NCT02362035 · FLOW
Participant flow
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- groups
- description
- All participants in this study received both study drugs and were therefore analysed together as a single treatment arm. Participants receiving the different regimens were not analysed separately by regimen, as the study was designed to assess the safety of the combination study treatment. The study included N=161 participants who received both acalabrutinib and pembrolizumab and are summarized together (from First stage safety lead-in and Second stage expansion). Stage 3 (additional expansion in subjects with Myelofibrosis) was planned but not conducted.
- id
- FG000
- title
- Acalabrutinib + Pembrolizumab
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 67
- type
- Death
- reasons
- group Id
- FG000
- num Subjects
- 3
- type
- Lost to Follow-up
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Adverse Event
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Physician Decision
- reasons
- group Id
- FG000
- num Subjects
- 10
- type
- Subject started another cancer therapy
- reasons
- group Id
- FG000
- num Subjects
- 45
- type
- Study terminated by sponsor
- reasons
- group Id
- FG000
- num Subjects
- 2
- type
- Decision by subject not related to AE/SAE
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Decision by PI not related to AE/SAE
- reasons
- group Id
- FG000
- num Subjects
- 11
- type
- Disease progression
- reasons
- group Id
- FG000
- num Subjects
- 20
- type
- Withdrawal by Subject
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 161
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 0
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 161
- type
- NOT COMPLETED
- title
- Overall Study
- pre Assignment Details
- For the ACE-LY-005 program, Study Terminated by Sponsor refers to the following: Patients receiving treatment benefits will continue to be provided with study medication in the Post Final Analysis Management of the trial. No further data collection for analysis and reporting will be completed after the final Analysis
Complete source fields
- groups
- description
- All participants in this study received both study drugs and were therefore analysed together as a single treatment arm. Participants receiving the different regimens were not analysed separately by regimen, as the study was designed to assess the safety of the combination study treatment. The study included N=161 participants who received both acalabrutinib and pembrolizumab and are summarized together (from First stage safety lead-in and Second stage expansion). Stage 3 (additional expansion in subjects with Myelofibrosis) was planned but not conducted.
- id
- FG000
- title
- Acalabrutinib + Pembrolizumab
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 67
- type
- Death
- reasons
- group Id
- FG000
- num Subjects
- 3
- type
- Lost to Follow-up
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Adverse Event
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Physician Decision
- reasons
- group Id
- FG000
- num Subjects
- 10
- type
- Subject started another cancer therapy
- reasons
- group Id
- FG000
- num Subjects
- 45
- type
- Study terminated by sponsor
- reasons
- group Id
- FG000
- num Subjects
- 2
- type
- Decision by subject not related to AE/SAE
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Decision by PI not related to AE/SAE
- reasons
- group Id
- FG000
- num Subjects
- 11
- type
- Disease progression
- reasons
- group Id
- FG000
- num Subjects
- 20
- type
- Withdrawal by Subject
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 161
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 0
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 161
- type
- NOT COMPLETED
- title
- Overall Study
- pre Assignment Details
- For the ACE-LY-005 program, Study Terminated by Sponsor refers to the following: Patients receiving treatment benefits will continue to be provided with study medication in the Post Final Analysis Management of the trial. No further data collection for analysis and reporting will be completed after the final Analysis
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Preserved source evidence · Not medical advice
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