TriangleNCT00434161 · OUTCOME
Incidence of Second Primary Malignancies or Other Malignancies
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
- During long-term follow up phase (maximum of 10 years)
What was measured
All comparisons for the long-term safety endpoints were based on the combined palifermin group versus placebo (placebo over palifermin). Incidence of new or secondary malignancies by treatment group was provided (incidence of new or secondary malignancies at the follow-up visit - yes, no, no assessment -, and number of subjects with new or secondary malignancies, per type of malignancies). The long-term safety evaluations were summarized for the subgroups defined by the factors used for randomization using descriptive statistics.
Analysis population: total of 277 subjects were included in the Safety subset of the original study report (220 Palifermin and 57 placebo). Follow-up time for all subjects, defined as the date of randomization to the last known alive date. For subjects who were alive at the last contact the number of subjects for the palifermin group was 162 and for the placebo 47.
Groups in this outcome
Palifermin (Palifermin Before Only and, Before and After)
Subjects to receive palifermin before-high dose chemotherapy (total 3 doses) and matched placebo after-high dose chemotherapy (total 3 doses) AND Subjects to receive palifermin before- and after-high dose chemotherapy (total of 6 doses)
Placebo
Subjects to receive matched placebo before- and after-high dose chemotherapy
| Group | Source count |
|---|---|
| Palifermin (Palifermin Before Only and, Before and After) | 220 |
| Placebo | 57 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Palifermin (Palifermin Before Only and, Before and After) | 1 | Not reported | Not reported | Not reported | Not reported |
| Placebo | 6 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 6
- denoms
- counts
- group Id
- OG000
- value
- 220
- group Id
- OG001
- value
- 57
- units
- Participants
- description
- All comparisons for the long-term safety endpoints were based on the combined palifermin group versus placebo (placebo over palifermin). Incidence of new or secondary malignancies by treatment group was provided (incidence of new or secondary malignancies at the follow-up visit - yes, no, no assessment -, and number of subjects with new or secondary malignancies, per type of malignancies). The long-term safety evaluations were summarized for the subgroups defined by the factors used for randomization using descriptive statistics.
- groups
- description
- Subjects to receive palifermin before-high dose chemotherapy (total 3 doses) and matched placebo after-high dose chemotherapy (total 3 doses) AND Subjects to receive palifermin before- and after-high dose chemotherapy (total of 6 doses)
- id
- OG000
- title
- Palifermin (Palifermin Before Only and, Before and After)
- description
- Subjects to receive matched placebo before- and after-high dose chemotherapy
- id
- OG001
- title
- Placebo
- param Type
- NUMBER
- population Description
- total of 277 subjects were included in the Safety subset of the original study report (220 Palifermin and 57 placebo). Follow-up time for all subjects, defined as the date of randomization to the last known alive date. For subjects who were alive at the last contact the number of subjects for the palifermin group was 162 and for the placebo 47.
- reporting Status
- POSTED
- time Frame
- During long-term follow up phase (maximum of 10 years)
- title
- Incidence of Second Primary Malignancies or Other Malignancies
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice