Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
MYCAPSSA™ (formerly Octreolin™) is a proprietary oral form of the approved injectable medical product octreotide used to treat acromegaly. This study will evaluate the efficacy and safety of MYCAPSSA™ treatment in patients with acromegaly.
The study consisted of 2 periods, a Core Treatment Period of up to 7 months and an optional Extension Treatment Period of up to 6 months, for a total study duration of up to 13 months. The Core Treatment Period consisted of 2 phases, a Dose Escalation Phase of at least 2 months to identify the therapeutic dose for each study participant and a Fixed Dose Phase of 2 to 5 months during which the therapeutic dose was maintained.
Participants were eligible to enter the Fixed Dose Phase of the Core Treatment Period if they were clinically and biochemically controlled. The same criteria were used to allow entry into the voluntary 6-month Extension Treatment Period.
The Core Treatment Period of the study was completed if the participant had at least 2 months of treatment in the Fixed Dose Phase and a total treatment duration of at least 7 months. Participants who elected to continue into the Extension Treatment Period maintained their therapeutic dose during this period. At the end of the study (after the last dose of MYCAPSSA in either the Core Treatment Period or the Extension Treatment Period), there was a 2-week follow-up period for safety assessments.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Octreotide capsules | Experimental | Participants received octreotide capsules orally twice a day for up to 13 months. Dosing started at 40 mg per day (20 in the morning + 20 in the evening) and increased to 60 mg per day (40 in the morning + 20 in the evening) or 80 mg per day (40 in the morning + 40 in the evening) if there was inadequate IGF-1 suppression. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Octreotide capsules | Drug | Octreotide was provided in hard gelatin capsules. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Responders at the End of the Core Treatment Period | A responder was defined as a participant with a serum insulin-like growth factor-1 (IGF-1) concentration < 1.3 times the upper limit of normal (adjusted for age and gender) and a growth hormone (GH) concentration < 2.5 ng/mL. The growth hormone concentration was the mean of 5 fasted GH serum concentrations collected at 30 minute intervals for 2 hours, 2 to 4 hours post-octreotide dose. IGF-1 concentration was determined in serum samples taken at the same visits GH concentration was assessed. | End of the core treatment period (up to 7 months) |
| Percentage of Responders at the End of the Extension Treatment Period | A responder was defined as a participant with a serum insulin-like growth factor-1 (IGF-1) concentration < 1.3 times the upper limit of normal (adjusted for age and gender) and a growth hormone (GH) concentration < 2.5 ng/mL. The growth hormone concentration was the mean of 5 fasted GH serum concentrations collected at 30 minute intervals for 2 hours, 2 to 4 hours post-octreotide dose. IGF-1 concentration was determined in serum samples taken at the same visits GH concentration was assessed. | End of the extension treatment period (up to 13 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Specified IGF-1 and GH Concentrations at Baseline and at the End of the Core Treatment Period | Percentage of participants with the following serum insulin-like growth factor-1 (IGF-1) and growth hormone (GH) concentrations at Baseline and at the end of the core treatment period (ECTP): IGF-1 < 1.3 times the upper limit of normal (ULN) and GH < 5.0 ng/mL, IGF-1 < 1.3 times ULN and GH < 1.0 ng/mL, IGF-1 ≤ 1.0 times ULN and GH < 5.0 ng/mL, IGF-1 ≤ 1.0 times ULN and GH < 2.5 ng/mL, IGF-1 ≤ 1.0 times ULN and GH < 1.0 ng/mL, IGF-1 < 1.3 times ULN, IGF-1 ≤ 1.0 times ULN, GH < 5.0 ng/mL, GH < 2.5 ng/mL, GH < 1.0 ng/mL, IGF-1 ≥ 1.3 times ULN and GH < 2.5 ng/mL, IGF-1 < 1.3 times ULN and GH ≥ 2.5 ng/mL, and IGF-1 ≥ 1.3 times ULN and GH ≥ 2.5 ng/mL. The growth hormone concentration was the mean of 5 fasted GH serum concentrations collected at 30 minute intervals for 2 hours, 2 to 4 hours post-octreotide dose. IGF-1 concentration was determined in serum samples taken at the same visits GH concentration was assessed. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Shlomo Melmed, MD | Cedars-Sinai Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States | ||
| Campus Charité Mitte |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34173129 | Derived | Labadzhyan A, Nachtigall LB, Fleseriu M, Gordon MB, Molitch M, Kennedy L, Samson SL, Greenman Y, Biermasz N, Bolanowski M, Haviv A, Ludlam W, Patou G, Strasburger CJ. Oral octreotide capsules for the treatment of acromegaly: comparison of 2 phase 3 trial results. Pituitary. 2021 Dec;24(6):943-953. doi: 10.1007/s11102-021-01163-2. Epub 2021 Jun 25. | |
| 25664604 |
| Label | URL |
|---|---|
| Sponsor website | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Octreotide Capsules | Participants received octreotide capsules orally twice a day for up to 13 months. Dosing started at 40 mg per day (20 in the morning + 20 in the evening) and increased to 60 mg per day (40 in the morning + 20 in the evening) or 80 mg per day (40 in the morning + 40 in the evening) if there was inadequate IGF-1 suppression. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Core Treatment Period |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Baseline and the end of the core treatment period (up to 7 months) |
| Maintenance of Response During the Fixed Dose Phase of the Core Treatment Period | Maintenance of response during the fixed dose phase of the core treatment period was defined as the percentage of participants with an insulin-like growth factor-1 (IGF-1) concentration < 1.3 times the upper limit of normal at the beginning of the fixed dose phase of the core treatment period and at the end of the core treatment period. IGF-1 concentration was determined in serum samples taken at the same visits growth hormone concentration was assessed. | Beginning of the fixed dose phase of the core treatment period and the end of the core treatment period (up to 7 months) |
| Percentage of Participants With Specified IGF-1 and GH Concentrations at the Beginning and at the End of the Extension Treatment Period | Percentage of participants with the following serum insulin-like growth factor-1 (IGF-1) and growth hormone (GH) concentrations at the beginning (BETP) and at the end (EETP) of the extension treatment period: IGF-1 < 1.3 times the upper level of normal (ULN) and GH < 5.0 ng/mL, IGF-1 < 1.3 times ULN and GH < 1.0 ng/mL, IGF-1 ≤ 1.0 times ULN and GH < 5.0 ng/mL, IGF-1 ≤ 1.0 times ULN and GH < 2.5 ng/mL, IGF-1 ≤ 1.0 times ULN and GH < 1.0 ng/mL, IGF-1 < 1.3 times ULN, IGF-1 ≤ 1.0 times ULN, GH < 5.0 ng/mL, GH < 2.5 ng/mL, GH < 1.0 ng/mL, IGF-1 ≥ 1.3 times ULN and GH < 2.5 ng/mL, IGF-1 < 1.3 times ULN and GH ≥ 2.5 ng/mL, and IGF-1 ≥ 1.3 times ULN and GH ≥ 2.5 ng/mL. The growth hormone concentration was the mean of 5 fasted GH serum concentrations collected at 30 minute intervals for 2 hours, 2 to 4 hours post-octreotide dose. IGF-1 concentration was determined in serum samples taken at the same visits GH concentration was assessed. | Beginning and the end of the extension treatment period (up to 6 months) |
| Maintenance of Response During the Extension Treatment Period | Maintenance of an insulin-like growth factor-1 (IGF-1) response during the extension treatment period was defined as the percentage of participants with an IGF-1 concentration < 1.3 times the upper limit of normal at the beginning of the extension treatment period and at the end of the extension treatment period. IGF-1 concentration was determined in serum samples taken at the same visits growth hormone concentration was assessed. | Beginning of the extension treatment period and the end of the extension treatment period (up to 13 months) |
| Percentage of Participants With Improved or Maintained Acromegaly Symptoms at the End of the Extension Treatment Period | The severity (absent, mild, moderate, severe) of the 5 acromegaly symptoms headache, perspiration, asthenia, swelling of extremities, and joint pain was assessed at Baseline and at the end of the extension treatment period. The percentage of participants with improved or maintained (no change) acromegaly symptoms from Baseline at the end of the extension treatment period is reported. | Baseline and the end of the extension treatment period (up to 13 months) |
| Percentage of Participants With ≥ 1, 2, or 3 Acromegaly Symptoms at Baseline and at the End of the Extension Treatment Period | Reported is the percentage of participants who had ≥ 1, 2, or 3 of the 5 symptoms of acromegaly (headaches, perspiration, asthenia, swelling of extremities, or joint pain) of any severity (mild, moderate, or severe). This was a post hoc analysis. | Baseline and the end of the extension treatment period (up to 13 months) |
| Berlin |
| Germany |
| ENDOC Center for Endocrine Tumors | Hamburg | 20357 | Germany |
| Medizinische Klinik Innenstadt | Munich | 80336 | Germany |
| Max Planck Institute of Psychiatry | Munich | 80804 | Germany |
| Praxis for Endocrimology and Diabetology in Oldenburg | Oldenburg | 26122 | Germany |
| Military Hospital, State Health Center 2nd Department of Internal Medicine | Budapest | 1062 | Hungary |
| Semmelweiss University | Budapest | 1088 | Hungary |
| University of Pecs | Pécs | 7624 | Hungary |
| University of Szeged | Szeged | 6720 | Hungary |
| Servizio di Endocrinologia A.O. Spedali Civili di Brescia | Brescia | 25128 | Italy |
| Dipartimento Clinico Sperimentale di Medicina e Farmacologia | Messina | 98125 | Italy |
| Ospedale Molinette | Torino | 10126 | Italy |
| Hospital of Lithuanian University of Health Sciences Kauno Klinikos | Kaunas | 50009 | Lithuania |
| Vilnius University Hospital Santariskiu Clinics Center of Endocrinology | Vilnius | 8661 | Lithuania |
| Unidad de Investigacion Clinica Cardiometabolica de Occidente | Guadalajara Jalisco | 44150 | Mexico |
| Instituto Nacional de Neurologia y Neurocirugía - National Institute of Neurology and Neurosurgery | Mexico City | 14269 | Mexico |
| Centro Medico ABC | Mexico City | 5300 | Mexico |
| Leiden University Medical Centre | Leiden | 2333 ZA | Netherlands |
| Erasmus University Medical Center | Rotterdam | 3015 CE | Netherlands |
| Autonomous Public Clinical Hospital No. 5 | Katowice | 40- 952 | Poland |
| Department of Endocrinology - Jagiellonian University, Krakow | Krakow | 31-501 | Poland |
| Clinical Hospital of Medical University in Poznan | Poznan | 60-355 | Poland |
| Bielanski Hospital | Warsaw | 01 - 809 | Poland |
| Wroclaw Medical University | Wroclaw | 50-367 | Poland |
| Endocrinology Institute C.I.Parhon | Bucharest | 11863 | Romania |
| County Emergency Hospital, Sf. Spiridon, Department of Endocrinology | Iași | 700111 | Romania |
| Clinic for Endocrinology, Diabetes and Metabolism Diseases, Clinical Center of Serbia | Belgrade | 11000 | Serbia |
| Clinical Center of Vojvodina | Novi Sad | 21000 | Serbia |
| University Hospital Bratislava, Hospital of L.Derer | Bratislava | 833 05 | Slovakia |
| National Institute of Endocrinology and Diabetology | Ľubochňa | 034 91 | Slovakia |
| Department of Endocrinology and Diabetes, University Medical Centre | Ljubliana | 1525 | Slovenia |
| University of Warwick - Medical School | Coventry | CV2 2DX | United Kingdom |
| St Bartholomew's Hospital West | London | EC1M 6BQ | United Kingdom |
| The Christie Hospital NHS Trust | Manchester | M13 9WL | United Kingdom |
| Oxford Centre for Diabetes, Endocrinology and Metabolism | Oxford | OX37LJ | United Kingdom |
| Melmed S, Popovic V, Bidlingmaier M, Mercado M, van der Lely AJ, Biermasz N, Bolanowski M, Coculescu M, Schopohl J, Racz K, Glaser B, Goth M, Greenman Y, Trainer P, Mezosi E, Shimon I, Giustina A, Korbonits M, Bronstein MD, Kleinberg D, Teichman S, Gliko-Kabir I, Mamluk R, Haviv A, Strasburger C. Safety and efficacy of oral octreotide in acromegaly: results of a multicenter phase III trial. J Clin Endocrinol Metab. 2015 Apr;100(4):1699-708. doi: 10.1210/jc.2014-4113. Epub 2015 Feb 9. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Extension Treatment Period |
|
|
Safety population: All participants enrolled in the study who received any amount of the study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Octreotide Capsules | Participants received octreotide capsules orally twice a day for up to 13 months. Dosing started at 40 mg per day (20 in the morning + 20 in the evening) and increased to 60 mg per day (40 in the morning + 20 in the evening) or 80 mg per day (40 in the morning + 40 in the evening) if there was inadequate IGF-1 suppression. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | 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 | Percentage of Responders at the End of the Core Treatment Period | A responder was defined as a participant with a serum insulin-like growth factor-1 (IGF-1) concentration < 1.3 times the upper limit of normal (adjusted for age and gender) and a growth hormone (GH) concentration < 2.5 ng/mL. The growth hormone concentration was the mean of 5 fasted GH serum concentrations collected at 30 minute intervals for 2 hours, 2 to 4 hours post-octreotide dose. IGF-1 concentration was determined in serum samples taken at the same visits GH concentration was assessed. | Modified intent-to-treat population: All enrolled participants who received any amount of study drug and who had at least 1 IGF-1 or GH assessment after the first dose of octreotide. | Posted | Number | 95% Confidence Interval | Percentage of responders | End of the core treatment period (up to 7 months) |
|
|
| ||||||||||||||||||||||||||||||||||
| Primary | Percentage of Responders at the End of the Extension Treatment Period | A responder was defined as a participant with a serum insulin-like growth factor-1 (IGF-1) concentration < 1.3 times the upper limit of normal (adjusted for age and gender) and a growth hormone (GH) concentration < 2.5 ng/mL. The growth hormone concentration was the mean of 5 fasted GH serum concentrations collected at 30 minute intervals for 2 hours, 2 to 4 hours post-octreotide dose. IGF-1 concentration was determined in serum samples taken at the same visits GH concentration was assessed. | Extension intent-to-treat population: All participants who entered the extension treatment period and received any amount of study drug during the extension treatment period. | Posted | Number | 95% Confidence Interval | Percentage of responders | End of the extension treatment period (up to 13 months) |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Specified IGF-1 and GH Concentrations at Baseline and at the End of the Core Treatment Period | Percentage of participants with the following serum insulin-like growth factor-1 (IGF-1) and growth hormone (GH) concentrations at Baseline and at the end of the core treatment period (ECTP): IGF-1 < 1.3 times the upper limit of normal (ULN) and GH < 5.0 ng/mL, IGF-1 < 1.3 times ULN and GH < 1.0 ng/mL, IGF-1 ≤ 1.0 times ULN and GH < 5.0 ng/mL, IGF-1 ≤ 1.0 times ULN and GH < 2.5 ng/mL, IGF-1 ≤ 1.0 times ULN and GH < 1.0 ng/mL, IGF-1 < 1.3 times ULN, IGF-1 ≤ 1.0 times ULN, GH < 5.0 ng/mL, GH < 2.5 ng/mL, GH < 1.0 ng/mL, IGF-1 ≥ 1.3 times ULN and GH < 2.5 ng/mL, IGF-1 < 1.3 times ULN and GH ≥ 2.5 ng/mL, and IGF-1 ≥ 1.3 times ULN and GH ≥ 2.5 ng/mL. The growth hormone concentration was the mean of 5 fasted GH serum concentrations collected at 30 minute intervals for 2 hours, 2 to 4 hours post-octreotide dose. IGF-1 concentration was determined in serum samples taken at the same visits GH concentration was assessed. | Modified intent-to-treat population: All enrolled participants who received any amount of study drug and who had at least 1 IGF-1 or GH assessment after the first dose of octreotide. | Posted | Number | Percentage of participants | Baseline and the end of the core treatment period (up to 7 months) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Maintenance of Response During the Fixed Dose Phase of the Core Treatment Period | Maintenance of response during the fixed dose phase of the core treatment period was defined as the percentage of participants with an insulin-like growth factor-1 (IGF-1) concentration < 1.3 times the upper limit of normal at the beginning of the fixed dose phase of the core treatment period and at the end of the core treatment period. IGF-1 concentration was determined in serum samples taken at the same visits growth hormone concentration was assessed. | Fixed dose population: All enrolled participants who received any amount of study drug, who had at least 1 IGF-1 or GH assessment after the first dose of octreotide, and who entered the fixed dose phase of the core treatment period. | Posted | Number | Percentage of participants | Beginning of the fixed dose phase of the core treatment period and the end of the core treatment period (up to 7 months) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Specified IGF-1 and GH Concentrations at the Beginning and at the End of the Extension Treatment Period | Percentage of participants with the following serum insulin-like growth factor-1 (IGF-1) and growth hormone (GH) concentrations at the beginning (BETP) and at the end (EETP) of the extension treatment period: IGF-1 < 1.3 times the upper level of normal (ULN) and GH < 5.0 ng/mL, IGF-1 < 1.3 times ULN and GH < 1.0 ng/mL, IGF-1 ≤ 1.0 times ULN and GH < 5.0 ng/mL, IGF-1 ≤ 1.0 times ULN and GH < 2.5 ng/mL, IGF-1 ≤ 1.0 times ULN and GH < 1.0 ng/mL, IGF-1 < 1.3 times ULN, IGF-1 ≤ 1.0 times ULN, GH < 5.0 ng/mL, GH < 2.5 ng/mL, GH < 1.0 ng/mL, IGF-1 ≥ 1.3 times ULN and GH < 2.5 ng/mL, IGF-1 < 1.3 times ULN and GH ≥ 2.5 ng/mL, and IGF-1 ≥ 1.3 times ULN and GH ≥ 2.5 ng/mL. The growth hormone concentration was the mean of 5 fasted GH serum concentrations collected at 30 minute intervals for 2 hours, 2 to 4 hours post-octreotide dose. IGF-1 concentration was determined in serum samples taken at the same visits GH concentration was assessed. | Extension intent-to-treat population: All participants who entered the extension treatment period and received any amount of study drug during the extension treatment period. | Posted | Number | Percentage of participants | Beginning and the end of the extension treatment period (up to 6 months) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Maintenance of Response During the Extension Treatment Period | Maintenance of an insulin-like growth factor-1 (IGF-1) response during the extension treatment period was defined as the percentage of participants with an IGF-1 concentration < 1.3 times the upper limit of normal at the beginning of the extension treatment period and at the end of the extension treatment period. IGF-1 concentration was determined in serum samples taken at the same visits growth hormone concentration was assessed. | Extension intent-to-treat population: All participants who entered the extension treatment period and received any amount of study drug during the extension treatment period. | Posted | Number | 95% Confidence Interval | Percentage of participants | Beginning of the extension treatment period and the end of the extension treatment period (up to 13 months) |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Improved or Maintained Acromegaly Symptoms at the End of the Extension Treatment Period | The severity (absent, mild, moderate, severe) of the 5 acromegaly symptoms headache, perspiration, asthenia, swelling of extremities, and joint pain was assessed at Baseline and at the end of the extension treatment period. The percentage of participants with improved or maintained (no change) acromegaly symptoms from Baseline at the end of the extension treatment period is reported. | Extension intent-to-treat population: All participants who entered the extension treatment period and received any amount of study drug during the extension treatment period. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline and the end of the extension treatment period (up to 13 months) |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With ≥ 1, 2, or 3 Acromegaly Symptoms at Baseline and at the End of the Extension Treatment Period | Reported is the percentage of participants who had ≥ 1, 2, or 3 of the 5 symptoms of acromegaly (headaches, perspiration, asthenia, swelling of extremities, or joint pain) of any severity (mild, moderate, or severe). This was a post hoc analysis. | Extension intent-to-treat population: All participants who entered the extension treatment period and received any amount of study drug during the extension treatment period. | Posted | Number | Percentage of participants | Baseline and the end of the extension treatment period (up to 13 months) |
|
|
Not provided
Safety population: All participants enrolled in the study who received any amount of the study drug.
The total number of participants with adverse events is greater than the 155 participants enrolled in the study since this was a dose-escalation study and adverse events occurred at all dose levels.
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 | Octreotide 40 mg | Participants received octreotide 20 mg orally twice a day for up to 13 months. | 1 | 155 | 9 | 155 | 103 | 155 |
| EG001 | Octreotide 60 mg | Participants received octreotide 40 mg in the morning and octreotide 20 mg in the evening orally for up to 13 months. | 0 | 91 | 7 | 91 | 51 | 91 |
| EG002 | Octreotide 80 mg | Participants received octreotide 40 mg in the morning and octreotide 40 mg in the evening orally for up to 13 months. | 1 | 58 | 8 | 58 | 31 | 58 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholelithiasis | Hepatobiliary disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Bile duct obstruction | Hepatobiliary disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Transient ischemic attack | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Chronic sinusitis | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Corneal abscess | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Herpes simplex ophthalmic | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Breast cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | Systematic Assessment |
| |
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | Systematic Assessment |
| |
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Intervertebral disc protusion | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Polymyalgia Rheumatica | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Impaired healing | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Spleen disorder | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| Pancreatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (14.0) | Systematic Assessment |
|
The results of the study cannot be published for a period of up to 150 days, 60 days for sponsor review and 90 days for patent protection. In addition, the first publication may only occur after the first multi-center publication or, if no such multi-center publication is made, 12-18 months after completion of the study at all study sites.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shlomo Melmed, MD | Cedars-Sinai Medical Center | 310 423-4691 | melmed@csmc.edu |
| ID | Term |
|---|---|
| D000172 | Acromegaly |
| ID | Term |
|---|---|
| D001849 | Bone Diseases, Endocrine |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006964 | Hyperpituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015282 | Octreotide |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
|
|
|
|
|
|