TriangleNCT00025259 · OUTCOME
Grade 3 or 4 Non-hematologic Toxicity
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Number of participants
- Interval / dispersion
- Not reported
- Time frame
- Protocol therapy: the overall duration of which is: (n=1684) an average of 137.3 days, median 133.0 days, interquartile range: 101.0, 164.0 days.
What was measured
Occurrence of any grade 4 non-hematologic toxicity or grade 3 non-hematologic toxicity which doesn't respond to treatment within 7 days despite recommended therapy modification, or toxic death, which is any death primarily attributable to treatment. Grade 3 is defined to be severe or medically significant but not immediate life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 refers to toxicities with life-threatening consequences; urgent intervention indicated.
Analysis population: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Groups in this outcome
Arm I (Patients Off-therapy Before Callback-Induction Only)
All patients-off therapy before callback-Induction only
Arm II (RER With CR [ABVE-PC, IFRT])
RER with Complete Response - IFRT (Standard Arm)
Arm III (RER With CR [ABVE-PC])
RER with Complete Response - no IFRT ( Reduced Therapy Arm)
Arm IV (RER With Less Than CR [ABVE-PC, IFRT])
RER with less than Complete Response - IFRT
Arm V (RER With PD)
RER with Progressive Disease - Off Therapy
Arm VI (SER [DECA, ABVE-PC, IFRT])
SER - randomized to DECAX2 + ABVE-PCX2 + IFRT
Arm VII (SER [ABVE-PC, IFRT])
SER - randomized to ABVE-PCX2 + IFRT
| Group | Source count |
|---|---|
| Arm I (Patients Off-therapy Before Callback-Induction Only) | 38 |
| Arm II (RER With CR [ABVE-PC, IFRT]) | 380 |
| Arm III (RER With CR [ABVE-PC]) | 382 |
| Arm IV (RER With Less Than CR [ABVE-PC, IFRT]) | 571 |
| Arm V (RER With PD) | 36 |
| Arm VI (SER [DECA, ABVE-PC, IFRT]) | 153 |
| Arm VII (SER [ABVE-PC, IFRT]) | 152 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Patients Off-therapy Before Callback-Induction Only) | 10 | Not reported | Not reported | Not reported | Not reported |
| Arm II (RER With CR [ABVE-PC, IFRT]) | 153 | Not reported | Not reported | Not reported | Not reported |
| Arm III (RER With CR [ABVE-PC]) | 130 | Not reported | Not reported | Not reported | Not reported |
| Arm IV (RER With Less Than CR [ABVE-PC, IFRT]) | 216 | Not reported | Not reported | Not reported | Not reported |
| Arm V (RER With PD) | 11 | Not reported | Not reported | Not reported | Not reported |
| Arm VI (SER [DECA, ABVE-PC, IFRT]) | 62 | Not reported | Not reported | Not reported | Not reported |
| Arm VII (SER [ABVE-PC, IFRT]) | 45 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 153
- group Id
- OG002
- value
- 130
- group Id
- OG003
- value
- 216
- group Id
- OG004
- value
- 11
- group Id
- OG005
- value
- 62
- group Id
- OG006
- value
- 45
- denoms
- counts
- group Id
- OG000
- value
- 38
- group Id
- OG001
- value
- 380
- group Id
- OG002
- value
- 382
- group Id
- OG003
- value
- 571
- group Id
- OG004
- value
- 36
- group Id
- OG005
- value
- 153
- group Id
- OG006
- value
- 152
- units
- Participants
- description
- Occurrence of any grade 4 non-hematologic toxicity or grade 3 non-hematologic toxicity which doesn't respond to treatment within 7 days despite recommended therapy modification, or toxic death, which is any death primarily attributable to treatment. Grade 3 is defined to be severe or medically significant but not immediate life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 refers to toxicities with life-threatening consequences; urgent intervention indicated.
- groups
- description
- All patients-off therapy before callback-Induction only
- id
- OG000
- title
- Arm I (Patients Off-therapy Before Callback-Induction Only)
- description
- RER with Complete Response - IFRT (Standard Arm)
- id
- OG001
- title
- Arm II (RER With CR [ABVE-PC, IFRT])
- description
- RER with Complete Response - no IFRT ( Reduced Therapy Arm)
- id
- OG002
- title
- Arm III (RER With CR [ABVE-PC])
- description
- RER with less than Complete Response - IFRT
- id
- OG003
- title
- Arm IV (RER With Less Than CR [ABVE-PC, IFRT])
- description
- RER with Progressive Disease - Off Therapy
- id
- OG004
- title
- Arm V (RER With PD)
- description
- SER - randomized to DECAX2 + ABVE-PCX2 + IFRT
- id
- OG005
- title
- Arm VI (SER [DECA, ABVE-PC, IFRT])
- description
- SER - randomized to ABVE-PCX2 + IFRT
- id
- OG006
- title
- Arm VII (SER [ABVE-PC, IFRT])
- param Type
- NUMBER
- population Description
- Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
- reporting Status
- POSTED
- time Frame
- Protocol therapy: the overall duration of which is: (n=1684) an average of 137.3 days, median 133.0 days, interquartile range: 101.0, 164.0 days.
- title
- Grade 3 or 4 Non-hematologic Toxicity
- type
- SECONDARY
- unit Of Measure
- Number of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice