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The purpose of this study is to evaluate the effect of recombinant human heat shock protein 70-polyvalent peptide complex (HerpV) vaccine administration on recurring episodes of genital herpes by evaluating viral shedding before and after treatment.
This study will evaluate the biological effectiveness and safety of the HerpV vaccine in combination with adjuvant QS-21. The Safety and tolerability of HerpV plus QS-21 will also be evaluated by collecting number and severity of adverse events throughout the study.
Participants will undergo a baseline/ screening period. This is a 45 day period when the participant collects a swab of the genital area each day. In case of a recurrence, participant will be required to collect two swabs a day. If the participant collects at least 80% of the swabbing samples and meets all eligibility criteria they may enroll in the study.
Study Period 1 consists of three treatments and a 45 day swabbing period after the last treatment. The participant will collect swabs of the genital region each day for 45 days.
Participants who successfully complete Study Period 1 will proceed to Study Period 2. They will receive a booster injection of study drug or placebo according to their original randomization assignment. The participants will again enter a 45 day swabbing period, collecting swabs of the genital area each day for 45 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HerpV 240 μg + QS-21 50 μg | Experimental | Participants will receive a combination of HerpV 240 micrograms (μg) and QS-21 50 μg injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1. At Week 24, participants who completed treatment period 1 will receive a booster dose of combination of HerpV 240 μg and QS-21 50 μg in treatment period 2. Each treatment period will be followed by a washout period of 1 week. |
|
| Placebo | Placebo Comparator | Participants will receive a placebo injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1 and at Week 24 in treatment period 2. Each treatment period will be followed by a washout period of 1 week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HerpV and QS-21 | Drug | HerpV (recombinant human heat shock protein 70 [rh-Hsc70] polyvalent peptide complex) in combination with adjuvant QS-21 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Overall Viral Shedding Rate From Baseline (Week -7 to 0) to Post-treatment Period (Weeks 6 to 13) | The viral shedding rate was defined as the number of days with genital swab positive for herpes simplex virus (HSV) deoxyribonucleic acid (DNA), as measured by quantitative real-time polymerase chain reaction (PCR), relative to the total number of days with available swabs. The viral shedding rate was defined as the number of days with genital swab positive for herpes simplex virus (HSV) deoxyribonucleic acid (DNA), as measured by quantitative real-time polymerase chain reaction (PCR), relative to the total number of days with available swabs. Overall viral shedding rate = number of days with positive PCR/total number of days PCR results collected. Change in overall viral shedding rate was calculated within participants comparing baseline with post-treatment, and summarized across all participants. Percent change in viral shedding rate and 95% CI are reported. | Baseline, Weeks 6-13 |
| Percent Change in Overall Viral Shedding Rate From Baseline (Week -7 to 0) to Post-treatment Period (Weeks 26 to 33) | The viral shedding rate was defined as the number of days with genital swab positive for HSV DNA, as measured by quantitative real-time PCR, relative to the total number of days with available swabs. The viral shedding rate was defined as the number of days with genital swab positive for herpes simplex virus (HSV) deoxyribonucleic acid (DNA), as measured by quantitative real-time polymerase chain reaction (PCR), relative to the total number of days with available swabs. Overall viral shedding rate = number of days with positive PCR/total number of days PCR results collected. Change in overall viral shedding rate was calculated within participants comparing baseline with post-treatment, and summarized across all participants. Percent change in viral shedding rate and 95% CI are reported. | Baseline, Weeks 26-33 |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Peripheral Blood Mononuclear Cell Immune Response at Any Time | Baseline through Week 26 | |
| Number of Participants With CD8+ Immune Response at Any Time | Baseline through Week 26 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Agenus Medical Monitor | Agenus Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Westover Heights Clinic | Portland | Oregon | 97210 | United States | ||
| Center for Clinical Studies - Texas Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21945262 | Background | Wald A, Koelle DM, Fife K, Warren T, Leclair K, Chicz RM, Monks S, Levey DL, Musselli C, Srivastava PK. Safety and immunogenicity of long HSV-2 peptides complexed with rhHsc70 in HSV-2 seropositive persons. Vaccine. 2011 Nov 3;29(47):8520-9. doi: 10.1016/j.vaccine.2011.09.046. Epub 2011 Sep 21. |
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| ID | Title | Description |
|---|---|---|
| FG000 | HerpV + QS-21 | Participants received a combination of HerpV (recombinant human heat shock protein 70 [rh-Hsc70] polyvalent peptide complex) 240 micrograms (μg) and QS-21 50 μg injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1. At Week 24, participants who completed treatment period 1 received a booster dose of combination of HerpV 240 μg and QS-21 50 μg in treatment period 2. Each treatment period was followed by a washout period of 1 week. |
| FG001 | Placebo | Participants received placebo (phosphate buffered saline [PBS]) injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1 and at Week 24 in treatment period 2. Each treatment period was followed by a washout period of 1 week. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
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| ID | Title | Description |
|---|---|---|
| BG000 | HerpV + QS-21 | Participants received a combination of HerpV 240 μg and QS-21 50 μg injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1. At Week 24, participants who completed treatment period 1 received a booster dose of combination of HerpV 240 μg and QS-21 50 μg in treatment period 2. Each treatment period was followed by a washout period of 1 week. |
| 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 | Percent Change in Overall Viral Shedding Rate From Baseline (Week -7 to 0) to Post-treatment Period (Weeks 6 to 13) | The viral shedding rate was defined as the number of days with genital swab positive for herpes simplex virus (HSV) deoxyribonucleic acid (DNA), as measured by quantitative real-time polymerase chain reaction (PCR), relative to the total number of days with available swabs. The viral shedding rate was defined as the number of days with genital swab positive for herpes simplex virus (HSV) deoxyribonucleic acid (DNA), as measured by quantitative real-time polymerase chain reaction (PCR), relative to the total number of days with available swabs. Overall viral shedding rate = number of days with positive PCR/total number of days PCR results collected. Change in overall viral shedding rate was calculated within participants comparing baseline with post-treatment, and summarized across all participants. Percent change in viral shedding rate and 95% CI are reported. | Efficacy population included all randomized participants who received all 3 vaccinations of Herp-V vaccine and were compliant with the study procedures. This outcome measure was planned to be analyzed for "HerpV + QS-21" arm only. | Posted | Number | 95% Confidence Interval | percentage change | Baseline, Weeks 6-13 |
Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
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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 | HerpV + QS-21 | Participants received a combination of HerpV 240 μg and QS-21 50 μg injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1. At Week 24, participants who completed treatment period 1 received a booster dose of combination of HerpV 240 μg and QS-21 50 μg in treatment period 2. Each treatment period was followed by a washout period of 1 week. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholecystitis | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Agenus, Inc. Clinical Trial Information | Agenus Inc. | 781-674-4265 | clinicaltrialinfo@Agenusbio.com |
Not provided
| ID | Term |
|---|---|
| D006558 | Herpes Genitalis |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C078785 | saponin QA-21V1 |
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|
| Placebo | Drug | phosphate buffered saline |
|
| Houston |
| Texas |
| 77030 |
| United States |
| Center for Clinical Studies - Cypress | Houston | Texas | 77065 | United States |
| Center for Clinical Studies- Webster | Houston | Texas | 77598 | United States |
| University of Washington Virology Research Clinic | Seattle | Washington | 98104 | United States |
| Investigator's decision |
|
| Sponsor's decision |
|
| Noncompliance |
|
| Other than specified |
|
| BG001 |
| Placebo |
Participants received placebo (PBS) injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1 and at Week 24 in treatment period 2. Each treatment period was followed by a washout period of 1 week. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | HerpV + QS-21 | Participants received a combination of HerpV 240 μg and QS-21 50 μg injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1. At Week 24, participants who completed treatment period 1 received a booster dose of combination of HerpV 240 μg and QS-21 50 μg in treatment period 2. Each treatment period was followed by a washout period of 1 week. |
|
|
| Primary | Percent Change in Overall Viral Shedding Rate From Baseline (Week -7 to 0) to Post-treatment Period (Weeks 26 to 33) | The viral shedding rate was defined as the number of days with genital swab positive for HSV DNA, as measured by quantitative real-time PCR, relative to the total number of days with available swabs. The viral shedding rate was defined as the number of days with genital swab positive for herpes simplex virus (HSV) deoxyribonucleic acid (DNA), as measured by quantitative real-time polymerase chain reaction (PCR), relative to the total number of days with available swabs. Overall viral shedding rate = number of days with positive PCR/total number of days PCR results collected. Change in overall viral shedding rate was calculated within participants comparing baseline with post-treatment, and summarized across all participants. Percent change in viral shedding rate and 95% CI are reported. | Efficacy population included all randomized participants who received all 3 vaccinations of Herp-V vaccine and were compliant with the study procedures. This outcome measure was planned to be analyzed for "HerpV + QS-21" arm only. | Posted | Number | 95% Confidence Interval | percentage change | Baseline, Weeks 26-33 |
|
|
|
| Other Pre-specified | Number of Participants With Peripheral Blood Mononuclear Cell Immune Response at Any Time | Efficacy population included all randomized participants who received all 3 vaccinations of Herp-V vaccine and were compliant with the study procedures. Here, Overall number of participants analyzed signifies participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | Baseline through Week 26 |
|
|
|
| Other Pre-specified | Number of Participants With CD8+ Immune Response at Any Time | Efficacy population included all randomized participants who received all 3 vaccinations of Herp-V vaccine and were compliant with the study procedures. Here, Overall number of participants analyzed signifies participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | Baseline through Week 26 |
|
|
|
| 3 |
| 70 |
| 67 |
| 70 |
| EG001 | Placebo | Participants received placebo (PBS) injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1 and at Week 24 in treatment period 2. Each treatment period was followed by a washout period of 1 week. | 0 | 10 | 10 | 10 |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Ear discomfort | Ear and labyrinth disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hyperacusis | Ear and labyrinth disorders | MedDRA 15.1 | Systematic Assessment |
|
| Thyroid mass | Endocrine disorders | MedDRA 15.1 | Systematic Assessment |
|
| Erythema of eyelid | Eye disorders | MedDRA 15.1 | Systematic Assessment |
|
| Eye pruritus | Eye disorders | MedDRA 15.1 | Systematic Assessment |
|
| Eyelid edema | Eye disorders | MedDRA 15.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Abdominal pain, upper | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Anorectal discomfort | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hemorrhoids | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Paresthesia, oral | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Tongue disorder | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Tooth impacted | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Axillary pain | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Feeling cold | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Induration | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Inflammation | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Influenza-like illness | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Injection-site cyst | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Injection-site erythema | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Injection-site hematoma | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Injection-site induration | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Injection-site pain | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Injection-site paresthesia | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Injection-site pruritus | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Injection-site rash | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Injection-site swelling | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Injection-site ulcer | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Injection-site vesicles | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Injection-site warmth | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Vaccination-site warmth | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hypertransaminasemia | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Chlamydial infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Furuncle | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Gastroenteritis, viral | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Perirectal abscess | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Pharyngitis, streptococcal | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Rash, pustular | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Vaginal abscess | Infections and infestations | MedDRA 15.1 | Systematic Assessment | This is a gender specific AE that affects only female participants. |
|
| Vulvovaginal candidiasis | Infections and infestations | MedDRA 15.1 | Systematic Assessment | This is a gender specific AE that affects only female participants. |
|
| Vulvovaginitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment | This is a gender specific AE that affects only female participants. |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Procedural nausea | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Activated partial thromboplastin time prolonged | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Blood growth hormone decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Axillary mass | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Neck mass | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Breast cancer, in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Rectal cancer, stage II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Balance disorder | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Disturbance in attention | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hyperesthesia | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Nerve compression | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Paresthesia | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Mid-cycle spotting | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 15.1 | Systematic Assessment | This is a gender specific AE that affects only female participants. |
|
| Anxiety | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Restlessness | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Bladder discomfort | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pyuria | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Breast mass | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cervical polyp | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment | This is a gender specific AE that affects only female participants. |
|
| Menstrual disorder | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment | This is a gender specific AE that affects only female participants. |
|
| Pelvic pain | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment | This is a gender specific AE that affects only female participants. |
|
| Penile pain | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment | This is a gender specific AE that affects only male participants. |
|
| Sexual dysfunction | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment |
|
| Vaginal laceration | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment | This is a gender specific AE that affects only female participants. |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Tonsillar hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cold sweat | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dermatitis, contact | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Erythema, multiforme | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pruritis | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pruritis, generalized | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Rash, pruritic | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
Not provided
Not provided
| D006561 | Herpes Simplex |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D005832 | Genital Diseases, Male |
| D052801 | Male Urogenital Diseases |