NCT03107988 · OUTCOME
Describe Hematological Toxicities (A2)
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
- All toxicities from enrollment through 30 days following end of protocol therapy, an average of 10 months
What was measured
Proportion of patients with any grade 3 or greater hematological toxicities in A2
Groups in this outcome
Cohort A2 DL 3A
Lorlatinib will be given at 100 mg orally once daily continuously for 28 days. Patients must be 18 years of age or older at time of enrollment. Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
Cohort A2 DL4A
Lorlatinib will be given at 150 mg orally once daily continuously for 28 days. Patients must be 18 years of age or older at time of enrollment. Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
Cohort A2 DL4A Expansion
Lorlatinib will be given at 150 mg orally once daily continuously for 28 days. Patients must be 18 years of age or older at time of enrollment. Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
| Group | Source count |
|---|---|
| Cohort A2 DL 3A | 6 |
| Cohort A2 DL4A | 6 |
| Cohort A2 DL4A Expansion | 4 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A2 DL 3A | 3 | Not reported | Not reported | Not reported | Not reported |
| Cohort A2 DL4A | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort A2 DL4A Expansion | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 4
- units
- Participants
- description
- Proportion of patients with any grade 3 or greater hematological toxicities in A2
- groups
- description
- Lorlatinib will be given at 100 mg orally once daily continuously for 28 days. Patients must be 18 years of age or older at time of enrollment. Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
- id
- OG000
- title
- Cohort A2 DL 3A
- description
- Lorlatinib will be given at 150 mg orally once daily continuously for 28 days. Patients must be 18 years of age or older at time of enrollment. Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
- id
- OG001
- title
- Cohort A2 DL4A
- description
- Lorlatinib will be given at 150 mg orally once daily continuously for 28 days. Patients must be 18 years of age or older at time of enrollment. Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
- id
- OG002
- title
- Cohort A2 DL4A Expansion
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- All toxicities from enrollment through 30 days following end of protocol therapy, an average of 10 months
- title
- Describe Hematological Toxicities (A2)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice
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