Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-173725 | Other Identifier | Japic |
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
To evaluate the efficacy and safety of subcutaneous (SC) administration of TEV-48125 (monthly TEV-48125 225 mg and TEV-48125 675 mg once over a period of 3 months) compared with placebo for preventive treatment in Episodic Migraine patients
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TEV-48125 (225/225/225 mg) group | Experimental | TEV-48125 will be subcutaneously administered once monthly for 3 months (225/225/225 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 Days) Average Number of Migraine Days 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, the subjects were asked to enter headache data in the electronic headache diary for the previous 24-hour period. Subjects who reported 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 follows: Mild headache, Moderate headache, Severe headache. 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 |
|---|---|---|
| Proportion of Subjects Reaching at Least 50% Reduction 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, the subjects were asked to enter headache data in the electronic headache diary for the previous 24-hour period. Subjects who reported 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 follows: Mild headache, Moderate headache, Severe headache. Subjects also recorded the presence or absence of photophobia, phonophobia, nausea, or vomiting, and the status of use of any acute headache medications. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Patients who have previously failed (lack of efficacy) 2 or more of the clusters of the medications for treatment of migraine after use for at least 3 months at accepted migraine therapeutic doses
- Hematological, cardiac, renal, endocrine, pulmonary, gastrointestinal, genitourinary, neurologic, hepatic, or ocular disease considered clinically significant in the judgment of the investigator
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
|---|---|---|---|
| 39221611 | Derived | Tatsumoto M, Ishida M, Iba K, Kim BK, Ning X, Osawa C, Nakai M, Kurita Y. Effects of fremanezumab on migraine-associated symptoms and medication use in Japanese and Korean patients with episodic migraine: Exploratory endpoint analysis of a multicenter, randomized, double-blind, placebo-controlled trial. Headache. 2025 Mar;65(3):399-406. doi: 10.1111/head.14810. Epub 2024 Sep 2. | |
| 35139816 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | TEV-48125 (225/225/225 mg) Group | TEV-48125 will be subcutaneously administered once monthly for 3 months (225/225/225 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
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | TEV-48125 (225/225/225 mg) Group | TEV-48125 will be subcutaneously administered once monthly for 3 months (225/225/225 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 Days) Average Number of Migraine Days 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, the subjects were asked to enter headache data in the electronic headache diary for the previous 24-hour period. Subjects who reported 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 follows: Mild headache, Moderate headache, Severe headache. 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 migraine days. | 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.
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 | TEV-48125 (225/225/225 mg) Group | TEV-48125 will be subcutaneously administered once monthly for 3 months (225/225/225 mg). |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eosinophilia | Blood and lymphatic system disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Otsuka Pharmaceutical Co., LTD. | +81-3-6361-7366 | CL_OPCJ_RDA_Team@otsuka.jp |
Not provided
| 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 | Jun 15, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 12, 2019 | Jun 16, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000604315 | fremanezumab |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
|
| 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 reported 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 Migraine Days During the 12-week Period After the First Dose of IMP in Patients Not Receiving Concomitant Preventive Migraine Medications | Headache-related efficacy endpoints were derived from headache variables collected using an eDiary. On each day, the subjects were asked to enter headache data in the electronic headache diary for the previous 24-hour period. Subjects who reported 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 follows: Mild headache, Moderate headache, Severe headache. 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 Migraine Disability Assessment (MIDAS) Questionnaire at 4 Weeks After the Final (Third) Dose of IMP | Using the MIDAS questionnaire, subjects assessed the degree of headache-related disability based on lost days of activity in 3 domains (work, household work, and nonwork) over the last 3 months. The MIDAS questionnaire was a 5-item instrument. The total of the scores of the first 5 questions was used for grading the level of disability, with scores of 0 to 5, 6 to 10, 11 to 20, and ≥ 21 interpreted as disability grades I (little or no disability), II (mild disability), III (moderate disability), and IV (severe disability), respectively. | Baseline, 4 weeks |
| 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. |
| Withdrawal by Subject |
|
| 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 | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | TEV-48125 (225/225/225 mg) Group | TEV-48125 will be subcutaneously administered once monthly for 3 months (225/225/225 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 | Proportion of Subjects Reaching at Least 50% Reduction 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, the subjects were asked to enter headache data in the electronic headache diary for the previous 24-hour period. Subjects who reported 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 follows: Mild headache, Moderate headache, Severe headache. 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 migraine days. "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 reported 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 migraine days. "Overall Number of Participants Analyzed" = the number of subjects with both baseline and assessment at each visit. | Posted | Mean | Standard Error | days/month | Baseline, 12 weeks |
|
|
|
| Secondary | Mean Change From Baseline in the Monthly Average Number of Migraine Days During the 12-week Period After the First Dose of IMP in Patients Not Receiving Concomitant Preventive Migraine Medications | Headache-related efficacy endpoints were derived from headache variables collected using an eDiary. On each day, the subjects were asked to enter headache data in the electronic headache diary for the previous 24-hour period. Subjects who reported 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 follows: Mild headache, Moderate headache, Severe headache. 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 migraine days. "Overall Number of Participants Analyzed" = the number of subjects with both baseline and assessment at each visit. | Posted | Mean | Standard Error | days/month | Baseline, 12 weeks |
|
|
|
| Secondary | Mean Change From Baseline in Disability Score, as Measured by Migraine Disability Assessment (MIDAS) Questionnaire at 4 Weeks After the Final (Third) Dose of IMP | Using the MIDAS questionnaire, subjects assessed the degree of headache-related disability based on lost days of activity in 3 domains (work, household work, and nonwork) over the last 3 months. The MIDAS questionnaire was a 5-item instrument. The total of the scores of the first 5 questions was used for grading the level of disability, with scores of 0 to 5, 6 to 10, 11 to 20, and ≥ 21 interpreted as disability grades I (little or no disability), II (mild disability), III (moderate disability), and IV (severe disability), respectively. | Full Analysis set (FAS): Subjects who received the IMP at least once and had baseline and Week 12 data on monthly average number of migraine days. "Overall Number of Participants Analyzed" = the number of subjects with both baseline and assessment at each visit. | Posted | Mean | Standard Error | score on a scale | Baseline, 4 weeks |
|
|
|
| 0 |
| 121 |
| 0 |
| 121 |
| 69 |
| 121 |
| 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 | 118 | 0 | 118 | 74 | 118 |
| EG002 | Placebo Group | Placebo will be subcutaneously administered once monthly for 3 months (placebo/placebo/placebo). | 0 | 117 | 0 | 117 | 77 | 117 |
| Neutropenia | Blood and lymphatic system disorders | 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 |
|
| Purpura non-thrombocytopenic | Blood and lymphatic system disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Vertigo positional | Ear and labyrinth disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Sudden hearing loss | Ear and labyrinth disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Chalazion | Eye disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Eye pruritus | Eye disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Glaucoma | Eye disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Keratitis | Eye disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Gastritis | 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 |
|
| Stomatitis | Gastrointestinal disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Toothache | 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 |
|
| Constipation | Gastrointestinal disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Gastrointestinal pain | Gastrointestinal disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Injection site induration | 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 rash | General disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Injection site dermatitis | General disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Injection site haemorrhage | General disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Injection site macule | 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 discomfort | General disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Feeling abnormal | General disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Feeling cold | General disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Injection site bruising | General disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Injection site eczema | General disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Injection site haematoma | General disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Injection site urticaria | General disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Injection site warmth | General disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary 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 |
|
| Bacterial vulvovaginitis | Infections and infestations | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Helicobacter infection | Infections and infestations | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Streptococcal infection | Infections and infestations | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Anal abscess | Infections and infestations | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Gastroenteritis | 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 |
|
| Otitis externa | Infections and infestations | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Periodontitis | 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 |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Thermal burn | 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 |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Skin abrasion | Injury, poisoning and procedural complications | 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 creatine phosphokinase increased | Investigations | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Blood urine present | Investigations | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Glucose urine present | Investigations | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Blood glucose decreased | Investigations | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Occult blood positive | Investigations | 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 |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Joint swelling | 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 |
|
| Pain in extremity | 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 |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Intervertebral disc protrusion | 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 |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Hyperaesthesia | Nervous system disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Vascular headache | Nervous system disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Dizziness | 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 |
|
| Radial nerve palsy | Nervous system disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Panic disorder | Psychiatric disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Stress | Psychiatric disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Calculus urinary | Renal and urinary disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Pelvic pain | Reproductive system and breast disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Cervical polyp | Reproductive system and breast disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Menstruation irregular | Reproductive system and breast disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Rhinitis allergic | 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 |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Nasal congestion | 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 |
|
| Alopecia | 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 |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Haemorrhage subcutaneous | 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 |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
| Tumour excision | Surgical and medical procedures | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
Not provided
Not provided
| D009422 | Nervous System Diseases |