TriangleNCT03269136 · OUTCOME
Part 2: Number of Participants With 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 32.3 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 received at least 1 full or partial dose of study medication.
Groups in this outcome
Part 2A: PF-06863135 SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 44 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 76 mcg as a SC injection 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.
| Group | Source count |
|---|---|
| Part 2A: PF-06863135 SC | 15 |
Reported measurements
Participants with TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2A: PF-06863135 SC | 15 | Not reported | Not reported | Not reported | Not reported |
Participants with serious AEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2A: PF-06863135 SC | 12 | Not reported | Not reported | Not reported | Not reported |
Participants with treatment related AEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2A: PF-06863135 SC | 13 | Not reported | Not reported | Not reported | Not reported |
Participants with grade 3 or 4 AEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2A: PF-06863135 SC | 11 | Not reported | Not reported | Not reported | Not reported |
Participants with grade 5 AEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2A: PF-06863135 SC | 3 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 15
- title
- Participants with TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 12
- title
- Participants with serious AEs
- categories
- measurements
- group Id
- OG000
- value
- 13
- title
- Participants with treatment related AEs
- categories
- measurements
- group Id
- OG000
- value
- 11
- title
- Participants with grade 3 or 4 AEs
- categories
- measurements
- group Id
- OG000
- value
- 3
- title
- Participants with grade 5 AEs
- denoms
- counts
- group Id
- OG000
- value
- 15
- 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 MM received PF-06863135 at a priming dose of 44 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 76 mcg as a SC injection 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.
- id
- OG000
- title
- Part 2A: PF-06863135 SC
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety analysis set included all participants who received 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 32.3 months)
- title
- Part 2: Number of Participants With 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
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice