TriangleNCT00094653 · OUTCOME
Percentage of Participants With Worst On-Study Renal Abnormalities
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- Not reported
- Time frame
- On-study adverse events include all AEs reported between the first dose and 70 days after the last dose of study therapy (end of the study was defined as the time at which 481 deaths were observed [264 weeks]).
What was measured
CTCAE v3.0 Grades 0 through 4 of severity for each AE based on this general guideline: Grade 0=Normal, Grade 1=Mild AE, Grade 2=Moderate AE, Grade 3=Severe AE, Grade 4=Life-threatening or disabling AE.
Analysis population: All subjects who received at least 1 dose or any partial dose of study medication. N=Number of participants analyzed; n=number of participants with given laboratory evaluation.
Groups in this outcome
Ipilimumab Plus gp100
Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288\[288V\]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217\[210M\]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
Ipilimumab Monotherapy
Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
gp100
Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288\[288V\]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217\[210M\]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
| Group | Source count |
|---|---|
| Ipilimumab Plus gp100 | 380 |
| Ipilimumab Monotherapy | 131 |
| gp100 | 132 |
Reported measurements
Creatinine, Grade 0 (n=353, 121, 128)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ipilimumab Plus gp100 | 89.5 | Not reported | Not reported | Not reported | Not reported |
| Ipilimumab Monotherapy | 88.4 | Not reported | Not reported | Not reported | Not reported |
| gp100 | 88.3 | Not reported | Not reported | Not reported | Not reported |
Creatinine, Grade 1 (n=353, 121, 128)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ipilimumab Plus gp100 | 8.8 | Not reported | Not reported | Not reported | Not reported |
| Ipilimumab Monotherapy | 9.9 | Not reported | Not reported | Not reported | Not reported |
| gp100 | 9.4 | Not reported | Not reported | Not reported | Not reported |
Creatinine, Grade 2 (n=353, 121, 128)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ipilimumab Plus gp100 | 1.4 | Not reported | Not reported | Not reported | Not reported |
| Ipilimumab Monotherapy | 1.7 | Not reported | Not reported | Not reported | Not reported |
| gp100 | 2.3 | Not reported | Not reported | Not reported | Not reported |
Creatinine, Grade 3 (n=353, 121, 128)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ipilimumab Plus gp100 | 0.3 | Not reported | Not reported | Not reported | Not reported |
| Ipilimumab Monotherapy | 0 | Not reported | Not reported | Not reported | Not reported |
| gp100 | 0 | Not reported | Not reported | Not reported | Not reported |
Creatinine, Grade 4 (n=353, 121, 128)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ipilimumab Plus gp100 | 0 | Not reported | Not reported | Not reported | Not reported |
| Ipilimumab Monotherapy | 0 | Not reported | Not reported | Not reported | Not reported |
| gp100 | 0 | Not reported | Not reported | Not reported | Not reported |
Creatinine, Grade 1-4 (n=353, 121, 128)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ipilimumab Plus gp100 | 10.5 | Not reported | Not reported | Not reported | Not reported |
| Ipilimumab Monotherapy | 11.6 | Not reported | Not reported | Not reported | Not reported |
| gp100 | 11.7 | Not reported | Not reported | Not reported | Not reported |
Creatinine, Grade 3-4 (n=353, 121, 128)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ipilimumab Plus gp100 | 0.3 | Not reported | Not reported | Not reported | Not reported |
| Ipilimumab Monotherapy | 0 | Not reported | Not reported | Not reported | Not reported |
| gp100 | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 89.5
- group Id
- OG001
- value
- 88.4
- group Id
- OG002
- value
- 88.3
- title
- Creatinine, Grade 0 (n=353, 121, 128)
- categories
- measurements
- group Id
- OG000
- value
- 8.8
- group Id
- OG001
- value
- 9.9
- group Id
- OG002
- value
- 9.4
- title
- Creatinine, Grade 1 (n=353, 121, 128)
- categories
- measurements
- group Id
- OG000
- value
- 1.4
- group Id
- OG001
- value
- 1.7
- group Id
- OG002
- value
- 2.3
- title
- Creatinine, Grade 2 (n=353, 121, 128)
- categories
- measurements
- group Id
- OG000
- value
- 0.3
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- title
- Creatinine, Grade 3 (n=353, 121, 128)
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- title
- Creatinine, Grade 4 (n=353, 121, 128)
- categories
- measurements
- group Id
- OG000
- value
- 10.5
- group Id
- OG001
- value
- 11.6
- group Id
- OG002
- value
- 11.7
- title
- Creatinine, Grade 1-4 (n=353, 121, 128)
- categories
- measurements
- group Id
- OG000
- value
- 0.3
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- title
- Creatinine, Grade 3-4 (n=353, 121, 128)
- denoms
- counts
- group Id
- OG000
- value
- 380
- group Id
- OG001
- value
- 131
- group Id
- OG002
- value
- 132
- units
- Participants
- description
- CTCAE v3.0 Grades 0 through 4 of severity for each AE based on this general guideline: Grade 0=Normal, Grade 1=Mild AE, Grade 2=Moderate AE, Grade 3=Severe AE, Grade 4=Life-threatening or disabling AE.
- groups
- description
- Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288\[288V\]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217\[210M\]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
- id
- OG000
- title
- Ipilimumab Plus gp100
- description
- Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
- id
- OG001
- title
- Ipilimumab Monotherapy
- description
- Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288\[288V\]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217\[210M\]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
- id
- OG002
- title
- gp100
- param Type
- NUMBER
- population Description
- All subjects who received at least 1 dose or any partial dose of study medication. N=Number of participants analyzed; n=number of participants with given laboratory evaluation.
- reporting Status
- POSTED
- time Frame
- On-study adverse events include all AEs reported between the first dose and 70 days after the last dose of study therapy (end of the study was defined as the time at which 481 deaths were observed [264 weeks]).
- title
- Percentage of Participants With Worst On-Study Renal Abnormalities
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice