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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-000197-14 | EudraCT Number |
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The purpose of this study was to evaluate the safety and efficacy of extended dosing of donidalorsen administered subcutaneously (SC), with alternative dosing and/or dose frequency with donidalorsen in participants with hereditary angioedema (HAE).
This was an open-label extension study of donidalorsen in 20 participants with HAE. The length of participation in the study was approximately 68 weeks, which included an up to 4-week qualification period, a 52-week treatment period, and a 12-week post-treatment period. Following the Week 53 treatment period visit, participants received donidalorsen in an extended treatment period for up to an additional 156 weeks. Participants taking part in the extended treatment period entered the 12-week post-treatment period after completion of, or early termination from, the extended treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HAE-1/HAE-2 | Experimental | Participants with hereditary angioedema Type I/Type II (HAE-1/HAE-2) who received placebo or donidalorsen, 80 milligrams (mg), SC once every 4 weeks, in the previous study ISIS 721744-CS2 (NCT04030598), received donidalorsen, 80 mg, SC once every 4 weeks, from Week 1 to Week 13 (Fixed Dosing Period). Starting From Week 17 (Flexible Dosing Period), participants had 3 different dosing options as: 80 mg every 4 weeks, 80 mg every 8 weeks for participants who were attack-free for ≥12 weeks, 100 mg every 4 weeks for participants who were not attack-free for ≥12 weeks up to Week 53 based on the investigator and sponsor medical monitor recommendation. Participants continued flexible dosing from Week 53 for up to approximately 209 weeks. |
|
| HAE-nC1-INH | Experimental | Participants with hereditary angioedema with normal C1-inhibitor (HAE-nC1-INH) who received donidalorsen, 80 mg, SC, once every 4 weeks, in the previous study ISIS 721744-CS2 (NCT04030598), continued to receive donidalorsen, 80 mg, SC once every 4 weeks, from Week 1 to Week 13 (Fixed Dosing Period). Starting From Week 17 (Flexible Dosing Period), participants had 2 different dosing options as: 80 mg every 4 weeks, and 100 mg every 4 weeks for participants who were not attack-free for ≥12 weeks up to Week 53 based on the investigator and sponsor medical monitor recommendation. Participants continued flexible dosing from Week 53 for up to approximately 209 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Donidalorsen | Drug | Donidalorsen administered SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | An adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not the AE is considered related to the medicinal (investigational) product. TEAEs were defined as those AEs that either started or worsened in severity on or after the date/time of first administration of study drug in this OLE Study. TEAEs included both serious and non-serious TEAEs. | Up to Week 221 |
| Percentage of Participants With Clinically Meaningful Changes in Clinical Laboratory Assessments | Clinical laboratory tests including clinical chemistry, hematology, coagulation, complement, inflammatory, urinalysis were performed. The percentage of participants with clinically meaningful changes were reported. Clinical meaningfulness was determined by the investigator. | Up to Week 221 |
| Percentage of Participants With Clinically Meaningful Changes in Vital Signs | Vital sign measurements including heart rate, respiratory rate, body temperature, systolic and diastolic blood pressure and pulse pressure were assessed. Percentage of participants with clinically meaningful changes in the vital signs were reported. Clinically meaningfulness was determined by the investigator. | Up to Week 221 |
| Percentage of Participants With Clinically Meaningful Changes in Electrocardiograms (ECGs) Parameters | The ECG parameters included ventricular rate, PR interval, QRS duration, QTc, QT corrected using the Fridericia's formula (QTcF), QT corrected using the Bazett's formula (QTcB), and overall interpretation. Percentage of participants with clinically meaningful changes in the ECG parameters were reported. Clinical meaningfulness was determined by the investigator. | Up to Week 221 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Time-normalized HAE Attack (Per 4 Weeks) Rate | HAE attack rate was calculated for each participant as the number of HAE attacks occurring during the respective period divided by the number of days the participant contributed to this period multiplied by 28 days. An HAE attack was defined as an event with signs or symptoms consistent with an attack in at least 1 of the locations: peripheral angioedema (cutaneous swelling involving an extremity, the face, neck, torso, and/or genitourinary region), abdominal angioedema (abdominal pain, with or without abdominal distention, nausea, vomiting, or diarrhea), laryngeal angioedema (stridor, dyspnea, difficulty speaking, difficulty swallowing, throat tightening, or swelling of the tongue, palate, uvula, or larynx). A negative change from baseline in HAE attacks indicates an improvement in HAE attacks. |
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Inclusion Criteria:
Exclusion Criteria:
1. Have any new condition or worsening of an existing condition or change or anticipated change in medication, which in the opinion of the Investigator would make the participant unsuitable for enrollment, or could interfere with the participant participating in or completing the study
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ionis Investigative Site | Scottsdale | Arizona | 85251 | United States | ||
| Ionis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41802598 | Derived | Manning ME, de Lange M, Bernstein JA, Craig T, Lumry WR, Raasch J, Tachdjian R, Bordone L, Deng Y, Newman KB, Cohn DM. Donidalorsen for hereditary angioedema: Long-term results from a 4-year, phase 2, open-label extension study. Ann Allergy Asthma Immunol. 2026 Jun;136(6):699-705.e1. doi: 10.1016/j.anai.2026.02.019. Epub 2026 Mar 7. | |
| 38009241 |
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Ionis may share anonymized individual participant data, aggregated clinical data, and other types of data that support the results in this study. Data requests from qualified researchers will be considered once all three of the following criteria are met: (1) 12 months from marketing approval of the study drug in both the United States and European Union; (2) 18 months from conclusion of the study; and (3) 6 months from publication of study article. Access would be via a secure environment and is contingent upon approval of a research proposal and entry into an appropriate data use agreement. Requests to access data can be submitted via the website https://vivli.org/ourmember/ionis/.
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A total of 20 subjects were enrolled to receive study drug ISIS 721744 in this study.
Participants took part in the study from 31 March 2020 to 24 January 2025.
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| ID | Title | Description |
|---|---|---|
| FG000 | HAE-1/HAE-2 | Participants with hereditary angioedema Type I/Type II (HAE-1/HAE-2) who received placebo or donidalorsen, 80 milligrams (mg), SC once every 4 weeks, in the previous study ISIS 721744-CS2 (NCT04030598), received donidalorsen, 80 mg, SC once every 4 weeks, from Week 1 to Week 13 (Fixed Dosing Period). Starting From Week 17 (Flexible Dosing Period), participants had 3 different dosing options as: 80 mg every 4 weeks, 80 mg every 8 weeks for participants who were attack-free for ≥12 weeks, 100 mg every 4 weeks for participants who were not attack-free for ≥12 weeks up to Week 53 based on the investigator and sponsor medical monitor recommendation. Participants continued flexible dosing from Week 53 for up to approximately 209 weeks. |
| FG001 | HAE-nC1-INH | Participants with hereditary angioedema with normal C1-inhibitor (HAE-nC1-INH) who received donidalorsen, 80 mg, SC, once every 4 weeks, in the previous study ISIS 721744-CS2 (NCT04030598), continued to receive donidalorsen, 80 mg, SC once every 4 weeks, from Week 1 to Week 13 (Fixed Dosing Period). Starting From Week 17 (Flexible Dosing Period), participants had 2 different dosing options as: 80 mg every 4 weeks, and 100 mg every 4 weeks for participants who were not attack-free for ≥12 weeks up to Week 53 based on the investigator and sponsor medical monitor recommendation. Participants continued flexible dosing from Week 53 for up to approximately 209 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The safety population included all enrolled participants who received at least 1 dose in the open-label extension (OLE) study.
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| ID | Title | Description |
|---|---|---|
| BG000 | HAE-1/HAE-2 | Participants with HAE-1/HAE-2 who received placebo or donidalorsen, 80 mg, SC once every 4 weeks, in the previous study ISIS 721744-CS2 (NCT04030598), received donidalorsen, 80 mg, SC once every 4 weeks, from Week 1 to Week 13 (Fixed Dosing Period). Starting From Week 17 (Flexible Dosing Period), participants had 3 different dosing options as: 80 mg every 4 weeks, 80 mg every 8 weeks for participants who were attack-free for ≥12 weeks, 100 mg every 4 weeks for participants who were not attack-free for ≥12 weeks up to Week 53 based on the investigator and sponsor medical monitor recommendation. Participants continued flexible dosing from Week 53 for up to approximately 209 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | An adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not the AE is considered related to the medicinal (investigational) product. TEAEs were defined as those AEs that either started or worsened in severity on or after the date/time of first administration of study drug in this OLE Study. TEAEs included both serious and non-serious TEAEs. | The safety population included all enrolled participants who received at least 1 dose in the OLE study. | Posted | Number | percentage of participants | Up to Week 221 |
|
Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fixed-dose Period: HAE-1/HAE-2 | Participants with HAE-1/HAE-2 who received placebo or donidalorsen, 80 mg, SC once every 4 weeks, in the previous study ISIS 721744-CS2 (NCT04030598), received donidalorsen, 80 mg, SC once every 4 weeks, from Week 1 to Week 13 in this study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA26.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA26.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ionis Pharmaceuticals, Inc. | Ionis Pharmaceuticals, Inc. | 760-603-2346 | globalregulatoryaffairs@ionis.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 19, 2024 | Apr 17, 2026 | Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D054179 | Angioedemas, Hereditary |
| ID | Term |
|---|---|
| D000799 | Angioedema |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000081208 | Hereditary Complement Deficiency Diseases |
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| ID | Term |
|---|---|
| C000723381 | donidalorsen |
| C000711268 | IONIS-PKK-LRx |
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| Percentage of Participants Who Received At Least One Concomitant Medication | Concomitant medications include medications that participants were exposed to on or after the first dose of ISIS 721744 in the OLE study. Percentage of participants who received at least one concomitant medication were reported. | Up to Week 221 |
| Up to Week 221 |
| Percentage of Participants Who Used On-demand Medications | The most commonly used on-demand medications during the On-Treatment Period were C1 esterase inhibitors (human) and icatibant, which were allowed per-protocol for treatment of acute attacks. | Up to Week 221 |
| Santa Monica |
| California |
| 90404 |
| United States |
| Ionis Investigative Site | Plymouth | Minnesota | 55446 | United States |
| Ionis Investigative Site | Cincinnati | Ohio | 45231 | United States |
| Ionis Investigative Site | Hershey | Pennsylvania | 17033 | United States |
| Ionis Investigative Site | Dallas | Texas | 75231 | United States |
| Ionis Investigative Site | Amsterdam | 1105 AZ | Netherlands |
| Petersen RS, Bordone L, Riedl MA, Tachdjian R, Craig TJ, Lumry WR, Manning ME, Bernstein JA, Raasch J, Zuraw BL, Deng Y, Newman KB, Alexander VJ, Lui C, Schneider E, Cohn DM. A phase 2 open-label extension study of prekallikrein inhibition with donidalorsen for hereditary angioedema. Allergy. 2024 Mar;79(3):724-734. doi: 10.1111/all.15948. Epub 2023 Nov 27. |
| BG001 | HAE-nC1-INH | Participants with HAE-nC1-INH who received donidalorsen, 80 mg, SC, once every 4 weeks, in the previous study ISIS 721744-CS2 (NCT04030598), continued to receive donidalorsen, 80 mg, SC once every 4 weeks, from Week 1 to Week 13 (Fixed Dosing Period). Starting From Week 17 (Flexible Dosing Period), participants had 2 different dosing options as: 80 mg every 4 weeks, and 100 mg every 4 weeks for participants who were not attack-free for ≥12 weeks up to Week 53 based on the investigator and sponsor medical monitor recommendation. Participants continued flexible dosing from Week 53 for up to approximately 209 weeks. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Fixed-dose Period: HAE-nC1-INH | Participants with HAE-nC1-INH who received placebo in the previous study ISIS 721744-CS2 (NCT04030598), received donidalorsen, 80 mg, SC once every 4 weeks, from Week 1 to Week 13 in this study. |
| OG002 | Flexible-dose Period: HAE-1/HAE-2 (Donidalorsen 80 mg Every 4 Weeks) | Participants with HAE-1/HAE-2 who were attack free for ≥12 weeks after entering the OLE study received donidalorsen 80 mg, every 4 weeks, from Week 17 to Week 209 in this study. |
