NCT02488759 · OUTCOME
Neoadjuvant: Number of Participants With Drug-Related Select Adverse Events (AEs)
An Investigational Immuno-therapy Study to Investigate the Safety and Effectiveness of Nivolumab, and Nivolumab Combination Therapy in Virus-associated Tumors · Source last updated 2023-11-13
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
- From first dose to 30 days post last dose (Up to 2 months)
What was measured
Number of participants with any grade of drug-related select adverse events (AEs) including endocrine, gastrointestinal, hepatic, pulmonary, renal, skin, and hypersensitivity AEs in Neoadjuvant cohort
Analysis population: All treated participants in the neoadjuvant cohort
Groups in this outcome
Neoadjuvant
Nivolumab administered intravenously (IV) over 30 minutes at 240 mg for 2 doses, on Day 1 and Day 15
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 |
|---|
| Neoadjuvant | 123 |
|---|
Reported measurements
Endocrine AEs
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Neoadjuvant | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
Gastrointestinal AEs
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Neoadjuvant | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
Hepatic AEs
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Neoadjuvant | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
Pulmonary AEs
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Neoadjuvant | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Renal AEs
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Neoadjuvant | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Skin AEs
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Neoadjuvant | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
Hypersensitivity/Infusion Reaction AEs
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Neoadjuvant | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- title
- Endocrine AEs
- title
- Gastrointestinal AEs
- title
- Hepatic AEs
- title
- Pulmonary AEs
- title
- Renal AEs
- title
- Skin AEs
- title
- Hypersensitivity/Infusion Reaction AEs
- description
- Number of participants with any grade of drug-related select adverse events (AEs) including endocrine, gastrointestinal, hepatic, pulmonary, renal, skin, and hypersensitivity AEs in Neoadjuvant cohort
- groups
- description
- Nivolumab administered intravenously (IV) over 30 minutes at 240 mg for 2 doses, on Day 1 and Day 15
- id
- OG000
- title
- Neoadjuvant
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All treated participants in the neoadjuvant cohort
- reporting Status
- POSTED
- time Frame
- From first dose to 30 days post last dose (Up to 2 months)
- title
- Neoadjuvant: Number of Participants With Drug-Related Select Adverse Events (AEs)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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