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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-011285-29 | EudraCT Number |
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This study examines the effect of a small molecule inhibitor to the Sonic Hedgehog pathway on select hematologic malignancies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-04449913 | Drug | Escalating doses of PF-04449913 administered as tablets PO QD continuously in 28 day cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With First Cycle Dose-limiting Toxicities (DLTs) | Any DLT event in Cycle 1: 1) Grade >=3 non-hematologic toxicity that had been maximally treated, 2) prolonged myelosupression that lasted greater than (>) 42 days from the point of detection in a normal bone marrow (less than [<] 500 per microliter [/uL] or platelet count <10,000/uL, or hemoglobin <8 gram per deciliter [g/dL] with <5% blasts and no evidence of disease or dysplasia), 3) inability to deliver >= 80% of the planned doses due to PF-04449913 related non-hematologic and hematologic toxicities | Cycle 1 Day 1 to end of Cycle 1 (28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Treatment-emergent Adverse Events (AEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 3.0) Grade | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs are events which occurred between first dose of study drug and 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. If the same participant in a given treatment had more than 1 occurrence in the same preferred term event category, only the worst CTCAE grade (1 = mild AE, 2 = moderate AE, 3 = severe AE, 4 = life-threatening or disabling AE, 5 = death related to AE) was reported. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSD Medical Center - La Jolla | La Jolla | California | 92037 | United States | ||
| Moores UCSD Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33993815 | Derived | Fostvedt LK, Shaik N, Martinelli G, Wagner AJ, Ruiz-Garcia A. Exposure-response modeling of the effect of glasdegib on cardiac repolarization in patients with cancer. Expert Rev Clin Pharmacol. 2021 Jul;14(7):927-935. doi: 10.1080/17512433.2021.1925538. Epub 2021 May 18. | |
| 26688487 | Derived | Martinelli G, Oehler VG, Papayannidis C, Courtney R, Shaik MN, Zhang X, O'Connell A, McLachlan KR, Zheng X, Radich J, Baccarani M, Kantarjian HM, Levin WJ, Cortes JE, Jamieson C. Treatment with PF-04449913, an oral smoothened antagonist, in patients with myeloid malignancies: a phase 1 safety and pharmacokinetics study. Lancet Haematol. 2015 Aug;2(8):e339-46. doi: 10.1016/S2352-3026(15)00096-4. Epub 2015 Jul 26. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Title | Description |
|---|---|---|
| FG000 | PF-04449913 5 mg | Participants received oral single agent PF-04449913 tablets 5 milligram (mg) once on Day -6 (as a lead-in dose), followed by once daily (QD) dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days). |
| FG001 | PF-04449913 10 mg | Participants received oral single agent PF-04449913 tablets 10 mg once on Day -6 (as a lead-in dose), followed by QD dosing from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days). |
| FG002 | PF-04449913 20 mg | Participants received oral single agent PF-04449913 tablets 20 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days). |
| FG003 | PF-04449913 40 mg | Participants received oral single agent PF-04449913 tablets 40 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days). |
| FG004 | PF-04449913 80 mg | Participants received oral single agent PF-04449913 tablets 80 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days). |
| FG005 | PF-04449913 120 mg | Participants received oral single agent PF-04449913 tablets 120 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days). |
| FG006 | PF-04449913 180 mg | Participants received oral single agent PF-04449913 tablets 180 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days). |
| FG007 | PF-04449913 270 mg | Participants received oral single agent PF-04449913 tablets 270 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days). |
| FG008 | PF-04449913 400 mg | Participants received oral single agent PF-04449913 tablets 400 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days). |
| FG009 | PF-04449913 600 mg | Participants received oral single agent PF-04449913 tablets 600 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PF-04449913 5 mg | Participants received oral single agent PF-04449913 tablets 5 milligram (mg) once on Day -6 (as a lead-in dose), followed by once daily (QD) dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days). |
| BG001 | PF-04449913 10 mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With First Cycle Dose-limiting Toxicities (DLTs) | Any DLT event in Cycle 1: 1) Grade >=3 non-hematologic toxicity that had been maximally treated, 2) prolonged myelosupression that lasted greater than (>) 42 days from the point of detection in a normal bone marrow (less than [<] 500 per microliter [/uL] or platelet count <10,000/uL, or hemoglobin <8 gram per deciliter [g/dL] with <5% blasts and no evidence of disease or dysplasia), 3) inability to deliver >= 80% of the planned doses due to PF-04449913 related non-hematologic and hematologic toxicities | Only participants who did not have major treatment deviations in Cycle 1 were evaluable for DLT. | Posted | Count of Participants | Participants | Cycle 1 Day 1 to end of Cycle 1 (28 days) |
|
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The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PF-04449913 5 mg | Participants received oral single agent PF-04449913 tablets 5 milligram (mg) once on Day -6 (as a lead-in dose), followed by once daily (QD) dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 16.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 16.0 | Non-systematic Assessment |
