TriangleNCT01970865 · OUTCOME
Number of Participants With Treatment-Emergent Adverse Events (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
AE: any untoward medical occurrence in clinical investigation participant administered a product or medical device, regardless of causal relationship to study treatment. Treatment-emergent AEs (TEAEs): AEs which occurred for first time during effective duration of treatment or AEs that increased in severity during treatment. Serious AEs (SAEs): any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or caused prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of ability to conduction normal life function). AEs included SAEs and non-serious AEs. Severity was graded as per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.Grade1: mild, Grade2: moderate, Grade3: severe, Grade4: Life threatening consequences; urgent intervention indicated, Grade 5: death related to AE.
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
AEs (all causality)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 10 mg QD (Phase 1) | 3 | Not reported | Not reported | Not reported | Not reported |
| 25 mg QD (Phase 1) | 3 | Not reported | Not reported | Not reported | Not reported |
| 50 mg QD (Phase 1) | 3 | Not reported | Not reported | Not reported | Not reported |
| 75 mg QD (Phase 1) | 12 | Not reported | Not reported | Not reported | Not reported |
| 100 mg QD (Phase 1) | 17 | Not reported | Not reported | Not reported | Not reported |
| 150 mg QD (Phase 1) | 3 | Not reported | Not reported | Not reported | Not reported |
| 200 mg QD (Phase 1) | 3 | Not reported | Not reported | Not reported | Not reported |
| 35 mg BID (Phase 1) | 3 | Not reported | Not reported | Not reported | Not reported |
| 75 mg BID (Phase 1) | 3 | Not reported | Not reported | Not reported | Not reported |
| 100 mg BID (Phase 1) | 4 | Not reported | Not reported | Not reported | Not reported |
| EXP-1 (Phase 2) | 30 | Not reported | Not reported | Not reported | Not reported |
| EXP-2 (Phase 2) | 27 | Not reported | Not reported | Not reported | Not reported |
| EXP-3 (Phase 2) | 59 | Not reported | Not reported | Not reported | Not reported |
| EXP-4 (Phase 2) | 65 | Not reported | Not reported | Not reported | Not reported |
| EXP-5 (Phase 2) | 46 | Not reported | Not reported | Not reported | Not reported |
| EXP-6 (Phase 2) | 47 | Not reported | Not reported | Not reported | Not reported |
| DDI Sub-study | 32 | Not reported | Not reported | Not reported | Not reported |
AEs (treatment-related)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 10 mg QD (Phase 1) | 3 | Not reported | Not reported | Not reported | Not reported |
| 25 mg QD (Phase 1) | 3 | Not reported | Not reported | Not reported | Not reported |
| 50 mg QD (Phase 1) | 3 | Not reported | Not reported | Not reported | Not reported |
| 75 mg QD (Phase 1) | 11 | Not reported | Not reported | Not reported | Not reported |
| 100 mg QD (Phase 1) | 16 | Not reported | Not reported | Not reported | Not reported |
| 150 mg QD (Phase 1) | 3 | Not reported | Not reported | Not reported | Not reported |
| 200 mg QD (Phase 1) | 3 | 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) | 3 | Not reported | Not reported | Not reported | Not reported |
| 100 mg BID (Phase 1) | 4 | Not reported | Not reported | Not reported | Not reported |
| EXP-1 (Phase 2) | 30 | Not reported | Not reported | Not reported | Not reported |
| EXP-2 (Phase 2) | 27 | Not reported | Not reported | Not reported | Not reported |
| EXP-3 (Phase 2) | 56 | Not reported | Not reported | Not reported | Not reported |
| EXP-4 (Phase 2) | 61 | Not reported | Not reported | Not reported | Not reported |
| EXP-5 (Phase 2) | 43 | Not reported | Not reported | Not reported | Not reported |
| EXP-6 (Phase 2) | 45 | Not reported | Not reported | Not reported | Not reported |
| DDI Sub-study | 31 | Not reported | Not reported | Not reported | Not reported |
SAEs (all causality)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 10 mg QD (Phase 1) | 3 | Not reported | Not reported | Not reported | Not reported |
| 25 mg QD (Phase 1) | 2 | 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) | 6 | Not reported | Not reported | Not reported | Not reported |
| 100 mg QD (Phase 1) | 10 | Not reported | Not reported | Not reported | Not reported |
| 150 mg QD (Phase 1) | 3 | Not reported | Not reported | Not reported | Not reported |
| 200 mg QD (Phase 1) | 2 | 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) | 2 | Not reported | Not reported | Not reported | Not reported |
| 100 mg BID (Phase 1) | 2 | Not reported | Not reported | Not reported | Not reported |
| EXP-1 (Phase 2) | 15 | Not reported | Not reported | Not reported | Not reported |
| EXP-2 (Phase 2) | 11 | Not reported | Not reported | Not reported | Not reported |
| EXP-3 (Phase 2) | 34 | Not reported | Not reported | Not reported | Not reported |
| EXP-4 (Phase 2) | 31 | Not reported | Not reported | Not reported | Not reported |
| EXP-5 (Phase 2) | 23 | Not reported | Not reported | Not reported | Not reported |
| EXP-6 (Phase 2) | 21 | Not reported | Not reported | Not reported | Not reported |
| DDI Sub-study | 13 | Not reported | Not reported | Not reported | Not reported |
SAEs (treatment-related)
| 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) | 1 | 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) | 1 | 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) | 3 | 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) | 3 | 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) | 8 | Not reported | Not reported | Not reported | Not reported |
| EXP-4 (Phase 2) | 6 | Not reported | Not reported | Not reported | Not reported |
| EXP-5 (Phase 2) | 6 | Not reported | Not reported | Not reported | Not reported |
| EXP-6 (Phase 2) | 4 | Not reported | Not reported | Not reported | Not reported |
| DDI Sub-study | 1 | Not reported | Not reported | Not reported | Not reported |
Grade 3 or 4 (all causality)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 10 mg QD (Phase 1) | 3 | Not reported | Not reported | Not reported | Not reported |
| 25 mg QD (Phase 1) | 3 | 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) | 6 | Not reported | Not reported | Not reported | Not reported |
| 100 mg QD (Phase 1) | 12 | Not reported | Not reported | Not reported | Not reported |
| 150 mg QD (Phase 1) | 3 | Not reported | Not reported | Not reported | Not reported |
| 200 mg QD (Phase 1) | 2 | 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) | 1 | Not reported | Not reported | Not reported | Not reported |
| 100 mg BID (Phase 1) | 4 | Not reported | Not reported | Not reported | Not reported |
| EXP-1 (Phase 2) | 22 | Not reported | Not reported | Not reported | Not reported |
| EXP-2 (Phase 2) | 22 | Not reported | Not reported | Not reported | Not reported |
| EXP-3 (Phase 2) | 43 | Not reported | Not reported | Not reported | Not reported |
| EXP-4 (Phase 2) | 50 | Not reported | Not reported | Not reported | Not reported |
| EXP-5 (Phase 2) | 36 | Not reported | Not reported | Not reported | Not reported |
| EXP-6 (Phase 2) | 36 | Not reported | Not reported | Not reported | Not reported |
| DDI Sub-study | 24 | Not reported | Not reported | Not reported | Not reported |
Grade 3 or 4 (treatment-related)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 10 mg QD (Phase 1) | 2 | Not reported | Not reported | Not reported | Not reported |
| 25 mg QD (Phase 1) | 2 | 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) | 3 | Not reported | Not reported | Not reported | Not reported |
| 100 mg QD (Phase 1) | 6 | Not reported | Not reported | Not reported | Not reported |
| 150 mg QD (Phase 1) | 2 | 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) | 1 | Not reported | Not reported | Not reported | Not reported |
| 100 mg BID (Phase 1) | 3 | Not reported | Not reported | Not reported | Not reported |
| EXP-1 (Phase 2) | 13 | Not reported | Not reported | Not reported | Not reported |
| EXP-2 (Phase 2) | 15 | Not reported | Not reported | Not reported | Not reported |
| EXP-3 (Phase 2) | 31 | Not reported | Not reported | Not reported | Not reported |
| EXP-4 (Phase 2) | 31 | Not reported | Not reported | Not reported | Not reported |
| EXP-5 (Phase 2) | 22 | Not reported | Not reported | Not reported | Not reported |
| EXP-6 (Phase 2) | 25 | Not reported | Not reported | Not reported | Not reported |
| DDI Sub-study | 16 | Not reported | Not reported | Not reported | Not reported |
Grade 5 (all causality)
| 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) | 1 | 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) | 1 | Not reported | Not reported | Not reported | Not reported |
| 100 mg QD (Phase 1) | 4 | Not reported | Not reported | Not reported | Not reported |
| 150 mg QD (Phase 1) | 2 | 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) | 1 | 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) | 3 | Not reported | Not reported | Not reported | Not reported |
| EXP-2 (Phase 2) | 3 | Not reported | Not reported | Not reported | Not reported |
| EXP-3 (Phase 2) | 10 | Not reported | Not reported | Not reported | Not reported |
| EXP-4 (Phase 2) | 11 | Not reported | Not reported | Not reported | Not reported |
| EXP-5 (Phase 2) | 9 | Not reported | Not reported | Not reported | Not reported |
| EXP-6 (Phase 2) | 7 | Not reported | Not reported | Not reported | Not reported |
| DDI Sub-study | 5 | Not reported | Not reported | Not reported | Not reported |
Grade 5 (treatment-related)
| 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) | 0 | 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) | 0 | Not reported | Not reported | Not reported | Not reported |
| EXP-6 (Phase 2) | 0 | Not reported | Not reported | Not reported | Not reported |
| DDI Sub-study | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- 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
- title
- AEs (all causality)
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 11
- group Id
- OG004
- value
- 16
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 3
- group Id
- OG009
- value
- 4
- group Id
- OG010
- value
- 30
- group Id
- OG011
- value
- 27
- title
- AEs (treatment-related)
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 10
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 2
- group Id
- OG009
- value
- 2
- group Id
- OG010
- value
- 15
- group Id
- OG011
- value
- 11
- title
- SAEs (all causality)
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 1
- group Id
- OG010
- value
- 3
- group Id
- OG011
- value
- 0
- title
- SAEs (treatment-related)
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 12
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 1
- group Id
- OG009
- value
- 4
- group Id
- OG010
- value
- 22
- group Id
- OG011
- value
- 22
- title
- Grade 3 or 4 (all causality)
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 1
- group Id
- OG009
- value
- 3
- group Id
- OG010
- value
- 13
- group Id
- OG011
- value
- 15
- title
- Grade 3 or 4 (treatment-related)
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 1
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 3
- group Id
- OG011
- value
- 3
- title
- Grade 5 (all causality)
- 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
- Grade 5 (treatment-related)
- 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
- AE: any untoward medical occurrence in clinical investigation participant administered a product or medical device, regardless of causal relationship to study treatment. Treatment-emergent AEs (TEAEs): AEs which occurred for first time during effective duration of treatment or AEs that increased in severity during treatment. Serious AEs (SAEs): any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or caused prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of ability to conduction normal life function). AEs included SAEs and non-serious AEs. Severity was graded as per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.Grade1: mild, Grade2: moderate, Grade3: severe, Grade4: Life threatening consequences; urgent intervention indicated, Grade 5: death related to AE.
- 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 Treatment-Emergent Adverse Events (Phase 1, Phase 2 and DDI Sub-study)
- type
- SECONDARY
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice