Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This post-marketing observational study (PMOS) will be conducted in a prospective, single-arm, single-country, multicenter format. The investigational sites will be consulting rooms of GPs (general practitioner), pneumologists and centers with experience in the treatment of patients with acute infections of trachea, bronchi, AECB (acute exacerbation of chronic bronchitis) and CAP (mild community-acquired pneumonia). Since this will be a post-marketing observational study, Klacid SR will be prescribed in usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. Objective: to describe the effectiveness of the treatment with repeated administration of Klacid SR in patients with acute tracheitis, acute tracheobronchitis or acute bronchitis; or in patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose administered within this study.
Follow-up of participants should enable three visits during this period. At the Screening Visit the decision for Klacid SR therapy in a dose of 500 -1000 mg once daily will be made. The Second Visit will occur 8 - 16 days after study initiation. The Last Visit will be a phone call to the participant after 30 days from the initiation of the treatment. Study visits will be defined as "V1" = Screening Visit, "V2" = Visit in which Klacid SR therapy will be terminated and "V3" = Phone call 30 days after initiation of Klacid SR therapy.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Respiratory Infections | Czech patients with acute tracheitis, acute tracheobronchitis or acute bronchitis; or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid®SR treatment 6 weeks prior to the next Klacid®SR dose or in intervals: 7-week - 3- month, 4- month - 12- month, 13- month - 24- month prior to the next Klacid®SR dose (next Klacid®SR dose = dose administered within this PMOS). |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Disappearance or Significant Alleviation of Symptoms | Overall therapeutic response, "yes" or "no" was determined by the physician based on subjective response regarding disappearance or significant alleviation of symptoms following treatment. The physician also considered objective findings such as auscultation and or chest X-ray results (if available) when determining overall therapeutic response. | Day 8 - 16 |
| Change in Auscultation Findings, Regression of Chest X-ray Findings (Recorded by the Physician) | Auscultation findings (abnormal breath sounds) were assessed at the initial visit (Day 0) and the second visit (Day 8 -16) by the physician. "Regression of chest X-ray findings" were not recorded as it is not part of routine clinical practice to confirm X-ray regression after the participant has clinically recovered from Community-Acquired Pneumonia (CAP). | Day 0, Day 8 - 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Body Temperature | Number of participants in which body temperature was increased (temperature above 37 degrees Celsius). | Day 0, Day 8-16 |
| Bacteriological Investigation (if Available) | The type of agent present in the infection was assessed using bacteriological investigation. Occurrence of the most common agents was reported. Participants may have had more than one pathogen present. Test results were not available prior to enrollment but were reported during the study. |
Not provided
Inclusion Criteria:
Men, women at least 18 years old.
Patients treated with Klacid®SR between 6 weeks and 24 months prior to start of the PMOS.
