TriangleNCT00675428 · OUTCOME
Number of Participants With Dose Limiting Toxicities (DLTs)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- Day 1 up to Day 28
What was measured
DLTs = any ≥grade 3 toxicity related to treatment; treatment delays of ≥7 days due to any toxicity related to treatment, with the exception of hepatic transaminases; or alanine and/or aspartate aminotransferase (ALT and/or AST) \>3\*upper limit of normal (ULN) with either a total bilirubin \>2\*ULN or an international normalized ratio (INR) \>1.5 related to treatment, or with the appearance of worsening fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, or eosinophilia.
Groups in this outcome
Natalizumab 300 mg
Intravenous (IV) infusions of natalizumab 300 mg once every 28 days for 6 months.
Natalizumab 450 mg
Intravenous (IV) infusions of natalizumab 450 mg once every 28 days for 6 months.
| Group | Source count |
|---|---|
| Natalizumab 300 mg | 3 |
| Natalizumab 450 mg | 3 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Natalizumab 300 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Natalizumab 450 mg | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- units
- Participants
- description
- DLTs = any ≥grade 3 toxicity related to treatment; treatment delays of ≥7 days due to any toxicity related to treatment, with the exception of hepatic transaminases; or alanine and/or aspartate aminotransferase (ALT and/or AST) \>3\*upper limit of normal (ULN) with either a total bilirubin \>2\*ULN or an international normalized ratio (INR) \>1.5 related to treatment, or with the appearance of worsening fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, or eosinophilia.
- groups
- description
- Intravenous (IV) infusions of natalizumab 300 mg once every 28 days for 6 months.
- id
- OG000
- title
- Natalizumab 300 mg
- description
- Intravenous (IV) infusions of natalizumab 450 mg once every 28 days for 6 months.
- id
- OG001
- title
- Natalizumab 450 mg
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- Day 1 up to Day 28
- title
- Number of Participants With Dose Limiting Toxicities (DLTs)
- type
- PRIMARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice