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| ID | Type | Description | Link |
|---|---|---|---|
| 2009_651 |
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A study in 2-5 year old children to evaluate the safety and tolerability of montelukast and placebo administered once daily at bed time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Montelukast |
|
| 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| montelukast sodium | Drug | one chewable 4-mg montelukast tablet, once daily at bedtime for 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Clinical Adverse Experiences (CAE) Reported by Patients - Base Study | An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product | 12 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Drug-related CAEs Reported by Patients - Base Study | Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs | 12 weeks of treatment |
| Number of Patients With Serious CAEs Reported by Patients - Base Study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11533366 | Result | Knorr B, Franchi LM, Bisgaard H, Vermeulen JH, LeSouef P, Santanello N, Michele TM, Reiss TF, Nguyen HH, Bratton DL. Montelukast, a leukotriene receptor antagonist, for the treatment of persistent asthma in children aged 2 to 5 years. Pediatrics. 2001 Sep;108(3):E48. doi: 10.1542/peds.108.3.e48. |
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Base Study: Patients who required excluded medication and those who did not meet a minimum predefined level of asthma symptoms and β-agonist use during run-in (Period I) were excluded from randomization (Period II).
Extension Study (Period III): Patients who did not complete Visit 9 of Base Study were not eligible for the optional Extension.
Base Study: 93 sites in the United States (US) and other countries in Africa, Australia, Europe, North America, and South America. Therapy period: Dec-1997 to Mar-1999.
Extension Study: 75 sites in the US and other countries in Africa, Australia, Europe, North America, and South America. Therapy period: Mar-1998 to Mar-2001.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks. |
| FG001 | Usual Care | "Usual care," defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some patients receiving montelukast in Period II were switched to usual care in the Extension Study. Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the "usual care" treatment group in Period III. |
| FG002 | Montelukast | Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks. Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Base Study - (Period II) |
|
| |||||||||||||||||||||
| Extension Study - (Period III) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks. |
| BG001 | Montelukast | Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks. |
| 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 | Number of Patients With Clinical Adverse Experiences (CAE) Reported by Patients - Base Study | An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product | All patients who took study medication were included in the analysis. | Posted | Number | Participants | 12 weeks of treatment |
|
During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
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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 | Placebo | Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drug Overdose (Period II) | Injury, poisoning and procedural complications | CRISP dictionary | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fever (Period II) | General disorders | CRISP dictionary | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C093875 | montelukast |
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| Comparator: Placebo |
| Drug |
one chewable placebo tablet, once daily at bedtime for 12 weeks |
|
Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose |
| 12 weeks of treatment |
| Number of Patients With Serious Drug-related CAEs Reported by Patients - Base Study | Patients who reported serious drug-related CAEs during 12 weeks of treatment | 12 weeks of treatment |
| Number of Patients Who Were Discontinued Due to CAEs - Base Study | Patients who were discontinued due to CAEs during 12 weeks of treatment | 12 weeks of treatment |
| Number of Patients Who Were Discontinued Due to Drug-related CAEs - Base Study | Patients who were discontinued due to drug-related CAEs during 12 weeks of treatment | 12 weeks of treatment |
| Number of Patients Who Were Discontinued Due to Serious CAEs - Base Study | Patients who were discontinued due to serious CAEs during 12 weeks of treatment | 12 weeks of treatment |
| Number of Patients With Laboratory Adverse Experiences (LAEs) - Base Study | A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product | 12 weeks of treatment |
| Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) - Base Study | Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs | 12 weeks of treatment |
| Number of Patients Who Were Discontinued Due to LAEs - Base Study | Patients who were discontinued due to LAEs during 12 weeks of treatment | 12 weeks of treatment |
| Number of Patients Who Were Discontinued Due to Drug-related LAEs - Base Study | Patients who were discontinued due to drug-related LAEs during 12 weeks of treatment | 12 weeks of treatment |
| Number of Patients With Clinical Adverse Experiences (CAE) Reported by Patients - Extension | An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product | up to 2.8 years |
| Number of Patients With Drug-related CAEs Reported by Patients - Extension | Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs | up to 2.8 years |
| Number of Patients With Serious CAEs Reported by Patients - Extension | Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose | up to 2.8 years |
| Number of Patients With Serious Drug-related CAEs Reported by Patients - Extension | Patients who reported serious drug-related CAEs up to 2.8 years of treatment | up to 2.8 years |
| Number of Patients Who Were Discontinued Due to CAEs - Extension | Patients who were discontinued due to CAEs up to 2.8 years of treatment | up to 2.8 years |
| Number of Patients Who Were Discontinued Due to Drug-related CAEs - Extension | Patients who were discontinued due to drug-related CAEs with up to 2.8 years of treatment | up to 2.8 years |
| Number of Patients Who Were Discontinued Due to Serious CAEs - Extension | Patients who were discontinued due to serious CAEs with up to 2.8 years of treatment | up to 2.8 years |
| Number of Patients Who Were Discontinued Due to Serious Drug-related CAEs - Extension | Patients who were discontinued due to serious drug-related CAEs with up to 2.8 years of treatment | up to 2.8 years |
| Number of Patients With Laboratory Adverse Experiences (LAEs) - Extension | A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product | up to 2.8 years |
| Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) - Extension | Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs | up to 2.8 years |
| Number of Patients With Serious LAEs - Extension | Serious LAEs are any LAEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose | up to 2.8 years |
| Number of Patients With Serious Drug-related Laboratory Adverse Experiences (LAEs) - Extension | Patients who reported serious drug-related LAEs up to 2.8 years of treatment | up to 2.8 years |
| Number of Patients Who Were Discontinued Due to LAEs - Extension | Patients who were discontinued due to LAEs up to 2.8 years of treatment | up to 2.8 years |
| Number of Patients Who Were Discontinued Due to Drug-related LAEs - Extension | Patients who were discontinued due to drug-related LAEs with up to 2.8 years of treatment | up to 2.8 years |
| Number of Patients Who Were Discontinued Due to Serious LAEs - Extension | Patients who were discontinued due to serious LAEs with up to 2.8 years of treatment | up to 2.8 years |
| Number of Patients Who Were Discontinued Due to Serious Drug-related LAEs - Extension | Patients who were discontinued due to serious drug-related LAEs with up to 2.8 years of treatment | up to 2.8 years |
| Lost to Follow-up |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Site Error |
|
| NOT COMPLETED |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Number of Patients With Drug-related CAEs Reported by Patients - Base Study | Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs | All patients who took study medication were included in the analysis. Drug relationship for 1 patient in the Placebo group should have been listed as definitely not drug related. | Posted | Number | Participants | 12 weeks of treatment |
|
|
|
| Secondary | Number of Patients With Serious CAEs Reported by Patients - Base Study | Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose | All patients who took study medication were included in the analysis. A serious CAE (study drug overdose) prior to randomization in the Placebo group is not included in this number | Posted | Number | Participants | 12 weeks of treatment |
|
|
|
| Secondary | Number of Patients With Serious Drug-related CAEs Reported by Patients - Base Study | Patients who reported serious drug-related CAEs during 12 weeks of treatment | All patients who took study medication were included in the analysis. | Posted | Number | Participants | 12 weeks of treatment |
|
|
|
| Secondary | Number of Patients Who Were Discontinued Due to CAEs - Base Study | Patients who were discontinued due to CAEs during 12 weeks of treatment | All patients who took study medication were included in the analysis. | Posted | Number | Participants | 12 weeks of treatment |
|
|
|
| Secondary | Number of Patients Who Were Discontinued Due to Drug-related CAEs - Base Study | Patients who were discontinued due to drug-related CAEs during 12 weeks of treatment | All patients who took study medication were included in the analysis. | Posted | Number | Participants | 12 weeks of treatment |
|
|
|
| Secondary | Number of Patients Who Were Discontinued Due to Serious CAEs - Base Study | Patients who were discontinued due to serious CAEs during 12 weeks of treatment | All patients who took study medication were included in the analysis. | Posted | Number | Participants | 12 weeks of treatment |
|
|
|
| Secondary | Number of Patients With Laboratory Adverse Experiences (LAEs) - Base Study | A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product | All patients who took study medication and had at least one laboratory test post baseline were included in the analysis. | Posted | Number | Participants | 12 weeks of treatment |
|
|
|
| Secondary | Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) - Base Study | Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs | All patients who took study medication and had at least one laboratory test post baseline were included in the analysis. | Posted | Number | Participants | 12 weeks of treatment |
|
|
|
| Secondary | Number of Patients Who Were Discontinued Due to LAEs - Base Study | Patients who were discontinued due to LAEs during 12 weeks of treatment | All patients who took study medication and had at least one laboratory test post baseline were included in the analysis. | Posted | Number | Participants | 12 weeks of treatment |
|
|
|
| Secondary | Number of Patients Who Were Discontinued Due to Drug-related LAEs - Base Study | Patients who were discontinued due to drug-related LAEs during 12 weeks of treatment | All patients who took study medication and had at least one laboratory test post baseline were included in the analysis. | Posted | Number | Participants | 12 weeks of treatment |
|
|
|
| Secondary | Number of Patients With Clinical Adverse Experiences (CAE) Reported by Patients - Extension | An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product | All patients who took study medication were included in the analysis. | Posted | Number | Participants | up to 2.8 years |
|
|
|
| Secondary | Number of Patients With Drug-related CAEs Reported by Patients - Extension | Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs | All patients who took study medication were included in the analysis. | Posted | Number | Participants | up to 2.8 years |
|
|
|
| Secondary | Number of Patients With Serious CAEs Reported by Patients - Extension | Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose | All patients who took study medication were included in the analysis. | Posted | Number | Participants | up to 2.8 years |
|
|
|
| Secondary | Number of Patients With Serious Drug-related CAEs Reported by Patients - Extension | Patients who reported serious drug-related CAEs up to 2.8 years of treatment | All patients who took study medication were included in the analysis. | Posted | Number | Participants | up to 2.8 years |
|
|
|
| Secondary | Number of Patients Who Were Discontinued Due to CAEs - Extension | Patients who were discontinued due to CAEs up to 2.8 years of treatment | All patients who took study medication were included in the analysis. | Posted | Number | Participants | up to 2.8 years |
|
|
|
| Secondary | Number of Patients Who Were Discontinued Due to Drug-related CAEs - Extension | Patients who were discontinued due to drug-related CAEs with up to 2.8 years of treatment | All patients who took study medication were included in the analysis. | Posted | Number | Participants | up to 2.8 years |
|
|
|
| Secondary | Number of Patients Who Were Discontinued Due to Serious CAEs - Extension | Patients who were discontinued due to serious CAEs with up to 2.8 years of treatment | All patients who took study medication were included in the analysis. | Posted | Number | Participants | up to 2.8 years |
|
|
|
| Secondary | Number of Patients Who Were Discontinued Due to Serious Drug-related CAEs - Extension | Patients who were discontinued due to serious drug-related CAEs with up to 2.8 years of treatment | All patients who took study medication were included in the analysis. | Posted | Number | Participants | up to 2.8 years |
|
|
|
| Secondary | Number of Patients With Laboratory Adverse Experiences (LAEs) - Extension | A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product | All patients who took study medication were included in the analysis. | Posted | Number | Participants | up to 2.8 years |
|
|
|
| Secondary | Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) - Extension | Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs | All patients who took study medication and had at least one laboratory test post baseline were included in the analysis. | Posted | Number | Participants | up to 2.8 years |
|
|
|
| Secondary | Number of Patients With Serious LAEs - Extension | Serious LAEs are any LAEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose | All patients who took study medication and had any laboratory tests performed were included in the analysis. | Posted | Number | Participants | up to 2.8 years |
|
|
|
| Secondary | Number of Patients With Serious Drug-related Laboratory Adverse Experiences (LAEs) - Extension | Patients who reported serious drug-related LAEs up to 2.8 years of treatment | All patients who took study medication and had at least one laboratory test post baseline were included in the analysis. | Posted | Number | Participants | up to 2.8 years |
|
|
|
| Secondary | Number of Patients Who Were Discontinued Due to LAEs - Extension | Patients who were discontinued due to LAEs up to 2.8 years of treatment | All patients who took study medication and had at least one laboratory test post baseline were included in the analysis. | Posted | Number | Participants | up to 2.8 years |
|
|
|
| Secondary | Number of Patients Who Were Discontinued Due to Drug-related LAEs - Extension | Patients who were discontinued due to drug-related LAEs with up to 2.8 years of treatment | All patients who took study medication and had at least one laboratory test post baseline were included in the analysis. | Posted | Number | Participants | up to 2.8 years |
|
|
|
| Secondary | Number of Patients Who Were Discontinued Due to Serious LAEs - Extension | Patients who were discontinued due to serious LAEs with up to 2.8 years of treatment | All patients who took study medication and had at least one laboratory test post baseline were included in the analysis. | Posted | Number | Participants | up to 2.8 years |
|
|
|
| Secondary | Number of Patients Who Were Discontinued Due to Serious Drug-related LAEs - Extension | Patients who were discontinued due to serious drug-related LAEs with up to 2.8 years of treatment | All patients who took study medication and had at least one laboratory test post baseline were included in the analysis. | Posted | Number | Participants | up to 2.8 years |
|
|
|
| 9 |
| 228 |
| 188 |
| 228 |
| EG001 | Usual Care | "Usual care," defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some patients receiving montelukast in Period II were switched to usual care in the Extension Study. Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the "usual care" treatment group in Period III. | 15 | 157 | 148 | 157 |
| EG002 | Montelukast | Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks. Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together. | 56 | 461 | 435 | 461 |
| Drug Overdose (Period III) | Injury, poisoning and procedural complications | CRISP dictionary | Non-systematic Assessment |
|
| Infection, Viral (Period III) | Infections and infestations | CRISP dictionary | Non-systematic Assessment |
|
| Pain, Abdominal (Period III) | General disorders | CRISP dictionary | Non-systematic Assessment |
|
| Trauma (Period III) | Injury, poisoning and procedural complications | CRISP dictionary | Non-systematic Assessment |
|
| Tachycardia (Period III) | Injury, poisoning and procedural complications | CRISP dictionary | Non-systematic Assessment |
|
| Appendicitis (Period III) | Infections and infestations | CRISP dictionary | Non-systematic Assessment |
|
| Gastroenteritis (Period II) | Gastrointestinal disorders | CRISP dictionary | Non-systematic Assessment |
|
| Gastroenteritis, Infectious (Period III) | Infections and infestations | CRISP dictionary | Non-systematic Assessment |
|
| Gastroesophageal Reflux (Period III) | Gastrointestinal disorders | CRISP dictionary | Non-systematic Assessment |
|
| Infection, Intra-Abdominal (Period III) | Infections and infestations | CRISP dictionary | Non-systematic Assessment |
|
| Thirst (Period II) | General disorders | CRISP dictionary | Non-systematic Assessment |
|
| Thirst (Period III) | General disorders | CRISP dictionary | Non-systematic Assessment |
|
| Vomiting (Period III) | Gastrointestinal disorders | CRISP dictionary | Non-systematic Assessment |
|
| Alkaline Phosphatase Increased (Period III) | Investigations | CRISP dictionary | Non-systematic Assessment |
|
