TriangleNCT00471497 · OUTCOME
Duration of Both a ≥ 4 and ≥ 4.5 Log Reduction in BCR-ABL Transcripts
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- approx. 11 years
What was measured
It is defined as the time from the date of first documented BCR-ABL ratio of ≤ 0.01% and ≤ 0.0032% to the earliest of the following: Loss of BCR-ABL ratio of ≤ 0.01% and ≤ 0.0032%, respectively, CML-related death or progression to AP/BC during study treatment. The time will be censored at last molecular assessment (PCR) date for patients for whom none of the above events is reported.
Analysis population: Full analysis Set (FAS): Contained 846 randomized patients. Patients were analyzed according to the treatment they were randomized to, regardless of actual treatment received
Groups in this outcome
Imatinib 400 mg QD
Patients randomized to this arm were to receive 400 mg imatinib once a day (QD). If the patient required a dose escalation from 400 mg/day, the patient was to receive 400 mg imatinib twice daily orally. Imatinib was taken with food and a large glass of water. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits during the study. In cases of vomiting doses were not to be repeated
Nilotinb 300 mg BID
Patients who were randomized to this arm were to receive nilotinib 300 mg twice a day (BID) by mouth each morning and evening approximately 12 hours apart. If the morning or evening dose was delayed for more than 4 hours, the patient was to skip this dose and resume dosing with the next dose as per the original schedule in order to prevent overdosing. No imatinib washout period was necessary prior to administration of nilotinib. Nilotinib was not to be taken with food. No food was to be consumed for at least 2 hours before the dose was taken and no additional oral intake other than water was to be consumed for at least one hour after the dose was taken. Patients were instructed to swallow capsules whole with a full 8 ounce glass of water, and not to chew them. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits. Vomited doses were not to be repeated.
Nilotinib 400 mg BID
Patients who were randomized to this arm were to receive nilotinib 400 mg twice a day (BID) by mouth each morning and evening approximately 12 hours apart. If the morning or evening dose was delayed for more than 4 hours, the patient was to skip this dose and resume dosing with the next dose as per the original schedule in order to prevent overdosing. No imatinib washout period was necessary prior to administration of nilotinib. Nilotinib was not to be taken with food. No food was to be consumed for at least 2 hours before the dose was taken and no additional oral intake other than water was to be consumed for at least one hour after the dose was taken. Patients were instructed to swallow capsules whole with a full 8 ounce glass of water, and not to chew them. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits. Vomited doses were not to be repeated.
| Group | Source count |
|---|---|
| Imatinib 400 mg QD | 283 |
| Nilotinb 300 mg BID | 282 |
| Nilotinib 400 mg BID | 281 |
Reported measurements
duration of first molecular response of <=0.01%
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Imatinib 400 mg QD | NA | Not reported | NA | NA | NA = not enough events to calculate median and CI of this molecular response (BCR-ABL ratio of ≤ 0.01%) |
| Nilotinb 300 mg BID | NA | Not reported | NA | NA | NA = not enough events to calculate median and CI of this molecular response (BCR-ABL ratio of ≤ 0.01%) |
| Nilotinib 400 mg BID | NA | Not reported | NA | NA | NA = not enough events to calculate median and CI of this molecular response (BCR-ABL ratio of ≤ 0.01%) |
duration of first molecular response of <=0.0032%
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Imatinib 400 mg QD | NA | Not reported | NA | NA | NA = not enough events to calculate median and CI of this molecular response (BCR-ABL ratio of ≤ 0.0032%) |
| Nilotinb 300 mg BID | NA | Not reported | NA | NA | NA = not enough events to calculate median and CI of this molecular response (BCR-ABL ratio of ≤ 0.0032%) |
| Nilotinib 400 mg BID | NA | Not reported | NA | NA | NA = not enough events to calculate median and CI of this molecular response (BCR-ABL ratio of ≤ 0.0032%) |
Complete source fields
- classes
- categories
- measurements
- comment
- NA = not enough events to calculate median and CI of this molecular response (BCR-ABL ratio of ≤ 0.01%)
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- NA = not enough events to calculate median and CI of this molecular response (BCR-ABL ratio of ≤ 0.01%)
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- NA = not enough events to calculate median and CI of this molecular response (BCR-ABL ratio of ≤ 0.01%)
- group Id
- OG002
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- title
- duration of first molecular response of <=0.01%
- categories
- measurements
- comment
- NA = not enough events to calculate median and CI of this molecular response (BCR-ABL ratio of ≤ 0.0032%)
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- NA = not enough events to calculate median and CI of this molecular response (BCR-ABL ratio of ≤ 0.0032%)
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- NA = not enough events to calculate median and CI of this molecular response (BCR-ABL ratio of ≤ 0.0032%)
- group Id
- OG002
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- title
- duration of first molecular response of <=0.0032%
- denoms
- counts
- group Id
- OG000
- value
- 283
- group Id
- OG001
- value
- 282
- group Id
- OG002
- value
- 281
- units
- Participants
- description
- It is defined as the time from the date of first documented BCR-ABL ratio of ≤ 0.01% and ≤ 0.0032% to the earliest of the following: Loss of BCR-ABL ratio of ≤ 0.01% and ≤ 0.0032%, respectively, CML-related death or progression to AP/BC during study treatment. The time will be censored at last molecular assessment (PCR) date for patients for whom none of the above events is reported.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients randomized to this arm were to receive 400 mg imatinib once a day (QD). If the patient required a dose escalation from 400 mg/day, the patient was to receive 400 mg imatinib twice daily orally. Imatinib was taken with food and a large glass of water. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits during the study. In cases of vomiting doses were not to be repeated
- id
- OG000
- title
- Imatinib 400 mg QD
- description
- Patients who were randomized to this arm were to receive nilotinib 300 mg twice a day (BID) by mouth each morning and evening approximately 12 hours apart. If the morning or evening dose was delayed for more than 4 hours, the patient was to skip this dose and resume dosing with the next dose as per the original schedule in order to prevent overdosing. No imatinib washout period was necessary prior to administration of nilotinib. Nilotinib was not to be taken with food. No food was to be consumed for at least 2 hours before the dose was taken and no additional oral intake other than water was to be consumed for at least one hour after the dose was taken. Patients were instructed to swallow capsules whole with a full 8 ounce glass of water, and not to chew them. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits. Vomited doses were not to be repeated.
- id
- OG001
- title
- Nilotinb 300 mg BID
- description
- Patients who were randomized to this arm were to receive nilotinib 400 mg twice a day (BID) by mouth each morning and evening approximately 12 hours apart. If the morning or evening dose was delayed for more than 4 hours, the patient was to skip this dose and resume dosing with the next dose as per the original schedule in order to prevent overdosing. No imatinib washout period was necessary prior to administration of nilotinib. Nilotinib was not to be taken with food. No food was to be consumed for at least 2 hours before the dose was taken and no additional oral intake other than water was to be consumed for at least one hour after the dose was taken. Patients were instructed to swallow capsules whole with a full 8 ounce glass of water, and not to chew them. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits. Vomited doses were not to be repeated.
- id
- OG002
- title
- Nilotinib 400 mg BID
- param Type
- MEDIAN
- population Description
- Full analysis Set (FAS): Contained 846 randomized patients. Patients were analyzed according to the treatment they were randomized to, regardless of actual treatment received
- reporting Status
- POSTED
- time Frame
- approx. 11 years
- title
- Duration of Both a ≥ 4 and ≥ 4.5 Log Reduction in BCR-ABL Transcripts
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice