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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-002211-18 | EudraCT Number |
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The purpose of this study is to determine if AMG 334 is effective in treating migraines in patients who have failed other preventive migraine treatments.
This study was a double blind, placebo-controlled, randomized trial in adult patients with episodic migraine. There was a screening period of 2 weeks to assess initial eligibility, and a 4-week baseline period. After randomization, participants entered the double-blind treatment epoch (DBTE) and had clinic visits for 12 weeks. All participants who completed the DBTE were eligible to enter the Open-Label Treatment Epoch (OLTE) for up to 156 weeks. All participants had a 12 week Follow-Up Epoch and a a Follow-Up visit 16 weeks after the last dose of AMG334 unless the participant continued on commercially available AMG334. Participants who had demonstrated clinical benefit were eligible to enter a Post Trial Access (PTA-Open Label Treatment Epoch) of flexible duration for approximately 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo DB | Placebo Comparator | Matching placebo subcutaneous injections administered every 4 weeks during Double-Blind Epoch |
|
| AMG334 140 mg DB | Experimental | AMG334 70 mg subcutaneous injections (2) administered every 4 weeks during Double-Blind Epoch |
|
| AMG334 140 mg DB cont on AMG334 140 mg | Experimental | AMG334 70 mg subcutaneous injections (2) during DB continued on AMG334 140 mg in Open-Label Epoch |
|
| Placebo in DB to AMG334 140 mg | Experimental | Placebo in Double-Blind Epoch (DB) switched to AMG334 140 mg in Open-Label Epoch |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMG334 (70 mg) Pre-Filled Syringe (PFS) | Biological | Two injections of AMG 334 70 mg (equaling 140 mg total dose) will be administered via subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With at Least 50% Reduction From Baseline of Monthly Migraine Days (MMD) in the Last Month (Last 4 Weeks of Treatment) | A migraine day was defined as any calendar day in which the subject experienced a qualified migraine headache defined as: with/without aura, lasting ≥ 30 minutes with at least 1 criteria: 1. ≥ 2 of following pain features: unilateral, throbbing, moderate to severe or exacerbated with exercise/physical activity, 2. ≥ 1 of the following symptoms: nausea and/or vomiting, photophobia and phonophobia. If a migraine-specific medication (ie, triptan or ergotamine) was taken during aura, or a headache, it was counted as a migraine day regardless of duration and pain features/associated symptoms. | Baseline, Month 3 (last 4 weeks of treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Monthly Migraine Days (MMD) in the Last Month (Last 4 Weeks of Treatment) | A migraine day was defined as any calendar day in which the subject experienced a qualified migraine headache defined as: with/without aura, lasting ≥ 30 minutes with at least 1 criteria: 1. ≥ 2 of following pain features: unilateral, throbbing, moderate to severe or exacerbated with exercise/physical activity, 2. ≥ 1 of the following symptoms: nausea and/or vomiting, photophobia and phonophobia. If a migraine-specific medication (ie, triptan or ergotamine) was taken during aura, or a headache, it was counted as a migraine day regardless of duration and pain features/associated symptoms. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Heidelberg | 3084 | Australia | |||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38669638 | Derived | Reuter U, Goadsby PJ, Ferrari MD, Da Silva Lima GP, Mondal S, Kalim J, Hasan F, Wen S, Arkuszewski M, Pandhi S, Stites T, Lanteri-Minet M. Efficacy and Safety of Erenumab in Participants With Episodic Migraine in Whom 2-4 Prior Preventive Treatments Had Failed: LIBERTY 3-Year Study. Neurology. 2024 May;102(10):e209349. doi: 10.1212/WNL.0000000000209349. Epub 2024 Apr 26. | |
| 35978286 |
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Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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333 participants were screened for the trial
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| ID | Title | Description |
|---|---|---|
| FG000 | AMG334 140 mg DB | AMG334 140 mg subcutaneous injections administered every 4 weeks during Double-Blind Epoch |
| FG001 | Placebo DB | Matching placebo subcutaneous injections administered every 4 weeks during Double-Blind Epoch |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double-Blind Treatment Epoch |
|
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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 | May 22, 2020 | Jan 22, 2022 |
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| Placebo Pre-Filled Syringe (PFS) | Biological | Subcutaneous injection of matching placebo |
|
| Baseline, Month 3 (last 4 weeks of treatment) |
| Change From Baseline in Physical Impairment and Everyday Activities as Measured by the Migraine Physical Function Impact Diary (MPFID) at Month 3 | MPFID has 2 domains: Everyday Activities, which consisted of 7 items and Physical Impairment with 5 items using a 5-point scale. Scores were summed across each domain and were then transformed and used for analyses. Transforming MPFID domain scores ranged from 0-100, where higher scores were indicative of greater migraine impact (ie, higher burden) | Baseline, Month 3 (last 4 weeks of treatment) |
| Change in the Number of Monthly Acute Migraine-specific Medication Treatment Days at Month 3 | Number of days on which acute migraine-specific medications were used were recorded in eDiary between each monthly IP dose. Migraine-Specific medications included two categories of medications: triptan-based migraine medications and ergotamine-based migraine medications. Monthly migraine-specific medication use at baseline was the number of migraine-specific medication treatment days in the baseline period. | Baseline, Month 3 (last 4 weeks of treatment) |
| Percentage of Participants With a 75% Reduction From Baseline of Monthly Migraine Days (MMD) in the Last Month (Last 4 Weeks of Treatment) | A migraine day was defined as any calendar day in which the subject experienced a qualified migraine headache defined as: with/without aura, lasting ≥ 30 minutes with at least 1 criteria: 1. ≥ 2 of following pain features: unilateral, throbbing, moderate to severe or exacerbated with exercise/physical activity, 2. ≥ 1 of the following symptoms: nausea and/or vomiting, photophobia and phonophobia. If a migraine-specific medication (ie, triptan or ergotamine) was taken during aura, or a headache, it was counted as a migraine day regardless of duration and pain features/associated symptoms. | Baseline, Month 3 (last 4 weeks of treatment) |
| Percentage of Participants With a 100% Reduction From Baseline of Monthly Migraine Days (MMD) in the Last Month (Last 4 Weeks of Treatment) | A migraine day was defined as any calendar day in which the subject experienced a qualified migraine headache defined as: with/without aura, lasting ≥ 30 minutes with at least 1 criteria: 1. ≥ 2 of following pain features: unilateral, throbbing, moderate to severe or exacerbated with exercise/physical activity, 2. ≥ 1 of the following symptoms: nausea and/or vomiting, photophobia and phonophobia. If a migraine-specific medication (ie, triptan or ergotamine) was taken during aura, or a headache, it was counted as a migraine day regardless of duration and pain features/associated symptoms. | Baseline, Month 3 (last 4 weeks of treatment) |
| Number of Participants Who Developed Anti-AMG334 Antibodies | Blood samples for immunogenicity testing were collected for the measurement of anti-AMG334 binding antibodies. | Baseline up to approximately 180 weeks |
| Innsbruck |
| A 6020 |
| Austria |
| Novartis Investigative Site | Vienna | 1090 | Austria |
| Novartis Investigative Site | Brussels | 1090 | Belgium |
| Novartis Investigative Site | Ghent | 9000 | Belgium |
| Novartis Investigative Site | Hasselt | 3500 | Belgium |
| Novartis Investigative Site | Leuven | 3000 | Belgium |
| Novartis Investigative Site | Prague | CZE | 120 00 | Czechia |
| Novartis Investigative Site | Czech Republic | 18600 | Czechia |
| Novartis Investigative Site | Prague | 140 59 | Czechia |
| Novartis Investigative Site | Glostrup Municipality | 2600 | Denmark |
| Novartis Investigative Site | Helsinki | 00180 | Finland |
| Novartis Investigative Site | Helsinki | 00930 | Finland |
| Novartis Investigative Site | Turku | 20100 | Finland |
| Novartis Investigative Site | Lille | 59037 | France |
| Novartis Investigative Site | Marseille | 13885 | France |
| Novartis Investigative Site | Nice | 06003 | France |
| Novartis Investigative Site | Berlin | 10435 | Germany |
| Novartis Investigative Site | Berlin | 13353 | Germany |
| Novartis Investigative Site | Bielefeld | D 33647 | Germany |
| Novartis Investigative Site | Bochum | 44787 | Germany |
| Novartis Investigative Site | Erlangen | 91054 | Germany |
| Novartis Investigative Site | Essen | 45147 | Germany |
| Novartis Investigative Site | Hamburg | 20251 | Germany |
| Novartis Investigative Site | Kiel | 24149 | Germany |
| Novartis Investigative Site | Leipzig | 04107 | Germany |
| Novartis Investigative Site | München | 81377 | Germany |
| Novartis Investigative Site | Tübingen | 72076 | Germany |
| Novartis Investigative Site | Wiesbaden | 65191 | Germany |
| Novartis Investigative Site | Athens | GR | 115 25 | Greece |
| Novartis Investigative Site | Glyfada | 16675 | Greece |
| Novartis Investigative Site | Marousi | 15125 | Greece |
| Novartis Investigative Site | Bologna | BO | 40139 | Italy |
| Novartis Investigative Site | Florence | FI | 50139 | Italy |
| Novartis Investigative Site | Roma | RM | 00189 | Italy |
| Novartis Investigative Site | Milan | 20133 | Italy |
| Novartis Investigative Site | Naples | 80138 | Italy |
| Novartis Investigative Site | Palermo | 90127 | Italy |
| Novartis Investigative Site | Sittard-Geleen | BG | 6162 BG | Netherlands |
| Novartis Investigative Site | Leiden | 2333 ZA | Netherlands |
| Novartis Investigative Site | Nijmegen | 6532 SZ | Netherlands |
| Novartis Investigative Site | Hamar | 2317 | Norway |
| Novartis Investigative Site | Sandvika | 1337 | Norway |
| Novartis Investigative Site | Santander | Cantabria | 39008 | Spain |
| Novartis Investigative Site | Valladolid | Castille and León | 47011 | Spain |
| Novartis Investigative Site | Barcelona | Catalonia | 08035 | Spain |
| Novartis Investigative Site | Fuenlabrada | Madrid | 28942 | Spain |
| Novartis Investigative Site | Pozuelo de Alarcón | Madrid | 28223 | Spain |
| Novartis Investigative Site | Zaragoza | 50009 | Spain |
| Novartis Investigative Site | Lund | 222 22 | Sweden |
| Novartis Investigative Site | Stockholm | 114 33 | Sweden |
| Novartis Investigative Site | Uppsala | SE-751 85 | Sweden |
| Novartis Investigative Site | Vällingby | 162 68 | Sweden |
| Novartis Investigative Site | Bad Zurzach | 5330 | Switzerland |
| Novartis Investigative Site | Lausanne | 1011 | Switzerland |
| Novartis Investigative Site | Zollikon | 8702 | Switzerland |
| Novartis Investigative Site | Brighton | East Sussex | BN2 5BE | United Kingdom |
| Novartis Investigative Site | Stoke-on-Trent | Staffordshire | ST46QG | United Kingdom |
| Novartis Investigative Site | London | SE5 9RS | United Kingdom |
| Derived |
| Lampl C, Kraus V, Lehner K, Loop B, Chehrenama M, Maczynska Z, Ritter S, Klatt J, Snellman J. Safety and tolerability of erenumab in individuals with episodic or chronic migraine across age groups: a pooled analysis of placebo-controlled trials. J Headache Pain. 2022 Aug 18;23(1):104. doi: 10.1186/s10194-022-01470-4. |
| 34845002 | Derived | Ferrari MD, Reuter U, Goadsby PJ, Paiva da Silva Lima G, Mondal S, Wen S, Tenenbaum N, Pandhi S, Lanteri-Minet M, Stites T. Two-year efficacy and safety of erenumab in participants with episodic migraine and 2-4 prior preventive treatment failures: results from the LIBERTY study. J Neurol Neurosurg Psychiatry. 2022 Mar;93(3):254-262. doi: 10.1136/jnnp-2021-327480. Epub 2021 Nov 29. |
| 33910942 | Derived | Goadsby PJ, Reuter U, Lanteri-Minet M, Paiva da Silva Lima G, Hours-Zesiger P, Fernandes C, Wen S, Tenenbaum N, Kataria A, Ferrari MD, Klatt J. Long-term Efficacy and Safety of Erenumab: Results From 64 Weeks of the LIBERTY Study. Neurology. 2021 May 31;96(22):e2724-e2735. doi: 10.1212/WNL.0000000000012029. |
| 33402419 | Derived | Lanteri-Minet M, Goadsby PJ, Reuter U, Wen S, Hours-Zesiger P, Ferrari MD, Klatt J. Effect of erenumab on functional outcomes in patients with episodic migraine in whom 2-4 preventives were not useful: results from the LIBERTY study. J Neurol Neurosurg Psychiatry. 2021 May;92(5):466-472. doi: 10.1136/jnnp-2020-324396. Epub 2021 Jan 5. |
| 30360965 | Derived | Reuter U, Goadsby PJ, Lanteri-Minet M, Wen S, Hours-Zesiger P, Ferrari MD, Klatt J. Efficacy and tolerability of erenumab in patients with episodic migraine in whom two-to-four previous preventive treatments were unsuccessful: a randomised, double-blind, placebo-controlled, phase 3b study. Lancet. 2018 Nov 24;392(10161):2280-2287. doi: 10.1016/S0140-6736(18)32534-0. Epub 2018 Oct 22. |
| FG002 | AMG334 140 mg DB Cont on AMG334 140 mg | AMG334 140 mg subcutaneous injections during DB continued on AMG334 140 mg in Open-Label Epoch |
| FG003 | Placebo DB to AMG334 140 mg | Placebo in Double-Blind Epoch (DB) switched to AMG334 140 mg in Open-Label Epoch |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Open-Label Treatment Epoch |
|
|
| Safety Follow-Up Epoch |
|
|
| Post-Trial Access Epoch |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | AMG334 140 mg DB | AMG334 140 mg subcutaneous injections administered every 4 weeks during Double-Blind Epoch |
| BG001 | Placebo DB | Matching placebo subcutaneous injections administered every 4 weeks during Double-Blind Epoch |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Monthly Migraine Days at Baseline | A migraine day was defined as any calendar day in which the subject experienced a qualified migraine headache defined as: with/without aura, lasting ≥ 30 minutes with at least 1 criteria: 1. ≥ 2 of following pain features: unilateral, throbbing, moderate to severe or exacerbated with exercise/physical activity, 2. ≥ 1 of the following symptoms: nausea and/or vomiting, photophobia and phonophobia. If a migraine-specific medication (ie, triptan or ergotamine) was taken during aura, or a headache, it was counted as a migraine day regardless of duration and pain features/associated symptoms. | Mean | Standard Deviation | Migraine days/month |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With at Least 50% Reduction From Baseline of Monthly Migraine Days (MMD) in the Last Month (Last 4 Weeks of Treatment) | A migraine day was defined as any calendar day in which the subject experienced a qualified migraine headache defined as: with/without aura, lasting ≥ 30 minutes with at least 1 criteria: 1. ≥ 2 of following pain features: unilateral, throbbing, moderate to severe or exacerbated with exercise/physical activity, 2. ≥ 1 of the following symptoms: nausea and/or vomiting, photophobia and phonophobia. If a migraine-specific medication (ie, triptan or ergotamine) was taken during aura, or a headache, it was counted as a migraine day regardless of duration and pain features/associated symptoms. | Full analysis set | Posted | Number | Percentage of participants | Baseline, Month 3 (last 4 weeks of treatment) |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Monthly Migraine Days (MMD) in the Last Month (Last 4 Weeks of Treatment) | A migraine day was defined as any calendar day in which the subject experienced a qualified migraine headache defined as: with/without aura, lasting ≥ 30 minutes with at least 1 criteria: 1. ≥ 2 of following pain features: unilateral, throbbing, moderate to severe or exacerbated with exercise/physical activity, 2. ≥ 1 of the following symptoms: nausea and/or vomiting, photophobia and phonophobia. If a migraine-specific medication (ie, triptan or ergotamine) was taken during aura, or a headache, it was counted as a migraine day regardless of duration and pain features/associated symptoms. | Number of participants with both baseline and valid post baseline value from the Full Analysis Set | Posted | Mean | Standard Error | Monthly migraine days | Baseline, Month 3 (last 4 weeks of treatment) |
|
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| Secondary | Change From Baseline in Physical Impairment and Everyday Activities as Measured by the Migraine Physical Function Impact Diary (MPFID) at Month 3 | MPFID has 2 domains: Everyday Activities, which consisted of 7 items and Physical Impairment with 5 items using a 5-point scale. Scores were summed across each domain and were then transformed and used for analyses. Transforming MPFID domain scores ranged from 0-100, where higher scores were indicative of greater migraine impact (ie, higher burden) | Number of participants with both baseline and valid post baseline value from the Full Analysis Set | Posted | Mean | Standard Error | scores on a scale | Baseline, Month 3 (last 4 weeks of treatment) |
|
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| Secondary | Change in the Number of Monthly Acute Migraine-specific Medication Treatment Days at Month 3 | Number of days on which acute migraine-specific medications were used were recorded in eDiary between each monthly IP dose. Migraine-Specific medications included two categories of medications: triptan-based migraine medications and ergotamine-based migraine medications. Monthly migraine-specific medication use at baseline was the number of migraine-specific medication treatment days in the baseline period. | Number of participants with both baseline and valid post baseline value from the Full Analysis Set | Posted | Mean | Standard Error | Migraine treatment specific days/month | Baseline, Month 3 (last 4 weeks of treatment) |
|
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| Secondary | Percentage of Participants With a 75% Reduction From Baseline of Monthly Migraine Days (MMD) in the Last Month (Last 4 Weeks of Treatment) | A migraine day was defined as any calendar day in which the subject experienced a qualified migraine headache defined as: with/without aura, lasting ≥ 30 minutes with at least 1 criteria: 1. ≥ 2 of following pain features: unilateral, throbbing, moderate to severe or exacerbated with exercise/physical activity, 2. ≥ 1 of the following symptoms: nausea and/or vomiting, photophobia and phonophobia. If a migraine-specific medication (ie, triptan or ergotamine) was taken during aura, or a headache, it was counted as a migraine day regardless of duration and pain features/associated symptoms. | Full analysis set | Posted | Number | Percentage of participants | Baseline, Month 3 (last 4 weeks of treatment) |
|
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| Secondary | Percentage of Participants With a 100% Reduction From Baseline of Monthly Migraine Days (MMD) in the Last Month (Last 4 Weeks of Treatment) | A migraine day was defined as any calendar day in which the subject experienced a qualified migraine headache defined as: with/without aura, lasting ≥ 30 minutes with at least 1 criteria: 1. ≥ 2 of following pain features: unilateral, throbbing, moderate to severe or exacerbated with exercise/physical activity, 2. ≥ 1 of the following symptoms: nausea and/or vomiting, photophobia and phonophobia. If a migraine-specific medication (ie, triptan or ergotamine) was taken during aura, or a headache, it was counted as a migraine day regardless of duration and pain features/associated symptoms. | Full analysis set | Posted | Number | Percentage of participants | Baseline, Month 3 (last 4 weeks of treatment) |
