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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-173723 | Other Identifier | Japic |
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To evaluate the efficacy and safety of subcutaneous (SC) administration of TEV-48125 [monthly TEV-48125 225 mg (loading dose only: 675 mg) and TEV-48125 675 mg once over a period of 3 months] compared with placebo for preventive treatment in Chronic Migraine patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TEV-48125 (675/225/225 mg) group | Experimental | TEV-48125 will be subcutaneously administered once monthly for 3 months (675/225/225 mg). |
|
| TEV-48125 (675 mg/placebo/placebo) group | Experimental | TEV-48125 or placebo will be subcutaneously administered once monthly for 3 months (675 mg/ placebo/placebo). |
|
| Placebo group | Placebo Comparator | Placebo will be subcutaneously administered once monthly for 3 months (placebo/placebo/placebo). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TEV-48125 | Drug | TEV-48125 will be subcutaneously administered once monthly for 3 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in the Monthly (28 Day) Average Number of Headache Days of at Least Moderate Severity During the 12-week Period After the First Dose of Investigational Medicinal Product (IMP) | Headache-related efficacy endpoints were derived from headache variables collected using an eDiary. On each day, subjects entered headache data in the electronic headache diary for the previous 24-hour period. Subjects who had experienced headache on the previous day answered questions about the headache (ie, occurrence of headache, duration of headache, maximum severity of headache, presence/absence of associated symptoms, and use of acute headache medications). Overall headache duration was recorded numerically, in hours, as well as number of hours with headache of at least moderate severity. If headache was reported, then headache severity was subjectively rated by the subject as mild, moderate, or severe. Subjects also recorded the presence or absence of photophobia, phonophobia, nausea, or vomiting, and the status of use of any acute headache medications. | Baseline, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in the Monthly Average Number of Migraine Days During the 12-week Period After the First Dose of IMP | Headache-related efficacy endpoints were derived from headache variables collected using an eDiary. On each day, subjects entered headache data in the electronic headache diary for the previous 24-hour period. Subjects who had experienced headache on the previous day answered questions about the headache (ie, occurrence of headache, duration of headache, maximum severity of headache, presence/absence of associated symptoms, and use of acute headache medications). Overall headache duration was recorded numerically, in hours, as well as number of hours with headache of at least moderate severity. If headache was reported, then headache severity was subjectively rated by the subject as mild, moderate, or severe. Subjects also recorded the presence or absence of photophobia, phonophobia, nausea, or vomiting, and the status of use of any acute headache medications. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Takehisa Matsumaru | Otsuka Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saitama Medical University Hospital | Iruma | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35139816 | Derived | Takeshima T, Nakai M, Shibasaki Y, Ishida M, Kim BK, Ning X, Koga N. Early onset of efficacy with fremanezumab in patients with episodic and chronic migraine: subanalysis of two phase 2b/3 trials in Japanese and Korean patients. J Headache Pain. 2022 Feb 9;23(1):24. doi: 10.1186/s10194-022-01393-0. |
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| ID | Title | Description |
|---|---|---|
| FG000 | TEV-48125 (675/225/225 mg) Group | TEV-48125 will be subcutaneously administered once monthly for 3 months (675/225/225 mg). |
| FG001 | TEV-48125 (675 mg/Placebo/Placebo) Group | TEV-48125 or placebo will be subcutaneously administered once monthly for 3 months (675 mg/ placebo/placebo). |
| FG002 | Placebo Group | Placebo will be subcutaneously administered once monthly for 3 months (placebo/placebo/placebo). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | TEV-48125 (675/225/225 mg) Group | TEV-48125 will be subcutaneously administered once monthly for 3 months (675/225/225 mg). |
| BG001 | TEV-48125 (675 mg/Placebo/Placebo) Group | TEV-48125 or placebo will be subcutaneously administered once monthly for 3 months (675 mg/ placebo/placebo). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change From Baseline in the Monthly (28 Day) Average Number of Headache Days of at Least Moderate Severity During the 12-week Period After the First Dose of Investigational Medicinal Product (IMP) | Headache-related efficacy endpoints were derived from headache variables collected using an eDiary. On each day, subjects entered headache data in the electronic headache diary for the previous 24-hour period. Subjects who had experienced headache on the previous day answered questions about the headache (ie, occurrence of headache, duration of headache, maximum severity of headache, presence/absence of associated symptoms, and use of acute headache medications). Overall headache duration was recorded numerically, in hours, as well as number of hours with headache of at least moderate severity. If headache was reported, then headache severity was subjectively rated by the subject as mild, moderate, or severe. Subjects also recorded the presence or absence of photophobia, phonophobia, nausea, or vomiting, and the status of use of any acute headache medications. | Full Analysis set (FAS): Subjects who received the IMP at least once and had baseline and Week 12 data on monthly average number of headache days of at least moderate severity | Posted | Mean | Standard Error | days/month | Baseline, 12 weeks |
Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once