Patients:
Exclusion Criteria:
Not provided
Not provided
Not provided
patients with: acute tracheitis, acute tracheobronchitis or acute bronchitis, acute exacerbation of chronic bronchitis, mild community-acquired pneumonia
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Adam Hloska, M.D. | Abbott Laboratories, s.r.o. (Czech Republic) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 37381 | Bílina | 418 01 | Czechia | |||
| Site Reference ID/Investigator# 37391 |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Klacid SR Treatment | Adult Czech participants with acute tracheitis, acute tracheobronchitis or acute bronchitis; or participants with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose dose administered within this study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Day 0 |
| Cough and Its Character | Number of participants in which cough was present, and if present, type of cough (irritating, productive, both or not reported) | Day 0, Day 8-16 |
| Dyspnea and Its Type | Presence of dyspnea (difficulty breathing) and type of dyspnea (exertional, resting, both, or not reported). | Day 0, Day 8-16 |
| Auscultation | Participants with abnormal auscultation findings (abnormal breath sounds) and type of findings (wheezing, crackles, both, or not reported). | Day 0, Day 8-16 |
| Chest X-ray in Case of Community-Acquired Pneumonia (CAP) | Number of participants in which X-ray findings were suggestive of pneumonia. In participants where the physician suspected CAP, a chest X-ray was performed and reviewed to determine whether findings were indicative of pneumonia. | Day 0 |
| Study Drug Given as the First, Second or Third Antimicrobial Treatment | Number of participants who received Klacid SR as the first, second or third (further) antimicrobial agent. | Day 0 |
| Compliance | Number of participants who took their medication according to the prescribed regimen (dose and duration) during the study. | Day 8 - 16 |
| Termination of Treatment Due to Noncompliance | Number of participants who discontinued Klacid SR treatment early due to noncompliance with the recommended study medication regimen. | Day 8 - 16 |
| Bílina |
| 418 01 |
| Czechia |
| Site Reference ID/Investigator# 37282 | Blansko | 678 01 | Czechia |
| Site Reference ID/Investigator# 37324 | Blansko | 678 01 | Czechia |
| Site Reference ID/Investigator# 37424 | Boskovice | 680 01 | Czechia |
| Site Reference ID/Investigator# 37329 | Brandýs nad Labem | 250 01 | Czechia |
| Site Reference ID/Investigator# 37268 | Brno | 602 00 | Czechia |
| Site Reference ID/Investigator# 37299 | Brno | 602 00 | Czechia |
| Site Reference ID/Investigator# 37331 | Brno | 602 00 | Czechia |
| Site Reference ID/Investigator# 37396 | Brno | 602 00 | Czechia |
| Site Reference ID/Investigator# 37411 | Brno | 602 00 | Czechia |
| Site Reference ID/Investigator# 37403 | Brno | 60200 | Czechia |
| Site Reference ID/Investigator# 37380 | Brno | 616 00 | Czechia |
| Site Reference ID/Investigator# 37327 | Brno | 636 00 | Czechia |
| Site Reference ID/Investigator# 37443 | Břeclav | 690 02 | Czechia |
| Site Reference ID/Investigator# 37429 | Bučovice | 685 01 | Czechia |
| Site Reference ID/Investigator# 37444 | Bučovice | 685 01 | Czechia |
| Site Reference ID/Investigator# 37433 | Buštěhrad | 273 43 | Czechia |
| Site Reference ID/Investigator# 37362 | Cheb | 350 03 | Czechia |
| Site Reference ID/Investigator# 47286 | Cheb | 35002 | Czechia |
| Site Reference ID/Investigator# 37413 | Chrudim | 537 01 | Czechia |
| Site Reference ID/Investigator# 37374 | Čáslav | 286 01 | Czechia |
| Site Reference ID/Investigator# 37267 | České Budějovice | 370 01 | Czechia |
| Site Reference ID/Investigator# 37269 | České Budějovice | 370 01 | Czechia |
| Site Reference ID/Investigator# 37298 | České Budějovice | 370 01 | Czechia |
| Site Reference ID/Investigator# 37302 | České Budějovice | 370 01 | Czechia |
| Site Reference ID/Investigator# 37392 | České Budějovice | 370 05 | Czechia |
| Site Reference ID/Investigator# 37408 | České Budějovice | 370 87 | Czechia |
| Site Reference ID/Investigator# 37372 | Děčín | 405 01 | Czechia |
| Site Reference ID/Investigator# 37394 | Děčín | 40501 | Czechia |
| Site Reference ID/Investigator# 37263 | Holešov | 769 01 | Czechia |
| Site Reference ID/Investigator# 43230 | Holešov | 769 01 | Czechia |
| Site Reference ID/Investigator# 26623 | Hradec Králové | 500 02 | Czechia |
| Site Reference ID/Investigator# 37270 | Hradec Králové | 500 02 | Czechia |
| Site Reference ID/Investigator# 37371 | Hradec Králové | 500 02 | Czechia |
| Site Reference ID/Investigator# 43225 | Hradec Králové | 500 02 | Czechia |
| Site Reference ID/Investigator# 37367 | Hranice | 753 01 | Czechia |
| Site Reference ID/Investigator# 37274 | Hrádek | 338 42 | Czechia |
| Site Reference ID/Investigator# 37364 | Hřebeč | 273 45 | Czechia |
| Site Reference ID/Investigator# 37404 | Jablonec nad Nisou | 466 04 | Czechia |
| Site Reference ID/Investigator# 47283 | Jablonec nad Nisou | 468 01 | Czechia |
| Site Reference ID/Investigator# 43229 | Jaroměř | 551 02 | Czechia |
| Site Reference ID/Investigator# 37376 | Jindřichův Hradec | 377 01 | Czechia |
| Site Reference ID/Investigator# 37290 | Kaplice | 382 41 | Czechia |
| Site Reference ID/Investigator# 37369 | Karlovy Vary | 360 01 | Czechia |
| Site Reference ID/Investigator# 37445 | Karlovy Vary | 360 01 | Czechia |
| Site Reference ID/Investigator# 37363 | Karlovy Vary | 360 17 | Czechia |
| Site Reference ID/Investigator# 37283 | Kladno | 272 01 | Czechia |
| Site Reference ID/Investigator# 37382 | Kolín | 280 02 | Czechia |
| Site Reference ID/Investigator# 37368 | Konice | 798 52 | Czechia |
| Site Reference ID/Investigator# 37415 | Konice | 798 52 | Czechia |
| Site Reference ID/Investigator# 37272 | Kralovice | 331 41 | Czechia |
| Site Reference ID/Investigator# 42162 | Kunovice | 68604 | Czechia |
| Site Reference ID/Investigator# 43224 | Kyjov | 697 01 | Czechia |
| Site Reference ID/Investigator# 37323 | Letohrad | 561 51 | Czechia |
| Site Reference ID/Investigator# 37389 | Liberec | 460 01 | Czechia |
| Site Reference ID/Investigator# 37416 | Litomyšl | 570 01 | Czechia |
| Site Reference ID/Investigator# 37384 | Litvínov | 43542 | Czechia |
| Site Reference ID/Investigator# 37428 | Mariánské Lázně | 353 01 | Czechia |
| Site Reference ID/Investigator# 37289 | Mělník | 276 01 | Czechia |
| Site Reference ID/Investigator# 37293 | Městec Králové | 289 03 | Czechia |
| Site Reference ID/Investigator# 43228 | Mohelnice | 78985 | Czechia |
| Site Reference ID/Investigator# 43233 | Mohelnice | 78985 | Czechia |
| Site Reference ID/Investigator# 43227 | Moravská Třebová | 571 01 | Czechia |
| Site Reference ID/Investigator# 47290 | Most | Czechia |
| Site Reference ID/Investigator# 37297 | Neratovice | 277 11 | Czechia |
| Site Reference ID/Investigator# 37397 | Nový Bor | 473 01 | Czechia |
| Site Reference ID/Investigator# 37303 | Nový Jičín | 741 01 | Czechia |
| Site Reference ID/Investigator# 37400 | Nový Jičín | 741 01 | Czechia |
| Site Reference ID/Investigator# 37399 | Obříství | 277 42 | Czechia |
| Site Reference ID/Investigator# 37279 | Olomouc | 772 00 | Czechia |
| Site Reference ID/Investigator# 37280 | Olomouc | 772 00 | Czechia |
| Site Reference ID/Investigator# 37395 | Pardubice | 530 03 | Czechia |
| Site Reference ID/Investigator# 37271 | Pilsen | 301 00 | Czechia |
| Site Reference ID/Investigator# 37273 | Pilsen | 304 11 | Czechia |
| Site Reference ID/Investigator# 37423 | Pilsen | 323 00 | Czechia |
| Site Reference ID/Investigator# 37431 | Pilsen | 326 00 | Czechia |
| Site Reference ID/Investigator# 47284 | Planá | 348 15 | Czechia |
| Site Reference ID/Investigator# 37325 | Poděbrady | 290 01 | Czechia |
| Site Reference ID/Investigator# 47282 | Poděbrady | 290 01 | Czechia |
| Site Reference ID/Investigator# 37375 | Prague | 100 00 | Czechia |
| Site Reference ID/Investigator# 37398 | Prague | 120 00 | Czechia |
| Site Reference ID/Investigator# 37410 | Prague | 130 00 | Czechia |
| Site Reference ID/Investigator# 37387 | Prague | 140 00 | Czechia |
| Site Reference ID/Investigator# 37390 | Prague | 140 00 | Czechia |
| Site Reference ID/Investigator# 43232 | Prague | 140 00 | Czechia |
| Site Reference ID/Investigator# 43365 | Prague | 140 00 | Czechia |
| Site Reference ID/Investigator# 37288 | Prague | 141 00 | Czechia |
| Site Reference ID/Investigator# 37300 | Prague | 141 00 | Czechia |
| Site Reference ID/Investigator# 37301 | Prague | 141 00 | Czechia |
| Site Reference ID/Investigator# 37328 | Prague | 141 00 | Czechia |
| Site Reference ID/Investigator# 37330 | Prague | 141 00 | Czechia |
| Site Reference ID/Investigator# 37332 | Prague | 141 00 | Czechia |
| Site Reference ID/Investigator# 43236 | Prague | 142 00 | Czechia |
| Site Reference ID/Investigator# 37262 | Prague | 149 00 | Czechia |
| Site Reference ID/Investigator# 37295 | Prague | 150 00 | Czechia |
| Site Reference ID/Investigator# 37427 | Prague | 158 00 | Czechia |
| Site Reference ID/Investigator# 37275 | Prague | 160 00 | Czechia |
| Site Reference ID/Investigator# 37419 | Prague | 163 00 | Czechia |
| Site Reference ID/Investigator# 37438 | Prague | 169 00 | Czechia |
| Site Reference ID/Investigator# 37326 | Prague | 181 00 | Czechia |
| Site Reference ID/Investigator# 37414 | Prague | 190 00 | Czechia |
| Site Reference ID/Investigator# 47289 | Prague | 190 00 | Czechia |
| Site Reference ID/Investigator# 37291 | Prague | 198 00 | Czechia |
| Site Reference ID/Investigator# 37294 | Prague | 198 00 | Czechia |
| Site Reference ID/Investigator# 37437 | Prostějov | 796 01 | Czechia |
| Site Reference ID/Investigator# 37430 | Prostějov | 796 04 | Czechia |
| Site Reference ID/Investigator# 37378 | Příbor | 742 58 | Czechia |
| Site Reference ID/Investigator# 37412 | Příbor | 742 58 | Czechia |
| Site Reference ID/Investigator# 37432 | Příbram | 261 01 | Czechia |
| Site Reference ID/Investigator# 37425 | Příbram | 261 95 | Czechia |
| Site Reference ID/Investigator# 37442 | Rakovník | 269 29 | Czechia |
| Site Reference ID/Investigator# 37393 | Raspenava | 464 01 | Czechia |
| Site Reference ID/Investigator# 37421 | Rožnov pod Radhoštěm | 756 61 | Czechia |
| Site Reference ID/Investigator# 37287 | Sadová | 612 00 | Czechia |
| Site Reference ID/Investigator# 37406 | Šlapanice | 664 51 | Czechia |
| Site Reference ID/Investigator# 37383 | Štětí | 41108 | Czechia |
| Site Reference ID/Investigator# 37278 | Šumperk | 787 01 | Czechia |
| Site Reference ID/Investigator# 43223 | Šumperk | 78701 | Czechia |
| Site Reference ID/Investigator# 43234 | Šumperk | 78752 | Czechia |
| Site Reference ID/Investigator# 37285 | Tachov | 347 42 | Czechia |
| Site Reference ID/Investigator# 37386 | Teplice | 415 01 | Czechia |
| Site Reference ID/Investigator# 37264 | Třebíč | 674 01 | Czechia |
| Site Reference ID/Investigator# 37277 | Třebíč | 674 01 | Czechia |
| Site Reference ID/Investigator# 43231 | Třeboň | 379 01 | Czechia |
| Site Reference ID/Investigator# 37405 | Třinec | 739 61 | Czechia |
| Site Reference ID/Investigator# 43366 | Týn | 375 01 | Czechia |
| Site Reference ID/Investigator# 37265 | Týn nad Vltavou | 375 01 | Czechia |
| Site Reference ID/Investigator# 37434 | Uherské Hradiště | 686 01 | Czechia |
| Site Reference ID/Investigator# 37365 | Uherský Brod | 688 01 | Czechia |
| Site Reference ID/Investigator# 37284 | Velké Pavlovice | 691 06 | Czechia |
| Site Reference ID/Investigator# 37385 | Vlašim | 258 01 | Czechia |
| Site Reference ID/Investigator# 37366 | Zdar | 591 01 | Czechia |
| Site Reference ID/Investigator# 43235 | Zlín | 762 75 | Czechia |
| Site Reference ID/Investigator# 37322 | Žamberk | 56421 | Czechia |
| Participants Analyzed |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Klacid SR Treatment | Adult Czech participants with acute tracheitis, acute tracheobronchitis or acute bronchitis; or participants with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose dose administered within this study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| ||||||||||||||||||||||||||
| Sex/Gender, Customized | Gender was not reported in this study. | Number | Participants |
| |||||||||||||||||||||||||
| Region of Enrollment | Number | 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 | Disappearance or Significant Alleviation of Symptoms | Overall therapeutic response, "yes" or "no" was determined by the physician based on subjective response regarding disappearance or significant alleviation of symptoms following treatment. The physician also considered objective findings such as auscultation and or chest X-ray results (if available) when determining overall therapeutic response. | A total of 3130 participants were enrolled into the study and 3128 were included in the analysis. Two participants were excluded from the analysis as they did not meet entry criteria (2 participants were less than 18 years of age). | Posted | Number | Participants | Day 8 - 16 |
|
|
| ||||||||||||||||||||||||||
| Primary | Change in Auscultation Findings, Regression of Chest X-ray Findings (Recorded by the Physician) | Auscultation findings (abnormal breath sounds) were assessed at the initial visit (Day 0) and the second visit (Day 8 -16) by the physician. "Regression of chest X-ray findings" were not recorded as it is not part of routine clinical practice to confirm X-ray regression after the participant has clinically recovered from Community-Acquired Pneumonia (CAP). | Posted | Number | participants | Day 0, Day 8 - 16 |
|
| ||||||||||||||||||||||||||||
| Secondary | Body Temperature | Number of participants in which body temperature was increased (temperature above 37 degrees Celsius). | Of the 3128 participants included in the analysis, body temperature was not reported for 6 participants at the Initial visit, and 14 participants at the Second visit. | Posted | Number | Participants | Day 0, Day 8-16 |
|
| |||||||||||||||||||||||||||
| Secondary | Bacteriological Investigation (if Available) | The type of agent present in the infection was assessed using bacteriological investigation. Occurrence of the most common agents was reported. Participants may have had more than one pathogen present. Test results were not available prior to enrollment but were reported during the study. | Of the 3128 participants included in the analysis, 225 participants had bacteriological investigations conducted at the Initial visit (Day 0). Some participants had more than one finding. | Posted | Number | participants | Day 0 |
|
| |||||||||||||||||||||||||||
| Secondary | Cough and Its Character | Number of participants in which cough was present, and if present, type of cough (irritating, productive, both or not reported) | Posted | Count of Participants | Participants | Day 0, Day 8-16 |
|
| ||||||||||||||||||||||||||||
| Secondary | Dyspnea and Its Type | Presence of dyspnea (difficulty breathing) and type of dyspnea (exertional, resting, both, or not reported). | Posted | Number | Participants | Day 0, Day 8-16 |
|
| ||||||||||||||||||||||||||||
| Secondary | Auscultation | Participants with abnormal auscultation findings (abnormal breath sounds) and type of findings (wheezing, crackles, both, or not reported). | Of the 3128 participants included in the analysis, auscultation findings were not reported for 38 participants at the initial visit and 116 participants at the final visit. | Posted | Number | Participants | Day 0, Day 8-16 |
|
| |||||||||||||||||||||||||||
| Secondary | Chest X-ray in Case of Community-Acquired Pneumonia (CAP) | Number of participants in which X-ray findings were suggestive of pneumonia. In participants where the physician suspected CAP, a chest X-ray was performed and reviewed to determine whether findings were indicative of pneumonia. | Chest X-ray was performed in 294 of the participants for whom the physician suspected pneumonia. | Posted | Number | Participants | Day 0 |
|
| |||||||||||||||||||||||||||
| Secondary | Study Drug Given as the First, Second or Third Antimicrobial Treatment | Number of participants who received Klacid SR as the first, second or third (further) antimicrobial agent. | Posted | Number | Participants | Day 0 |
|
| ||||||||||||||||||||||||||||
| Secondary | Compliance | Number of participants who took their medication according to the prescribed regimen (dose and duration) during the study. | Posted | Number | Participants | Day 8 - 16 |
|
| ||||||||||||||||||||||||||||
| Secondary | Termination of Treatment Due to Noncompliance | Number of participants who discontinued Klacid SR treatment early due to noncompliance with the recommended study medication regimen. | A total of 3128 participants were included in the analysis. | Posted | Number | Participants | Day 8 - 16 |
|
|
Adverse events were reported from the start to the completion of treatment with Klacid SR (8 to 16 days). Serious adverse events and relapse were reported for up to 30 days after the initiation of physician prescribed study treatment.
Investigator monitored study participants for adverse events as per usual practice.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Klacid SR Treatment | Adult Czech participants with acute tracheitis, acute tracheobronchitis or acute bronchitis; or participants with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose dose administered within this study. | 2 | 3,128 | 7 | 3,128 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tuberculosis pleuritis | Infections and infestations | MedDRA v 13.1 | Systematic Assessment |
| |
| Pulmonary tumor | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bad taste in mouth | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Loss of appetite | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Burning tongue | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Bitter taste in mouth | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Gastrointestinal tract symptoms | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | Abbott | 1-800-633-9110 |
| ID | Term |
|---|---|
| D014136 | Tracheitis |
| D001991 | Bronchitis |
| D029481 | Bronchitis, Chronic |
| D000098968 | Community-Acquired Pneumonia |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
| D014133 | Tracheal Diseases |
| D001982 | Bronchial Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017714 | Community-Acquired Infections |
| D011014 | Pneumonia |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| 40 to 49 years of age |
|
| 50 to 59 years of age |
|
| 60 to 69 years of age |
|
| 70 to 79 years of age |
|
| 80 to 89 years of age |
|
| 90 years of age and older |
|
|
|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Initial Visit - Presence of dyspnea |
| |||||
| a) Exertional |
| |||||
| b) Resting |
| |||||
| c) Both exertional and resting |
| |||||
| d) Type of dyspnea not reported |
| |||||
| Initial Visit - Dyspnea not present |
| |||||
| Second Visit - Presence of dyspnea |
| |||||
| a) Exertional- |
| |||||
| b) Resting- |
| |||||
| c) Both exertional and resting- |
| |||||
| d) Type of dyspnea not reported- |
| |||||
| Second Visit -Dyspnea not present |
|
|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
|