|
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| Secondary | Number of Participants Who Developed Anti-AMG334 Antibodies | Blood samples for immunogenicity testing were collected for the measurement of anti-AMG334 binding antibodies. | Posted | Number | participants | Baseline up to approximately 180 weeks |
|
|
Adverse events were reported from the first dose of study treatment through the completion of the up to 196-week trial for a maximum treatment exposure of 199 weeks (includes 4 week follow-up).
Safety dataset included only those patients, who received at least one dose of study drug. Among 246 patients randomized, two patients in AMG334 and one in Placebo groups were not dosed and were not included.
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 | AMG334 140 mg DB | AMG334 140 mg subcutaneous injections administered every 4 weeks during Double-Blind Epoch | 0 | 119 | 2 | 119 | 44 | 119 |
| EG001 | Placebo DB | Matching placebo subcutaneous injections administered every 4 weeks during Double-Blind Epoch | 0 | 124 | 1 | 124 | 43 | 124 |
| EG002 | AMG334 140 mg DB Cont on AMG334 140 mg | AMG334 140 mg subcutaneous injections during DB continued on AMG334 140 mg in Open-Label Epoch | 0 | 118 | 16 | 118 | 94 | 118 |
| EG003 | Placebo DB to AMG334 140 mg | Placebo in Double-Blind Epoch (DB) switched to AMG334 140 mg in Open-Label Epoch | 0 | 122 | 18 | 122 | 101 | 122 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Extrasystoles | Cardiac disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Dacryostenosis acquired | Eye disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Inflammation of lacrimal passage | Eye disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Retinal vein thrombosis | Eye disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Anal fissure | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Colitis ischaemic | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Biliary colic | Hepatobiliary disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Allergy to arthropod sting | Immune system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Chronic sinusitis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Herpes simplex hepatitis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA (23.1) | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA (23.1) | Systematic Assessment |
| |
| Traumatic fracture | Injury, poisoning and procedural complications | MedDRA (23.1) | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Cervix carcinoma stage 0 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.1) | Systematic Assessment |
| |
| Myelofibrosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.1) | Systematic Assessment |
| |
| Pituitary tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.1) | Systematic Assessment |
| |
| Aura | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Medication overuse headache | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Status migrainosus | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Calculus urinary | Renal and urinary disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Postmenopausal haemorrhage | Reproductive system and breast disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Injection site haematoma | General disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (23.1) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | + 1 862 778 8300 | Novartis.email@Novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 8, 2018 | Jan 22, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D006261 | Headache |
| D012008 | Recurrence |
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
Not provided
Not provided
| Adverse Event |
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| New therapy for study indication |
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| Physician Decision |
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| Pregnancy |
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| Subject/guardian decision |
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| Protocol deviation |
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| Lost to Follow-up |
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| Male |
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| Asian |
|
| Unknown |
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| Other |
|
| Participants |
|
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| Title |
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| Denominators |
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| Categories |
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