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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 | TEV-48125 (675/225/225 mg) Group | TEV-48125 will be subcutaneously administered once monthly for 3 months (675/225/225 mg). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Brain contusion | Injury, poisoning and procedural complications | MedDRA Ver. 22.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Otsuka Pharmaceutical Co., LTD. | +81-3-6361-7366 | CL_OPCJ_RDA_Team@otsuka.jp |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 8, 2019 | May 16, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 12, 2019 | May 16, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C000604315 | fremanezumab |
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| TEV-48125 or placebo | Drug | TEV-48125 or placebo will be subcutaneously administered once monthly for 3 months. |
|
| Placebo | Drug | Placebo will be subcutaneously administered once monthly for 3 months. |
|
| Baseline, 12 weeks |
| Proportion of Subjects Reaching at Least 50% Reduction in the Monthly Average Number of Headache Days of at Least Moderate Severity During the 12-week Period After the First Dose of IMP | Headache-related efficacy endpoints were derived from headache variables collected using an eDiary. On each day, subjects entered headache data in the electronic headache diary for the previous 24-hour period. Subjects who had experienced headache on the previous day answered questions about the headache (ie, occurrence of headache, duration of headache, maximum severity of headache, presence/absence of associated symptoms, and use of acute headache medications). Overall headache duration was recorded numerically, in hours, as well as number of hours with headache of at least moderate severity. If headache was reported, then headache severity was subjectively rated by the subject as mild, moderate, or severe. Subjects also recorded the presence or absence of photophobia, phonophobia, nausea, or vomiting, and the status of use of any acute headache medications. | 12 weeks |
| Mean Change From Baseline in the Monthly Average Number of Days With Use of Any Acute Headache Medications During the 12-week Period After the First Dose of IMP | Headache-related efficacy endpoints were derived from headache variables collected using an eDiary. On each day, subjects entered headache data in the electronic headache diary for the previous 24-hour period. Subjects who had experienced headache on the previous day answered questions about the headache (ie, occurrence of headache, duration of headache, maximum severity of headache, presence/absence of associated symptoms, and use of acute headache medications). | Baseline, 12 weeks |
| Mean Change From Baseline in the Monthly Average Number of Headache Days of at Least Moderate Severity During the 12-week Period After the First Dose of IMP in Subjects Not Receiving Concomitant Preventive Migraine Medications | Headache-related efficacy endpoints were derived from headache variables collected using an eDiary. On each day, subjects entered headache data in the electronic headache diary for the previous 24-hour period. Subjects who had experienced headache on the previous day answered questions about the headache (ie, occurrence of headache, duration of headache, maximum severity of headache, presence/absence of associated symptoms, and use of acute headache medications). Overall headache duration was recorded numerically, in hours, as well as number of hours with headache of at least moderate severity. If headache was reported, then headache severity was subjectively rated by the subject as mild, moderate, or severe. Subjects also recorded the presence or absence of photophobia, phonophobia, nausea, or vomiting, and the status of use of any acute headache medications." | Baseline, 12 weeks |
| Mean Change From Baseline in Disability Score, as Measured by 6-Item Headache Impact Test (HIT-6) at 4 Weeks After the Final (Third) Dose of IMP | Subjects assessed the impact of headache on social functioning, role functioning, vitality, cognitive functioning, and psychological distress, using the HIT-6. The HIT-6 total score will be obtained from summation of the 6 question points.Each question is answered on the scale ranging with the following response options: 6 points (never), 8 points (rarely), 10 points (sometimes), 11 points (very often), and 13 points (always). | Baseline, 4 weeks |
| Withdrawal by Subject |
|
| Other than specified |
|
| BG002 | Placebo Group | Placebo will be subcutaneously administered once monthly for 3 months (placebo/placebo/placebo). |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | TEV-48125 (675/225/225 mg) Group | TEV-48125 will be subcutaneously administered once monthly for 3 months (675/225/225 mg). |
| OG001 | TEV-48125 (675 mg/Placebo/Placebo) Group | TEV-48125 or placebo will be subcutaneously administered once monthly for 3 months (675 mg/ placebo/placebo). |
| OG002 | Placebo Group | Placebo will be subcutaneously administered once monthly for 3 months (placebo/placebo/placebo). |
|
|
| Secondary | Mean Change From Baseline in the Monthly Average Number of Migraine Days During the 12-week Period After the First Dose of IMP | Headache-related efficacy endpoints were derived from headache variables collected using an eDiary. On each day, subjects entered headache data in the electronic headache diary for the previous 24-hour period. Subjects who had experienced headache on the previous day answered questions about the headache (ie, occurrence of headache, duration of headache, maximum severity of headache, presence/absence of associated symptoms, and use of acute headache medications). Overall headache duration was recorded numerically, in hours, as well as number of hours with headache of at least moderate severity. If headache was reported, then headache severity was subjectively rated by the subject as mild, moderate, or severe. Subjects also recorded the presence or absence of photophobia, phonophobia, nausea, or vomiting, and the status of use of any acute headache medications. | Full Analysis set (FAS): Subjects who received the IMP at least once and had baseline and Week 12 data on monthly average number of headache days of at least moderate severity | Posted | Mean | Standard Error | days/month | Baseline, 12 weeks |
|
|
|
| Secondary | Proportion of Subjects Reaching at Least 50% Reduction in the Monthly Average Number of Headache Days of at Least Moderate Severity During the 12-week Period After the First Dose of IMP | Headache-related efficacy endpoints were derived from headache variables collected using an eDiary. On each day, subjects entered headache data in the electronic headache diary for the previous 24-hour period. Subjects who had experienced headache on the previous day answered questions about the headache (ie, occurrence of headache, duration of headache, maximum severity of headache, presence/absence of associated symptoms, and use of acute headache medications). Overall headache duration was recorded numerically, in hours, as well as number of hours with headache of at least moderate severity. If headache was reported, then headache severity was subjectively rated by the subject as mild, moderate, or severe. Subjects also recorded the presence or absence of photophobia, phonophobia, nausea, or vomiting, and the status of use of any acute headache medications. | Full Analysis set (FAS): Subjects who received the IMP at least once and had baseline and Week 12 data on monthly average number of headache days of at least moderate severity "Overall Number of Participants Analyzed" = the number of subjects meeting responder criteria | Posted | Number | percentage of participants | 12 weeks |
|
|
|
| Secondary | Mean Change From Baseline in the Monthly Average Number of Days With Use of Any Acute Headache Medications During the 12-week Period After the First Dose of IMP | Headache-related efficacy endpoints were derived from headache variables collected using an eDiary. On each day, subjects entered headache data in the electronic headache diary for the previous 24-hour period. Subjects who had experienced headache on the previous day answered questions about the headache (ie, occurrence of headache, duration of headache, maximum severity of headache, presence/absence of associated symptoms, and use of acute headache medications). | Full Analysis set (FAS): Subjects who received the IMP at least once and had baseline and Week 12 data on monthly average number of headache days of at least moderate severity | Posted | Mean | Standard Error | days/month | Baseline, 12 weeks |
|
|
|
| Secondary | Mean Change From Baseline in the Monthly Average Number of Headache Days of at Least Moderate Severity During the 12-week Period After the First Dose of IMP in Subjects Not Receiving Concomitant Preventive Migraine Medications | Headache-related efficacy endpoints were derived from headache variables collected using an eDiary. On each day, subjects entered headache data in the electronic headache diary for the previous 24-hour period. Subjects who had experienced headache on the previous day answered questions about the headache (ie, occurrence of headache, duration of headache, maximum severity of headache, presence/absence of associated symptoms, and use of acute headache medications). Overall headache duration was recorded numerically, in hours, as well as number of hours with headache of at least moderate severity. If headache was reported, then headache severity was subjectively rated by the subject as mild, moderate, or severe. Subjects also recorded the presence or absence of photophobia, phonophobia, nausea, or vomiting, and the status of use of any acute headache medications." | Full Analysis set (FAS): Subjects who received the IMP at least once and had baseline and Week 12 data on monthly average number of headache days of at least moderate severity | Posted | Mean | Standard Error | days/month | Baseline, 12 weeks |
|
|
|
| Secondary | Mean Change From Baseline in Disability Score, as Measured by 6-Item Headache Impact Test (HIT-6) at 4 Weeks After the Final (Third) Dose of IMP | Subjects assessed the impact of headache on social functioning, role functioning, vitality, cognitive functioning, and psychological distress, using the HIT-6. The HIT-6 total score will be obtained from summation of the 6 question points.Each question is answered on the scale ranging with the following response options: 6 points (never), 8 points (rarely), 10 points (sometimes), 11 points (very often), and 13 points (always). | Full Analysis set (FAS): Subjects who received the IMP at least once and had baseline and Week 12 data on monthly average number of headache days of at least moderate severity | Posted | Mean | Standard Error | score on a scale | Baseline, 4 weeks |
|
|
|
| 0 |
| 188 |
| 3 |
| 188 |
| 115 |
| 188 |
| EG001 | TEV-48125 (675 mg/Placebo/Placebo) Group | TEV-48125 or placebo will be subcutaneously administered once monthly for 3 months (675 mg/ placebo/placebo). | 0 | 190 | 1 | 190 | 116 | 190 |
| EG002 | Placebo Group | Placebo will be subcutaneously administered once monthly for 3 months (placebo/placebo/placebo). | 0 | 191 | 1 | 191 | 117 | 191 |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Intestinal haemorrhage | Gastrointestinal disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Prinzmetal angina | Cardiac disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Bundle branch block right | Cardiac disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Left ventricular hypertrophy | Cardiac disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Deafness neurosensory | Ear and labyrinth disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Meniere's disease | Ear and labyrinth disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Astigmatism | Eye disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Conjunctival cyst | Eye disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Conjunctivitis allergic | Eye disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Ocular discomfort | Eye disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Asthenopia | Eye disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Blepharospasm | Eye disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Chalazion | Eye disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Retinopathy solar | Eye disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Chronic gastritis | Gastrointestinal disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Tooth loss | Gastrointestinal disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Enterocolitis | Gastrointestinal disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Anal fissure | Gastrointestinal disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Colitis ischaemic | Gastrointestinal disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Epigastric discomfort | Gastrointestinal disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Gastric polyps | Gastrointestinal disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Lumbar hernia | Gastrointestinal disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Periodontal inflammation | Gastrointestinal disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Salivary gland mass | Gastrointestinal disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Injection site induration | General disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Injection site pain | General disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Injection site haemorrhage | General disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Injection site rash | General disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Generalised oedema | General disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Injection site bruising | General disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Injection site dermatitis | General disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Injection site inflammation | General disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Thirst | General disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Herpes virus infection | Infections and infestations | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Gingivitis | Infections and infestations | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Kaposi's varicelliform eruption | Infections and infestations | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Vulvitis | Infections and infestations | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Helicobacter infection | Infections and infestations | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Parotitis | Infections and infestations | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Pharyngotonsillitis | Infections and infestations | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Pulpitis dental | Infections and infestations | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Streptococcal infection | Infections and infestations | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Stab wound | Injury, poisoning and procedural complications | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Dental restoration failure | Injury, poisoning and procedural complications | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Muscle contusion | Injury, poisoning and procedural complications | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Post-traumatic neck syndrome | Injury, poisoning and procedural complications | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Urine leukocyte esterase positive | Investigations | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Blood urine present | Investigations | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Blood potassium increased | Investigations | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Eosinophil count increased | Investigations | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Weight increased | Investigations | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Decreased appetite | Investigations | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Diabetic complication | Metabolism and nutrition disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Temporomandibular joint syndrome | Musculoskeletal and connective tissue disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Spinal deformity | Musculoskeletal and connective tissue disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Cognitive disorder | Nervous system disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Hypersomnia | Nervous system disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Monoplegia | Nervous system disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Amnestic disorder | Nervous system disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Intercostal neuralgia | Nervous system disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Memory impairment | Nervous system disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Alcoholic hangover | Psychiatric disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Mental fatigue | Psychiatric disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Panic disorder | Psychiatric disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Menorrhagia | Reproductive system and breast disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Premenstrual syndrome | Reproductive system and breast disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Reflux laryngitis | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Throat tightness | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Miliaria | Skin and subcutaneous tissue disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Onycholysis | Skin and subcutaneous tissue disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Solar dermatitis | Skin and subcutaneous tissue disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Peripheral coldness | Vascular disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Neurogenic shock | Vascular disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
Not provided
Not provided
| D009422 | Nervous System Diseases |