TriangleNCT02721732 · OUTCOME
Number of Patients Who Experienced Treatment-related Adverse Event (TRAE)
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
- First day of administration of study medication through 30 days following last dose, an average of 4 years.
What was measured
Per protocol, the number and percentage of patients with any treatment-related AE was summarized for all study patients combined. Patients were monitored for AE from the first day of administration of study medication through 30 days following last dose. Each AE (as defined by NCI CTCAE v4.03) was counted only once for a given subject. In the event a patient experienced repeated episodes of the same AE, then the event with the highest severity and/or strongest causal relationship to study treatment was used for purposes of tabulations.
Analysis population: It was a pre-specified objective. All patients who have received at least 1 dose of study medication were included in the safety analysis. A total of 157 patients were treated on this study. One patient enrolled in the ACC cohort was excluded from the study due to change in the diagnosis following histological assessment of the surgical specimen.
Groups in this outcome
All Patients Who Received at Least One Dose of the Drug
MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle
| Group | Source count |
|---|---|
| All Patients Who Received at Least One Dose of the Drug | 156 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Patients Who Received at Least One Dose of the Drug | 88 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- calculate Pct
- false
- classes
- categories
- measurements
- group Id
- OG000
- value
- 88
- denoms
- counts
- group Id
- OG000
- value
- 156
- units
- Participants
- description
- Per protocol, the number and percentage of patients with any treatment-related AE was summarized for all study patients combined. Patients were monitored for AE from the first day of administration of study medication through 30 days following last dose. Each AE (as defined by NCI CTCAE v4.03) was counted only once for a given subject. In the event a patient experienced repeated episodes of the same AE, then the event with the highest severity and/or strongest causal relationship to study treatment was used for purposes of tabulations.
- groups
- description
- MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle
- id
- OG000
- title
- All Patients Who Received at Least One Dose of the Drug
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- It was a pre-specified objective. All patients who have received at least 1 dose of study medication were included in the safety analysis. A total of 157 patients were treated on this study. One patient enrolled in the ACC cohort was excluded from the study due to change in the diagnosis following histological assessment of the surgical specimen.
- reporting Status
- POSTED
- time Frame
- First day of administration of study medication through 30 days following last dose, an average of 4 years.
- title
- Number of Patients Who Experienced Treatment-related Adverse Event (TRAE)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice