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To assess the efficacy of olaparib when given in combination with paclitaxel compared with paclitaxel alone as defined by progression-free survival (PFS), in all patients with recurrent and metastatic gastric cancer who progress following first-line therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Olaparib + paclitaxel |
|
| 2 | Active Comparator | paclitaxel + placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| olaparib | Drug | 100mg BID oral tablet continuous |
| |
| paclitaxel |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) in the Overall Study Population | PFS is defined as the time from randomisation till objective progression or death. In absence of progression or death, the time is calculated from randomisation till last evaluable scanning visit. | Tumour assessments were carried out at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed maximum up to 27 months |
| Progression Free Survival (PFS) in Patients With Tumours Defined as Homologous Recombination Deficient by Loss of Ataxia-Telangiectasia Mutation (ATM) Protein [ATM Negative Patients] | PFS is defined as the time from randomisation till objective progression or death. In absence of progression or death, the time is calculated from randomisation till last evaluable scanning visit. | Tumour assessments are carried out at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed maximum up to 27 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) in the Overall Study Population | Overall survival is defined as the duration from randomisation till death. In absence of death, the time is calculated from randomisation till the date subject last known to be alive. | Survival follow up from randomisation till death of the patient or till end of study in absence of death, assessed maximum up to 27 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jane Robertson, BSc, MBCHB, MD | AstraZeneca | Study Director |
| Yung-Jue Bang, MD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Goyang-si | 410-769 | South Korea | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38504422 | Derived | Chan KH, Rutazanaa D, Wray C, Thosani N, Yang V, Cen P. Promising Response of Olaparib in Patient With Germline ATM-Mutated Metastatic Gastric Cancer. J Investig Med High Impact Case Rep. 2024 Jan-Dec;12:23247096241240176. doi: 10.1177/23247096241240176. |
| Label | URL |
|---|---|
| CSR\_Synopsis\_D0810C00039 | View source |
Not provided
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.
All request will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Patients of either sex, age more than 17 years with recurrent or metastatic gastric cancer that had progressed following first line therapy, a confirmed Ataxia Telangiectasia Mutation (ATM) status, Eastern Co operative Oncology Group (ECOG) performance status ≤2, normal organ and bone marrow function, and life expectancy ≥16 weeks.
This study was conducted at 13 sites in South Korea. Enrolment started in February 2010 and was completed in May 2012. In total 124 patients were randomised in the study (62 in the olaparib+paclitaxel arm and 62 in the placebo+paclitaxel arm).
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| ID | Title | Description |
|---|---|---|
| FG000 | Olaparib+Paclitaxel | Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy. |
| FG001 | Placebo+Paclitaxel | Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Olaparib+Paclitaxel | Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age at time of randomisation |
| 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 | Progression Free Survival (PFS) in the Overall Study Population | PFS is defined as the time from randomisation till objective progression or death. In absence of progression or death, the time is calculated from randomisation till last evaluable scanning visit. | Full analysis set including all randomised patients | Posted | Median | Inter-Quartile Range | months | Tumour assessments were carried out at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed maximum up to 27 months |
|
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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 | OLAPARIB 100MG BD + PACLITAXEL / OLAPARIB 200MG BD |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 15 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 15 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anitra Fielding | AstraZeneca | +44 1625 517178 | aztrial_results_posting@astrazeneca.com |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C531550 | olaparib |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Drug |
iv infusion 80mg/m2 on Day 1, 8 and 15 of a 28 day cycle |
|
|
| Placebo | Drug | 100mg BID oral tablet to match olaparib tablet |
|
| Overall Survival (OS) in ATM Negative Patients | Overall survival is defined as the duration from randomisation till death. In absence of death, the time is calculated from randomisation till the date subject last known to be alive. | Survival follow up from randomisation till death of the patient or till end of study in absence of death, assessed maximum up to 27 months |
| Objective Response Rate (ORR) in the Overall Study Population | Objective response rate is the proportion of patients with at least one measurable lesion at baseline, who experienced complete or partial response at least once during the assessment period, according to the definitions of Response Evaluation Criteria In Solid Tumours (RECIST version 1.1). | Tumour assessments carried out at baseline, 28 days before randomisation then every 8 weeks until week 40, after week 40 assessments will be carried out every 16 weeks until objective disease progression, assessed maximum up to 27 months |
| Objective Response Rate (ORR) in the ATM Negative Patients | Objective response rate is the proportion of ATM negative patients with at least one measurable lesion at baseline, who experienced complete or partial response at least once during the assessment period, according to the definitions of Response Evaluation Criteria In Solid Tumours (RECIST version 1.1). | Tumour assessments carried out at baseline, 28 days before randomisation then every 8 weeks until week 40, after week 40 assessments will be carried out every 16 weeks until objective disease progression, assessed maximum up to 27 months |
| Percentage Change in Tumour Size at Week 8 in the Overall Study Population | Percentage change in tumour size from baseline to Week 8 calculated as 100 X (week 8 tumour size - baseline tumour size) / (baseline tumour size) | Tumour scans done at Baseline and week 8 |
| Percentage Change in Tumour Size at Week 8 in the ATM Negative Patients | Percentage change in tumour size from baseline to Week 8 calculated as 100 X (week 8 tumour size - baseline tumour size) / (baseline tumour size) | Tumour scans done at Baseline and week 8 |
| Time to Deterioration in Global Quality of Life (QoL) Score in the Overall Study Population | Time calculated from randomisation till worsening of Global QoL score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data | Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months |
| Time to Deterioration in QoL Fatigue Score in the Overall Study Population | Time calculated from randomisation till worsening of fatigue score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data | Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months |
| Time to Deterioration in QoL Nausea & Vomiting Domain Score in the Overall Study Population | Time calculated from randomisation till worsening of nausea & vomiting domain score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data | Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months |
| Time to Deterioration in QoL Pain Domain Score in the Overall Study Population | Time calculated from randomisation till worsening of pain domain score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data | Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months |
| Time to Deterioration in QoL Dysphagia Domain Score in the Overall Study Population | Time calculated from randomisation till worsening of dysphagia domain score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data | Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months |
| Time to Deterioration in QoL Eating Restriction Domain Score in the Overall Study Population | Time calculated from randomisation till worsening of eating restriction domain score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data | Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months |
| Time to Deterioration in QoL Stomach Pain Domain Score in the Overall Study Population | Time calculated from randomisation till worsening of stomach pain domain score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data | Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months |
| Time to Deterioration in QoL Reflux Domain Score in the Overall Study Population | Time calculated from randomisation till worsening of reflux domain score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data | Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months |
| Time to Deterioration in QoL Anxiety Domain Score in the Overall Study Population | Time calculated from randomisation till worsening of anxiety domain score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data | Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months |
| Jeonnam |
| 519-763 |
| South Korea |
| Research Site | Seoul | 03722 | South Korea |
| Research Site | Seoul | 110-744 | South Korea |
| Research Site | Seoul | 134-791 | South Korea |
| Research Site | Seoul | 137-701 | South Korea |
| Research Site | Taegu | 705-035 | South Korea |
| D0810C00039Protocol\_and\_Amendments\_redacted\_SECURE | View source |
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Death |
|
| Placebo+Paclitaxel |
Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Age, Customized | Age category | Number | Participants |
|
| Sex: Female, Male | Gender | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Race | Number | Participants |
|
| ATM status | Ataxia-Telangiectasia Mutation (ATM) protein testing | Number | Participants |
|
| OG001 | Placebo+Paclitaxel | Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy. |
|
|
|
| Primary | Progression Free Survival (PFS) in Patients With Tumours Defined as Homologous Recombination Deficient by Loss of Ataxia-Telangiectasia Mutation (ATM) Protein [ATM Negative Patients] | PFS is defined as the time from randomisation till objective progression or death. In absence of progression or death, the time is calculated from randomisation till last evaluable scanning visit. | Full analysis set including randomised ATM negative patients | Posted | Median | Inter-Quartile Range | months | Tumour assessments are carried out at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed maximum up to 27 months |
|
|
|
|
| Secondary | Overall Survival (OS) in the Overall Study Population | Overall survival is defined as the duration from randomisation till death. In absence of death, the time is calculated from randomisation till the date subject last known to be alive. | Full analysis set including all randomised patients | Posted | Median | Inter-Quartile Range | months | Survival follow up from randomisation till death of the patient or till end of study in absence of death, assessed maximum up to 27 months |
|
|
|
|
| Secondary | Overall Survival (OS) in ATM Negative Patients | Overall survival is defined as the duration from randomisation till death. In absence of death, the time is calculated from randomisation till the date subject last known to be alive. | Full analysis set including randomised ATM negative patients | Posted | Median | Inter-Quartile Range | months | Survival follow up from randomisation till death of the patient or till end of study in absence of death, assessed maximum up to 27 months |
|
|
|
|
| Secondary | Objective Response Rate (ORR) in the Overall Study Population | Objective response rate is the proportion of patients with at least one measurable lesion at baseline, who experienced complete or partial response at least once during the assessment period, according to the definitions of Response Evaluation Criteria In Solid Tumours (RECIST version 1.1). | Evaluable for response population - randomised patients having measurable disease at baseline. | Posted | Number | Participants | Tumour assessments carried out at baseline, 28 days before randomisation then every 8 weeks until week 40, after week 40 assessments will be carried out every 16 weeks until objective disease progression, assessed maximum up to 27 months |
|
|
|
| Secondary | Objective Response Rate (ORR) in the ATM Negative Patients | Objective response rate is the proportion of ATM negative patients with at least one measurable lesion at baseline, who experienced complete or partial response at least once during the assessment period, according to the definitions of Response Evaluation Criteria In Solid Tumours (RECIST version 1.1). | Evaluable for response population ATM negative patients - randomised ATM negative patients having measurable disease at baseline. | Posted | Number | Participants | Tumour assessments carried out at baseline, 28 days before randomisation then every 8 weeks until week 40, after week 40 assessments will be carried out every 16 weeks until objective disease progression, assessed maximum up to 27 months |
|
|
|
| Secondary | Percentage Change in Tumour Size at Week 8 in the Overall Study Population | Percentage change in tumour size from baseline to Week 8 calculated as 100 X (week 8 tumour size - baseline tumour size) / (baseline tumour size) | Evaluable for response population - randomised patients having measurable disease at baseline. | Posted | Mean | Standard Deviation | Percent change | Tumour scans done at Baseline and week 8 |
|
|
|
| Secondary | Percentage Change in Tumour Size at Week 8 in the ATM Negative Patients | Percentage change in tumour size from baseline to Week 8 calculated as 100 X (week 8 tumour size - baseline tumour size) / (baseline tumour size) | Evaluable for response population ATM negative patients - randomised ATM negative patients having measurable disease at baseline. | Posted | Mean | Standard Deviation | Percent change | Tumour scans done at Baseline and week 8 |
|
|
|
| Secondary | Time to Deterioration in Global Quality of Life (QoL) Score in the Overall Study Population | Time calculated from randomisation till worsening of Global QoL score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data | Randomised patients having global score calculated at baseline and at least one post baseline visit | Posted | Median | Inter-Quartile Range | months | Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months |
|
|
|
| Secondary | Time to Deterioration in QoL Fatigue Score in the Overall Study Population | Time calculated from randomisation till worsening of fatigue score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data | Randomised patients having fatigue score calculated at baseline and at least one post baseline visit | Posted | Median | Inter-Quartile Range | months | Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months |
|
|
|
| Secondary | Time to Deterioration in QoL Nausea & Vomiting Domain Score in the Overall Study Population | Time calculated from randomisation till worsening of nausea & vomiting domain score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data | Randomised patients having nausea & vomiting domain score calculated at baseline and at least one post baseline visit | Posted | Median | Inter-Quartile Range | months | Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months |
|
|
|
| Secondary | Time to Deterioration in QoL Pain Domain Score in the Overall Study Population | Time calculated from randomisation till worsening of pain domain score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data | Randomised patients having pain domain score calculated at baseline and at least one post baseline visit | Posted | Median | Inter-Quartile Range | months | Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months |
|
|
|
| Secondary | Time to Deterioration in QoL Dysphagia Domain Score in the Overall Study Population | Time calculated from randomisation till worsening of dysphagia domain score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data | Randomised patients having dysphagia domain score calculated at baseline and at least one post baseline visit | Posted | Median | Inter-Quartile Range | months | Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months |
|
|
|
| Secondary | Time to Deterioration in QoL Eating Restriction Domain Score in the Overall Study Population | Time calculated from randomisation till worsening of eating restriction domain score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data | Randomised patients having eating restriction domain score calculated at baseline and at least one post baseline visit | Posted | Median | Inter-Quartile Range | months | Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months |
|
|
|
| Secondary | Time to Deterioration in QoL Stomach Pain Domain Score in the Overall Study Population | Time calculated from randomisation till worsening of stomach pain domain score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data | Randomised patients having stomach pain domain score calculated at baseline and at least one post baseline visit | Posted | Median | Inter-Quartile Range | months | Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months |
|
|
|
| Secondary | Time to Deterioration in QoL Reflux Domain Score in the Overall Study Population | Time calculated from randomisation till worsening of reflux domain score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data | Randomised patients having reflux domain score calculated at baseline and at least one post baseline visit | Posted | Median | Inter-Quartile Range | months | Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months |
|
|
|
| Secondary | Time to Deterioration in QoL Anxiety Domain Score in the Overall Study Population | Time calculated from randomisation till worsening of anxiety domain score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data | Randomised patients having anxiety domain score calculated at baseline and at least one post baseline visit | Posted | Median | Inter-Quartile Range | months | Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months |
|
|
|
| 17 |
| 61 |
| 61 |
| 61 |
| EG001 | PLACEBO 100MG BD + PACLITAXEL / PLACEBO 200MG BD | 23 | 62 | 62 | 62 |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 15 | Systematic Assessment |
|
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 15 | Systematic Assessment |
|
| ASTHENIA | General disorders | MedDRA 15 | Systematic Assessment |
|
| CHOLANGITIS | Hepatobiliary disorders | MedDRA 15 | Systematic Assessment |
|
| HYPERBILIRUBINAEMIA | Hepatobiliary disorders | MedDRA 15 | Systematic Assessment |
|
| RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 15 | Systematic Assessment |
|
| LIGAMENT SPRAIN | Injury, poisoning and procedural complications | MedDRA 15 | Systematic Assessment |
|
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 15 | Systematic Assessment |
|
| DELIRIUM | Psychiatric disorders | MedDRA 15 | Systematic Assessment |
|
| COLITIS | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
|
| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
|
| HAEMATEMESIS | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
|
| HAEMORRHOIDS | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
|
| OBSTRUCTION GASTRIC | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
|
| UPPER GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
|
| FATIGUE | General disorders | MedDRA 15 | Systematic Assessment |
|
| PAIN | General disorders | MedDRA 15 | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA 15 | Systematic Assessment |
|
| JAUNDICE | Hepatobiliary disorders | MedDRA 15 | Systematic Assessment |
|
| APPENDICITIS | Infections and infestations | MedDRA 15 | Systematic Assessment |
|
| CYSTITIS | Infections and infestations | MedDRA 15 | Systematic Assessment |
|
| ENTEROCOLITIS INFECTIOUS | Infections and infestations | MedDRA 15 | Systematic Assessment |
|
| HERPES ZOSTER | Infections and infestations | MedDRA 15 | Systematic Assessment |
|
| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 15 | Systematic Assessment |
|
| PNEUMONIA | Infections and infestations | MedDRA 15 | Systematic Assessment |
|
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 15 | Systematic Assessment |
|
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 15 | Systematic Assessment |
|
| CEREBRAL INFARCTION | Nervous system disorders | MedDRA 15 | Systematic Assessment |
|
| CEREBRAL ISCHAEMIA | Nervous system disorders | MedDRA 15 | Systematic Assessment |
|
| SYNCOPE | Nervous system disorders | MedDRA 15 | Systematic Assessment |
|
| ALCOHOLISM | Psychiatric disorders | MedDRA 15 | Systematic Assessment |
|
| HYDRONEPHROSIS | Renal and urinary disorders | MedDRA 15 | Systematic Assessment |
|
| PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Systematic Assessment |
|
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Systematic Assessment |
|
| HYPOTENSION | Vascular disorders | MedDRA 15 | Systematic Assessment |
|
| THROMBOSIS | Vascular disorders | MedDRA 15 | Systematic Assessment |
|
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 15 | Systematic Assessment |
|
| IRON DEFICIENCY ANAEMIA | Blood and lymphatic system disorders | MedDRA 15 | Systematic Assessment |
|
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 15 | Systematic Assessment |
|
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 15 | Systematic Assessment |
|
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 15 | Systematic Assessment |
|
| ANGINA PECTORIS | Cardiac disorders | MedDRA 15 | Systematic Assessment |
|
| PALPITATIONS | Cardiac disorders | MedDRA 15 | Systematic Assessment |
|
| EAR PAIN | Ear and labyrinth disorders | MedDRA 15 | Systematic Assessment |
|
| CATARACT | Eye disorders | MedDRA 15 | Systematic Assessment |
|
| DRY EYE | Eye disorders | MedDRA 15 | Systematic Assessment |
|
| EYE PAIN | Eye disorders | MedDRA 15 | Systematic Assessment |
|
| PTERYGIUM | Eye disorders | MedDRA 15 | Systematic Assessment |
|
| VISION BLURRED | Eye disorders | MedDRA 15 | Systematic Assessment |
|
| ABDOMINAL DISCOMFORT | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
|
| ABDOMINAL DISTENSION | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
|
| ABDOMINAL PAIN LOWER | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
|
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
|
| ASCITES | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
|
| BREATH ODOUR | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
|
| CHEILITIS | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
|
| DRY MOUTH | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
|
| DYSPEPSIA | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
|
| EPIGASTRIC DISCOMFORT | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
|
| ERUCTATION | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
|
| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
|
| GINGIVAL PAIN | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
|
| GINGIVITIS | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
|
| HAEMATEMESIS | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
|
| LIP PAIN | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
|
| MOUTH ULCERATION | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
|
| ORAL PAIN | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
|
| REFLUX GASTRITIS | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
|
| STOMATITIS | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
|
| TOOTHACHE | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
|
| CHILLS | General disorders | MedDRA 15 | Systematic Assessment |
|
| FACE OEDEMA | General disorders | MedDRA 15 | Systematic Assessment |
|
| FATIGUE | General disorders | MedDRA 15 | Systematic Assessment |
|
| GENERALISED OEDEMA | General disorders | MedDRA 15 | Systematic Assessment |
|
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA 15 | Systematic Assessment |
|
| IRRITABILITY | General disorders | MedDRA 15 | Systematic Assessment |
|
| LOCALISED OEDEMA | General disorders | MedDRA 15 | Systematic Assessment |
|
| MUCOSAL INFLAMMATION | General disorders | MedDRA 15 | Systematic Assessment |
|
| NON-CARDIAC CHEST PAIN | General disorders | MedDRA 15 | Systematic Assessment |
|
| OEDEMA | General disorders | MedDRA 15 | Systematic Assessment |
|
| OEDEMA PERIPHERAL | General disorders | MedDRA 15 | Systematic Assessment |
|
| PAIN | General disorders | MedDRA 15 | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA 15 | Systematic Assessment |
|
| HEPATOTOXICITY | Hepatobiliary disorders | MedDRA 15 | Systematic Assessment |
|
| JAUNDICE | Hepatobiliary disorders | MedDRA 15 | Systematic Assessment |
|
| LIVER DISORDER | Hepatobiliary disorders | MedDRA 15 | Systematic Assessment |
|
| ANAL ABSCESS | Infections and infestations | MedDRA 15 | Systematic Assessment |
|
| BRONCHIOLITIS | Infections and infestations | MedDRA 15 | Systematic Assessment |
|
| BRONCHOPNEUMONIA | Infections and infestations | MedDRA 15 | Systematic Assessment |
|
| HERPES ZOSTER | Infections and infestations | MedDRA 15 | Systematic Assessment |
|
| NASOPHARYNGITIS | Infections and infestations | MedDRA 15 | Systematic Assessment |
|
| PHARYNGITIS | Infections and infestations | MedDRA 15 | Systematic Assessment |
|
| PNEUMONIA | Infections and infestations | MedDRA 15 | Systematic Assessment |
|
| RASH PUSTULAR | Infections and infestations | MedDRA 15 | Systematic Assessment |
|
| RHINITIS | Infections and infestations | MedDRA 15 | Systematic Assessment |
|
| TONSILLITIS | Infections and infestations | MedDRA 15 | Systematic Assessment |
|
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 15 | Systematic Assessment |
|
| EXCORIATION | Injury, poisoning and procedural complications | MedDRA 15 | Systematic Assessment |
|
| PROCEDURAL PAIN | Injury, poisoning and procedural complications | MedDRA 15 | Systematic Assessment |
|
| AMYLASE INCREASED | Investigations | MedDRA 15 | Systematic Assessment |
|
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 15 | Systematic Assessment |
|
| BLOOD ALKALINE PHOSPHATASE INCREASED | Investigations | MedDRA 15 | Systematic Assessment |
|
| BLOOD BILIRUBIN INCREASED | Investigations | MedDRA 15 | Systematic Assessment |
|
| BLOOD CREATININE INCREASED | Investigations | MedDRA 15 | Systematic Assessment |
|
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | Investigations | MedDRA 15 | Systematic Assessment |
|
| HAEMOGLOBIN | Investigations | MedDRA 15 | Systematic Assessment |
|
| HAEMOGLOBIN DECREASED | Investigations | MedDRA 15 | Systematic Assessment |
|
| NEUTROPHIL COUNT DECREASED | Investigations | MedDRA 15 | Systematic Assessment |
|
| WEIGHT DECREASED | Investigations | MedDRA 15 | Systematic Assessment |
|
| WHITE BLOOD CELL COUNT DECREASED | Investigations | MedDRA 15 | Systematic Assessment |
|
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 15 | Systematic Assessment |
|
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 15 | Systematic Assessment |
|
| HYPERKALAEMIA | Metabolism and nutrition disorders | MedDRA 15 | Systematic Assessment |
|
| HYPERMAGNESAEMIA | Metabolism and nutrition disorders | MedDRA 15 | Systematic Assessment |
|
| HYPOALBUMINAEMIA | Metabolism and nutrition disorders | MedDRA 15 | Systematic Assessment |
|
| HYPOCALCAEMIA | Metabolism and nutrition disorders | MedDRA 15 | Systematic Assessment |
|
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 15 | Systematic Assessment |
|
| HYPOMAGNESAEMIA | Metabolism and nutrition disorders | MedDRA 15 | Systematic Assessment |
|
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA 15 | Systematic Assessment |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 15 | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 15 | Systematic Assessment |
|
| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA 15 | Systematic Assessment |
|
| FLANK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 15 | Systematic Assessment |
|
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA 15 | Systematic Assessment |
|
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA 15 | Systematic Assessment |
|
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 15 | Systematic Assessment |
|
| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 15 | Systematic Assessment |
|
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 15 | Systematic Assessment |
|
| POLYMYALGIA RHEUMATICA | Musculoskeletal and connective tissue disorders | MedDRA 15 | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | MedDRA 15 | Systematic Assessment |
|
| HYPOAESTHESIA | Nervous system disorders | MedDRA 15 | Systematic Assessment |
|
| LUMBAR RADICULOPATHY | Nervous system disorders | MedDRA 15 | Systematic Assessment |
|
| NEUROPATHY PERIPHERAL | Nervous system disorders | MedDRA 15 | Systematic Assessment |
|
| PARAESTHESIA | Nervous system disorders | MedDRA 15 | Systematic Assessment |
|
| PERIPHERAL SENSORY NEUROPATHY | Nervous system disorders | MedDRA 15 | Systematic Assessment |
|
| SYNCOPE | Nervous system disorders | MedDRA 15 | Systematic Assessment |
|
| ANXIETY | Psychiatric disorders | MedDRA 15 | Systematic Assessment |
|
| DISORIENTATION | Psychiatric disorders | MedDRA 15 | Systematic Assessment |
|
| MENTAL DISORDER | Psychiatric disorders | MedDRA 15 | Systematic Assessment |
|
| MOOD ALTERED | Psychiatric disorders | MedDRA 15 | Systematic Assessment |
|
| DYSURIA | Renal and urinary disorders | MedDRA 15 | Systematic Assessment |
|
| HAEMOGLOBINURIA | Renal and urinary disorders | MedDRA 15 | Systematic Assessment |
|
| HYDRONEPHROSIS | Renal and urinary disorders | MedDRA 15 | Systematic Assessment |
|
| MICTURITION URGENCY | Renal and urinary disorders | MedDRA 15 | Systematic Assessment |
|
| NOCTURIA | Renal and urinary disorders | MedDRA 15 | Systematic Assessment |
|
| POLLAKIURIA | Renal and urinary disorders | MedDRA 15 | Systematic Assessment |
|
| URETHRAL PAIN | Renal and urinary disorders | MedDRA 15 | Systematic Assessment |
|
| URINARY RETENTION | Renal and urinary disorders | MedDRA 15 | Systematic Assessment |
|
| GENITAL RASH | Reproductive system and breast disorders | MedDRA 15 | Systematic Assessment |
|
| PELVIC DISCOMFORT | Reproductive system and breast disorders | MedDRA 15 | Systematic Assessment |
|
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Systematic Assessment |
|
| DYSPHONIA | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Systematic Assessment |
|
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Systematic Assessment |
|
| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Systematic Assessment |
|
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Systematic Assessment |
|
| HAEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Systematic Assessment |
|
| HICCUPS | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Systematic Assessment |
|
| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Systematic Assessment |
|
| NASAL DISCOMFORT | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Systematic Assessment |
|
| ORGANISING PNEUMONIA | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Systematic Assessment |
|
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Systematic Assessment |
|
| PRODUCTIVE COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Systematic Assessment |
|
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Systematic Assessment |
|
| SPUTUM INCREASED | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Systematic Assessment |
|
| TONSILLAR INFLAMMATION | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Systematic Assessment |
|
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA 15 | Systematic Assessment |
|
| BLISTER | Skin and subcutaneous tissue disorders | MedDRA 15 | Systematic Assessment |
|
| DERMATITIS ACNEIFORM | Skin and subcutaneous tissue disorders | MedDRA 15 | Systematic Assessment |
|
| HYPERHIDROSIS | Skin and subcutaneous tissue disorders | MedDRA 15 | Systematic Assessment |
|
| NAIL DISORDER | Skin and subcutaneous tissue disorders | MedDRA 15 | Systematic Assessment |
|
| ONYCHOLYSIS | Skin and subcutaneous tissue disorders | MedDRA 15 | Systematic Assessment |
|
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 15 | Systematic Assessment |
|
| RASH | Skin and subcutaneous tissue disorders | MedDRA 15 | Systematic Assessment |
|
| SKIN DISORDER | Skin and subcutaneous tissue disorders | MedDRA 15 | Systematic Assessment |
|
| SKIN HYPERPIGMENTATION | Skin and subcutaneous tissue disorders | MedDRA 15 | Systematic Assessment |
|
| URTICARIA | Skin and subcutaneous tissue disorders | MedDRA 15 | Systematic Assessment |
|
| HOT FLUSH | Vascular disorders | MedDRA 15 | Systematic Assessment |
|
| HYPOTENSION | Vascular disorders | MedDRA 15 | Systematic Assessment |
|
| PERIPHERAL COLDNESS | Vascular disorders | MedDRA 15 | Systematic Assessment |
|
| PHLEBITIS | Vascular disorders | MedDRA 15 | Systematic Assessment |
|
| THROMBOSIS | Vascular disorders | MedDRA 15 | Systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
|
| MELAENA | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
|
| PROCTALGIA | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
|
| ASTHENIA | General disorders | MedDRA 15 | Systematic Assessment |
|
| HYPERBILIRUBINAEMIA | Hepatobiliary disorders | MedDRA 15 | Systematic Assessment |
|
| BRONCHITIS | Infections and infestations | MedDRA 15 | Systematic Assessment |
|
| FURUNCLE | Infections and infestations | MedDRA 15 | Systematic Assessment |
|
| HERPES VIRUS INFECTION | Infections and infestations | MedDRA 15 | Systematic Assessment |
|
| PARONYCHIA | Infections and infestations | MedDRA 15 | Systematic Assessment |
|
| SEPSIS | Infections and infestations | MedDRA 15 | Systematic Assessment |
|
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 15 | Systematic Assessment |
|
| DYSGEUSIA | Nervous system disorders | MedDRA 15 | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA 15 | Systematic Assessment |
|
| DEPRESSION | Psychiatric disorders | MedDRA 15 | Systematic Assessment |
|
| INSOMNIA | Psychiatric disorders | MedDRA 15 | Systematic Assessment |
|
| RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Systematic Assessment |
|
Not provided
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |