NCT03552393 · OUTCOME
Change in Mircera Dose Over Time
Ascertain the Optimal Starting Dose of Mircera Given Subcutaneously for Maintenance Treatment of Anemia in Pediatric Patients With Chronic Kidney Disease on Dialysis or Not Yet on Dialysis. · Source last updated 2022-03-07
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- micrograms (µg)
- Interval / dispersion
- Full Range
- Time frame
- Week 1 to Week 17
What was measured
A dose change was defined as a change in the administered dose strength compared to the preceding dose.
Analysis population: Safety population included all participants who received at least one dose of study drug regardless of whether they withdrew prematurely or not. Number analyzed signifies number of participants evaluable at specified time points.
Groups in this outcome
Mircera
Mircera was administered subcutaneously once every 4 weeks.
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 |
|---|
| Mircera | 40 |
|---|
Reported measurements
Week 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Mircera | 40 |
|---|
Values in micrograms (µg) · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Mircera | 75.00 | Not reported | 15.0 | 360.0 | Not reported |
|---|
Week 5
Analysis denominator · Participants
| Group | Source count |
|---|
| Mircera | 39 |
|---|
Values in micrograms (µg) · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Mircera | 75.00 | Not reported | 15.0 | 360.0 | Not reported |
|---|
Change at Week 5
Analysis denominator · Participants
| Group | Source count |
|---|
| Mircera | 39 |
|---|
Values in micrograms (µg) · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Mircera | 0.00 | Not reported | -50.0 | 75.0 | Not reported |
|---|
Week 9
Analysis denominator · Participants
| Group | Source count |
|---|
| Mircera | 39 |
|---|
Values in micrograms (µg) · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Mircera | 50.00 | Not reported | 0.0 | 360.0 | Not reported |
|---|
Change at Week 9
Analysis denominator · Participants
| Group | Source count |
|---|
| Mircera | 39 |
|---|
Values in micrograms (µg) · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Mircera | 0.00 | Not reported | -250.0 | 190.0 | Not reported |
|---|
Week 13
Analysis denominator · Participants
| Group | Source count |
|---|
| Mircera | 38 |
|---|
Values in micrograms (µg) · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Mircera | 50.00 | Not reported | 0.0 | 360.0 | Not reported |
|---|
Change at Week 13
Analysis denominator · Participants
| Group | Source count |
|---|
| Mircera | 38 |
|---|
Values in micrograms (µg) · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Mircera | -25.00 | Not reported | -120.0 | 210.0 | Not reported |
|---|
Week 17
Analysis denominator · Participants
| Group | Source count |
|---|
| Mircera | 38 |
|---|
Values in micrograms (µg) · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Mircera | 50.00 | Not reported | 0.0 | 250.0 | Not reported |
|---|
Change at Week 17
Analysis denominator · Participants
| Group | Source count |
|---|
| Mircera | 38 |
|---|
Values in micrograms (µg) · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Mircera | -20.00 | Not reported | -250.0 | 120.0 | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 15.0
- upper Limit
- 360.0
- value
- 75.00
- title
- Week 1
- categories
- measurements
- group Id
- OG000
- lower Limit
- 15.0
- upper Limit
- 360.0
- value
- 75.00
- title
- Week 5
- categories
- measurements
- group Id
- OG000
- lower Limit
- -50.0
- upper Limit
- 75.0
- value
- 0.00
- title
- Change at Week 5
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 360.0
- value
- 50.00
- title
- Week 9
- categories
- measurements
- group Id
- OG000
- lower Limit
- -250.0
- upper Limit
- 190.0
- value
- 0.00
- title
- Change at Week 9
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 360.0
- value
- 50.00
- title
- Week 13
- categories
- measurements
- group Id
- OG000
- lower Limit
- -120.0
- upper Limit
- 210.0
- value
- -25.00
- title
- Change at Week 13
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 250.0
- value
- 50.00
- title
- Week 17
- categories
- measurements
- group Id
- OG000
- lower Limit
- -250.0
- upper Limit
- 120.0
- value
- -20.00
- title
- Change at Week 17
- description
- A dose change was defined as a change in the administered dose strength compared to the preceding dose.
- dispersion Type
- Full Range
- groups
- description
- Mircera was administered subcutaneously once every 4 weeks.
- id
- OG000
- title
- Mircera
- param Type
- MEDIAN
- population Description
- Safety population included all participants who received at least one dose of study drug regardless of whether they withdrew prematurely or not. Number analyzed signifies number of participants evaluable at specified time points.
- reporting Status
- POSTED
- time Frame
- Week 1 to Week 17
- title
- Change in Mircera Dose Over Time
- type
- SECONDARY
- unit Of Measure
- micrograms (µg)
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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