NCT01970865 · OUTCOME
Number of Participants With Absolute Values and Change From Baseline in QTcF Meeting Pre-defined Criteria (Phase 1, Phase 2 and DDI Sub-study)
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
- From first dose of study treatment to end of treatment (maximum of 8 years for Phase 1, maximum of 7.5 years for Phase 2 and up to a maximum of 6 years approx. for DDI sub study)
What was measured
Triplicate 12-lead electrocardiograms (ECGs) were performed approximately 2 minutes apart to determine mean QTc interval (QT interval corrected for heart rate). QT interval was corrected for heart rate using Fridericia's formula to provide QTcF. Absolute values and changes from baseline were summarized according to pre-defined criteria. Baseline was defined as the last evaluation on or prior to the first dose of study treatment.
Analysis population: The safety analysis set included all enrolled participants who received at least 1 dose of PF-06463922.
Groups in this outcome
10 mg QD (Phase 1)
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
25 mg QD (Phase 1)
PF-06463922 25 mg was orally given QD in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
50 mg QD (Phase 1)
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
75 mg QD (Phase 1)
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
100 mg QD (Phase 1)
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
150 mg QD (Phase 1)
PF-06463922 150 mg was orally given QD in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
200 mg QD (Phase 1)
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
35 mg BID (Phase 1)
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
| Group | Source count |
|---|---|
| 10 mg QD (Phase 1) | 3 |
| 25 mg QD (Phase 1) | 3 |
| 50 mg QD (Phase 1) | 3 |
| 75 mg QD (Phase 1) | 12 |
| 100 mg QD (Phase 1) | 17 |
| 150 mg QD (Phase 1) | 3 |
| 200 mg QD (Phase 1) | 3 |
| 35 mg BID (Phase 1) | 3 |
| 75 mg BID (Phase 1) | 3 |
| 100 mg BID (Phase 1) | 4 |
| EXP-1 (Phase 2) | 30 |
| EXP-2 (Phase 2) | 27 |
| EXP-3 (Phase 2) | 60 |
| EXP-4 (Phase 2) | 65 |
| EXP-5 (Phase 2) | 46 |
| EXP-6 (Phase 2) | 47 |
| DDI Sub-study | 32 |
Reported measurements
QTcF: 450 to <480 msec
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 10 mg QD (Phase 1) | 1 | Not reported | Not reported | Not reported | Not reported |
| 25 mg QD (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 50 mg QD (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 75 mg QD (Phase 1) | 2 | Not reported | Not reported | Not reported | Not reported |
| 100 mg QD (Phase 1) | 1 | Not reported | Not reported | Not reported | Not reported |
| 150 mg QD (Phase 1) | 1 | Not reported | Not reported | Not reported | Not reported |
| 200 mg QD (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 35 mg BID (Phase 1) | 2 | Not reported | Not reported | Not reported | Not reported |
| 75 mg BID (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 100 mg BID (Phase 1) | 1 | Not reported | Not reported | Not reported | Not reported |
| EXP-1 (Phase 2) | 5 | Not reported | Not reported | Not reported | Not reported |
| EXP-2 (Phase 2) | 8 | Not reported | Not reported | Not reported | Not reported |
| EXP-3 (Phase 2) | 11 | Not reported | Not reported | Not reported | Not reported |
| EXP-4 (Phase 2) | 9 | Not reported | Not reported | Not reported | Not reported |
| EXP-5 (Phase 2) | 13 | Not reported | Not reported | Not reported | Not reported |
| EXP-6 (Phase 2) | 9 | Not reported | Not reported | Not reported | Not reported |
| DDI Sub-study | 7 | Not reported | Not reported | Not reported | Not reported |
QTcF: 480 to <500 msec
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 10 mg QD (Phase 1) | 1 | Not reported | Not reported | Not reported | Not reported |
| 25 mg QD (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 50 mg QD (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 75 mg QD (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 100 mg QD (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 150 mg QD (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 200 mg QD (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 35 mg BID (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 75 mg BID (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 100 mg BID (Phase 1) | 1 | Not reported | Not reported | Not reported | Not reported |
| EXP-1 (Phase 2) | 1 | Not reported | Not reported | Not reported | Not reported |
| EXP-2 (Phase 2) | 1 | Not reported | Not reported | Not reported | Not reported |
| EXP-3 (Phase 2) | 3 | Not reported | Not reported | Not reported | Not reported |
| EXP-4 (Phase 2) | 0 | Not reported | Not reported | Not reported | Not reported |
| EXP-5 (Phase 2) | 1 | Not reported | Not reported | Not reported | Not reported |
| EXP-6 (Phase 2) | 1 | Not reported | Not reported | Not reported | Not reported |
| DDI Sub-study | 1 | Not reported | Not reported | Not reported | Not reported |
QTcF: >=500 msec
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 10 mg QD (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 25 mg QD (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 50 mg QD (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 75 mg QD (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 100 mg QD (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 150 mg QD (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 200 mg QD (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 35 mg BID (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 75 mg BID (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 100 mg BID (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| EXP-1 (Phase 2) | 0 | Not reported | Not reported | Not reported | Not reported |
| EXP-2 (Phase 2) | 0 | Not reported | Not reported | Not reported | Not reported |
| EXP-3 (Phase 2) | 1 | Not reported | Not reported | Not reported | Not reported |
| EXP-4 (Phase 2) | 1 | Not reported | Not reported | Not reported | Not reported |
| EXP-5 (Phase 2) | 1 | Not reported | Not reported | Not reported | Not reported |
| EXP-6 (Phase 2) | 0 | Not reported | Not reported | Not reported | Not reported |
| DDI Sub-study | 1 | Not reported | Not reported | Not reported | Not reported |
QTcF Increase: 30 to <60 msec
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 10 mg QD (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 25 mg QD (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 50 mg QD (Phase 1) | 1 | Not reported | Not reported | Not reported | Not reported |
| 75 mg QD (Phase 1) | 3 | Not reported | Not reported | Not reported | Not reported |
| 100 mg QD (Phase 1) | 3 | Not reported | Not reported | Not reported | Not reported |
| 150 mg QD (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 200 mg QD (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 35 mg BID (Phase 1) | 1 | Not reported | Not reported | Not reported | Not reported |
| 75 mg BID (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 100 mg BID (Phase 1) | 1 | Not reported | Not reported | Not reported | Not reported |
| EXP-1 (Phase 2) | 10 | Not reported | Not reported | Not reported | Not reported |
| EXP-2 (Phase 2) | 8 | Not reported | Not reported | Not reported | Not reported |
| EXP-3 (Phase 2) | 18 | Not reported | Not reported | Not reported | Not reported |
| EXP-4 (Phase 2) | 20 | Not reported | Not reported | Not reported | Not reported |
| EXP-5 (Phase 2) | 7 | Not reported | Not reported | Not reported | Not reported |
| EXP-6 (Phase 2) | 12 | Not reported | Not reported | Not reported | Not reported |
| DDI Sub-study | 7 | Not reported | Not reported | Not reported | Not reported |
QTcF: >=60 msec
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 10 mg QD (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 25 mg QD (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 50 mg QD (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 75 mg QD (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 100 mg QD (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 150 mg QD (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 200 mg QD (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 35 mg BID (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 75 mg BID (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 100 mg BID (Phase 1) | 1 | Not reported | Not reported | Not reported | Not reported |
| EXP-1 (Phase 2) | 0 | Not reported | Not reported | Not reported | Not reported |
| EXP-2 (Phase 2) | 0 | Not reported | Not reported | Not reported | Not reported |
| EXP-3 (Phase 2) | 1 | Not reported | Not reported | Not reported | Not reported |
| EXP-4 (Phase 2) | 1 | Not reported | Not reported | Not reported | Not reported |
| EXP-5 (Phase 2) | 3 | Not reported | Not reported | Not reported | Not reported |
| EXP-6 (Phase 2) | 1 | Not reported | Not reported | Not reported | Not reported |
| DDI Sub-study | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 1
- group Id
- OG010
- value
- 5
- group Id
- OG011
- value
- 8
- title
- QTcF: 450 to <480 msec
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 1
- group Id
- OG010
- value
- 1
- group Id
- OG011
- value
- 1
- title
- QTcF: 480 to <500 msec
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- title
- QTcF: >=500 msec
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 1
- group Id
- OG010
- value
- 10
- group Id
- OG011
- value
- 8
- title
- QTcF Increase: 30 to <60 msec
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 1
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- title
- QTcF: >=60 msec
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 12
- group Id
- OG004
- value
- 17
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 3
- group Id
- OG009
- value
- 4
- group Id
- OG010
- value
- 30
- group Id
- OG011
- value
- 27
- units
- Participants
- description
- Triplicate 12-lead electrocardiograms (ECGs) were performed approximately 2 minutes apart to determine mean QTc interval (QT interval corrected for heart rate). QT interval was corrected for heart rate using Fridericia's formula to provide QTcF. Absolute values and changes from baseline were summarized according to pre-defined criteria. Baseline was defined as the last evaluation on or prior to the first dose of study treatment.
- groups
- description
- PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
- id
- OG000
- title
- 10 mg QD (Phase 1)
- description
- PF-06463922 25 mg was orally given QD in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
- id
- OG001
- title
- 25 mg QD (Phase 1)
- description
- PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
- id
- OG002
- title
- 50 mg QD (Phase 1)
- description
- PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
- id
- OG003
- title
- 75 mg QD (Phase 1)
- description
- PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
- id
- OG004
- title
- 100 mg QD (Phase 1)
- description
- PF-06463922 150 mg was orally given QD in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
- id
- OG005
- title
- 150 mg QD (Phase 1)
- description
- PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
- id
- OG006
- title
- 200 mg QD (Phase 1)
- description
- PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
- id
- OG007
- title
- 35 mg BID (Phase 1)
- description
- PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
- id
- OG008
- title
- 75 mg BID (Phase 1)
- description
- PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
- id
- OG009
- title
- 100 mg BID (Phase 1)
- description
- Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
- id
- OG010
- title
- EXP-1 (Phase 2)
- description
- Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
- id
- OG011
- title
- EXP-2 (Phase 2)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The safety analysis set included all enrolled participants who received at least 1 dose of PF-06463922.
- reporting Status
- POSTED
- time Frame
- From first dose of study treatment to end of treatment (maximum of 8 years for Phase 1, maximum of 7.5 years for Phase 2 and up to a maximum of 6 years approx. for DDI sub study)
- title
- Number of Participants With Absolute Values and Change From Baseline in QTcF Meeting Pre-defined Criteria (Phase 1, Phase 2 and DDI Sub-study)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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