Some participants were administered the lead-in dose at other times (other than Day -6 as stated) due to changes in the timing of the lead-in dose as the protocol was amended a few times.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C000592580 | glasdegib |
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| Baseline up to 28 days post last dose of study medication (maximum duration: 537 days) |
| Percentage of Participants With Treatment-related Adverse Events (AEs), by NCI CTCAE Version 3.0) Grade | An AE was any untoward medical occurrence in a participant. Treatment-related AEs are events that were assessed by the investigator as related to study medication. If the same participant in a given treatment had more than 1 occurrence in the same preferred term event category, only the worst CTCAE grade (1 = mild AE, 2 = moderate AE, 3 = severe AE, 4 = life-threatening or disabling AE, 5 = death related to AE) was reported. | Baseline up to 28 days post last dose of study medication (maximum duration: 537 days) |
| Number of Participants With Vital Signs Values Meeting Categorical Summarization Criteria | Participants with systolic blood pressure (BP) less than (<) 90 millimeters of mercury (mmHg), maximum increase and decrease from baseline systolic BP of more than or equal to (>=) 30 mmHg, diastolic BP <50 mmHg, maximum increase and decrease from baseline diastolic BP >=20 mmHg, and a heart rate of more than (>) 120 beats per minute (bpm) at any time post dose were summarized. | Screening up to maximum of 537 days |
| Number of Participants With Laboratory Test Abnormalities | Number of participants with laboratory test abnormalities without regard to baseline abnormality as per the pre defined criteria were reported. Laboratory test parameters included hematology, coagulation, liver function, renal function, electrolytes, clinical chemistry, and urinalysis (dipstick and microscopy). | Screening to EOT (maximum duration: 537 days) |
| Hedgehog Biomarker Modulation: Relative GLI1 Gene Expression to Baseline for Normal Skin on Cycle 1 Day 21 | Ribonucleic acid (RNA) was extracted from skin samples and complementary deoxyribonucleic acid (cDNA) was prepared. Gene expression was measured using custom Taqman low density array (TLDA) cards run on the Applied Biosystems ViiATM 7 system. | Baseline, Cycle 1 Day 21 |
| Maximum Observed Plasma Concentration (Cmax) on Lead-in | Pre-dose, 0.5, 1, 2, 4, 8, 24, 48, 96 and 120 hours post-dose during the lead-in period (Day -6) |
| Maximum Observed Plasma Concentration (Cmax) on Cycle 1 Day 21 | Pre-dose, 0.5, 1, 2, 4, 8, 24 hours post-dose on Cycle 1 Day 21 |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) on Lead-in | Pre-dose, 0.5, 1, 2, 4, 8, 24, 48, 96 and 120 hours post-dose during the lead-in period (Day -6) |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) on Cycle 1 Day 21 | Pre-dose, 0.5, 1, 2, 4, 8, 24 hours post-dose on Cycle 1 Day 21 |
| Apparent Oral Clearance (CL/F) on Lead-in | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. | Pre-dose, 0.5, 1, 2, 4, 8, 24, 48, 96 and 120 hours post-dose during the lead-in period (Day -6) |
| Apparent Oral Clearance (CL/F) on Cycle 1 Day 21 | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. | Pre-dose, 0.5, 1, 2, 4, 8, 24 hours post-dose on Cycle 1 Day 21 |
| Apparent Volume of Distribution (Vz/F) on Lead-in | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed. | Pre-dose, 0.5, 1, 2, 4, 8, 24, 48, 96 and 120 hours post-dose during the lead-in period (Day -6) |
| Plasma Decay Half-life (t1/2) on Lead-in | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | Pre-dose, 0.5, 1, 2, 4, 8, 24, 48, 96 and 120 hours post-dose during the lead-in period (Day -6) |
| Area Under the Plasma Concentration-time Profile From Time Zero to Infinity (AUCinf) on Lead-in | Pre-dose, 0.5, 1, 2, 4, 8, 24, 48, 96 and 120 hours post-dose during the lead-in period (Day -6) |
| Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) on Cycle 1 Day 21 | Pre-dose, 0.5, 1, 2, 4, 8, 24 hours post-dose on Cycle 1 Day 21 |
| Average Plasma Concentration (Cavg) on Cycle 1 Day 21 | Pre-dose, 0.5, 1, 2, 4, 8, 24 hours post-dose on Cycle 1 Day 21 |
| Minimum Plasma Concentration (Cmin) on Cycle 1 Day 21 | Pre-dose, 0.5, 1, 2, 4, 8, 24 hours post-dose on Cycle 1 Day 21 |
| Pre-dose Concentration (Ctrough) on Cycle 1 Day 21 | Pre-dose on Cycle 1 Day 21 |
| Accumulation Ratio (Rac) | Accumulation ratio was calculated as AUCtau at steady state (Cycle 1/Day 21)/AUCtau on Cycle 1 Day 1. | Pre-dose, 1 hour post-dose on Cycle 1 Day 1; Pre-dose, 0.5, 1, 2, 4, 8 and 24 hours post-dose on Cycle 1 Day 21 |
| Linearity Ratio (Rss) | Linearity ratio was calculated as AUCtau at steady state (Cycle 1/Day 21)/AUCinf after single dose (Lead-in Period [Day -6]). | Pre-dose, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose during the lead-in period (Day -6); Pre-dose, 0.5, 1, 2, 4, 8 and 24 hours post-dose on Cycle 1 Day 21 |
| Renal Clearance on Cycle 1 Day 21 | Renal clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by the kidneys. | Pre-dose, 0.5, 1, 2, 4, 8, 24 hours post-dose on Cycle 1 Day 21 |
| Amount of Unchanged Drug Excreted in Urine (Over the Dosing Interval) on Cycle 1 Day 21 | Pre-dose, 0.5, 1, 2, 4, 8, 24 hours post-dose on Cycle 1 Day 21 |
| Percentage of Dose Excreted Unchanged in Urine (Over the Dosing Interval) on Cycle 1 Day 21 | Pre-dose, 0.5, 1, 2, 4, 8, 24 hours post-dose on Cycle 1 Day 21 |
| Percentage of Participants With Objective Response (OR) | Percentage of participants with OR based on assessment of disease response according to disease specific response criteria (hematologic, cytogenetic and molecular responses). Results were analyzed based on malignancies, according to the planned analysis. | Baseline to end of study (up to 537 days) |
| Time to Progression (TTP) | Time in months from start of study treatment to first documentation of objective disease progression or death due to cancer, whichever comes first. TTP was calculated as (first event date - date of first dose of study medication + 1)/30.4. Disease progression was determined from oncologic assessment data (where data met the criteria for disease progression: categorized as early progressor from chronic phase [CP], progressor to accelerated phase [AP] or blast crisis [BC] from CP or return to CP, progressor to AP to BC, loss of confirmed complete hematologic response, or loss of major cytogenetic response). | Baseline to end of study, up to 36 months |
| Duration of Response (DR) | Time in months from the first documentation of objective response to objective disease progression or death due to any cancer. DR was calculated as [date of first documentation of progression or death due to cancer - date of first disease response + 1]/30.4. DR was calculated for the subgroup of participants with an objective disease response. | Baseline to end of study, up to 36 months |
| Progression-Free Survival (PFS) | Time in months from start of study treatment to first documentation of objective disease progression or death due to any cause. PFS was calculated as [first event date - date of first dose of study medication + 1]/30.4. Disease progression was determined from oncologic assessment data (where data met the criteria for disease progression: categorized as early progressor from CP, progressor to AP or BC from CP or return to CP, progressor to AP to BC, loss of confirmed complete hematologic response, or loss of major cytogenetic response; or from adverse event data (where the outcome was "Death"). | Baseline to end of study, up to 36 months |
| Number of Participants With Increase From Baseline in Corrected QT Interval Using Fridericia's Formula (QTcF) | Triplicate 12-lead electrocardiogram (ECG) measurements (each recording separated by approximately 2 minutes) were performed and the average was calculated. The time from ECG Q wave to the end of the T wave corresponding to electrical systole (QT) was corrected for heart rate (QTc). QTc using Fridericia's formula (QTcF) was calculated. Participants with maximum increase from baseline of <30 millisecond (msec), 30 to <60 msec and >=60 msec were summarized. | Screening; predose, 1, 4, 24 hours (hr) postdose on Day -6; predose, 1 hr postdose on Cycle 1 Day 1; 1 hr postdose on Cycle 1 Days 8, 15; Day 1 of every subsequent cycle; predose, 1, 2, 4, 24 hr postdose for Cycle 1 Day 21; EOT (max reached: Cycle 20) |
| Number of Participants With Decrease From Baseline in QTcF Interval | Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and the average was calculated. QTcF was calculated. Participants with maximum decrease from baseline of <30 msec, 30 to <60 msec and >=60 msec were summarized. | Baseline up to maximum of 537 days |
| Number of Participants With Post-baseline QTcF Interval >= 500 Msec | Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and the average was calculated. QTcF was calculated. Participants with post-baseline absolute QTcF values >=500 msec were summarized. | Baseline up to maximum of 537 days |
| La Jolla |
| California |
| 92093 |
| United States |
| UCSD Medical Center - Hillcrest | San Diego | California | 92103 | United States |
| The University of Texas M.D. Anderson Cancer Center | Houston | Texas | 77030-4009 | United States |
| University of Washington Medical Center, Seattle Cancer Care Alliance | Seattle | Washington | 98109-1023 | United States |
| U.O. di Ematologia | Bologna | 40138 | Italy |
| Participant refused further follow-up |
|
| Lost to Follow-up |
|
| Physician Decision |
|
| Disease progression |
|
| Participant went for transplant |
|
Participants received oral single agent PF-04449913 tablets 10 mg once on Day -6 (as a lead-in dose), followed by QD dosing from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days). |
| BG002 | PF-04449913 20 mg | Participants received oral single agent PF-04449913 tablets 20 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days). |
| BG003 | PF-04449913 40 mg | Participants received oral single agent PF-04449913 tablets 40 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days). |
| BG004 | PF-04449913 80 mg | Participants received oral single agent PF-04449913 tablets 80 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days). |
| BG005 | PF-04449913 120 mg | Participants received oral single agent PF-04449913 tablets 120 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days). |
| BG006 | PF-04449913 180 mg | Participants received oral single agent PF-04449913 tablets 180 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days). |
| BG007 | PF-04449913 270 mg | Participants received oral single agent PF-04449913 tablets 270 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days). |
| BG008 | PF-04449913 400 mg | Participants received oral single agent PF-04449913 tablets 400 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days). |
| BG009 | PF-04449913 600 mg | Participants received oral single agent PF-04449913 tablets 600 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days). |
| BG010 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | PF-04449913 10 mg | Participants received oral single agent PF-04449913 tablets 10 mg once on Day -6 (as a lead-in dose), followed by QD dosing from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days). |
| OG002 | PF-04449913 20 mg | Participants received oral single agent PF-04449913 tablets 20 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days). |
| OG003 | PF-04449913 40 mg | Participants received oral single agent PF-04449913 tablets 40 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days). |
| OG004 | PF-04449913 80 mg | Participants received oral single agent PF-04449913 tablets 80 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days). |
| OG005 | PF-04449913 120 mg | Participants received oral single agent PF-04449913 tablets 120 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days). |
| OG006 | PF-04449913 180 mg | Participants received oral single agent PF-04449913 tablets 180 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days). |
| OG007 | PF-04449913 270 mg | Participants received oral single agent PF-04449913 tablets 270 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days). |
| OG008 | PF-04449913 400 mg | Participants received oral single agent PF-04449913 tablets 400 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days). |
| OG009 | PF-04449913 600 mg | Participants received oral single agent PF-04449913 tablets 600 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days). |
|
|
| Secondary | Percentage of Participants With Treatment-emergent Adverse Events (AEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 3.0) Grade | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs are events which occurred between first dose of study drug and 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. If the same participant in a given treatment had more than 1 occurrence in the same preferred term event category, only the worst CTCAE grade (1 = mild AE, 2 = moderate AE, 3 = severe AE, 4 = life-threatening or disabling AE, 5 = death related to AE) was reported. | The safety analysis set consisted of all enrolled participants who received at least 1 dose of PF-04449913, including the lead-in dose. | Posted | Number | percentage of participants | Baseline up to 28 days post last dose of study medication (maximum duration: 537 days) |
|
|
|
| Secondary | Percentage of Participants With Treatment-related Adverse Events (AEs), by NCI CTCAE Version 3.0) Grade | An AE was any untoward medical occurrence in a participant. Treatment-related AEs are events that were assessed by the investigator as related to study medication. If the same participant in a given treatment had more than 1 occurrence in the same preferred term event category, only the worst CTCAE grade (1 = mild AE, 2 = moderate AE, 3 = severe AE, 4 = life-threatening or disabling AE, 5 = death related to AE) was reported. | The safety analysis set consisted of all enrolled participants who received at least 1 dose of PF-04449913, including the lead-in dose. | Posted | Number | percentage of participants | Baseline up to 28 days post last dose of study medication (maximum duration: 537 days) |
|
|
|
| Secondary | Number of Participants With Vital Signs Values Meeting Categorical Summarization Criteria | Participants with systolic blood pressure (BP) less than (<) 90 millimeters of mercury (mmHg), maximum increase and decrease from baseline systolic BP of more than or equal to (>=) 30 mmHg, diastolic BP <50 mmHg, maximum increase and decrease from baseline diastolic BP >=20 mmHg, and a heart rate of more than (>) 120 beats per minute (bpm) at any time post dose were summarized. | The safety analysis set consisted of all enrolled participants who received at least 1 dose of PF-04449913, including the lead-in dose. | Posted | Count of Participants | Participants | Screening up to maximum of 537 days |
|
|
|
| Secondary | Number of Participants With Laboratory Test Abnormalities | Number of participants with laboratory test abnormalities without regard to baseline abnormality as per the pre defined criteria were reported. Laboratory test parameters included hematology, coagulation, liver function, renal function, electrolytes, clinical chemistry, and urinalysis (dipstick and microscopy). | The safety analysis set consisted of all enrolled participants who received at least 1 dose of PF-04449913, including the lead-in dose. | Posted | Count of Participants | Participants | Screening to EOT (maximum duration: 537 days) |
|
|
|
| Secondary | Hedgehog Biomarker Modulation: Relative GLI1 Gene Expression to Baseline for Normal Skin on Cycle 1 Day 21 | Ribonucleic acid (RNA) was extracted from skin samples and complementary deoxyribonucleic acid (cDNA) was prepared. Gene expression was measured using custom Taqman low density array (TLDA) cards run on the Applied Biosystems ViiATM 7 system. | The pharmacodynamic (PD) analysis population included all enrolled participants who received at least 1 dose of PF-04449913 and had at least 1 PD parameter in at least 1 treatment period. Results were not collected and reported for the other reporting arms since none of the participants in those arms had evaluable PD samples. | Posted | Number | ratio | Baseline, Cycle 1 Day 21 |
|
|
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| Secondary | Maximum Observed Plasma Concentration (Cmax) on Lead-in | The pharmacokinetic (PK) analysis set included all enrolled and treated (received at least 1 dose of study medication) participants who had at least 1 of the PK parameters of interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram/milliliter (ng/mL) | Pre-dose, 0.5, 1, 2, 4, 8, 24, 48, 96 and 120 hours post-dose during the lead-in period (Day -6) |
|
|
|
| Secondary | Maximum Observed Plasma Concentration (Cmax) on Cycle 1 Day 21 | PK analysis set included all enrolled and treated (received at least 1 dose of study medication) participants who had at least 1 of the PK parameters of interest. N = the number of participants analyzed for Cycle 1. 1 participant from the 270-mg arm had dose reduction to 180 mg and is analyzed and reported under the 180-mg arm. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Pre-dose, 0.5, 1, 2, 4, 8, 24 hours post-dose on Cycle 1 Day 21 |
|
|
|
| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) on Lead-in | The PK analysis set included all enrolled and treated (received at least 1 dose of study medication) participants who had at least 1 of the PK parameters of interest. | Posted | Median | Full Range | hours | Pre-dose, 0.5, 1, 2, 4, 8, 24, 48, 96 and 120 hours post-dose during the lead-in period (Day -6) |
|
|
|
| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) on Cycle 1 Day 21 | PK analysis set included all enrolled and treated (received at least 1 dose of study medication) participants who had at least 1 of the PK parameters of interest. N = the number of participants analyzed for Cycle 1. 1 participant from the 270-mg arm had dose reduction to 180 mg and is analyzed and reported under the 180-mg arm. | Posted | Median | Full Range | hours | Pre-dose, 0.5, 1, 2, 4, 8, 24 hours post-dose on Cycle 1 Day 21 |
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|
|
| Secondary | Apparent Oral Clearance (CL/F) on Lead-in | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. | The PK analysis set included all enrolled and treated (received at least 1 dose of study medication) participants who had at least 1 of the PK parameters of interest. N = number of participants with available data for this PK parameter in this period. | Posted | Geometric Mean | Geometric Coefficient of Variation | liter (L)/hour | Pre-dose, 0.5, 1, 2, 4, 8, 24, 48, 96 and 120 hours post-dose during the lead-in period (Day -6) |
|
|
|
| Secondary | Apparent Oral Clearance (CL/F) on Cycle 1 Day 21 | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. | PK analysis set included all enrolled and treated (received at least 1 dose of study medication) participants who had at least 1 of the PK parameters of interest. N = the number of participants analyzed for Cycle 1. 1 participant from the 270-mg arm had dose reduction to 180 mg and is analyzed and reported under the 180-mg arm. | Posted | Geometric Mean | Geometric Coefficient of Variation | L/hour | Pre-dose, 0.5, 1, 2, 4, 8, 24 hours post-dose on Cycle 1 Day 21 |
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|
| Secondary | Apparent Volume of Distribution (Vz/F) on Lead-in | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed. | The PK analysis set included all enrolled and treated (received at least 1 dose of study medication) participants who had at least 1 of the PK parameters of interest. N = number of participants with available data for this PK parameter in this period. | Posted | Geometric Mean | Geometric Coefficient of Variation | liter (L) | Pre-dose, 0.5, 1, 2, 4, 8, 24, 48, 96 and 120 hours post-dose during the lead-in period (Day -6) |
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|
| Secondary | Plasma Decay Half-life (t1/2) on Lead-in | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | The PK analysis set included all enrolled and treated (received at least 1 dose of study medication) participants who had at least 1 of the PK parameters of interest. N = number of participants with available data for this PK parameter in this period. | Posted | Mean | Standard Deviation | hours | Pre-dose, 0.5, 1, 2, 4, 8, 24, 48, 96 and 120 hours post-dose during the lead-in period (Day -6) |
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|
|
| Secondary | Area Under the Plasma Concentration-time Profile From Time Zero to Infinity (AUCinf) on Lead-in | The PK analysis set included all enrolled and treated (received at least 1 dose of study medication) participants who had at least 1 of the PK parameters of interest. N = number of participants with available data for this PK parameter in this period. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hour/milliliter (ng*hr/mL) | Pre-dose, 0.5, 1, 2, 4, 8, 24, 48, 96 and 120 hours post-dose during the lead-in period (Day -6) |
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|
| Secondary | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) on Cycle 1 Day 21 | PK analysis set included all enrolled and treated (received at least 1 dose of study medication) participants who had at least 1 of the PK parameters of interest. N = the number of participants analyzed for Cycle 1. 1 participant from the 270-mg arm had dose reduction to 180 mg and is analyzed and reported under the 180-mg arm. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hour/mL | Pre-dose, 0.5, 1, 2, 4, 8, 24 hours post-dose on Cycle 1 Day 21 |
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|
| Secondary | Average Plasma Concentration (Cavg) on Cycle 1 Day 21 | PK analysis set included all enrolled and treated (received at least 1 dose of study medication) participants who had at least 1 of the PK parameters of interest. N = the number of participants analyzed for Cycle 1. 1 participant from the 270-mg arm had dose reduction to 180 mg and is analyzed and reported under the 180-mg arm. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Pre-dose, 0.5, 1, 2, 4, 8, 24 hours post-dose on Cycle 1 Day 21 |
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| Secondary | Minimum Plasma Concentration (Cmin) on Cycle 1 Day 21 | PK analysis set included all enrolled and treated (received at least 1 dose of study medication) participants who had at least 1 of the PK parameters of interest. N = the number of participants analyzed for Cycle 1. 1 participant from the 270-mg arm had dose reduction to 180 mg and is analyzed and reported under the 180-mg arm. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Pre-dose, 0.5, 1, 2, 4, 8, 24 hours post-dose on Cycle 1 Day 21 |
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|
| Secondary | Pre-dose Concentration (Ctrough) on Cycle 1 Day 21 | PK analysis set included all enrolled and treated (received at least 1 dose of study medication) participants who had at least 1 of the PK parameters of interest. N = number of participants with available data for this parameter in this period. 1 participant from the 270-mg arm had dose reduction to 180 mg and is analyzed and reported under 180-mg. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Pre-dose on Cycle 1 Day 21 |
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| Secondary | Accumulation Ratio (Rac) | Accumulation ratio was calculated as AUCtau at steady state (Cycle 1/Day 21)/AUCtau on Cycle 1 Day 1. | PK analysis set included all enrolled and treated (received at least 1 dose of study medication) participants who had at least 1 of the PK parameters of interest. N = the number of participants analyzed for Cycle 1. 1 participant from the 270-mg arm had dose reduction to 180 mg and is analyzed and reported under the 180-mg arm. | Posted | Median | Full Range | ratio | Pre-dose, 1 hour post-dose on Cycle 1 Day 1; Pre-dose, 0.5, 1, 2, 4, 8 and 24 hours post-dose on Cycle 1 Day 21 |