| Allergy (Period III) | Immune system disorders | CRISP dictionary | Non-systematic Assessment |
|
| Dehydration (Period II) | Metabolism and nutrition disorders | CRISP dictionary | Non-systematic Assessment |
|
| Dehydration (Period III) | Metabolism and nutrition disorders | CRISP dictionary | Non-systematic Assessment |
|
| Hypokalemia (Period III) | Investigations | CRISP dictionary | Non-systematic Assessment |
|
| Bipolar Disorder (Period II) | Psychiatric disorders | CRISP dictionary | Non-systematic Assessment |
|
| Concussion (Period III) | Injury, poisoning and procedural complications | CRISP dictionary | Non-systematic Assessment |
|
| Headache (Period III) | Nervous system disorders | CRISP dictionary | Non-systematic Assessment |
|
| Hyperkinesia (Period III) | Nervous system disorders | CRISP dictionary | Non-systematic Assessment |
|
| Hypersomnia (Period III) | Nervous system disorders | CRISP dictionary | Non-systematic Assessment |
|
| Meningitis (Period III) | Infections and infestations | CRISP dictionary | Non-systematic Assessment |
|
| Seizure Disorder (Period III) | Nervous system disorders | CRISP dictionary | Non-systematic Assessment |
|
| Somnolence (Period II) | Nervous system disorders | CRISP dictionary | Non-systematic Assessment |
|
| Somnolence (Period III) | Nervous system disorders | CRISP dictionary | Non-systematic Assessment |
|
| Tremor (Period III) | Nervous system disorders | CRISP dictionary | Non-systematic Assessment |
|
| Apnea (Period III) | Respiratory, thoracic and mediastinal disorders | CRISP dictionary | Non-systematic Assessment |
|
| Asthma (Period II) | Respiratory, thoracic and mediastinal disorders | CRISP dictionary | Non-systematic Assessment |
|
| Asthma (Period III) | Respiratory, thoracic and mediastinal disorders | CRISP dictionary | Non-systematic Assessment |
|
| Bronchoconstriction (Period III) | Respiratory, thoracic and mediastinal disorders | CRISP dictionary | Non-systematic Assessment |
|
| Hypoxemia (Period III) | Respiratory, thoracic and mediastinal disorders | CRISP dictionary | Non-systematic Assessment |
|
| Infection, Respiratory, Upper (Period II) | Infections and infestations | CRISP dictionary | Non-systematic Assessment |
|
| Infection, Respiratory, Upper (Period III) | Infections and infestations | CRISP dictionary | Non-systematic Assessment |
|
| Infiltrate, Pulmonary (Period II) | Respiratory, thoracic and mediastinal disorders | CRISP dictionary | Non-systematic Assessment |
|
| Pneumonia (Period II) | Infections and infestations | CRISP dictionary | Non-systematic Assessment |
|
| Pneumonia (Period III) | Infections and infestations | CRISP dictionary | Non-systematic Assessment |
|
| Pneumonia, Bacterial (Period III) | Infections and infestations | CRISP dictionary | Non-systematic Assessment |
|
| Pneumonia, Viral (Period III) | Infections and infestations | CRISP dictionary | Non-systematic Assessment |
|
| Sinusitis (Period III) | Respiratory, thoracic and mediastinal disorders | CRISP dictionary | Non-systematic Assessment |
|
| Pallor (Period III) | Skin and subcutaneous tissue disorders | CRISP dictionary | Non-systematic Assessment |
|
| Infection, Eyelid (Period III) | Infections and infestations | CRISP dictionary | Non-systematic Assessment |
|
| Mydriasis (Period II) | Eye disorders | CRISP dictionary | Non-systematic Assessment |
|
| Anomaly, Urogenital (Period III) | Renal and urinary disorders | CRISP dictionary | Non-systematic Assessment |
|
| Fever (Period III) | General disorders | CRISP dictionary | Non-systematic Assessment |
|
| Infection, Viral (Period III) | Infections and infestations | CRISP dictionary | Non-systematic Assessment |
|
| Pain, Abdominal (Period II) | General disorders | CRISP dictionary | Non-systematic Assessment |
|
| Pain, Abdominal (Period III) | General disorders | CRISP dictionary | Non-systematic Assessment |
|
| Trauma (Period III) | Injury, poisoning and procedural complications | CRISP dictionary | Non-systematic Assessment |
|
| Dental Caries (Period III) | Gastrointestinal disorders | CRISP dictionary | Non-systematic Assessment |
|
| Diarrhea (Period II) | Gastrointestinal disorders | CRISP dictionary | Non-systematic Assessment |
|
| Diarrhea (Period III) | Gastrointestinal disorders | CRISP dictionary | Non-systematic Assessment |
|
| Gastroenteritis (Period III) | Gastrointestinal disorders | CRISP dictionary | Non-systematic Assessment |
|
| Vomiting (Period II) | Gastrointestinal disorders | CRISP dictionary | Non-systematic Assessment |
|
| Vomiting (Period III) | Gastrointestinal disorders | CRISP dictionary | Non-systematic Assessment |
|
| Allergy (Period III) | Immune system disorders | CRISP dictionary | Non-systematic Assessment |
|
| Headache (Period II) | Nervous system disorders | CRISP dictionary | Non-systematic Assessment |
|
| Headache (Period III) | Nervous system disorders | CRISP dictionary | Non-systematic Assessment |
|
| Asthma (Period II) | Respiratory, thoracic and mediastinal disorders | CRISP dictionary | Non-systematic Assessment |
|
| Asthma (Period III) | Respiratory, thoracic and mediastinal disorders | CRISP dictionary | Non-systematic Assessment |
|
| Bronchitis (Period II) | Respiratory, thoracic and mediastinal disorders | CRISP dictionary | Non-systematic Assessment |
|
| Bronchitis (Period III) | Respiratory, thoracic and mediastinal disorders | CRISP dictionary | Non-systematic Assessment |
|
| Congestion, Nasal (Period III) | Respiratory, thoracic and mediastinal disorders | CRISP dictionary | Non-systematic Assessment |
|
| Cough (Period II) | Respiratory, thoracic and mediastinal disorders | CRISP dictionary | Non-systematic Assessment |
|
| Cough (Period III) | Respiratory, thoracic and mediastinal disorders | CRISP dictionary | Non-systematic Assessment |
|
| Epistaxis (Period III) | Respiratory, thoracic and mediastinal disorders | CRISP dictionary | Non-systematic Assessment |
|
| Infection, Respiratory (Period II) | Infections and infestations | CRISP dictionary | Non-systematic Assessment |
|
| Infection, Respiratory (Period III) | Infections and infestations | CRISP dictionary | Non-systematic Assessment |
|
| Infection, Respiratory, Upper (Period II) | Infections and infestations | CRISP dictionary | Non-systematic Assessment |
|
| Infection, Respiratory, Upper (Period III) | Infections and infestations | CRISP dictionary | Non-systematic Assessment |
|
| Influenza (Period III) | Infections and infestations | CRISP dictionary | Non-systematic Assessment |
|
| Laryngitis (Period III) | Respiratory, thoracic and mediastinal disorders | CRISP dictionary | Non-systematic Assessment |
|
| Pharyngitis (Period II) | Respiratory, thoracic and mediastinal disorders | CRISP dictionary | Non-systematic Assessment |
|
| Pharyngitis (Period III) | Respiratory, thoracic and mediastinal disorders | CRISP dictionary | Non-systematic Assessment |
|
| Pneumonia (Period III) | Infections and infestations | CRISP dictionary | Non-systematic Assessment |
|
| Rhinitis (Period II) | Respiratory, thoracic and mediastinal disorders | CRISP dictionary | Non-systematic Assessment |
|
| Rhinitis (Period III) | Respiratory, thoracic and mediastinal disorders | CRISP dictionary | Non-systematic Assessment |
|
| Rhinitis, Allergic (Period II) | Respiratory, thoracic and mediastinal disorders | CRISP dictionary | Non-systematic Assessment |
|
| Rhinitis, Allergic (Period III) | Respiratory, thoracic and mediastinal disorders | CRISP dictionary | Non-systematic Assessment |
|
| Rhinorrhea (Period II) | Respiratory, thoracic and mediastinal disorders | CRISP dictionary | Non-systematic Assessment |
|
| Rhinorrhea (Period III) | Respiratory, thoracic and mediastinal disorders | CRISP dictionary | Non-systematic Assessment |
|
| Sinus Disorder (Period III) | Respiratory, thoracic and mediastinal disorders | CRISP dictionary | Non-systematic Assessment |
|
| Sinusitis (Period II) | Respiratory, thoracic and mediastinal disorders | CRISP dictionary | Non-systematic Assessment |
|
| Sinusitis (Period III) | Respiratory, thoracic and mediastinal disorders | CRISP dictionary | Non-systematic Assessment |
|
| Tonsillitis (Period II) | Infections and infestations | CRISP dictionary | Non-systematic Assessment |
|
| Tonsillitis (Period III) | Infections and infestations | CRISP dictionary | Non-systematic Assessment |
|
| Rash (Period III) | Skin and subcutaneous tissue disorders | CRISP dictionary | Non-systematic Assessment |
|
| Urticaria (Period III) | Skin and subcutaneous tissue disorders | CRISP dictionary | Non-systematic Assessment |
|
| Varicella (Period III) | Skin and subcutaneous tissue disorders | CRISP dictionary | Non-systematic Assessment |
|
| Conjunctivitis (Period III) | Eye disorders | CRISP dictionary | Non-systematic Assessment |
|
| Otitis (Period II) | Ear and labyrinth disorders | CRISP dictionary | Non-systematic Assessment |
|
| Otitis (Period III) | Ear and labyrinth disorders | CRISP dictionary | Non-systematic Assessment |
|
| Otitis Media (Period II) | Ear and labyrinth disorders | CRISP dictionary | Non-systematic Assessment |
|
| Otitis Media (Period III) | Ear and labyrinth disorders | CRISP dictionary | Non-systematic Assessment |
|
| Pain, Ear (Period III) | Ear and labyrinth disorders | CRISP dictionary | Non-systematic Assessment |
|
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |