NCT01079936 · OUTCOME
Participants With Grade 3 =/> Adverse Events
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 90 after stem cell transplant
What was measured
Number of participants experiencing adverse events above a Grade 3 according to the Common Terminology Criteria for Adverse Events (CTCAE) version 2.
Groups in this outcome
25 Mg Lenalidomide
Lenalidomide dose level 25 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m\^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
50 mg Lenalidomide
Lenalidomide dose level 50 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m\^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
75 mg Lenalidomide
Lenalidomide dose level 75 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m\^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
100 mg Lenalidomide
Lenalidomide dose level 100 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m\^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
| Group | Source count |
|---|---|
| 25 Mg Lenalidomide | 3 |
| 50 mg Lenalidomide | 5 |
| 75 mg Lenalidomide | 24 |
| 100 mg Lenalidomide | 25 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 25 Mg Lenalidomide | 3 | Not reported | Not reported | Not reported | Not reported |
| 50 mg Lenalidomide | 5 | Not reported | Not reported | Not reported | Not reported |
| 75 mg Lenalidomide | 15 | Not reported | Not reported | Not reported | Not reported |
| 100 mg Lenalidomide | 17 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 15
- group Id
- OG003
- value
- 17
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 24
- group Id
- OG003
- value
- 25
- units
- Participants
- description
- Number of participants experiencing adverse events above a Grade 3 according to the Common Terminology Criteria for Adverse Events (CTCAE) version 2.
- groups
- description
- Lenalidomide dose level 25 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m\^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
- id
- OG000
- title
- 25 Mg Lenalidomide
- description
- Lenalidomide dose level 50 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m\^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
- id
- OG001
- title
- 50 mg Lenalidomide
- description
- Lenalidomide dose level 75 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m\^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
- id
- OG002
- title
- 75 mg Lenalidomide
- description
- Lenalidomide dose level 100 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m\^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
- id
- OG003
- title
- 100 mg Lenalidomide
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- Day 90 after stem cell transplant
- title
- Participants With Grade 3 =/> Adverse Events
- type
- PRIMARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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