NCT02155647 · OUTCOME
Part A: Number of Participants With Clinically Significant Abnormalities in Vital Signs Reported as Treatment Emergent Adverse Events (TEAEs)
Avelumab in Participants With Merkel Cell Carcinoma (JAVELIN Merkel 200) · Source last updated 2024-03-13
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
- Up to 325 weeks
What was measured
Vital signs including body temperature, body weight, respiratory rate, heart rate (after 5-minute rest), and arterial blood pressure (after 5-minute rest) were evaluated. Number of participants with clinically significant abnormalities in Vital Signs reported as TEAEs. Clinically Significance was decided by investigator.
Analysis population: Safety analysis set included all participants who received at least 1 dose of study treatment.
Groups in this outcome
Part A: Avelumab
Participants with metastatic Merkel cell carcinoma (MCC) after failing first-line chemotherapy received Avelumab at a dose of 10 milligram per kilogram (mg/kg) as 1-hour intravenous infusion once every 2 weeks until therapeutic failure, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the trial or investigational medicinal product occurs.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Part A: Avelumab | 88 |
|---|
Reported measurements
Body temperature Increased
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part A: Avelumab | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Weight Increased
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part A: Avelumab | 57 | Not reported | Not reported | Not reported | Not reported |
|---|
Weight Decreased
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part A: Avelumab | 54 | Not reported | Not reported | Not reported | Not reported |
|---|
Increased Heart Rate
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part A: Avelumab | 83 | Not reported | Not reported | Not reported | Not reported |
|---|
Decreased Heart Rate
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part A: Avelumab | 84 | Not reported | Not reported | Not reported | Not reported |
|---|
Increased Systolic Blood Pressure
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part A: Avelumab | 84 | Not reported | Not reported | Not reported | Not reported |
|---|
Decreased Systolic Blood Pressure
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part A: Avelumab | 84 | Not reported | Not reported | Not reported | Not reported |
|---|
Increased Diastolic Blood Pressure
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part A: Avelumab | 84 | Not reported | Not reported | Not reported | Not reported |
|---|
Decreased Diastolic Blood Pressure
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part A: Avelumab | 84 | Not reported | Not reported | Not reported | Not reported |
|---|
Increased Respiratory Rate
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part A: Avelumab | 81 | Not reported | Not reported | Not reported | Not reported |
|---|
Decreased Respiratory Rate
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part A: Avelumab | 81 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- title
- Body temperature Increased
- title
- Weight Increased
- title
- Weight Decreased
- title
- Increased Heart Rate
- title
- Decreased Heart Rate
- title
- Increased Systolic Blood Pressure
- title
- Decreased Systolic Blood Pressure
- title
- Increased Diastolic Blood Pressure
- title
- Decreased Diastolic Blood Pressure
- title
- Increased Respiratory Rate
- title
- Decreased Respiratory Rate
- description
- Vital signs including body temperature, body weight, respiratory rate, heart rate (after 5-minute rest), and arterial blood pressure (after 5-minute rest) were evaluated. Number of participants with clinically significant abnormalities in Vital Signs reported as TEAEs. Clinically Significance was decided by investigator.
- groups
- description
- Participants with metastatic Merkel cell carcinoma (MCC) after failing first-line chemotherapy received Avelumab at a dose of 10 milligram per kilogram (mg/kg) as 1-hour intravenous infusion once every 2 weeks until therapeutic failure, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the trial or investigational medicinal product occurs.
- id
- OG000
- title
- Part A: Avelumab
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety analysis set included all participants who received at least 1 dose of study treatment.
- reporting Status
- POSTED
- time Frame
- Up to 325 weeks
- title
- Part A: Number of Participants With Clinically Significant Abnormalities in Vital Signs Reported as Treatment Emergent Adverse Events (TEAEs)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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