Trial · NCT03627767
Study to Investigate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years and Over With Moderate to Severe Atopic Dermatitis With the Option of Rescue Treatment in Flaring Subjects
NCT03627767, Phase 3, Completed, Pfizer; results first posted 2021-09-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Investigate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years and Over With Moderate to Severe Atopic Dermatitis With the Option of Rescue Treatment in Flaring Subjects. Trials, record NCT03627767. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03627767
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Investigate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years and Over With Moderate to Severe Atopic Dermatitis With the Option of Rescue Treatment in Flaring Subjects
- NCT number
- NCT03627767
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,235 participants, actual
- Lead sponsor
- Pfizer
- Conditions
Dermatitis, Dermatitis, Atopic, Eczema, Skin Diseases, Skin Diseases, Genetic, Genetic Diseases, Inborn, Skin Diseases, Eczematous, Hypersensitivity, Hypersensitivity, Immediate, Immune System Diseases
- Interventions
- PF-04965842 100 mg, PF-04965842 200 mg, Placebo
- First posted
- 2018-08-13
- Last updated
- 2021-09-20
- Other registries' IDs
- eudract:2018-000501-23
- Results first posted
- 2021-09-20
- Limitations and caveats
- For outcome measure, Time to loss of response, the data collection window was extended for 45 days beyond the scheduled visit due to COVID 19.
Source ClinicalTrials.gov
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Loss of Response: Double-blind (DB) Period | From Day 1 of up to Week 40 of double blind period | Percentage of participants with loss of response requiring rescue treatment during double blind period was determined. Loss of response denoted as flare and was define as a loss of at least 50% of EASI total score at Week 12 and with an IGA score of 2 or higher. EASI quantifies severity of participant's atopic dermatitis (AD) based on both severity of lesion clinical signs and % of body surface area (BSA) affected. EASI is a composite scoring by AD clinical evaluator of degree of erythema, induration/papulation, excoriation, and lichenification for each of 4 body regions. EASI total score range from 0.0 to 72.0, with higher scores representing greater severity of AD. IGA assesses severity of AD on 5-point scale (0 to 4, higher scores = more severity), reflecting global consideration of erythema, induration and scaling. Where, 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate and 4 = severe. |
| Primary | Time to Loss of Response: Double-blind Period | From date of first dose of randomized treatment until the last dose of randomized treatment (if not entered rescue) or first day of rescue treatment (if entered rescue) (maximum up to Week 40, visit window was extended +/- 45 Days due to COVID 19) | Time (in days) to loss of response based on achieving IGA \>=2 was measured from date of first dose of randomized treatment until last dose of randomized treatment (if not entered rescue) or first day of rescue treatment (if entered rescue) and based on EASI, loss of at least 50% of EASI response at Week 12 and IGA score of 2 or higher. IGA assesses severity of AD on 5-point scale (0 to 4, higher scores=more severity), reflecting global consideration of erythema, induration and scaling with scores 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe. EASI quantifies severity of AD based on severity of lesion clinical signs and % of BSA affected. EASI composite score evaluates degree of erythema, induration/papulation, excoriation, and lichenification. |
| Secondary | Time to First Loss of Response Based on Investigator's Global Assessment (IGA) Score of 2 or Higher: Double-blind Period | From date of first dose of randomized treatment until the last dose of randomized treatment (if not entered rescue) or first day of rescue treatment (if entered rescue) (maximum up to Week 40, visit window +/- 7 Days) | Time (in days) to loss of response based on achieving IGA \>=2 (for the first time) as measured from date of first dose of randomized treatment until the last dose of randomized treatment (if not entered rescue) or first day of rescue treatment (if entered rescue). IGA assesses severity of AD on a 5-point scale (0 to 4, higher scores indicated more severity), reflecting global consideration of erythema, induration and scaling. Where, 0 = clear, AD is cleared; 1 = almost clear, AD not entirely cleared, light pink residual lesions; 2 = mild, AD with light red lesions; 3 = moderate, AD with red lesions; 4 = severe, AD with deep, dark red lesions. |
| Secondary | Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and a Reduction of Greater Than or Equal to (>=) 2 Points From Baseline at Weeks 12, 16, 28, 40, and 52: Double-blind Period | Baseline, Weeks 12, 16, 28, 40 and 52 | IGA assessed severity of AD on a 5-point scale (0 to 4, higher scores indicated more severity), reflecting global consideration of erythema, induration and scaling. Where, 0 = clear, AD is cleared; 1 = almost clear, AD not entirely cleared, light pink residual lesions; 2 = mild, AD with light red lesions; 3 = moderate, AD with red lesions; 4 = severe, AD with deep dark red lesions. |
| Secondary | Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=50% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period | Baseline, Weeks 12, 16, 28, 40 and 52 | EASI quantifies severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of BSA affected. Severity of clinical signs of AD (erythema \[E\], induration/papulation \[I\], excoriation \[Ex\] and lichenification \[L\]) was scored separately for each of 4 body regions (head and neck \[h\], upper limbs \[u\], trunk \[t\] \[including axillae and groin\] and lower limbs \[l\] \[including buttocks\]) on 4-point scale: 0 = absent; 1 = mild; 2 = moderate; 3 = severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score = 0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll); where A = area score. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD. |
| Secondary | Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=75% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period | Baseline, Weeks 12, 16, 28, 40 and 52 | EASI quantifies severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of BSA affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\] and lower limbs \[including buttocks\]) on 4-point scale: 0 = absent; 1 = mild; 2 = moderate; 3 = severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score = 0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll). Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD. |
| Secondary | Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=90% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period | Baseline, Weeks 12, 16, 28, 40 and 52 | EASI quantifies severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of BSA affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\] and lower limbs \[including buttocks\]) on 4-point scale: 0 = absent; 1 = mild; 2 = moderate; 3 = severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score = 0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll). Total EASI score ranged from 0.0 to 72.0, higher scores=greater severity of AD. |
| Secondary | Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=100% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period | Baseline, Weeks 12, 16, 28, 40 and 52 | EASI quantifies severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of BSA affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\] and lower limbs \[including buttocks\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll). Total EASI score ranged from 0.0 to 72.0, higher scores=greater severity of AD. |
| Secondary | Percentage of Participants With Greater Than or Equal 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period | Baseline, Weeks 12, 16, 28, 40 and 52 | Participants were asked to assess their worst itching due to AD over the past 24 hours on an NRS scale ranged from 0 (no itch) to 10 (worst itch imaginable), where higher scores indicated worse disease status. |
| Secondary | Percent Change From Baseline in Body Surface Area (BSA) at Weeks 12, 16, 28, 40 and 52: Double-blind Period | Baseline, Weeks 12, 16, 28, 40 and 52 | 4 body regions evaluated: head and neck, upper limbs, trunk (including axillae, groin/genitals), lower limbs (including buttocks) excluding scalp, palms, soles. BSA calculated by handprint method. Number (No) of handprints (size of participant's hand with fingers in closed position) fitting in affected area of a body region was estimated. Maximum No of handprints were 10, 20, 30, 40 for head and neck, upper limbs, trunk, and lower limbs respectively. Surface area (SA) of body region equivalent to 1 handprint: 1 handprint=10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. %Change BSA for a body region was calculated as=total No of handprints in a body region\* %SA equivalent to 1 handprint. %BSA for an individual: arithmetic mean of %BSA of all 4 body regions, ranged from 0-100%, higher values=greater AD severity. |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 registered outcomesOutcomes28
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Loss of Response: Double-blind (DB) Period | From Day 1 of up to Week 40 of double blind period | Full analysis set-randomized (FAS-RA) included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Missing event times were considered as right censored (CAR) on last date of randomized treatment. | percentage of participants | NUMBER |
| SECONDARY | Time to First Loss of Response Based on Investigator's Global Assessment (IGA) Score of 2 or Higher: Double-blind Period | From date of first dose of randomized treatment until the last dose of randomized treatment (if not entered rescue) or first day of rescue treatment (if entered rescue) (maximum up to Week 40, visit window +/- 7 Days) | FAS-RA included as all participants who were randomized at Week 12 and received at least one dose of study medication within the double-blind phase. Missing event times were considered as right censored (CAR) on last date of randomized treatment. Here, Overall 'Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | days | MEDIAN |
| SECONDARY | Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and a Reduction of Greater Than or Equal to (>=) 2 Points From Baseline at Weeks 12, 16, 28, 40, and 52: Double-blind Period | Baseline, Weeks 12, 16, 28, 40 and 52 | FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified time points. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=50% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period | Baseline, Weeks 12, 16, 28, 40 and 52 | FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for specified time points. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=75% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period | Baseline, Weeks 12, 16, 28, 40 and 52 | FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for specified time points. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=90% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period | Baseline, Weeks 12, 16, 28, 40 and 52 | FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for specified time points. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=100% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period | Baseline, Weeks 12, 16, 28, 40 and 52 | FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for specified time points. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Greater Than or Equal 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period | Baseline, Weeks 12, 16, 28, 40 and 52 | FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for specified time points. | percentage of participants | NUMBER |
| SECONDARY | Percent Change From Baseline in Body Surface Area (BSA) at Weeks 12, 16, 28, 40 and 52: Double-blind Period | Baseline, Weeks 12, 16, 28, 40 and 52 | FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for specified time points. | percent change | MEDIAN |
| SECONDARY | Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period | Baseline, Weeks 12, 16, 28, 40 and 52 | FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for specified time points. | percent change | MEDIAN |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 outcomesResults by group326
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Loss of Response: Double-blind (DB) Period | PF-04965842 200 mg OL to Placebo DB | 77.5 | percentage of participants | ||
| Percentage of Participants With Loss of Response: Double-blind (DB) Period | PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB | 39.6 | percentage of participants | ||
| Percentage of Participants With Loss of Response: Double-blind (DB) Period | PF-04965842 200 mg OL to PF-04965842 200 mg DB | 16.5 | percentage of participants | ||
| Time to First Loss of Response Based on Investigator's Global Assessment (IGA) Score of 2 or Higher: Double-blind Period | PF-04965842 200 mg OL to Placebo DB | 27.0 | 95% Confidence Interval 26.0 | days | |
| Time to First Loss of Response Based on Investigator's Global Assessment (IGA) Score of 2 or Higher: Double-blind Period | PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB | 78.0 | 95% Confidence Interval 32.0 | days | |
| Time to First Loss of Response Based on Investigator's Global Assessment (IGA) Score of 2 or Higher: Double-blind Period | PF-04965842 200 mg OL to PF-04965842 200 mg DB | 201.0 | 95% Confidence Interval 177.0 | days | |
Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and a Reduction of Greater Than or Equal to (>=) 2 Points From Baseline at Weeks 12, 16, 28, 40, and 52: Double-blind Period | PF-04965842 200 mg OL to Placebo DB | Week 12 | 99.6 | 95% Confidence Interval 98.9 to 100.0 | percentage of participants |
Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and a Reduction of Greater Than or Equal to (>=) 2 Points From Baseline at Weeks 12, 16, 28, 40, and 52: Double-blind Period | PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB | Week 12 | 99.6 | 95% Confidence Interval 98.9 to 100.0 | percentage of participants |
Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and a Reduction of Greater Than or Equal to (>=) 2 Points From Baseline at Weeks 12, 16, 28, 40, and 52: Double-blind Period | PF-04965842 200 mg OL to PF-04965842 200 mg DB | Week 12 | 99.2 | 95% Confidence Interval 98.2 to 100.0 | percentage of participants |
Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and a Reduction of Greater Than or Equal to (>=) 2 Points From Baseline at Weeks 12, 16, 28, 40, and 52: Double-blind Period | PF-04965842 200 mg OL to Placebo DB | Week 16 | 15.4 | 95% Confidence Interval 11.0 to 19.7 | percentage of participants |
1 to 10 of 326Source ClinicalTrials.gov
See all 326 results by groupParticipant flow70
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Open-label (OL) Run-in Period (12 Weeks) | STARTED | PF-04965842 200 mg OL | 1,235 | |
| Open-label (OL) Run-in Period (12 Weeks) | STARTED | PF-04965842 200 mg OL to Placebo DB | 0 | |
| Open-label (OL) Run-in Period (12 Weeks) | STARTED | PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB | 0 | |
| Open-label (OL) Run-in Period (12 Weeks) | STARTED | PF-04965842 200 mg OL to PF-04965842 200 mg DB | 0 | |
| Open-label (OL) Run-in Period (12 Weeks) | STARTED | PF-04965842 200 mg Rescue Period | 0 | |
| Open-label (OL) Run-in Period (12 Weeks) | Treated | PF-04965842 200 mg OL | 1,233 | |
| Open-label (OL) Run-in Period (12 Weeks) | Treated | PF-04965842 200 mg OL to Placebo DB | 0 | |
| Open-label (OL) Run-in Period (12 Weeks) | Treated | PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB | 0 | |
| Open-label (OL) Run-in Period (12 Weeks) | Treated | PF-04965842 200 mg OL to PF-04965842 200 mg DB | 0 | |
| Open-label (OL) Run-in Period (12 Weeks) | Treated | PF-04965842 200 mg Rescue Period | 0 |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 participant flowAdverse events240
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Blood creatine phosphokinase increased | Investigations | PF-04965842 200 mg OL | 43 | 1,233 | |
| other | Blood creatine phosphokinase increased | Investigations | PF-04965842 200 mg OL to Placebo DB | 11 | 267 | |
| other | Blood creatine phosphokinase increased | Investigations | PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB | 18 | 265 | |
| other | Blood creatine phosphokinase increased | Investigations | PF-04965842 200 mg OL to PF-04965842 200 mg DB | 25 | 266 | |
| other | Blood creatine phosphokinase increased | Investigations | PF-04965842 200 mg Rescue Period | 9 | 351 | |
| other | Headache | Nervous system disorders | PF-04965842 200 mg OL | 119 | 1,233 | |
| other | Headache | Nervous system disorders | PF-04965842 200 mg OL to Placebo DB | 31 | 267 | |
| other | Headache | Nervous system disorders | PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB | 24 | 265 | |
| other | Headache | Nervous system disorders | PF-04965842 200 mg OL to PF-04965842 200 mg DB | 31 | 266 | |
| other | Headache | Nervous system disorders | PF-04965842 200 mg Rescue Period | 12 | 351 |
1 to 10 of 240Source ClinicalTrials.gov
See all 240 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PF-04965842 200 mg OL | 1 | 1,233 |
| Total, all-cause mortality | PF-04965842 200 mg OL to Placebo DB | 0 | 267 |
| Total, all-cause mortality | PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB | 0 | 265 |
| Total, all-cause mortality | PF-04965842 200 mg OL to PF-04965842 200 mg DB | 0 | 266 |
| Total, all-cause mortality | PF-04965842 200 mg Rescue Period | 0 | 351 |
| Total, other adverse events | PF-04965842 200 mg OL | 482 | 1,233 |
| Total, other adverse events | PF-04965842 200 mg OL to Placebo DB | 158 | 267 |
| Total, other adverse events | PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB | 130 | 265 |
| Total, other adverse events | PF-04965842 200 mg OL to PF-04965842 200 mg DB | 152 | 266 |
| Total, other adverse events | PF-04965842 200 mg Rescue Period | 75 | 351 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers7
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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Read this trial from software.
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GET https://conductscience.org/api/trials/v1/NCT03627767/registered?page=2