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The purpose of this study is to determine if Olvi-Vec oncolytic immunotherapy is well tolerated with anti-tumor activity in patients diagnosed with recurrent or refractory ovarian cancer and peritoneal carcinomatosis.
Ovarian cancer (OC) remains the most lethal gynecologic malignancy owing to late detection, intrinsic and acquired chemo-resistance and remarkable heterogeneity. There is an unmet medical need to develop new therapy modalities. In preclinical studies, Olvi-Vec, has shown the ability to preferentially locate, colonize and destroy tumor cells in more than 30 different human tumors, including ovarian cancer. Olvi-Vec has been investigated in early stage clinical trials in the United States and Europe via systemic delivery as monotherapy and in combination with other therapies, and via regional delivery as monotherapy. Olvi-Vec treatment was well tolerated across different malignancies, routes of administration, and monotherapy as well as combination therapy protocols. The ability of Olvi-Vec to infect tumor tissue and kill tumor cells was demonstrated. In addition, virus-induced immune activation and favorable anti-tumor immune response have been observed. Evidences of anti-tumor efficacy and clinical benefits have also been documented.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1b - Cohort 1 | Experimental | Participants treated in Cohort 1 received 2 IP infusions at 3 x 10e9 pfu. |
|
| Phase 1b - Cohort 2 | Experimental | Participants treated in Cohort 2 received 2 IP infusions at 1 x 10e10 pfu. |
|
| Phase 1b - Cohort 3 | Experimental | Participants treated in Cohort 3 received 2 IP infusions at 2.5 x 10e10 pfu. |
|
| Phase 2 | Experimental | Participants treated in the Phase 2 portion received 2 IP infusions of Olvi-Vec at 3 x 10e9 pfu followed by platinum-doublet chemotherapy with or without bevacizumab. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olvi-Vec | Biological | Olvi-Vec is a genetically-engineered oncolytic vaccinia virus, which is administered via intraperitoneal infusion as multiple doses. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Related Treatment-emergent Adverse Event [Safety and Tolerability] (Phase 1b) | Determine safety and tolerability of administering 2 consecutive doses of Olvi-Vec via intraperitoneal catheter by the evaluation of the number of participants with related treatment-emergent adverse events (type, frequency, and severity) as assessed by CTCAE 4.03. | Change from baseline during Treatment and for 30 days following last dose over average of 2 years. |
| Progression-free Survival Following Treatment in Participants Enrolled in the Phase 2 Portion of Study With Platinum-resistant or Platinum-refractory Ovarian Cancer. | Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | For participants enrolled in the Phase 2 portion, outcome is from the date of starting chemotherapy until the date of first documented disease progression or date of death from any cause, whichever comes first, assessed up to 24 months. |
| Overall Response Rate (ORR) by Tumor Marker Cancer Antigen-125 (CA-125) for Participants Enrolled in the Phase 2 Portion of Study With Platinum-resistant or Platinum-refractory Ovarian Cancer | To assess anti-tumor response by Overall Response Rate by Tumor Marker Cancer Antigen-125 (CA-125) for participants who were enrolled in the Phase 2 portion of this study with platinum-resistant or platinum-refractory ovarian cancer. | Assessed pre-treatment, during treatment at 2- to 3-week intervals and post-treatment assessed up to 24 months. |
| Overall Response Rate (ORR) by RECIST 1.1 for Participants Enrolled in the Phase 2 Portion of the Study With Platinum-resistant or Platinum-refractory Ovarian Cancer | To assess anti-tumor response by Overall Response Rate (ORR) defined as disease control rate (DCR = CR + PR + SD≥15 weeks) by RECIST 1.1 criteria: Complete Response (CR) is a disappearance of all target lesions; Partial Response (PR) is at least a 30% decrease in the sum of the longest diameter of target lesions; stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to quality for progressive disease; Progressive Disease (PD) is at least a 20% increase in sum of longest diameter of target lesions, with an absolute increase of at least 5 mm, or the appearance of new lesions. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Tumor Response to Treatment for Participants Enrolled in the Phase 1b Portion of This Study | Participants enrolled in the Phase 1b study were assessed for best overall response to treatment with therapeutic intent by the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. criteria: Complete Response (CR) is a disappearance of all target lesions; Partial Response (PR) is at least a 30% decrease in the sum of the longest diameter of target lesions; stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to quality for progressive disease; Progressive Disease (PD) is at least a 20% increase in sum of longest diameter of target lesions, with an absolute increase of at least 5 mm, or the appearance of new lesions. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Immune-related Tumor Response | This exploratory outcome measure evaluates participants' best overall response to treatment with oncolytic immunotherapy assessed by Immune-related Response Criteria (immune-related complete response, immune-related partial response, immune-related stable disease, or immune-related progressive disease). | Assessed post-treatment at 6 to 12 week intervals or until disease progression or death from any cause, whichever comes first, assessed up to 24 months. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gynecologic Oncology Associates | Newport Beach | California | 92663 | United States | ||
| AdventHealth Cancer Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42383154 | Derived | Yu YA, Holloway RW, Mendivil AA, Ahmad S. Olvi-Vec oncolytic immunotherapy and reversal of platinum resistance in ovarian cancer. Gynecol Oncol Rep. 2026 Jun 19;66:102145. doi: 10.1016/j.gore.2026.102145. eCollection 2026 Aug. | |
| 37227734 | Derived | Holloway RW, Mendivil AA, Kendrick JE, Abaid LN, Brown JV, LeBlanc J, McKenzie ND, Mori KM, Ahmad S. Clinical Activity of Olvimulogene Nanivacirepvec-Primed Immunochemotherapy in Heavily Pretreated Patients With Platinum-Resistant or Platinum-Refractory Ovarian Cancer: The Nonrandomized Phase 2 VIRO-15 Clinical Trial. JAMA Oncol. 2023 Jul 1;9(7):903-908. doi: 10.1001/jamaoncol.2023.1007. |
| Label | URL |
|---|---|
| Sponsor's company website | View source |
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Participants were enrolled at 2 clinical sites in the United States. Enrollment into cohorts based on order of consented and eligible participants into an open cohort.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1b - Cohort 1 Participants | Participants treated in Cohort 1 received 2 consecutive intraperitoneal infusions of Olvi-Vec at 3 x 10e9 pfu. |
| FG001 | Phase 1b - Cohort 2 Participants | Participants treated in Cohort 2 received 2 consecutive intraperitoneal infusions of Olvi-Vec at 1 x 10e10 pfu |
| FG002 | Phase 1b - Cohort 3 Participants | Participants treated in Cohort 3 received 2 consecutive intraperitoneal infusions of Olvi-Vec at 2.5 x 10e10 pfu. |
| FG003 | Phase 2 - Cohort A Participants | Participants treated in Cohort A received 2 consecutive intraperitoneal infusions of Olvi-Vec at 3 x 10e9 pfu and may or may not have received platinum-doublet chemotherapy with or without bevacizumab. |
| FG004 | Phase 2 - Cohort C Participants | Participants treated in Cohort C received 2 consecutive intraperitoneal infusions of Olvi-Vec at 3 x 10e9 pfu and may or may not have received platinum-doublet chemotherapy with or without bevacizumab. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants who received at least 1 dose of Olvi-Vec.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1b - Cohort 1 Participants | Participants treated in Cohort 1 received 2 consecutive intraperitoneal infusions of Olvi-Vec at 3 x 10e9 pfu. |
| BG001 | Phase 1b - Cohort 2 Participants |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Related Treatment-emergent Adverse Event [Safety and Tolerability] (Phase 1b) | Determine safety and tolerability of administering 2 consecutive doses of Olvi-Vec via intraperitoneal catheter by the evaluation of the number of participants with related treatment-emergent adverse events (type, frequency, and severity) as assessed by CTCAE 4.03. | Participants who received at least 1 dose of Olvi-Vec via intraperitoneal catheter. | Posted | Count of Participants | Participants | Change from baseline during Treatment and for 30 days following last dose over average of 2 years. |
|
During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
Not provided
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 | Phase 1b - Cohort 1 | Participants treated in Cohort 1 received 2 IP infusions at 3 x 10e9 pfu. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Terry A. Chamberlin, CCRA - Executive Director, Clinical Trial Operations | Genelux Corportion | 619-865-6759 | terry.chamberlin@genelux.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 18, 2018 | Mar 26, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 18, 2018 | Mar 26, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D010534 | Peritoneal Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| D014615 | Vaccinia |
| D009369 | Neoplasms |
| D002277 | Carcinoma |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D011213 | Poxviridae Infections |
| D014777 | Virus Diseases |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
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Participants are enrolled in the open cohort at the time of study entry.
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|
| Platinum-doublet with or without bevacizumab | Drug | Carboplatin + choice of non-platinum chemotherapy drug: taxane, paclitaxel, nab-paclitaxel, gemcitabine or doxorubicin pegylated liposomal with or without bevacizumab. |
|
| For evaluable participants enrolled in the Phase 2 portion of this study with platinum-resistant or platinum-refractory ovarian cancer who were assessed at pre-treatment, during treatment at 6- to 12-week intervals and post-treatment up to 24 months. |
| Assessed post-treatment at 6 to 12 week intervals or until disease progression or death from any cause, whichever comes first, assessed up to 24 months. |
| CA-125 Response in Participants Enrolled in the Phase 1b Portion of This Study | CA-125 according to the Gynecologic Cancer Intergroup (GCIG) is measured by at least a 50% reduction in CA-125 levels from pre-treatment sample which is confirmed and maintained for at least 28 days. Pre-treatment CA-125 sample must be at least twice the upper limit of normal and obtained within 2 weeks prior to starting treatment. | Assessed pre-treatment, during treatment and post-treatment at 6 to 12 week intervals, assessed up to 24 months. |
| Determine Progression-free Survival Following Treatment (Phase 1b) | To assess the number of months of progression-free survival (PFS) by RECIST 1.1. | From the date of starting chemotherapy until the date of first documented disease progression or date of death from any cause, whichever comes first, assessed up to 24 months. |
| Overall Survival | To determine overall survival (OS) in the participant population. | By medical chart review until death or 3 years from the date of last treatment whichever comes first. |
| Clinical Benefit Rate | Defined as the percentage of patients who have achieved CR + PR + SD by RECIST 1.1. | Approximately 24 months |
| Orlando |
| Florida |
| 32804 |
| United States |
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
Participants treated in Cohort 2 received 2 consecutive intraperitoneal infusions of Olvi-Vec at 1 x 10e10 pfu.
| BG002 | Phase 1b - Cohort 3 Participants | Participants treated in Cohort 3 received 2 consecutive intraperitoneal infusions of Olvi-Vec at 2.5 x 10e10 pfu. |
| BG003 | Phase 2 - Cohort A Participants | Participants received 2 consecutive intraperitoneal infusions of Olvi-Vec at 3 x 10e9 pfu and received platinum-doublet chemotherapy with or without bevacizumab. |
| BG004 | Phase 2 - Cohort C Participants | Participants received 2 consecutive intraperitoneal infusions of Olvi-Vec at 3 x 10e9 pfu and received platinum-doublet chemotherapy with or without bevacizumab. |
| BG005 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Number | Participants |
|
| Platinum Disease | Count of Participants | Participants |
|
| Phase 1b - Cohort 2 Participants |
Participants received 2 consecutive days of intraperitoneal infusions of Olvi-Vec at 1 x 10e10 pfu. |
| OG002 | Phase 1b - Cohort 3 Participants | Participants received 2 consecutive days of intraperitoneal infusions of Olvi-Vec at 2.5 x 10e10 pfu. |
|
|
| Primary | Progression-free Survival Following Treatment in Participants Enrolled in the Phase 2 Portion of Study With Platinum-resistant or Platinum-refractory Ovarian Cancer. | Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | Evaluable participants who had at least one post-treatment imaging scan. | Posted | Median | 95% Confidence Interval | Number of months | For participants enrolled in the Phase 2 portion, outcome is from the date of starting chemotherapy until the date of first documented disease progression or date of death from any cause, whichever comes first, assessed up to 24 months. |
|
|
|
| Primary | Overall Response Rate (ORR) by Tumor Marker Cancer Antigen-125 (CA-125) for Participants Enrolled in the Phase 2 Portion of Study With Platinum-resistant or Platinum-refractory Ovarian Cancer | To assess anti-tumor response by Overall Response Rate by Tumor Marker Cancer Antigen-125 (CA-125) for participants who were enrolled in the Phase 2 portion of this study with platinum-resistant or platinum-refractory ovarian cancer. | Percent of participants | Posted | Number | Percent of participants | Assessed pre-treatment, during treatment at 2- to 3-week intervals and post-treatment assessed up to 24 months. |
|
|
|
| Primary | Overall Response Rate (ORR) by RECIST 1.1 for Participants Enrolled in the Phase 2 Portion of the Study With Platinum-resistant or Platinum-refractory Ovarian Cancer | To assess anti-tumor response by Overall Response Rate (ORR) defined as disease control rate (DCR = CR + PR + SD≥15 weeks) by RECIST 1.1 criteria: Complete Response (CR) is a disappearance of all target lesions; Partial Response (PR) is at least a 30% decrease in the sum of the longest diameter of target lesions; stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to quality for progressive disease; Progressive Disease (PD) is at least a 20% increase in sum of longest diameter of target lesions, with an absolute increase of at least 5 mm, or the appearance of new lesions. | Evaluable participants with at least one post-treatment imaging scan. | Posted | Number | Percent of participants | For evaluable participants enrolled in the Phase 2 portion of this study with platinum-resistant or platinum-refractory ovarian cancer who were assessed at pre-treatment, during treatment at 6- to 12-week intervals and post-treatment up to 24 months. |
|
|
|
| Secondary | Evaluation of Tumor Response to Treatment for Participants Enrolled in the Phase 1b Portion of This Study | Participants enrolled in the Phase 1b study were assessed for best overall response to treatment with therapeutic intent by the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. criteria: Complete Response (CR) is a disappearance of all target lesions; Partial Response (PR) is at least a 30% decrease in the sum of the longest diameter of target lesions; stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to quality for progressive disease; Progressive Disease (PD) is at least a 20% increase in sum of longest diameter of target lesions, with an absolute increase of at least 5 mm, or the appearance of new lesions. | Participants who had at least one post-treatment imaging scan. | Posted | Count of Participants | Participants | Assessed post-treatment at 6 to 12 week intervals or until disease progression or death from any cause, whichever comes first, assessed up to 24 months. |
|
|
|
| Secondary | CA-125 Response in Participants Enrolled in the Phase 1b Portion of This Study | CA-125 according to the Gynecologic Cancer Intergroup (GCIG) is measured by at least a 50% reduction in CA-125 levels from pre-treatment sample which is confirmed and maintained for at least 28 days. Pre-treatment CA-125 sample must be at least twice the upper limit of normal and obtained within 2 weeks prior to starting treatment. | Participants were evaluated by GCIG CA-125 response criteria. | Posted | Count of Participants | Participants | Assessed pre-treatment, during treatment and post-treatment at 6 to 12 week intervals, assessed up to 24 months. |
|
|
|
| Secondary | Determine Progression-free Survival Following Treatment (Phase 1b) | To assess the number of months of progression-free survival (PFS) by RECIST 1.1. | Participants with at least 1 post-treatment imaging scan. | Posted | Median | 95% Confidence Interval | Number of months | From the date of starting chemotherapy until the date of first documented disease progression or date of death from any cause, whichever comes first, assessed up to 24 months. |
|
|
|
| Secondary | Overall Survival | To determine overall survival (OS) in the participant population. | Participants who received at least 1 dose of Olvi-Vec treatment and chemotherapy with or without bevacizumab were included in this analysis. | Posted | Median | 95% Confidence Interval | Number of months | By medical chart review until death or 3 years from the date of last treatment whichever comes first. |
|
|
|
| Secondary | Clinical Benefit Rate | Defined as the percentage of patients who have achieved CR + PR + SD by RECIST 1.1. | Participants who had at least 1 post-treatment imaging scan. | Posted | Number | Percent of participants | Approximately 24 months |
|
|
|
| Other Pre-specified | Evaluation of Immune-related Tumor Response | This exploratory outcome measure evaluates participants' best overall response to treatment with oncolytic immunotherapy assessed by Immune-related Response Criteria (immune-related complete response, immune-related partial response, immune-related stable disease, or immune-related progressive disease). | This exploratory endpoint is considered not evaluable (NE) based on Immune-related response assessment criteria not being met. | Posted | Assessed post-treatment at 6 to 12 week intervals or until disease progression or death from any cause, whichever comes first, assessed up to 24 months. |
|
|
|
| 5 |
| 6 |
| 2 |
| 6 |
| 5 |
| 6 |
| EG001 | Phase 1b - Cohort 2 | Participants treated in Cohort 2 received 2 IP infusions at 1 x 10e10 pfu. | 5 | 5 | 1 | 5 | 5 | 5 |
| EG002 | Phase 1b - Cohort 3 | Participants treated in Cohort 3 received 2 IP infusions at 2.5 x 10e10 pfu. | 1 | 1 | 0 | 1 | 1 | 1 |
| EG003 | Phase 2 - Cohort A | Participants received 2 consecutive days of intraperitoneal infusions of Olvi-Vec at 3 x 10e9 pfu and received chemotherapy with or without bevacizumab. | 22 | 22 | 5 | 22 | 22 | 22 |
| EG004 | Phase 2 - Cohort C | Participants received 2 consecutive days of intraperitoneal infusions of Olvi-Vec at 3 x 10e9 pfu and received chemotherapy with or without bevacizumab. | 11 | 12 | 2 | 11 | 11 | 11 |
| Nausea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Abdominal rigidity | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Abdominal tenderness | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Retching | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Paresthesia | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Cold sweat | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Flushed | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
|
| Lymphoedema | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
|
Not provided
| D005831 |
| Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D000008 | Abdominal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D010532 | Peritoneal Diseases |
| D005184 | Fallopian Tube Diseases |
| D004266 | DNA Virus Infections |
| D007239 | Infections |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Stable Disease |
|
| Progressive Disease |
|
| Unevaluable |
|