| OG003 | Flexible-dose Period: HAE-1/HAE-2 (Donidalorsen 80 mg Every 8 Weeks) | Participants with HAE-1/HAE-2 who were attack free for ≥12 weeks after entering the OLE study received donidalorsen 80 mg, every 8 weeks, from Week 17 to Week 209 in this study. |
| OG004 | Flexible-dose Period: HAE-1/HAE-2 (Donidalorsen 100 mg Every 4 Weeks) | Participants with HAE-1/HAE-2 who were not attack free for ≥12 weeks after entering the OLE study received donidalorsen 100 mg, every 4 weeks, from Week 17 to Week 209 in this study. |
| OG005 | Flexible-dose Period: HAE-nC1-INH (Donidalorsen 80 mg Every 4 Weeks) | Participants with HAE-nC1-INH who were attack free for ≥12 weeks after entering the OLE study received donidalorsen, 80 mg, SC every 4 weeks, from Week 17 to Week 209 in this study. |
| OG006 | Flexible-dose Period: HAE-nC1-INH (Donidalorsen 100 mg Every 4 Weeks) | Participants with HAE-nC1-INH who were not attack free for ≥12 weeks after entering the OLE study received donidalorsen, 100 mg, SC every 4 weeks, from Week 17 to Week 209 in this study. |
|
|
| Primary | Percentage of Participants With Clinically Meaningful Changes in Clinical Laboratory Assessments | Clinical laboratory tests including clinical chemistry, hematology, coagulation, complement, inflammatory, urinalysis were performed. The percentage of participants with clinically meaningful changes were reported. Clinical meaningfulness was determined by the investigator. | The safety population included all enrolled participants who received at least 1 dose in the OLE study. | Posted | Number | percentage of participants | Up to Week 221 |
|
|
|
| Primary | Percentage of Participants With Clinically Meaningful Changes in Vital Signs | Vital sign measurements including heart rate, respiratory rate, body temperature, systolic and diastolic blood pressure and pulse pressure were assessed. Percentage of participants with clinically meaningful changes in the vital signs were reported. Clinically meaningfulness was determined by the investigator. | The safety population included all enrolled participants who received at least 1 dose in the OLE study. | Posted | Number | percentage of participants | Up to Week 221 |
|
|
|
| Primary | Percentage of Participants With Clinically Meaningful Changes in Electrocardiograms (ECGs) Parameters | The ECG parameters included ventricular rate, PR interval, QRS duration, QTc, QT corrected using the Fridericia's formula (QTcF), QT corrected using the Bazett's formula (QTcB), and overall interpretation. Percentage of participants with clinically meaningful changes in the ECG parameters were reported. Clinical meaningfulness was determined by the investigator. | The safety population included all enrolled participants who received at least 1 dose in the OLE study. | Posted | Number | percentage of participants | Up to Week 221 |
|
|
|
| Primary | Percentage of Participants Who Received At Least One Concomitant Medication | Concomitant medications include medications that participants were exposed to on or after the first dose of ISIS 721744 in the OLE study. Percentage of participants who received at least one concomitant medication were reported. | The safety population included all enrolled participants who received at least 1 dose in the OLE study. As pre-specified in SAP, this outcome measure was planned to be reported by overall for HAE-1/ HAE-2 and HAE-nC1-INH groups. | Posted | Number | percentage of participants | Up to Week 221 |
|
|
|
| Secondary | Percent Change From Baseline in Time-normalized HAE Attack (Per 4 Weeks) Rate | HAE attack rate was calculated for each participant as the number of HAE attacks occurring during the respective period divided by the number of days the participant contributed to this period multiplied by 28 days. An HAE attack was defined as an event with signs or symptoms consistent with an attack in at least 1 of the locations: peripheral angioedema (cutaneous swelling involving an extremity, the face, neck, torso, and/or genitourinary region), abdominal angioedema (abdominal pain, with or without abdominal distention, nausea, vomiting, or diarrhea), laryngeal angioedema (stridor, dyspnea, difficulty speaking, difficulty swallowing, throat tightening, or swelling of the tongue, palate, uvula, or larynx). A negative change from baseline in HAE attacks indicates an improvement in HAE attacks. | The intent-to-treat (ITT) population included all enrolled participants in the OLE study. | Posted | Mean | Standard Deviation | percent change | Up to Week 221 |
|
|
|
| Secondary | Percentage of Participants Who Used On-demand Medications | The most commonly used on-demand medications during the On-Treatment Period were C1 esterase inhibitors (human) and icatibant, which were allowed per-protocol for treatment of acute attacks. | The ITT population included all enrolled participants in the OLE study. Overall number of participants analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis for this outcome measure at specified timepoint. | Posted | Number | percentage of participants | Up to Week 221 |
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 12 |
| 17 |
| EG001 | Fixed-dose Period: HAE-nC1-INH | Participants with HAE-nC1-INH who received placebo in the previous study ISIS 721744-CS2 (NCT04030598), received donidalorsen, 80 mg, SC once every 4 weeks, from Week 1 to Week 13 in this study. | 0 | 3 | 0 | 3 | 2 | 3 |
| EG002 | Flexible-dose Period: HAE-1/HAE-2 (Donidalorsen 80 mg Every 4 Weeks) | Participants with HAE-1/HAE-2 who were attack free for ≥12 weeks after entering the OLE study received donidalorsen 80 mg, every 4 weeks, from Week 17 to Week 209 in this study. | 0 | 13 | 0 | 13 | 11 | 13 |
| EG003 | Flexible-dose Period: HAE-1/HAE-2 (Donidalorsen 80 mg Every 8 Weeks) | Participants with HAE-1/HAE-2 who were attack free for ≥12 weeks after entering the OLE study received donidalorsen 80 mg, every 8 weeks, from Week 17 to Week 209 in this study. | 0 | 8 | 0 | 8 | 5 | 8 |
| EG004 | Flexible-dose Period: HAE-1/HAE-2 (Donidalorsen 100 mg Every 4 Weeks) | Participants with HAE-1/HAE-2 who were not attack free for ≥12 weeks after entering the OLE study received donidalorsen 100 mg, every 4 weeks, from Week 17 to Week 209 in this study. | 0 | 1 | 0 | 1 | 1 | 1 |
| EG005 | Flexible-dose Period: HAE-nC1-INH (Donidalorsen 80 mg Every 4 Weeks) | Participants with HAE-nC1-INH who were attack free for ≥12 weeks after entering the OLE study received donidalorsen, 80 mg, SC every 4 weeks, from Week 17 to Week 209 in this study. | 0 | 1 | 1 | 1 | 1 | 1 |
| EG006 | Flexible-dose Period: HAE-nC1-INH (Donidalorsen 100 mg Every 4 Weeks) | Participants with HAE-nC1-INH who were not attack free for ≥12 weeks after entering the OLE study received donidalorsen, 100 mg, SC every 4 weeks, from Week 17 to Week 209 in this study. | 0 | 2 | 0 | 2 | 2 | 2 |
| Influenza | Infections and infestations | MedDRA26.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA26.1 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA26.1 | Systematic Assessment |
|
| Chlamydial infection | Infections and infestations | MedDRA26.1 | Systematic Assessment |
|
| Hand-foot-and-mouth disease | Infections and infestations | MedDRA26.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA26.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA26.1 | Systematic Assessment |
|
| Emotional distress | Psychiatric disorders | MedDRA26.1 | Systematic Assessment |
|
| Panic attack | Psychiatric disorders | MedDRA26.1 | Systematic Assessment |
|
| Seasonal affective disorder | Psychiatric disorders | MedDRA26.1 | Systematic Assessment |
|
| Toung Disorder | Gastrointestinal disorders | MedDRA26.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA26.1 | Systematic Assessment |
|
| Glucose tolerance impaired | Metabolism and nutrition disorders | MedDRA26.1 | Systematic Assessment |
|
| Axillary mass | Musculoskeletal and connective tissue disorders | MedDRA26.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA26.1 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA26.1 | Systematic Assessment |
|
| Obstructive sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA26.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA26.1 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA26.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA26.1 | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA26.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA26.1 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA26.1 | Systematic Assessment |
|
| Injection site irritation | General disorders | MedDRA26.1 | Systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA26.1 | Systematic Assessment |
|
| Axillary pain | General disorders | MedDRA26.1 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA26.1 | Systematic Assessment |
|
| Tenderness | General disorders | MedDRA26.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA26.1 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA26.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA26.1 | Systematic Assessment |
|
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA26.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA26.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA26.1 | Systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA26.1 | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA26.1 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA26.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA26.1 | Systematic Assessment |
|
| Bladder pain | Renal and urinary disorders | MedDRA26.1 | Systematic Assessment |
|
| Pelvic pain | Reproductive system and breast disorders | MedDRA26.1 | Systematic Assessment |
|
| Apnoea | Respiratory, thoracic and mediastinal disorders | MedDRA26.1 | Systematic Assessment |
|
| Vocal cord inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA26.1 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA26.1 | Systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA26.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA26.1 | Systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | MedDRA26.1 | Systematic Assessment |
|
| Abscess | Infections and infestations | MedDRA26.1 | Systematic Assessment |
|
| Acute sinusitis | Infections and infestations | MedDRA26.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA26.1 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA26.1 | Systematic Assessment |
