TriangleNCT01945775 · OUTCOME
Number of Participants Taking At-least One Concomitant Medication
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
- Talazoparib: Baseline up to a maximum duration of 71.3 months; Physician's Choice Treatment: Baseline up to maximum duration of 46.1 months
What was measured
Any medication (other than study drug) which was administered to participants during study after first dose of study drug were considered as concomitant medications.
Analysis population: Safety analysis population included all participants who received at least 1 dose of any study drug (talazoparib or protocol-specified PCT).
Groups in this outcome
Talazoparib
Participants received talazoparib 1 mg, orally, once daily until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or sponsor's decision to terminate the trial (up to a maximum of 70.2 months). One cycle was of 21 days.
Physician's Choice Treatment
Participants received 1 of the following drugs in specified regimens, as per the physician's choice: 1) capecitabine 1250 mg/m\^2 orally twice daily on Day 1 to 14 in each cycle; 2) eribulin mesylate 1.4 mg/m\^2 (equivalent to eribulin 1.23 mg/ m\^2), as 2 to 5 minute IV infusion on Day 1 and 8 in each cycle; 3) gemcitabine 1250 mg/m\^2 as 30-minute IV infusion on Day 1 and 8 in each cycle; 4) vinorelbine 30 mg/m\^2 as 6 to 10 minute IV infusion on Day 1, 8, and 15 in each cycle; until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or Sponsor's decision to terminate the trial (up to a maximum of 45.3 months). One cycle was of 21 days.
| Group | Source count |
|---|---|
| Talazoparib | 286 |
| Physician's Choice Treatment | 126 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Talazoparib | 281 | Not reported | Not reported | Not reported | Not reported |
| Physician's Choice Treatment | 126 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 281
- group Id
- OG001
- value
- 126
- denoms
- counts
- group Id
- OG000
- value
- 286
- group Id
- OG001
- value
- 126
- units
- Participants
- description
- Any medication (other than study drug) which was administered to participants during study after first dose of study drug were considered as concomitant medications.
- groups
- description
- Participants received talazoparib 1 mg, orally, once daily until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or sponsor's decision to terminate the trial (up to a maximum of 70.2 months). One cycle was of 21 days.
- id
- OG000
- title
- Talazoparib
- description
- Participants received 1 of the following drugs in specified regimens, as per the physician's choice: 1) capecitabine 1250 mg/m\^2 orally twice daily on Day 1 to 14 in each cycle; 2) eribulin mesylate 1.4 mg/m\^2 (equivalent to eribulin 1.23 mg/ m\^2), as 2 to 5 minute IV infusion on Day 1 and 8 in each cycle; 3) gemcitabine 1250 mg/m\^2 as 30-minute IV infusion on Day 1 and 8 in each cycle; 4) vinorelbine 30 mg/m\^2 as 6 to 10 minute IV infusion on Day 1, 8, and 15 in each cycle; until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or Sponsor's decision to terminate the trial (up to a maximum of 45.3 months). One cycle was of 21 days.
- id
- OG001
- title
- Physician's Choice Treatment
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety analysis population included all participants who received at least 1 dose of any study drug (talazoparib or protocol-specified PCT).
- reporting Status
- POSTED
- time Frame
- Talazoparib: Baseline up to a maximum duration of 71.3 months; Physician's Choice Treatment: Baseline up to maximum duration of 46.1 months
- title
- Number of Participants Taking At-least One Concomitant Medication
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice