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| ID | Type | Description | Link |
|---|---|---|---|
| B1771005 |
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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To evaluate the preliminary activity and pharmacokinetics of 2 separate doses and schedules of orally administered Temsirolimus (CCI-779) given in combination with daily letrozole, compared to letrozole alone, in the treatment of locally advanced or metastatic breast cancer in postmenopausal women. All patients must be appropriate to receive endocrine therapy as treatment for advanced disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Experimental |
| |
| C | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Letrozole / Temsirolimus (CCI-779) | Drug | Letrozole 2.5 mg daily + Temsirolimus (CCI-779) 10 mg daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Objective Response (OR) | OR measured as Complete response (CR) or Partial response (PR) confirmed by assessments performed no less than 4 weeks after the criteria for the response are first met. CR=disappearance of all target and non-target lesions with normalization of tumor marker level; PR=at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, referencing the screening sum LD. Target lesions=all measurable lesions up to 5 lesions per organ (10 lesions in total), representative of all involved organs, if possible; recorded and measured at screening. Non-target lesions=all other lesions. | Baseline, every 4 cycles (1 cycle is defined as a 14 day duration) up to Cycle 25, then every 6 cycles until disease progression |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Best Overall Response (Clinical Benefit) | Best response (CR, PR, or stable disease (SD) lasting ≥6 months) recorded from baseline to disease progression or recurrence (Progressive disease [PD]). CR=disappearance of all target and non-target lesions with normalization of tumor marker level; PR is ≥30% decrease in sum of LD of target lesions; SD=neither sufficient shrinkage to=PR nor sufficient increase to=PD, referencing smallest sum LD since treatment started; PD is ≥20% increase in sum of LD of target lesions referencing smallest sum of LD; appearance of ≥1 new lesions and/or unequivocal progression of existing non-target lesions. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
Not provided
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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In the initial protocol, doses of CCI-779 were 25 mg daily and 75 mg intermittent; per protocol amendment, dosing was modified to 10 mg daily and 30 mg intermittent. All dose levels are included in the reporting groups.
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| ID | Title | Description |
|---|---|---|
| FG000 | Let 2.5 mg Plus 10 mg Daily CCI-779 | Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779). |
| FG001 | Let 2.5 mg Plus 30 mg Intermittent CCI-779 | Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779). |
| FG002 | Let 2.5 mg Alone / Cross-over to 75 mg Intermittent CCI-779 | Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent 75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779). |
| FG003 | Let 2.5 mg Plus 25mg Daily CCI-779 | Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779). |
| FG004 | Let 2.5 mg Plus 75 mg Intermittent CCI-779 | Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Let 2.5 mg Plus 10 mg Daily CCI-779 | Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779). |
| BG001 | Let 2.5 mg Plus 30 mg Intermittent CCI-779 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 | Percentage of Participants With Objective Response (OR) | OR measured as Complete response (CR) or Partial response (PR) confirmed by assessments performed no less than 4 weeks after the criteria for the response are first met. CR=disappearance of all target and non-target lesions with normalization of tumor marker level; PR=at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, referencing the screening sum LD. Target lesions=all measurable lesions up to 5 lesions per organ (10 lesions in total), representative of all involved organs, if possible; recorded and measured at screening. Non-target lesions=all other lesions. | Intent to treat population (ITT) defined as all participants randomized in the study. Final efficacy analysis was not conducted because the development of temsirolimus (CCI-779) for the treatment of breast cancer was terminated. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, every 4 cycles (1 cycle is defined as a 14 day duration) up to Cycle 25, then every 6 cycles until disease progression |
|
Not provided
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
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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 | Let 2.5 mg Plus 10 mg Daily CCI-779 | Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | General disorders | COSTART | Systematic Assessment | Organ System "General disorders" equivalent to COSTART "Body as a whole". |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthenia | General disorders | COSTART | Systematic Assessment |
Clinical development of oral temsirolimus for treatment of locally advanced or metastatic breast cancer was terminated by Wyeth based on the results of a phase 3 clinical study with the combination temsirolimus and letrozole.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.govCallCenter@pfizer.com |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000077289 | Letrozole |
| C401859 | temsirolimus |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 |
Not provided
Not provided
Not provided
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| Letrozole / Temsirolimus (CCI-779) |
| Drug |
Letrozole 2.5 mg daily + Temsirolimus (CCI-779) intermittent 30 mg daily for five days every 2 weeks |
|
|
| Letrozole | Drug | Letrozole 2.5 mg daily |
|
|
| Baseline, every 4 cycles (1 cycle is defined as a 14 day duration) up to Cycle 25, then every 6 cycles until disease progression) |
| Time to Disease Progression | Number of days to disease progression defined as the interval from the date of randomization until the first date that recurrence or progression is documented; progression (at least 20% increase in the sum of the LD of target lesions taking as reference the smallest sum of LD; appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions). | Baseline, every 4 cycles (1 cycle is defined as a 14 day duration) up to Cycle 25, then every 6 cycles until disease progression) |
| Time to Treatment Failure | Number of days to treatment failure defined as interval from start of treatment to first date of progressive disease (at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD since the treatment started; appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions) or death or discontinuation of treatment due to Adverse Event, censored at last evaluation. | Baseline until Progressive disease, death, or discontinuation of study treatment |
| Percentage of Participants Exhibiting Freedom From Progression | Freedom from progression defined as CR (disappearance of all target and non-target lesions with normalization of tumor marker level), PR (at least a 30% decrease in sum of the LD of target lesions taking as reference the screening sum LD), or SD (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD [at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD since the treatment started; appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions]). | Baseline, 8 weeks, 6 months, 12 months, and 24 months |
| Duration of Response | Duration of response is measured from the time measurement criteria are met for CR or PR (whichever status is recorded first) until the first date that reoccurrence or PD is objectively documented, taking as reference for PD the smallest measurements recorded since the treatment started. SD is measured from the start of the treatment until the criteria for disease progression are met, taking as reference the smallest measurements recorded since the treatment started; the minimal time interval for duration of SD is 8 weeks. | Baseline, every 4 cycles (1 cycle is defined as a 14 day duration) up to Cycle 25, then every 6 cycles until disease progression) |
| Number of Participants With Survival | Number of participants with survival (alive) in the interval from start of treatment to last contact for participant or death as a result of any cause. | Baseline, every 4 cycles (1 cycle is defined as a 14 day duration) until death |
| Health Outcomes Assessment: EuroQol (EQ-5D) Health State Profile Score | EQ-5D is a self-administered questionnaire to assess health-related quality of life in 5 domains (mobility, self care, usual activities, pain or discomfort, and anxiety or depression). Scores from the 5 domains are used to calculate the Health State Profile Score as a single index value; range: 0.0 (death) to 1.0 (perfect health); higher scores indicate a better health state. | Prior to baseline, Cycle 7 (Week 12) and final visit (within 15 days of stopping study treatment) |
| Health Outcomes Assessment: European Organization for Research and Treatment of Cancer Quality of Life Questionaire (EORTC QLQ) BR23 | Assess specificity of breast cancer symptoms relevant to participant's perceived quality of life (disease related symptoms of dry mouth, eye pain, hair loss, hot flushes, attractiveness, future health, sexual activity, arm or shoulder pain, breast pain, swollen breast, and skin problems on the breast). 23-item assessment of symptoms or problems during the past week (items 1-13 and 17-23) or during the past 4 weeks (items 14-16); range from 1 (not at all) to 4 (very much). Index scores transformed and range from 0 to 100; higher scores indicate higher level of functioning and quality of life. | Prior to baseline, Cycle 7 (Week 12) and final visit (within 15 days of stopping study treatment) |
| Number of Participants With Antitumor Response in Relation to Expression of Akt Phosphorylation, Cyclin D1, PTEN, and p27 | Number of participants with antitumor response (CR [disappearance of all target and non-target lesions with normalization of tumor marker level] or PR [at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, referencing the screening sum LD]) in relation to plasma levels of Akt phosphorylation, cyclin D1, PTEN, and p27. | Prior to baseline, after Cycle 4 (Week 8), after Cycle 8 (Week 14), and cross-over or final visit (within 15 days of stopping study treatment) |
| Area Under the Concentration-time Curve (AUC) Sum | Area under the concentration-time curve to infinity (AUC) measured as hours multiplied by nanograms divided by milliliters (hr*ng/mL) for CCI-779, sirolimus and letrozole. Sum is calculated as the sum of CCI-779 plus sirolimus AUCs (AUCsum). | Cycle 1 Day 1 (1 cycle is defined as a 14 day duration) , Cycle 3 Day 1, and Cycle 4 Day 1, Day 6, Day 9, Day 11, and Day 12 |
| 24-hour Trough Concentration (C Trough) | C trough in whole blood measured as nanograms per milliliter (ng/mL). | Cycle 1 Day 1 (1 cycle is defined as a 14 day duration) , Cycle 3 Day 1, and Cycle 4 Day 1, Day 6, Day 9, Day 11, and Day 12 |
| Adverse Event |
|
| Other |
|
| Withdrawal by Subject |
|
| Symptomatic deterioration |
|
| Death |
|
Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
| BG002 | Let 2.5 mg Alone / Cross-over to 75 mg Intermittent CCI-779 | Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent 75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779). |
| BG003 | Let 2.5 mg Plus 25mg Daily CCI-779 | Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779). |
| BG004 | Let 2.5 mg Plus 75 mg Intermittent CCI-779 | Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779). |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Number | participants |
|
| OG000 | Let 2.5 mg Plus 10 mg Daily CCI-779 | Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779). |
| OG001 | Let 2.5 mg Plus 30 mg Intermittent CCI-779 | Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779). |
| OG002 | Let 2.5 mg Alone / Cross-over to 75 mg Intermittent CCI-779 | Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent 75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779). |
| OG003 | Let 2.5 mg Plus 25mg Daily CCI-779 | Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779). |
| OG004 | Let 2.5 mg Plus 75 mg Intermittent CCI-779 | Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779). |
|
| Secondary | Percentage of Participants With Best Overall Response (Clinical Benefit) | Best response (CR, PR, or stable disease (SD) lasting ≥6 months) recorded from baseline to disease progression or recurrence (Progressive disease [PD]). CR=disappearance of all target and non-target lesions with normalization of tumor marker level; PR is ≥30% decrease in sum of LD of target lesions; SD=neither sufficient shrinkage to=PR nor sufficient increase to=PD, referencing smallest sum LD since treatment started; PD is ≥20% increase in sum of LD of target lesions referencing smallest sum of LD; appearance of ≥1 new lesions and/or unequivocal progression of existing non-target lesions. | ITT; Final efficacy analysis was not conducted. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, every 4 cycles (1 cycle is defined as a 14 day duration) up to Cycle 25, then every 6 cycles until disease progression) |
|
|
| Secondary | Time to Disease Progression | Number of days to disease progression defined as the interval from the date of randomization until the first date that recurrence or progression is documented; progression (at least 20% increase in the sum of the LD of target lesions taking as reference the smallest sum of LD; appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions). | ITT; Final efficacy analysis was not conducted. | Posted | Mean | Standard Deviation | days | Baseline, every 4 cycles (1 cycle is defined as a 14 day duration) up to Cycle 25, then every 6 cycles until disease progression) |
|
|
| Secondary | Time to Treatment Failure | Number of days to treatment failure defined as interval from start of treatment to first date of progressive disease (at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD since the treatment started; appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions) or death or discontinuation of treatment due to Adverse Event, censored at last evaluation. | ITT; Final efficacy analysis was not conducted. | Posted | Mean | Standard Deviation | days | Baseline until Progressive disease, death, or discontinuation of study treatment |
|
|
| Secondary | Percentage of Participants Exhibiting Freedom From Progression | Freedom from progression defined as CR (disappearance of all target and non-target lesions with normalization of tumor marker level), PR (at least a 30% decrease in sum of the LD of target lesions taking as reference the screening sum LD), or SD (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD [at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD since the treatment started; appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions]). | ITT; Final efficacy analysis was not conducted. | Posted | Number | percentage of participants | Baseline, 8 weeks, 6 months, 12 months, and 24 months |
|
|
| Secondary | Duration of Response | Duration of response is measured from the time measurement criteria are met for CR or PR (whichever status is recorded first) until the first date that reoccurrence or PD is objectively documented, taking as reference for PD the smallest measurements recorded since the treatment started. SD is measured from the start of the treatment until the criteria for disease progression are met, taking as reference the smallest measurements recorded since the treatment started; the minimal time interval for duration of SD is 8 weeks. | ITT; Final efficacy analysis was not conducted. | Posted | Mean | Standard Deviation | days | Baseline, every 4 cycles (1 cycle is defined as a 14 day duration) up to Cycle 25, then every 6 cycles until disease progression) |
|
|
| Secondary | Number of Participants With Survival | Number of participants with survival (alive) in the interval from start of treatment to last contact for participant or death as a result of any cause. | ITT; Final efficacy analysis was not conducted. | Posted | Number | participants | Baseline, every 4 cycles (1 cycle is defined as a 14 day duration) until death |
|
|
| Secondary | Health Outcomes Assessment: EuroQol (EQ-5D) Health State Profile Score | EQ-5D is a self-administered questionnaire to assess health-related quality of life in 5 domains (mobility, self care, usual activities, pain or discomfort, and anxiety or depression). Scores from the 5 domains are used to calculate the Health State Profile Score as a single index value; range: 0.0 (death) to 1.0 (perfect health); higher scores indicate a better health state. | ITT; Final efficacy analysis was not conducted. | Posted | Number | scores on a scale | Prior to baseline, Cycle 7 (Week 12) and final visit (within 15 days of stopping study treatment) |
|
|
| Secondary | Health Outcomes Assessment: European Organization for Research and Treatment of Cancer Quality of Life Questionaire (EORTC QLQ) BR23 | Assess specificity of breast cancer symptoms relevant to participant's perceived quality of life (disease related symptoms of dry mouth, eye pain, hair loss, hot flushes, attractiveness, future health, sexual activity, arm or shoulder pain, breast pain, swollen breast, and skin problems on the breast). 23-item assessment of symptoms or problems during the past week (items 1-13 and 17-23) or during the past 4 weeks (items 14-16); range from 1 (not at all) to 4 (very much). Index scores transformed and range from 0 to 100; higher scores indicate higher level of functioning and quality of life. | ITT; Final efficacy analysis was not conducted. | Posted | Number | scores on a scale | Prior to baseline, Cycle 7 (Week 12) and final visit (within 15 days of stopping study treatment) |
|
|
| Secondary | Number of Participants With Antitumor Response in Relation to Expression of Akt Phosphorylation, Cyclin D1, PTEN, and p27 | Number of participants with antitumor response (CR [disappearance of all target and non-target lesions with normalization of tumor marker level] or PR [at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, referencing the screening sum LD]) in relation to plasma levels of Akt phosphorylation, cyclin D1, PTEN, and p27. | ITT; Final analysis was not conducted. | Posted | Number | participants | Prior to baseline, after Cycle 4 (Week 8), after Cycle 8 (Week 14), and cross-over or final visit (within 15 days of stopping study treatment) |
|
|
| Secondary | Area Under the Concentration-time Curve (AUC) Sum | Area under the concentration-time curve to infinity (AUC) measured as hours multiplied by nanograms divided by milliliters (hr*ng/mL) for CCI-779, sirolimus and letrozole. Sum is calculated as the sum of CCI-779 plus sirolimus AUCs (AUCsum). | ITT; Final analysis was not conducted. | Posted | Mean | Standard Deviation | hr*ng/mL | Cycle 1 Day 1 (1 cycle is defined as a 14 day duration) , Cycle 3 Day 1, and Cycle 4 Day 1, Day 6, Day 9, Day 11, and Day 12 |
|
|
| Secondary | 24-hour Trough Concentration (C Trough) | C trough in whole blood measured as nanograms per milliliter (ng/mL). | ITT; Final analysis was not conducted. | Posted | Mean | Standard Deviation | ng/mL | Cycle 1 Day 1 (1 cycle is defined as a 14 day duration) , Cycle 3 Day 1, and Cycle 4 Day 1, Day 6, Day 9, Day 11, and Day 12 |
|
|
| 12 |
| 33 |
| 33 |
| 33 |
| EG001 | Let 2.5 mg Plus 30 mg Intermittent CCI-779 | Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779). | 10 | 30 | 30 | 30 |
| EG002 | Let 2.5 mg Alone Prior to Cross-over to 75 mg Intermit CCI-779 | Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent (intermit)75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779). Includes events reported prior to the cross-over date for cross-over participants. | 9 | 33 | 32 | 33 |
| EG003 | After Cross-over to 75 mg Intermittent CCI-779 | Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779). Includes events reported after the cross-over date for cross-over participants. | 1 | 18 | 16 | 18 |
| EG004 | Let 2.5 mg Plus 25mg Daily CCI-779 | Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779). | 2 | 6 | 6 | 6 |
| EG005 | Let 2.5 mg Plus 75 mg Intermittent CCI-779 | Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779). | 1 | 6 | 6 | 6 |
|
| Death | General disorders | COSTART | Systematic Assessment |
|
| Infection | General disorders | COSTART | Systematic Assessment |
|
| Sepsis | General disorders | COSTART | Systematic Assessment |
|
| Accidental injury | General disorders | COSTART | Systematic Assessment |
|
| Chest pain | General disorders | COSTART | Systematic Assessment |
|
| Septic shock | General disorders | COSTART | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | COSTART | Systematic Assessment | Organ System "Cardiac disorders" equivalent to COSTART "Cardiovascular system". |
|
| Atrial fibrillation | Cardiac disorders | COSTART | Systematic Assessment |
|
| Cardiomyopathy | Cardiac disorders | COSTART | Systematic Assessment |
|
| Congestive heart failure | Cardiac disorders | COSTART | Systematic Assessment |
|
| Coronary artery disorder | Cardiac disorders | COSTART | Systematic Assessment |
|
| Deep vein thrombosis | Cardiac disorders | COSTART | Systematic Assessment |
|
| Hematoma | Cardiac disorders | COSTART | Systematic Assessment |
|
| Hemorrhage | Cardiac disorders | COSTART | Systematic Assessment |
|
| Hypertension | Cardiac disorders | COSTART | Systematic Assessment |
|
| Peripheral vascular disorder | Cardiac disorders | COSTART | Systematic Assessment |
|
| Pulmonary embolus | Cardiac disorders | COSTART | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | COSTART | Systematic Assessment | Organ System "Gastrointestinal disorders" equivalent to COSTART "Digestive system". |
|
| Mucositis | Gastrointestinal disorders | COSTART | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | COSTART | Systematic Assessment |
|
| Duodenal ulcer | Gastrointestinal disorders | COSTART | Systematic Assessment |
|
| Gastroenteritis | Gastrointestinal disorders | COSTART | Systematic Assessment |
|
| Gastrointestinal carcinoma | Gastrointestinal disorders | COSTART | Systematic Assessment |
|
| Hepatic failure | Gastrointestinal disorders | COSTART | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | COSTART | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | COSTART | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | COSTART | Systematic Assessment |
|
| Stomach ulcer | Gastrointestinal disorders | COSTART | Systematic Assessment |
|
| Diabetes mellitus | Endocrine disorders | COSTART | Systematic Assessment | Organ System "Endocrine disorders" equivalent to COSTART "Endocrine system". |
|
| Anemia | Blood and lymphatic system disorders | COSTART | Systematic Assessment | Organ System "Blood and lymphatic system disorders" equivalent to COSTART "Hemic and lymphatic system". |
|
| Neutropenia | Blood and lymphatic system disorders | COSTART | Systematic Assessment |
|
| Hypercalcemia | Metabolism and nutrition disorders | COSTART | Systematic Assessment | Organ System "Metabolism and nutrition disorders" equivalent to COSTART "Metabolic and nutritional". |
|
| Hyperglycemia | Metabolism and nutrition disorders | COSTART | Systematic Assessment |
|
| Hypomagnesemia | Metabolism and nutrition disorders | COSTART | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | COSTART | Systematic Assessment | Organ System "Musculoskeletal and connective tissue disorders" equivalent to COSTART "Musculoskeletal system". |
|
| Spinal cord compression | Nervous system disorders | COSTART | Systematic Assessment | Organ System "Nervous system disorders" equivalent to COSTART "Nervous system". |
|
| Delirium | Nervous system disorders | COSTART | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | COSTART | Systematic Assessment | Organ System "Respiratory, thoracic, and mediastinal disorders" equivalent to COSTART "Respiratory system". |
|
| Lung edema | Respiratory, thoracic and mediastinal disorders | COSTART | Systematic Assessment |
|
| Lung infiltration NOS | Respiratory, thoracic and mediastinal disorders | COSTART | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | COSTART | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | COSTART | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | COSTART | Systematic Assessment |
|
| Acute kidney failure | Renal and urinary disorders | COSTART | Systematic Assessment | Organ System "Renal and urinary disorders" equivalent to COSTART "Urogenital system". |
|
| Hydronephrosis | Renal and urinary disorders | COSTART | Systematic Assessment |
|
| Reaction unevaluable | Investigations | COSTART | Systematic Assessment | Organ System "Investigations" equivalent to COSTART "Terms not classifiable". |
|
| Pain | General disorders | COSTART | Systematic Assessment |
|
| Headache | General disorders | COSTART | Systematic Assessment |
|
| Back pain | General disorders | COSTART | Systematic Assessment |
|
| Infection | General disorders | COSTART | Systematic Assessment |
|
| Abdominal pain | General disorders | COSTART | Systematic Assessment |
|
| Chest pain | General disorders | COSTART | Systematic Assessment |
|
| Fever | General disorders | COSTART | Systematic Assessment |
|
| Accidental injury | General disorders | COSTART | Systematic Assessment |
|
| Flu syndrome | General disorders | COSTART | Systematic Assessment |
|
| Neck pain | General disorders | COSTART | Systematic Assessment |
|
| Cellulitis | General disorders | COSTART | Systematic Assessment |
|
| Chills | General disorders | COSTART | Systematic Assessment |
|
| Face edema | General disorders | COSTART | Systematic Assessment |
|
| Pelvic pain | General disorders | COSTART | Systematic Assessment |
|
| Lab test abnormal | General disorders | COSTART | Systematic Assessment |
|
| Malaise | General disorders | COSTART | Systematic Assessment |
|
| Neoplasm | General disorders | COSTART | Systematic Assessment |
|
| Sepsis | General disorders | COSTART | Systematic Assessment |
|
| Allergic reaction | General disorders | COSTART | Systematic Assessment |
|
| Cyst | General disorders | COSTART | Systematic Assessment |
|
| Generalized edema | General disorders | COSTART | Systematic Assessment |
|
| Abscess | General disorders | COSTART | Systematic Assessment |
|
| Chest pain substernal | General disorders | COSTART | Systematic Assessment |
|
| General physical health deterioration | General disorders | COSTART | Systematic Assessment |
|
| Hypothermia | General disorders | COSTART | Systematic Assessment |
|
| Moniliasis | General disorders | COSTART | Systematic Assessment |
|
| Vasodilatation | Cardiac disorders | COSTART | Systematic Assessment |
|
| Hypertension | Cardiac disorders | COSTART | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | COSTART | Systematic Assessment |
|
| Hemorrhage | Cardiac disorders | COSTART | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | COSTART | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | COSTART | Systematic Assessment |
|
| Congestive heart failure | Cardiac disorders | COSTART | Systematic Assessment |
|
| Peripheral vascular disorder | Cardiac disorders | COSTART | Systematic Assessment |
|
| Spider vein | Cardiac disorders | COSTART | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | COSTART | Systematic Assessment |
|
| Cardiovascular physical finding | Cardiac disorders | COSTART | Systematic Assessment |
|
| Deep vein thrombosis | Cardiac disorders | COSTART | Systematic Assessment |
|
| Hypotension | Cardiac disorders | COSTART | Systematic Assessment |
|
| Migraine | Cardiac disorders | COSTART | Systematic Assessment |
|
| Palpitation | Cardiac disorders | COSTART | Systematic Assessment |
|
| Shock | Cardiac disorders | COSTART | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | COSTART | Systematic Assessment |
|
| Valvular heart disease | Cardiac disorders | COSTART | Systematic Assessment |
|
| Varicose vein | Cardiac disorders | COSTART | Systematic Assessment |
|
| Vascular disorder | Cardiac disorders | COSTART | Systematic Assessment |
|
| Ventricular extrasystoles | Cardiac disorders | COSTART | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | COSTART | Systematic Assessment |
|
| Phlebitis | Cardiac disorders | COSTART | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | COSTART | Systematic Assessment |
|
| Mucositis | Gastrointestinal disorders | COSTART | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | COSTART | Systematic Assessment |
|
| Anorexia | Gastrointestinal disorders | COSTART | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | COSTART | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | COSTART | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | COSTART | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | COSTART | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | COSTART | Systematic Assessment |
|
| Aphthous stomatitis | Gastrointestinal disorders | COSTART | Systematic Assessment |
|
| Gastroenteritis | Gastrointestinal disorders | COSTART | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | COSTART | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | COSTART | Systematic Assessment |
|
| Gingivitis | Gastrointestinal disorders | COSTART | Systematic Assessment |
|
| Oral moniliasis | Gastrointestinal disorders | COSTART | Systematic Assessment |
|
| Rectal disorder | Gastrointestinal disorders | COSTART | Systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | COSTART | Systematic Assessment |
|
| Gamma glutamyl transpeptidase increased | Gastrointestinal disorders | COSTART | Systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | COSTART | Systematic Assessment |
|
| Glossitis | Gastrointestinal disorders | COSTART | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | COSTART | Systematic Assessment |
|
| Mouth pain | Gastrointestinal disorders | COSTART | Systematic Assessment |
|
| Stomach ulcer | Gastrointestinal disorders | COSTART | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | COSTART | Systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | COSTART | Systematic Assessment |
|
| Esophagitis | Gastrointestinal disorders | COSTART | Systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | COSTART | Systematic Assessment |
|
| Gastrointestinal physical finding | Gastrointestinal disorders | COSTART | Systematic Assessment |
|
| Gum hemorrhage | Gastrointestinal disorders | COSTART | Systematic Assessment |
|
| Gum hyperplasia | Gastrointestinal disorders | COSTART | Systematic Assessment |
|
| Hepatitis | Gastrointestinal disorders | COSTART | Systematic Assessment |
|
| Hiatal hernia | Gastrointestinal disorders | COSTART | Systematic Assessment |
|
| Periodontal abscess | Gastrointestinal disorders | COSTART | Systematic Assessment |
|
| Rectal hemorrhage | Gastrointestinal disorders | COSTART | Systematic Assessment |
|
| Stools abnormal | Gastrointestinal disorders | COSTART | Systematic Assessment |
|
| Tooth disorder | Gastrointestinal disorders | COSTART | Systematic Assessment |
|
| Esophageal stenosis | Gastrointestinal disorders | COSTART | Systematic Assessment |
|
| Diabetes mellitus | Endocrine disorders | COSTART | Systematic Assessment |
|
| Goiter | Endocrine disorders | COSTART | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | COSTART | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | COSTART | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | COSTART | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | COSTART | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | COSTART | Systematic Assessment |
|
| Lymphedema | Blood and lymphatic system disorders | COSTART | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | COSTART | Systematic Assessment |
|
| Ecchymosis | Blood and lymphatic system disorders | COSTART | Systematic Assessment |
|
| Granulocytosis | Blood and lymphatic system disorders | COSTART | Systematic Assessment |
|
| Iron deficiency anemia | Blood and lymphatic system disorders | COSTART | Systematic Assessment |
|
| Monocytosis | Blood and lymphatic system disorders | COSTART | Systematic Assessment |
|
| Peripheral edema | Metabolism and nutrition disorders | COSTART | Systematic Assessment |
|
| Hyperlipemia | Metabolism and nutrition disorders | COSTART | Systematic Assessment |
|
| Hypercholesteremia | Metabolism and nutrition disorders | COSTART | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | COSTART | Systematic Assessment |
|
| Weight loss | Metabolism and nutrition disorders | COSTART | Systematic Assessment |
|
| SGOT increased | Metabolism and nutrition disorders | COSTART | Systematic Assessment |
|
| SGPT increased | Metabolism and nutrition disorders | COSTART | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | COSTART | Systematic Assessment |
|
| Edema | Metabolism and nutrition disorders | COSTART | Systematic Assessment |
|
| Hypophosphatemia | Metabolism and nutrition disorders | COSTART | Systematic Assessment |
|
| Lactic dehydrogenase increased | Metabolism and nutrition disorders | COSTART | Systematic Assessment |
|
| Alkaline phosphatase increased | Metabolism and nutrition disorders | COSTART | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | COSTART | Systematic Assessment |
|
| Creatinine increased | Metabolism and nutrition disorders | COSTART | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | COSTART | Systematic Assessment |
|
| Hypercalcemia | Metabolism and nutrition disorders | COSTART | Systematic Assessment |
|
| Hyperchloremia | Metabolism and nutrition disorders | COSTART | Systematic Assessment |
|
| Hyperuricemia | Metabolism and nutrition disorders | COSTART | Systematic Assessment |
|
| BUN increased | Metabolism and nutrition disorders | COSTART | Systematic Assessment |
|
| Hypomagnesemia | Metabolism and nutrition disorders | COSTART | Systematic Assessment |
|
| Bilirubinemia | Metabolism and nutrition disorders | COSTART | Systematic Assessment |
|
| Hypernatremia | Metabolism and nutrition disorders | COSTART | Systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | COSTART | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | COSTART | Systematic Assessment |
|
| Hypoproteinemia | Metabolism and nutrition disorders | COSTART | Systematic Assessment |
|
| Weight gain | Metabolism and nutrition disorders | COSTART | Systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | COSTART | Systematic Assessment |
|
| Hypochloremia | Metabolism and nutrition disorders | COSTART | Systematic Assessment |
|
| Respiratory acidosis | Metabolism and nutrition disorders | COSTART | Systematic Assessment |
|
| Thirst | Metabolism and nutrition disorders | COSTART | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | COSTART | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | COSTART | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | COSTART | Systematic Assessment |
|
| Arthrosis | Musculoskeletal and connective tissue disorders | COSTART | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | COSTART | Systematic Assessment |
|
| Joint disorder | Musculoskeletal and connective tissue disorders | COSTART | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | COSTART | Systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | COSTART | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | COSTART | Systematic Assessment |
|
| Leg cramps | Musculoskeletal and connective tissue disorders | COSTART | Systematic Assessment |
|
| Musculoskeletal anomaly | Musculoskeletal and connective tissue disorders | COSTART | Systematic Assessment |
|
| Osteopenia | Musculoskeletal and connective tissue disorders | COSTART | Systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | COSTART | Systematic Assessment |
|
| Tenosynovitis | Musculoskeletal and connective tissue disorders | COSTART | Systematic Assessment |
|
| Bone necrosis | Musculoskeletal and connective tissue disorders | COSTART | Systematic Assessment |
|
| Coccydynia | Musculoskeletal and connective tissue disorders | COSTART | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | COSTART | Systematic Assessment |
|
| Myasthenia | Musculoskeletal and connective tissue disorders | COSTART | Systematic Assessment |
|
| Tetany | Musculoskeletal and connective tissue disorders | COSTART | Systematic Assessment |
|
| Tendon disorder | Musculoskeletal and connective tissue disorders | COSTART | Systematic Assessment |
|
| Insomnia | Nervous system disorders | COSTART | Systematic Assessment |
|
| Depression | Nervous system disorders | COSTART | Systematic Assessment |
|
| Paresthesia | Nervous system disorders | COSTART | Systematic Assessment |
|
| Dizziness | Nervous system disorders | COSTART | Systematic Assessment |
|
| Anxiety | Nervous system disorders | COSTART | Systematic Assessment |
|
| Vertigo | Nervous system disorders | COSTART | Systematic Assessment |
|
| Somnolence | Nervous system disorders | COSTART | Systematic Assessment |
|
| Hypesthesia | Nervous system disorders | COSTART | Systematic Assessment |
|
| Ataxia | Nervous system disorders | COSTART | Systematic Assessment |
|
| Carpal tunnel syndrome | Nervous system disorders | COSTART | Systematic Assessment |
|
| Emotional lability | Nervous system disorders | COSTART | Systematic Assessment |
|
| Hyperesthesia | Nervous system disorders | COSTART | Systematic Assessment |
|
| Neuropathic pain | Nervous system disorders | COSTART | Systematic Assessment |
|
| Neuropathy | Nervous system disorders | COSTART | Systematic Assessment |
|
| Tremor | Nervous system disorders | COSTART | Systematic Assessment |
|
| Abnormal gait | Nervous system disorders | COSTART | Systematic Assessment |
|
| Confusion | Nervous system disorders | COSTART | Systematic Assessment |
|
| Facial paralysis | Nervous system disorders | COSTART | Systematic Assessment |
|
| Hostility | Nervous system disorders | COSTART | Systematic Assessment |
|
| Hypotonia | Nervous system disorders | COSTART | Systematic Assessment |
|
| Incoordination | Nervous system disorders | COSTART | Systematic Assessment |
|
| Libido decreased | Nervous system disorders | COSTART | Systematic Assessment |
|
| emory impairment | Nervous system disorders | COSTART | Systematic Assessment |
|
| Nervousness | Nervous system disorders | COSTART | Systematic Assessment |
|
| Neuralgia | Nervous system disorders | COSTART | Systematic Assessment |
|
| Neuritis | Nervous system disorders | COSTART | Systematic Assessment |
|
| Parkinson's disease | Nervous system disorders | COSTART | Systematic Assessment |
|
| Phantom pain | Nervous system disorders | COSTART | Systematic Assessment |
|
| Ptosis | Nervous system disorders | COSTART | Systematic Assessment |
|
| Speech disorder | Nervous system disorders | COSTART | Systematic Assessment |
|
| Thinking abnormal | Nervous system disorders | COSTART | Systematic Assessment |
|
| Abnormal dreams | Nervous system disorders | COSTART | Systematic Assessment |
|
| Restless legs syndrome | Nervous system disorders | COSTART | Systematic Assessment |
|
| Stupor | Nervous system disorders | COSTART | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | COSTART | Systematic Assessment |
|
| Cough increased | Respiratory, thoracic and mediastinal disorders | COSTART | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | COSTART | Systematic Assessment |
|
| Pharyngitis | Respiratory, thoracic and mediastinal disorders | COSTART | Systematic Assessment |
|
| Rhinitis | Respiratory, thoracic and mediastinal disorders | COSTART | Systematic Assessment |
|
| Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | COSTART | Systematic Assessment |
|
| Sinusitis | Respiratory, thoracic and mediastinal disorders | COSTART | Systematic Assessment |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | COSTART | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | COSTART | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | COSTART | Systematic Assessment |
|
| Voice alteration | Respiratory, thoracic and mediastinal disorders | COSTART | Systematic Assessment |
|
| Lung infiltration NOS | Respiratory, thoracic and mediastinal disorders | COSTART | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | COSTART | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | COSTART | Systematic Assessment |
|
| Laryngitis | Respiratory, thoracic and mediastinal disorders | COSTART | Systematic Assessment |
|
| Nose dryness | Respiratory, thoracic and mediastinal disorders | COSTART | Systematic Assessment |
|
| Sputum increased | Respiratory, thoracic and mediastinal disorders | COSTART | Systematic Assessment |
|
| Apnea | Respiratory, thoracic and mediastinal disorders | COSTART | Systematic Assessment |
|
| Hemoptysis | Respiratory, thoracic and mediastinal disorders | COSTART | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | COSTART | Systematic Assessment |
|
| Lung disorder | Respiratory, thoracic and mediastinal disorders | COSTART | Systematic Assessment |
|
| Lung fibrosis | Respiratory, thoracic and mediastinal disorders | COSTART | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | COSTART | Systematic Assessment |
|
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | COSTART | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | COSTART | Systematic Assessment |
|
| Pulmonary physical finding | Respiratory, thoracic and mediastinal disorders | COSTART | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | COSTART | Systematic Assessment | Organ System "Skin and subcutaneous tissue disorders" equivalent to COSTART "Skin and appendages". |
|
| Nail disorder | Skin and subcutaneous tissue disorders | COSTART | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | COSTART | Systematic Assessment |
|
| Skin disorder | Skin and subcutaneous tissue disorders | COSTART | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | COSTART | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | COSTART | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | COSTART | Systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | COSTART | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | COSTART | Systematic Assessment |
|
| Fungal dermatitis | Skin and subcutaneous tissue disorders | COSTART | Systematic Assessment |
|
| Maculopapular rash | Skin and subcutaneous tissue disorders | COSTART | Systematic Assessment |
|
| Sweating | Skin and subcutaneous tissue disorders | COSTART | Systematic Assessment |
|
| Exfoliative dermatitis | Skin and subcutaneous tissue disorders | COSTART | Systematic Assessment |
|
| Folliculitis | Skin and subcutaneous tissue disorders | COSTART | Systematic Assessment |
|
| Herpes simplex | Skin and subcutaneous tissue disorders | COSTART | Systematic Assessment |
|
| Pruritic rash | Skin and subcutaneous tissue disorders | COSTART | Systematic Assessment |
|
| Skin discoloration | Skin and subcutaneous tissue disorders | COSTART | Systematic Assessment |
|
| Herpes zoster | Skin and subcutaneous tissue disorders | COSTART | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | COSTART | Systematic Assessment |
|
| Pustular rash | Skin and subcutaneous tissue disorders | COSTART | Systematic Assessment |
|
| Skin hypertrophy | Skin and subcutaneous tissue disorders | COSTART | Systematic Assessment |
|
| Vesiculobullous rash | Skin and subcutaneous tissue disorders | COSTART | Systematic Assessment |
|
| Hirsutism | Skin and subcutaneous tissue disorders | COSTART | Systematic Assessment |
|
| Melanosis | Skin and subcutaneous tissue disorders | COSTART | Systematic Assessment |
|
| Skin necrosis | Skin and subcutaneous tissue disorders | COSTART | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | COSTART | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | COSTART | Systematic Assessment | Organ System "Eye disorders" equivalent to COSTART "Special senses". |
|
| Abnormal vision | Eye disorders | COSTART | Systematic Assessment |
|
| Eye disorder | Eye disorders | COSTART | Systematic Assessment |
|
| Dry eyes | Eye disorders | COSTART | Systematic Assessment |
|
| Cataract specified | Eye disorders | COSTART | Systematic Assessment |
|
| Eye pain | Eye disorders | COSTART | Systematic Assessment |
|
| Glaucoma | Eye disorders | COSTART | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | COSTART | Systematic Assessment | Organ System "Ear and labyrinth disorders" equivalent to COSTART "Special senses". |
|
| Ear disorder | Ear and labyrinth disorders | COSTART | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | COSTART | Systematic Assessment |
|
| Deafness | Ear and labyrinth disorders | COSTART | Systematic Assessment |
|
| Otitis externa | Ear and labyrinth disorders | COSTART | Systematic Assessment |
|
| Urinary tract infection | Renal and urinary disorders | COSTART | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | COSTART | Systematic Assessment |
|
| Cystitis | Renal and urinary disorders | COSTART | Systematic Assessment |
|
| Vaginal moniliasis | Renal and urinary disorders | COSTART | Systematic Assessment |
|
| Vaginal dryness | Renal and urinary disorders | COSTART | Systematic Assessment |
|
| Metrorrhagia | Renal and urinary disorders | COSTART | Systematic Assessment |
|
| Vaginal hemorrhage | Renal and urinary disorders | COSTART | Systematic Assessment |
|
| Breast pain | Renal and urinary disorders | COSTART | Systematic Assessment |
|
| Leukorrhea | Renal and urinary disorders | COSTART | Systematic Assessment |
|
| Endometrial hyperplasia | Renal and urinary disorders | COSTART | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | COSTART | Systematic Assessment |
|
| Polyuria | Renal and urinary disorders | COSTART | Systematic Assessment |
|
| Urinary frequency | Renal and urinary disorders | COSTART | Systematic Assessment |
|
| Urinary hesitation | Renal and urinary disorders | COSTART | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | COSTART | Systematic Assessment |
|
| Urine abnormality | Renal and urinary disorders | COSTART | Systematic Assessment |
|
| Vaginitis | Renal and urinary disorders | COSTART | Systematic Assessment |
|
| Vulvovaginal disorder | Renal and urinary disorders | COSTART | Systematic Assessment |
|
| Reaction unevaluable | Investigations | COSTART | Systematic Assessment | Organ System "Investigations" equivalent to COSTART "Terms not classifiable". |
|
| Local reaction to procedure | Investigations | COSTART | Systematic Assessment | Organ System "Investigations" equivalent to COSTART "Adverse event associated with miscellaneous factors". |
|
| Allergic reaction other than drug | Investigations | COSTART | Systematic Assessment |
|
| Laboratory events not classified | Investigations | COSTART | Systematic Assessment |
|
| Taste loss | Nervous system disorders | COSTART | Systematic Assessment |
|
| Taste perversion | Nervous system disorders | COSTART | Systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |