TriangleNCT00923013 · OUTCOME
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAEv3.0)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From first study intervention,Study Day 1, Cycle 1-30 days after study agent up to day 35 for participants receiving cladribine only, up to day 80 for participants receiving cladribine+rituximab, &up to day 80 for participants receiving delayed rituximab.
What was measured
Here is the number of participants with serious and/or non-serious adverse events (AE's) assessed by the Common Terminology Criteria for Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Groups in this outcome
Cohort 1 Arm 1 SubGroup 1 -Cladribine + Rituximab
Participants with Hairy Cell Leukemia (HCL) with (62 participants) and without (68 participants) prior course of purine analog to be randomized between Arm 1 and Arm 2 (randomization stratified based upon prior purine analog \[yes/no\]). Cladribine + Rituximab.
Cohort 1 Arm 1 SubGroup 2 -Cladribine + Rituximab
Participants with Hairy Cell Leukemia (HCL) with (62 participants) and without (68 participants) prior course of purine analog to be randomized between Arm 1 and Arm 2 (randomization stratified based upon prior purine analog \[yes/no\]). Cladribine + Rituximab.
Cohort 1 Arm 2 SubGroup 1-Cladribine(+Rituximab After 6 Months if Minimal Residual Disease Detected)
Participants with Hairy Cell Leukemia (HCL) with (62 participants) and without (68 participants) prior course of purine analog to be randomized between Arm 1 and Arm 2 (randomization stratified based upon prior purine analog \[yes/no\]). Cladribine (+ Rituximab after 6 months if minimal residual disease (MRD) detected).
Cohort 1 Arm 2 SubGroup 2-Cladribine(+Rituximab After 6 Months if Minimal Residual Disease Detected)
Participants with Hairy Cell Leukemia (HCL) with (62 participants) and without (68 participants) prior course of purine analog to be randomized between Arm 1 and Arm 2 (randomization stratified based upon prior purine analog \[yes/no\]). Cladribine (+ Rituximab after 6 months if minimal residual disease (MRD) detected).
Cohort 2 Arm 3 SubGroup 1-Cladribine (Rituximab Before 1st of 5 Daily Doses of Cladribine on Day 1)
Participants with Hairy Cell Leukemia (HCL) without prior course of purine analog to be directly assigned to Arm 3 (25 participants; after completion of the 68 participants without prior purine analog in Cohort 1). Cladribine + Rituximab (Rituximab will be administered just before rather than after the 1st of the 5 daily doses of cladribine
Cohort 3Arm3 HairyCell LeukemiaVariant-Cladribine +(Rituximab Before 1st of 5 Daily Doses Cladribine
Participants with Hairy Cell Leukemia Variant (HCLv) to be directly assigned to Arm 3 (20 participants). Cladribine + Rituximab (Rituximab will be administered just before rather than after the 1st of the 5 daily doses of cladribine
| Group | Source count |
|---|---|
| Cohort 1 Arm 1 SubGroup 1 -Cladribine + Rituximab | 34 |
| Cohort 1 Arm 1 SubGroup 2 -Cladribine + Rituximab | 32 |
| Cohort 1 Arm 2 SubGroup 1-Cladribine(+Rituximab After 6 Months if Minimal Residual Disease Detected) | 34 |
| Cohort 1 Arm 2 SubGroup 2-Cladribine(+Rituximab After 6 Months if Minimal Residual Disease Detected) | 30 |
| Cohort 2 Arm 3 SubGroup 1-Cladribine (Rituximab Before 1st of 5 Daily Doses of Cladribine on Day 1) | 25 |
| Cohort 3Arm3 HairyCell LeukemiaVariant-Cladribine +(Rituximab Before 1st of 5 Daily Doses Cladribine | 20 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 Arm 1 SubGroup 1 -Cladribine + Rituximab | 34 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Arm 1 SubGroup 2 -Cladribine + Rituximab | 31 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Arm 2 SubGroup 1-Cladribine(+Rituximab After 6 Months if Minimal Residual Disease Detected) | 34 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Arm 2 SubGroup 2-Cladribine(+Rituximab After 6 Months if Minimal Residual Disease Detected) | 29 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 Arm 3 SubGroup 1-Cladribine (Rituximab Before 1st of 5 Daily Doses of Cladribine on Day 1) | 24 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3Arm3 HairyCell LeukemiaVariant-Cladribine +(Rituximab Before 1st of 5 Daily Doses Cladribine | 19 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 34