|
| Fungal skin infection | Infections and infestations | MedDRA26.1 | Systematic Assessment |
|
| Groin infection | Infections and infestations | MedDRA26.1 | Systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA26.1 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA26.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA26.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA26.1 | Systematic Assessment |
|
| Tinea infection | Infections and infestations | MedDRA26.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA26.1 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA26.1 | Systematic Assessment |
|
| Root canal infection | Infections and infestations | MedDRA26.1 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA26.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA26.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA26.1 | Systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA26.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA26.1 | Systematic Assessment |
|
| Food poisoning | Gastrointestinal disorders | MedDRA26.1 | Systematic Assessment |
|
| Salivary hypersecretion | Gastrointestinal disorders | MedDRA26.1 | Systematic Assessment |
|
| Change of bowel habit | Gastrointestinal disorders | MedDRA26.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA26.1 | Systematic Assessment |
|
| Diverticulum intestinal | Gastrointestinal disorders | MedDRA26.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA26.1 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA26.1 | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA26.1 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA26.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA26.1 | Systematic Assessment |
|
| Injection site discolouration | General disorders | MedDRA26.1 | Systematic Assessment |
|
| Injection site dryness | General disorders | MedDRA26.1 | Systematic Assessment |
|
| Injection site haematoma | General disorders | MedDRA26.1 | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA26.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA26.1 | Systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA26.1 | Systematic Assessment |
|
| Injection site induration | General disorders | MedDRA26.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA26.1 | Systematic Assessment |
|
| Allergic sinusitis | Respiratory, thoracic and mediastinal disorders | MedDRA26.1 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA26.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA26.1 | Systematic Assessment |
|
| Paranasal sinus discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA26.1 | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA26.1 | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA26.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA26.1 | Systematic Assessment |
|
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA26.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA26.1 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA26.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA26.1 | Systematic Assessment |
|
| Ageusia | Nervous system disorders | MedDRA26.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA26.1 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA26.1 | Systematic Assessment |
|
| Nerve compression | Nervous system disorders | MedDRA26.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA26.1 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA26.1 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA26.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA26.1 | Systematic Assessment |
|
| Stress | Psychiatric disorders | MedDRA26.1 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA26.1 | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA26.1 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA26.1 | Systematic Assessment |
|
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA26.1 | Systematic Assessment |
|
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA26.1 | Systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA26.1 | Systematic Assessment |
|
| Osteochondral fracture | Injury, poisoning and procedural complications | MedDRA26.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA26.1 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA26.1 | Systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA26.1 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA26.1 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA26.1 | Systematic Assessment |
|
| Prostatitis | Reproductive system and breast disorders | MedDRA26.1 | Systematic Assessment |
|
| Eye inflammation | Eye disorders | MedDRA26.1 | Systematic Assessment |
|
| Hepatic steatosis | Hepatobiliary disorders | MedDRA26.1 | Systematic Assessment |
|
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
| D000081207 | Primary Immunodeficiency Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D014581 | Urticaria |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D007153 | Immunologic Deficiency Syndromes |
|
| By the End of Flexible Dosing Period (Week 209) |
|
|