TriangleNCT00471497 · OUTCOME
Time to 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
- up to 84 months
What was measured
Time to BCR-ABL ratio of ≤ 0.01% and ≤ 0.0032% is defined as: date of first BCR-ABL ratio of ≤ 0.01% and ≤ 0.0032% - date of randomization +1.
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
time to first molecular response of <=0.01%
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Imatinib 400 mg QD | 30.46 | Not reported | 24.11 | 36.01 | Not reported |
| Nilotinb 300 mg BID | 19.38 | Not reported | 16.62 | 22.34 | Not reported |
| Nilotinib 400 mg BID | 22.70 | Not reported | 19.48 | 27.63 | Not reported |
time to first molecular response of <=0.0032%
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Imatinib 400 mg QD | 37.29 | Not reported | 33.45 | 41.63 | Not reported |
| Nilotinb 300 mg BID | 32.46 | Not reported | 23.23 | 38.67 | Not reported |
| Nilotinib 400 mg BID | 35.94 | Not reported | 30.39 | 41.00 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 24.11
- upper Limit
- 36.01
- value
- 30.46
- group Id
- OG001
- lower Limit
- 16.62
- upper Limit
- 22.34
- value
- 19.38
- group Id
- OG002
- lower Limit
- 19.48
- upper Limit
- 27.63
- value
- 22.70
- title
- time to first molecular response of <=0.01%
- categories
- measurements
- group Id
- OG000
- lower Limit
- 33.45
- upper Limit
- 41.63
- value
- 37.29
- group Id
- OG001
- lower Limit
- 23.23
- upper Limit
- 38.67
- value
- 32.46
- group Id
- OG002
- lower Limit
- 30.39
- upper Limit
- 41.00
- value
- 35.94
- title
- time to 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
- Time to BCR-ABL ratio of ≤ 0.01% and ≤ 0.0032% is defined as: date of first BCR-ABL ratio of ≤ 0.01% and ≤ 0.0032% - date of randomization +1.
- 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
- up to 84 months
- title
- Time to 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