- group Id
- OG001
- value
- 31
- group Id
- OG002
- value
- 34
- group Id
- OG003
- value
- 29
- group Id
- OG004
- value
- 24
- group Id
- OG005
- value
- 19
- denoms
- counts
- group Id
- OG000
- value
- 34
- group Id
- OG001
- value
- 32
- group Id
- OG002
- value
- 34
- group Id
- OG003
- value
- 30
- group Id
- OG004
- value
- 25
- group Id
- OG005
- value
- 20
- units
- Participants
- description
- Here is the number of participants with serious and/or non-serious adverse events (AE's) assessed by the Common Terminology Criteria for Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
- groups
- description
- Participants with Hairy Cell Leukemia (HCL) with (62 participants) and without (68 participants) prior course of purine analog to be randomized between Arm 1 and Arm 2 (randomization stratified based upon prior purine analog \[yes/no\]). Cladribine + Rituximab.
- id
- OG000
- title
- Cohort 1 Arm 1 SubGroup 1 -Cladribine + Rituximab
- description
- Participants with Hairy Cell Leukemia (HCL) with (62 participants) and without (68 participants) prior course of purine analog to be randomized between Arm 1 and Arm 2 (randomization stratified based upon prior purine analog \[yes/no\]). Cladribine + Rituximab.
- id
- OG001
- title
- Cohort 1 Arm 1 SubGroup 2 -Cladribine + Rituximab
- description
- Participants with Hairy Cell Leukemia (HCL) with (62 participants) and without (68 participants) prior course of purine analog to be randomized between Arm 1 and Arm 2 (randomization stratified based upon prior purine analog \[yes/no\]). Cladribine (+ Rituximab after 6 months if minimal residual disease (MRD) detected).
- id
- OG002
- title
- Cohort 1 Arm 2 SubGroup 1-Cladribine(+Rituximab After 6 Months if Minimal Residual Disease Detected)
- description
- Participants with Hairy Cell Leukemia (HCL) with (62 participants) and without (68 participants) prior course of purine analog to be randomized between Arm 1 and Arm 2 (randomization stratified based upon prior purine analog \[yes/no\]). Cladribine (+ Rituximab after 6 months if minimal residual disease (MRD) detected).
- id
- OG003
- title
- Cohort 1 Arm 2 SubGroup 2-Cladribine(+Rituximab After 6 Months if Minimal Residual Disease Detected)
- description
- Participants with Hairy Cell Leukemia (HCL) without prior course of purine analog to be directly assigned to Arm 3 (25 participants; after completion of the 68 participants without prior purine analog in Cohort 1). Cladribine + Rituximab (Rituximab will be administered just before rather than after the 1st of the 5 daily doses of cladribine
- id
- OG004
- title
- Cohort 2 Arm 3 SubGroup 1-Cladribine (Rituximab Before 1st of 5 Daily Doses of Cladribine on Day 1)
- description
- Participants with Hairy Cell Leukemia Variant (HCLv) to be directly assigned to Arm 3 (20 participants). Cladribine + Rituximab (Rituximab will be administered just before rather than after the 1st of the 5 daily doses of cladribine
- id
- OG005
- title
- Cohort 3Arm3 HairyCell LeukemiaVariant-Cladribine +(Rituximab Before 1st of 5 Daily Doses Cladribine
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- From first study intervention,Study Day 1, Cycle 1-30 days after study agent up to day 35 for participants receiving cladribine only, up to day 80 for participants receiving cladribine+rituximab, &up to day 80 for participants receiving delayed rituximab.
- title
- Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAEv3.0)
- type
- OTHER_PRE_SPECIFIED
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice