NCT02362035 · OUTCOME
Number of Participants With Any Study-Drug Related AE
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Number of participants
- Interval / dispersion
- Not reported
- Time frame
- 104 weeks
What was measured
Study drug-related AEs were those assessed by investigator as related to study treatment.
Analysis population: All participants in this study received both study drugs and were therefore analyzed together as a single treatment arm. Participants receiving the different regimens were not analyzed separately by regimen, as the study was designed to assess the safety of the combination study treatment.
Groups in this outcome
Acalabrutinib + Pembrolizumab
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.
| Group | Source count |
|---|---|
| Acalabrutinib + Pembrolizumab | 161 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Acalabrutinib + Pembrolizumab | 142 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 142
- denoms
- counts
- group Id
- OG000
- value
- 161
- units
- Participants
- description
- Study drug-related AEs were those assessed by investigator as related to study treatment.
- 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
- OG000
- title
- Acalabrutinib + Pembrolizumab
- param Type
- NUMBER
- population Description
- All participants in this study received both study drugs and were therefore analyzed together as a single treatment arm. Participants receiving the different regimens were not analyzed separately by regimen, as the study was designed to assess the safety of the combination study treatment.
- reporting Status
- POSTED
- time Frame
- 104 weeks
- title
- Number of Participants With Any Study-Drug Related AE
- type
- PRIMARY
- unit Of Measure
- Number of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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