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| Secondary | Linearity Ratio (Rss) | Linearity ratio was calculated as AUCtau at steady state (Cycle 1/Day 21)/AUCinf after single dose (Lead-in Period [Day -6]). | PK analysis set included all enrolled and treated (received at least 1 dose of study medication) participants who had at least 1 of the PK parameters of interest. N = the number of participants analyzed for Cycle 1. 1 participant from the 270-mg arm had dose reduction to 180 mg and is analyzed and reported under the 180-mg arm. | Posted | Median | Full Range | ratio | Pre-dose, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose during the lead-in period (Day -6); Pre-dose, 0.5, 1, 2, 4, 8 and 24 hours post-dose on Cycle 1 Day 21 |
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|
| Secondary | Renal Clearance on Cycle 1 Day 21 | Renal clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by the kidneys. | The PK analysis set included all enrolled and treated (received at least 1 dose of study medication) participants who had at least 1 of the PK parameters of interest. N = number of participants with available data for this PK parameter in this period. | Posted | Geometric Mean | Geometric Coefficient of Variation | L/hour | Pre-dose, 0.5, 1, 2, 4, 8, 24 hours post-dose on Cycle 1 Day 21 |
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| Secondary | Amount of Unchanged Drug Excreted in Urine (Over the Dosing Interval) on Cycle 1 Day 21 | The PK analysis set included all enrolled and treated (received at least 1 dose of study medication) participants who had at least 1 of the PK parameters of interest. N = number of participants with available data for this PK parameter in this period. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram (mcg) | Pre-dose, 0.5, 1, 2, 4, 8, 24 hours post-dose on Cycle 1 Day 21 |
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| Secondary | Percentage of Dose Excreted Unchanged in Urine (Over the Dosing Interval) on Cycle 1 Day 21 | The PK analysis set included all enrolled and treated (received at least 1 dose of study medication) participants who had at least 1 of the PK parameters of interest. N = number of participants with available data for this PK parameter in this period. | Posted | Geometric Mean | Geometric Coefficient of Variation | Percentage of dose | Pre-dose, 0.5, 1, 2, 4, 8, 24 hours post-dose on Cycle 1 Day 21 |
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| Secondary | Percentage of Participants With Objective Response (OR) | Percentage of participants with OR based on assessment of disease response according to disease specific response criteria (hematologic, cytogenetic and molecular responses). Results were analyzed based on malignancies, according to the planned analysis. | The Efficacy Analysis Set consisted of all enrolled participants who received Cycle 1 Day 1 dose of PF-04449913. | Posted | Number | Percentage of participants | Baseline to end of study (up to 537 days) |
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|
| Secondary | Time to Progression (TTP) | Time in months from start of study treatment to first documentation of objective disease progression or death due to cancer, whichever comes first. TTP was calculated as (first event date - date of first dose of study medication + 1)/30.4. Disease progression was determined from oncologic assessment data (where data met the criteria for disease progression: categorized as early progressor from chronic phase [CP], progressor to accelerated phase [AP] or blast crisis [BC] from CP or return to CP, progressor to AP to BC, loss of confirmed complete hematologic response, or loss of major cytogenetic response). | The Efficacy Analysis Set consisted of all enrolled participants who received Cycle 1 Day 1 dose of PF-04449913. | Posted | Median | 95% Confidence Interval | months | Baseline to end of study, up to 36 months |
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|
|
| Secondary | Duration of Response (DR) | Time in months from the first documentation of objective response to objective disease progression or death due to any cancer. DR was calculated as [date of first documentation of progression or death due to cancer - date of first disease response + 1]/30.4. DR was calculated for the subgroup of participants with an objective disease response. | The Efficacy Analysis Set consisted of all enrolled participants who received Cycle 1 Day 1 dose of PF-04449913. | Posted | Median | 95% Confidence Interval | months | Baseline to end of study, up to 36 months |
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|
|
| Secondary | Progression-Free Survival (PFS) | Time in months from start of study treatment to first documentation of objective disease progression or death due to any cause. PFS was calculated as [first event date - date of first dose of study medication + 1]/30.4. Disease progression was determined from oncologic assessment data (where data met the criteria for disease progression: categorized as early progressor from CP, progressor to AP or BC from CP or return to CP, progressor to AP to BC, loss of confirmed complete hematologic response, or loss of major cytogenetic response; or from adverse event data (where the outcome was "Death"). | The Efficacy Analysis Set consisted of all enrolled participants who received Cycle 1 Day 1 dose of PF-04449913. | Posted | Median | 95% Confidence Interval | months | Baseline to end of study, up to 36 months |
|
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|
| Secondary | Number of Participants With Increase From Baseline in Corrected QT Interval Using Fridericia's Formula (QTcF) | Triplicate 12-lead electrocardiogram (ECG) measurements (each recording separated by approximately 2 minutes) were performed and the average was calculated. The time from ECG Q wave to the end of the T wave corresponding to electrical systole (QT) was corrected for heart rate (QTc). QTc using Fridericia's formula (QTcF) was calculated. Participants with maximum increase from baseline of <30 millisecond (msec), 30 to <60 msec and >=60 msec were summarized. | QTc analysis set included all enrolled participants who had at least 1 ECG assessment after receiving at least 1 dose of PF-04449913. | Posted | Count of Participants | Participants | Screening; predose, 1, 4, 24 hours (hr) postdose on Day -6; predose, 1 hr postdose on Cycle 1 Day 1; 1 hr postdose on Cycle 1 Days 8, 15; Day 1 of every subsequent cycle; predose, 1, 2, 4, 24 hr postdose for Cycle 1 Day 21; EOT (max reached: Cycle 20) |
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| Secondary | Number of Participants With Decrease From Baseline in QTcF Interval | Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and the average was calculated. QTcF was calculated. Participants with maximum decrease from baseline of <30 msec, 30 to <60 msec and >=60 msec were summarized. | QTc analysis set included all enrolled participants who had at least 1 ECG assessment after receiving at least 1 dose of PF-04449913. | Posted | Count of Participants | Participants | Baseline up to maximum of 537 days |
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| Secondary | Number of Participants With Post-baseline QTcF Interval >= 500 Msec | Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and the average was calculated. QTcF was calculated. Participants with post-baseline absolute QTcF values >=500 msec were summarized. | QTc analysis set included all enrolled participants who had at least 1 ECG assessment after receiving at least 1 dose of PF-04449913. | Posted | Count of Participants | Participants | Baseline up to maximum of 537 days |
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| 2 |
| 3 |
| 3 |
| 3 |
| EG001 | PF-04449913 10 mg | Participants received oral single agent PF-04449913 tablets 10 mg once on Day -6 (as a lead-in dose), followed by QD dosing from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days). | 2 | 3 | 3 | 3 |
| EG002 | PF-04449913 20 mg | Participants received oral single agent PF-04449913 tablets 20 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days). | 2 | 4 | 4 | 4 |
| EG003 | PF-04449913 40 mg | Participants received oral single agent PF-04449913 tablets 40 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days). | 3 | 4 | 4 | 4 |
| EG004 | PF-04449913 80 mg | Participants received oral single agent PF-04449913 tablets 80 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days). | 5 | 8 | 8 | 8 |
| EG005 | PF-04449913 120 mg | Participants received oral single agent PF-04449913 tablets 120 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days). | 2 | 3 | 3 | 3 |
| EG006 | PF-04449913 180 mg | Participants received oral single agent PF-04449913 tablets 180 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days). | 2 | 3 | 3 | 3 |
| EG007 | PF-04449913 270 mg | Participants received oral single agent PF-04449913 tablets 270 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days). | 3 | 5 | 5 | 5 |
| EG008 | PF-04449913 400 mg | Participants received oral single agent PF-04449913 tablets 400 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days). | 8 | 9 | 9 | 9 |
| EG009 | PF-04449913 600 mg | Participants received oral single agent PF-04449913 tablets 600 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days). | 3 | 5 | 5 | 5 |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Splenic infarction | Blood and lymphatic system disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Gastritis haemorrhagic | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Disease progression | General disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Multi-organ failure | General disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Catheter site infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Escherichia sepsis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Pneumonal fungal | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Subcutaneous abscess | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Synovial rupture | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA 16.0 | Non-systematic Assessment |
|
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Capillary leak syndrome | Vascular disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Coagulopathy | Blood and lymphatic system disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Increased tendency to bruise | Blood and lymphatic system disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Splenomegaly | Blood and lymphatic system disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Bundle branch block left | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Left ventricular hypertrophy | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Supraventricular extrasystoles | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Ventricular extrasystoles | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Ear discomfort | Ear and labyrinth disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Eye oedema | Eye disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Abdominal tenderness | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Anorectal disorder | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Eructation | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Gastroduodenitis | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Gingival bleeding | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Gingival hypertrophy | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Hyperchlorhydria | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Lip swelling | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Oesophageal ulcer | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Oral disorder | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Oral mucosal blistering | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Proctalgia | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Salivary hypersecretion | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Tongue haematoma | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Condition aggravated | General disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Crepitations | General disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Early satiety | General disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Facial pain | General disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Impaired healing | General disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Localised oedema | General disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Nodule | General disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Oedema | General disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Spinal pain | General disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Systemic inflammatory response syndrome | General disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Biliary colic | Hepatobiliary disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Hepatomegaly | Hepatobiliary disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Candidiasis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Clostridium difficile infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Device related infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Enterobacter bacteraemia | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Furuncle | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Herpes virus infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Pneumocystis jiroveci pneumonia | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Pneumonia fungal | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Pulmonary mycosis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Rectal abscess | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Subcutaneous abscess | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Animal bite | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
|
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
|
| Transfusion reaction | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
|
| Activated partial thromboplastin time prolonged | Investigations | MedDRA 16.0 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
|
| Albumin urine present | Investigations | MedDRA 16.0 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
|
| Blood magnesium decreased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
|
| Blood pressure diastolic decreased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
|
| Clostridium test positive | Investigations | MedDRA 16.0 | Non-systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA 16.0 | Non-systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
|
| International normalised ratio increased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
|
| Lymph node palpable | Investigations | MedDRA 16.0 | Non-systematic Assessment |
|
| Monocyte count increased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
|
| Serum ferritin increased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
|
| Troponin increased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
|
| Weight increased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Fluid overload | Metabolism and nutrition disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Iron overload | Metabolism and nutrition disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Joint crepitation | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Limb asymmetry | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Trismus | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Blast cell crisis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Non-systematic Assessment |
|
| Leukaemia cutis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Non-systematic Assessment |
|
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Non-systematic Assessment |
|
| Renal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Sinus headache | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Mental status changes | Psychiatric disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Mood swings | Psychiatric disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Oliguria | Renal and urinary disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Oedema genital | Reproductive system and breast disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Penile blister | Reproductive system and breast disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Nail discomfort | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Papule | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Scab | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Blue toe syndrome | Vascular disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Capillary leak syndrome | Vascular disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 16.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Any AEs, Grade 2 |
|
| Any AEs, Grade 3 |
|
| Any AEs, Grade 4 |
|
| Any AEs, Grade 5 |
|
| Any AEs, Grade 2 |
|
| Any AEs, Grade 3 |
|
| Any AEs, Grade 4 |
|
| Any AEs, Grade 5 |
|
| Decrease from baseline systolic BP >=30 mmHg |
|
| Increase from baseline systolic BP >=30 mmHg |
|
| Diastolic BP <50 mmHg |
|
| Decrease from baseline diastolic BP >=20 mmHg |
|
| Increase from baseline diastolic BP >=20 mmHg |
|
| Heart rate >120 bpm at any time post dose |
|
| QTcF, maximum increase from baseline: 30-<60 msec |
|
| QTcF, maximum increase from baseline: >=60 msec |
|
| QTcF, maximum decrease from baseline: 30-<60 msec |
|
| QTcF, maximum decrease from baseline: >=60 msec |
|