV | 2 |
| Part 1: PF-06863135 30 mcg/kg IV | 5 |
| Part 1: PF-06863135 50 mcg/kg IV | 6 |
| Part 1: PF-06863135 80 mcg/kg SC | 6 |
| Part 1: PF-06863135 130 mcg/kg SC | 4 |
| Part 1: PF-06863135 215 mcg/kg SC | 4 |
| Part 1: PF-06863135 360 mcg/kg SC | 4 |
| Part 1: PF-06863135 600 mcg/kg SC | 6 |
| Part 1: PF-06863135 1000 mcg/kg SC | 6 |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | 7 |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | 13 |
| Part 1C: PF-06863135 + Lenalidomide SC | 4 |
| Part 1D: PF-06863135 + Pomalidomide SC | 9 |
| Part 1: PF-06863135 Total IV | 23 |
| Part 1: PF-06863135 Total SC | 30 |
| Part 1.1: PF-06863135 Total SC | 20 |
Reported measurements
Participants with AEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: PF-06863135 0.1 mcg/kg IV | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 0.3 mcg/kg IV | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 1 mcg/kg IV | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 3 mcg/kg IV | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 10 mcg/kg IV | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 30 mcg/kg IV | 5 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 50 mcg/kg IV | 6 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 80 mcg/kg SC | 6 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 130 mcg/kg SC | 4 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 215 mcg/kg SC | 4 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 360 mcg/kg SC | 4 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 600 mcg/kg SC | 6 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 1000 mcg/kg SC | 6 | Not reported | Not reported | Not reported | Not reported |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | 7 | Not reported | Not reported | Not reported | Not reported |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | 13 | Not reported | Not reported | Not reported | Not reported |
| Part 1C: PF-06863135 + Lenalidomide SC | 4 | Not reported | Not reported | Not reported | Not reported |
| Part 1D: PF-06863135 + Pomalidomide SC | 9 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 Total IV | 23 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 Total SC | 30 | Not reported | Not reported | Not reported | Not reported |
| Part 1.1: PF-06863135 Total SC | 20 | Not reported | Not reported | Not reported | Not reported |
Participants with serious TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: PF-06863135 0.1 mcg/kg IV | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 0.3 mcg/kg IV | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 1 mcg/kg IV | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 3 mcg/kg IV | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 10 mcg/kg IV | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 30 mcg/kg IV | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 50 mcg/kg IV | 5 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 80 mcg/kg SC | 4 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 130 mcg/kg SC | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 215 mcg/kg SC | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 360 mcg/kg SC | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 600 mcg/kg SC | 4 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 1000 mcg/kg SC | 5 | Not reported | Not reported | Not reported | Not reported |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | 6 | Not reported | Not reported | Not reported | Not reported |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | 9 | Not reported | Not reported | Not reported | Not reported |
| Part 1C: PF-06863135 + Lenalidomide SC | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 1D: PF-06863135 + Pomalidomide SC | 8 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 Total IV | 11 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 Total SC | 20 | Not reported | Not reported | Not reported | Not reported |
| Part 1.1: PF-06863135 Total SC | 15 | Not reported | Not reported | Not reported | Not reported |
Participants with treatment related AEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: PF-06863135 0.1 mcg/kg IV | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 0.3 mcg/kg IV | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 1 mcg/kg IV | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 3 mcg/kg IV | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 10 mcg/kg IV | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 30 mcg/kg IV | 4 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 50 mcg/kg IV | 6 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 80 mcg/kg SC | 4 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 130 mcg/kg SC | 4 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 215 mcg/kg SC | 4 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 360 mcg/kg SC | 4 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 600 mcg/kg SC | 6 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 1000 mcg/kg SC | 6 | Not reported | Not reported | Not reported | Not reported |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | 7 | Not reported | Not reported | Not reported | Not reported |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | 13 | Not reported | Not reported | Not reported | Not reported |
| Part 1C: PF-06863135 + Lenalidomide SC | 4 | Not reported | Not reported | Not reported | Not reported |
| Part 1D: PF-06863135 + Pomalidomide SC | 9 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 Total IV | 17 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 Total SC | 28 | Not reported | Not reported | Not reported | Not reported |
| Part 1.1: PF-06863135 Total SC | 20 | Not reported | Not reported | Not reported | Not reported |
Participants with grade 3 or 4 AEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: PF-06863135 0.1 mcg/kg IV | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 0.3 mcg/kg IV | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 1 mcg/kg IV | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 3 mcg/kg IV | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 10 mcg/kg IV | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 30 mcg/kg IV | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 50 mcg/kg IV | 6 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 80 mcg/kg SC | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 130 mcg/kg SC | 4 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 215 mcg/kg SC | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 360 mcg/kg SC | 4 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 600 mcg/kg SC | 4 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 1000 mcg/kg SC | 6 | Not reported | Not reported | Not reported | Not reported |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | 12 | Not reported | Not reported | Not reported | Not reported |
| Part 1C: PF-06863135 + Lenalidomide SC | 4 | Not reported | Not reported | Not reported | Not reported |
| Part 1D: PF-06863135 + Pomalidomide SC | 7 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 Total IV | 17 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 Total SC | 24 | Not reported | Not reported | Not reported | Not reported |
| Part 1.1: PF-06863135 Total SC | 15 | Not reported | Not reported | Not reported | Not reported |
Participants with grade 5 AEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: PF-06863135 0.1 mcg/kg IV | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 0.3 mcg/kg IV | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 1 mcg/kg IV | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 3 mcg/kg IV | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 10 mcg/kg IV | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 30 mcg/kg IV | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 50 mcg/kg IV | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 80 mcg/kg SC | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 130 mcg/kg SC | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 215 mcg/kg SC | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 360 mcg/kg SC | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 600 mcg/kg SC | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 1000 mcg/kg SC | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1C: PF-06863135 + Lenalidomide SC | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1D: PF-06863135 + Pomalidomide SC | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 Total IV | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 Total SC | 6 | Not reported | Not reported | Not reported | Not reported |
| Part 1.1: PF-06863135 Total SC | 4 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 5
- group Id
- OG006
- value
- 6
- group Id
- OG007
- value
- 6
- group Id
- OG008
- value
- 4
- group Id
- OG009
- value
- 4
- group Id
- OG010
- value
- 4
- group Id
- OG011
- value
- 6
- title
- Participants with AEs
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 5
- group Id
- OG007
- value
- 4
- group Id
- OG008
- value
- 1
- group Id
- OG009
- value
- 3
- group Id
- OG010
- value
- 3
- group Id
- OG011
- value
- 4
- title
- Participants with serious TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 6
- group Id
- OG007
- value
- 4
- group Id
- OG008
- value
- 4
- group Id
- OG009
- value
- 4
- group Id
- OG010
- value
- 4
- group Id
- OG011
- value
- 6
- title
- Participants with treatment related AEs
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 6
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 4
- group Id
- OG009
- value
- 3
- group Id
- OG010
- value
- 4
- group Id
- OG011
- value
- 4
- title
- Participants with grade 3 or 4 AEs
- 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
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 1
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 2
- title
- Participants with grade 5 AEs
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 5
- group Id
- OG006
- value
- 6
- group Id
- OG007
- value
- 6
- group Id
- OG008
- value
- 4
- group Id
- OG009
- value
- 4
- group Id
- OG010
- value
- 4
- group Id
- OG011
- value
- 6
- units
- Participants
- description
- AE: any untoward medical occurrence in clinical study participant, temporally associated with use of study intervention, whether or not considered related to intervention. TEAE: any event increasing in severity from baseline or event started during PF-06863135 therapy or within 30 days of last dose of drug. SAE: any untoward medical occurrence at any dose that resulted in either: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission via Pfizer product of infectious agent, pathogenic or non-pathogenic; or considered as important event. Treatment-related AE: AEs attributed to drug in participants who received drug. Relatedness was judged by investigator. NCI CTCAE v4.03, Grade 3= severe AE, Grade 4= life-threatening, urgent intervention indicated, Grade 5= death related to AE. AEs included SAEs and all non-SAEs.
- groups
- description
- Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
- id
- OG000
- title
- Part 1: PF-06863135 0.1 mcg/kg IV
- description
- Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
- id
- OG001
- title
- Part 1: PF-06863135 0.3 mcg/kg IV
- description
- Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
- id
- OG002
- title
- Part 1: PF-06863135 1 mcg/kg IV
- description
- Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
- id
- OG003
- title
- Part 1: PF-06863135 3 mcg/kg IV
- description
- Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
- id
- OG004
- title
- Part 1: PF-06863135 10 mcg/kg IV
- description
- Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
- id
- OG005
- title
- Part 1: PF-06863135 30 mcg/kg IV
- description
- Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
- id
- OG006
- title
- Part 1: PF-06863135 50 mcg/kg IV
- description
- Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
- id
- OG007
- title
- Part 1: PF-06863135 80 mcg/kg SC
- description
- Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
- id
- OG008
- title
- Part 1: PF-06863135 130 mcg/kg SC
- description
- Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
- id
- OG009
- title
- Part 1: PF-06863135 215 mcg/kg SC
- description
- Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
- id
- OG010
- title
- Part 1: PF-06863135 360 mcg/kg SC
- description
- Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
- id
- OG011
- title
- Part 1: PF-06863135 600 mcg/kg SC
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety analysis set included all participants who receive at least 1 full or partial dose of study medication.
- reporting Status
- POSTED
- time Frame
- From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to of 43.3 months)
- title
- Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03
- type
- SECONDARY
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice