TriangleNCT02130557 · OUTCOME
Number of Participants With Laboratory Test Abnormalities Based on National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) Version 4.03
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
- Baseline up to end of treatment (up to Month 60)
What was measured
Laboratory parameters included hematological (haemoglobin, lymphocytes \[absolute\], neutrophils \[absolute\], platelets and leukocytes) and biochemistry (albumin, alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, amylase, bilirubin, creatinine kinase, calcium, creatinine, glucose, potassium, lipase, magnesium, phosphate, sodium, urate) parameters. Abnormalities in laboratory tests were graded by NCI CTCAE version 4.03 as Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling. The number of participants with laboratory test abnormalities were reported.
Analysis population: Safety population included all participants who received at least 1 dose of study medication with treatment assignments designated to actual study treatment received.
Groups in this outcome
Bosutinib
Participants with Philadelphia chromosome-positive CML received bosutinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.
Imatinib
Participants with Philadelphia chromosome-positive CML received imatinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.
| Group | Source count |
|---|---|
| Bosutinib | 268 |
| Imatinib | 265 |
Reported measurements
Grade 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bosutinib | 6 | Not reported | Not reported | Not reported | Not reported |
| Imatinib | 7 | Not reported | Not reported | Not reported | Not reported |
Grade 2
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bosutinib | 67 | Not reported | Not reported | Not reported | Not reported |
| Imatinib | 59 | Not reported | Not reported | Not reported | Not reported |
Grade 3
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bosutinib | 133 | Not reported | Not reported | Not reported | Not reported |
| Imatinib | 154 | Not reported | Not reported | Not reported | Not reported |
Grade 4
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bosutinib | 61 | Not reported | Not reported | Not reported | Not reported |
| Imatinib | 45 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 7
- title
- Grade 1
- categories
- measurements
- group Id
- OG000
- value
- 67
- group Id
- OG001
- value
- 59
- title
- Grade 2
- categories
- measurements
- group Id
- OG000
- value
- 133
- group Id
- OG001
- value
- 154
- title
- Grade 3
- categories
- measurements
- group Id
- OG000
- value
- 61
- group Id
- OG001
- value
- 45
- title
- Grade 4
- denoms
- counts
- group Id
- OG000
- value
- 268
- group Id
- OG001
- value
- 265
- units
- Participants
- description
- Laboratory parameters included hematological (haemoglobin, lymphocytes \[absolute\], neutrophils \[absolute\], platelets and leukocytes) and biochemistry (albumin, alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, amylase, bilirubin, creatinine kinase, calcium, creatinine, glucose, potassium, lipase, magnesium, phosphate, sodium, urate) parameters. Abnormalities in laboratory tests were graded by NCI CTCAE version 4.03 as Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling. The number of participants with laboratory test abnormalities were reported.
- groups
- description
- Participants with Philadelphia chromosome-positive CML received bosutinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.
- id
- OG000
- title
- Bosutinib
- description
- Participants with Philadelphia chromosome-positive CML received imatinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.
- id
- OG001
- title
- Imatinib
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety population included all participants who received at least 1 dose of study medication with treatment assignments designated to actual study treatment received.
- reporting Status
- POSTED
- time Frame
- Baseline up to end of treatment (up to Month 60)
- title
- Number of Participants With Laboratory Test Abnormalities Based on National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) Version 4.03
- type
- OTHER_PRE_SPECIFIED
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice