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This is a single arm, multi-center, expanded access study of Iodine I 131 Tositumomab (BEXXAR) therapeutic regimen for patients with relapsed or refractory low-grade or transformed low-grade non-Hodgkin's B-cell lymphoma. The primary objective is to make Iodine I 131 Tositumomab more broadly available to patients. Secondary endpoints will be to obtain additional safety and efficacy information for this treatment regimen. Post study drug administration follow-ups will continue for up to ten years. These will include blood-work and adverse event assessments for 13 weeks post dosing, patient response evaluations at Week 13, Months 6, 12, 18, 24, and Long-Term Follow-ups every 6 months until the elapse of 5 years from the dosimetric dose and then annually thereafter through year 10. Thyroid function will be monitored annually during Long-term follow-up.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iodine I 131 Tositumomab Therapeutic Regimen | Biological | Patients will receive unlabeled Tositumomab (450 mg) followed by Tositumomab (35 mg) which has been trace-labeled with 5 mCi of Iodine-131 (dosimetric dose). Whole body counts using a gamma camera will be obtained 3 times between Days 0 and 7 following the dosimetric dose to determine a patient-specific mCi dose of Iodine-131 calculated to deliver the desired total body dose of radiation (either 65 cGy or 75 cGy). The therapeutic dose is administered 7-14 days after the dosimetric dose. Patients will receive unlabeled Tositumomab (450 mg) followed by Tositumomab (35 mg) labeled with the patient-specific dose of Iodine-131 (median dose in previous studies was approximately 85 mCi). Patients who are obese will be dosed based upon 137% of their calculated lean body mass. Patients will be treated with thyroid blocking medication at least 24 hours prior to the dosimetric dose and continuing for 14 days following the therapeutic dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Unconfirmed Response (Complete Response or Partial Response) and Unconfirmed Complete Response | A participant was defined as a responder if he/she sustained a complete response (CR: the disappearance of all detectable clinical and radiographic evidence of disease and all disease-related symptoms) or partial response (PR: greater than or equal to a 50% decrease in the sum of the product of perpendicular diameter [SPPD] determined at Baseline; no increase in the size of the other nodes, liver, or spleen; no new sites of disease). Response was evaluated by an investigator per guidelines developed by The International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma. | From randomization until the first documented complete response or partial response (up to 161 months) |
| Number of Participants With Confirmed Response (Complete Response or Partial Response) and Confirmed Complete Response | A participant was defined as a responder if he/she sustained a complete response (CR: the disappearance of all detectable clinical and radiographic evidence of disease and all disease-related symptoms) or partial response (PR: greater than or equal to a 50% decrease in the sum of the product of perpendicular diameter [SPPD] determined at Baseline; no increase in the size of the other nodes, liver, or spleen; no new sites of disease). Response was evaluated by an investigator per guidelines developed by The International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma. A confirmed response (CR and PR) requires that the response be confirmed by another response (same or better) at least 4 weeks apart. | From randomization until the first documented complete response or partial response (up to 161 months) |
| Duration of Response for Participants With Unconfirmed Response (CR+PR) | Duration of response is defined as the time from the first documented CR (the disappearance of all detectable clinical and radiographic evidence of disease and all disease-related symptoms) or PR (greater than or equal to a 50% decrease in the SPPD determined at Baseline; no increase in the size of the other nodes, liver, or spleen; no new sites of disease) until disease progression (PD). PD is defined as greater than or equal to a 50% increase from nadir in the SPPD for all measurable disease. Lesion changes believed to represent measurement variation associated with radiographic technique should not be classified as PD. Response was evaluated by an investigator per guidelines developed by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Treatment Failure | Time to treatment failure is defined as the time from the date of the dosimetric dose to the first occurrence of the following: treatment withdrawal, decision to seek additional therapy, study removal, disease progression, receipt of alternative therapy for lymphoma, or death study withdrawal for any reason. Participants withdrawn for reasons other than progression or death were censored at their date of withdrawal. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| BEX104545 | Annotated Case Report Form | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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NHL=Non-Hodgkin's Lymphoma.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tositumomab and Iodine I-131 Tositumomab | Participants were treated with a saturated solution of potassium iodide (KI), Lugol's solution, or KI tablets starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7-14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by the appropriate activity (mCi) of Iodine I-131 TST infused over 20 min, followed by a 10-min normal saline flush. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tositumomab and Iodine I-131 Tositumomab | Participants were treated with a saturated solution of potassium iodide (KI), Lugol's solution, or KI tablets starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7-14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by the appropriate activity (mCi) of Iodine I-131 TST infused over 20 min, followed by a 10-min normal saline flush. |
| 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 | Number of Participants With Unconfirmed Response (Complete Response or Partial Response) and Unconfirmed Complete Response | A participant was defined as a responder if he/she sustained a complete response (CR: the disappearance of all detectable clinical and radiographic evidence of disease and all disease-related symptoms) or partial response (PR: greater than or equal to a 50% decrease in the sum of the product of perpendicular diameter [SPPD] determined at Baseline; no increase in the size of the other nodes, liver, or spleen; no new sites of disease). Response was evaluated by an investigator per guidelines developed by The International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma. | Intent-to-Treat (ITT) Population: participants receiving any study drug. Only those participants evaluable for unconfirmed response (those with at least one response assessment) were analyzed. | Posted | Number | Participants | From randomization until the first documented complete response or partial response (up to 161 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 | Tositumomab and Iodine I-131 Tositumomab | Participants were treated with a saturated solution of potassium iodide (KI), Lugol's solution, or KI tablets starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7-14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by the appropriate activity (mCi) of Iodine I-131 TST infused over 20 min, followed by a 10-min normal saline flush. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Absolute neutrophil count < 1000 cells/mm^3 | Investigations | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| From the time of the first documented response (CR or PR) until disease progression (up to 161 months) |
| Duration of Response for Participants With Confirmed Response (CR+PR) | Duration of response is defined as the time from the first documented CR (the disappearance of all detectable clinical and radiographic evidence of disease and all disease-related symptoms) or PR (greater than or equal to a 50% decrease in the SPPD determined at Baseline; no increase in the size of the other nodes, liver, or spleen; no new sites of disease) until disease progression (PD). PD is defined as greater than or equal to a 50% increase from nadir in the SPPD for all measurable disease. Lesion changes believed to represent measurement variation associated with radiographic technique should not be classified as PD. Response was evaluated by an investigator per guidelines developed by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma. A confirmed response (CR and PR) requires that the response be confirmed by another response (same or better) at least 4 weeks apart. | From the time of the first documented response (CR or PR) until disease progression (up to 161 months) |
| Duration of Response (DOR) in Unconfirmed Complete Responders | DOR is defined as the time from the first documented response to the first documented disease progression. Unconfirmed CR is defined as the disappearance of all detectable clinical and radiographic evidence of disease and all disease-related symptoms. Response was evaluated by an investigator per guidelines developed by The International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma. | From the time of the first documented unconfirmed CR until PD (up to 161 months) |
| Duration of Response (DOR) in Confirmed Complete Responders | DOR is defined as the time from the first documented response to the first documented disease progression. CR is defined as the disappearance of all detectable clinical and radiographic evidence of disease and all disease-related symptoms. A confirmed response (CR and PR) requires that the response be confirmed by another response (same or better) at least 4 weeks apart. | From the time of the first documented CR until PD (up to 161 months) |
| Time to Progression or Death | Time to progression is defined as the time from the treatment start date to the first documented incidence of disease progression (PD) or death. PD is defined as greater than or equal to a 50% increase from nadir in the SPPD for all measurable disease. Lesion changes believed to represent measurement variation associated with radiographic technique should not be classified as PD. | From the treatment start date to the first documented incidence of disease progression (PD) or death (up to 161 months) |
| From the dosimetric dose to the first occurrence of the following: treatment withdrawal, decision to seek additional therapy, study removal, disease progression, receipt of alternative therapy, or death (up to 161 months) |
For additional information about this study please refer to the GSK Clinical Study Register |
| BEX104545 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| BEX104545 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| BEX104545 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| Progressive Disease |
|
| Death |
|
| Reason Not Specified |
|
| Completed 2 Years of Follow-up |
|
| Years |
|
| Gender | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Race data were not collected; ethnicity data were collected and are presented instead. | Number | participants |
|
| OG000 |
| Tositumomab and Iodine I-131 Tositumomab |
Participants were treated with a saturated solution of potassium iodide (KI), Lugol's solution, or KI tablets starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7-14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by the appropriate activity (mCi) of Iodine I-131 TST infused over 20 min, followed by a 10-min normal saline flush. |
|
|
| Primary | Number of Participants With Confirmed Response (Complete Response or Partial Response) and Confirmed Complete Response | A participant was defined as a responder if he/she sustained a complete response (CR: the disappearance of all detectable clinical and radiographic evidence of disease and all disease-related symptoms) or partial response (PR: greater than or equal to a 50% decrease in the sum of the product of perpendicular diameter [SPPD] determined at Baseline; no increase in the size of the other nodes, liver, or spleen; no new sites of disease). Response was evaluated by an investigator per guidelines developed by The International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma. A confirmed response (CR and PR) requires that the response be confirmed by another response (same or better) at least 4 weeks apart. | Intent-to-Treat (ITT) Population: participants receiving any study drug. Only those participants evaluable for confirmed response (those with at least one response assessment) were analyzed. | Posted | Number | Participants | From randomization until the first documented complete response or partial response (up to 161 months) |
|
|
|
| Primary | Duration of Response for Participants With Unconfirmed Response (CR+PR) | Duration of response is defined as the time from the first documented CR (the disappearance of all detectable clinical and radiographic evidence of disease and all disease-related symptoms) or PR (greater than or equal to a 50% decrease in the SPPD determined at Baseline; no increase in the size of the other nodes, liver, or spleen; no new sites of disease) until disease progression (PD). PD is defined as greater than or equal to a 50% increase from nadir in the SPPD for all measurable disease. Lesion changes believed to represent measurement variation associated with radiographic technique should not be classified as PD. Response was evaluated by an investigator per guidelines developed by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma. | ITT Population. Only those participants with an unconfirmed CR or PR were analyzed for duration of unconfirmed response. Participants who did not have disease progression were censored in the analysis at the date of their last contact. | Posted | Median | 95% Confidence Interval | Months | From the time of the first documented response (CR or PR) until disease progression (up to 161 months) |
|
|
|
| Primary | Duration of Response for Participants With Confirmed Response (CR+PR) | Duration of response is defined as the time from the first documented CR (the disappearance of all detectable clinical and radiographic evidence of disease and all disease-related symptoms) or PR (greater than or equal to a 50% decrease in the SPPD determined at Baseline; no increase in the size of the other nodes, liver, or spleen; no new sites of disease) until disease progression (PD). PD is defined as greater than or equal to a 50% increase from nadir in the SPPD for all measurable disease. Lesion changes believed to represent measurement variation associated with radiographic technique should not be classified as PD. Response was evaluated by an investigator per guidelines developed by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma. A confirmed response (CR and PR) requires that the response be confirmed by another response (same or better) at least 4 weeks apart. | ITT Population. Only those participants with a confirmed CR or PR were analyzed for duration of confirmed response. Participants who did not have disease progression were censored in the analysis at the date of their last contact. | Posted | Median | 95% Confidence Interval | Months | From the time of the first documented response (CR or PR) until disease progression (up to 161 months) |
|
|
|
| Primary | Duration of Response (DOR) in Unconfirmed Complete Responders | DOR is defined as the time from the first documented response to the first documented disease progression. Unconfirmed CR is defined as the disappearance of all detectable clinical and radiographic evidence of disease and all disease-related symptoms. Response was evaluated by an investigator per guidelines developed by The International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma. | ITT Population. Only those participants with an unconfirmed CR were included in this analysis of duration of response. Participants who did not have disease progression were censored in the analysis at the date of their last contact. | Posted | Median | 95% Confidence Interval | Months | From the time of the first documented unconfirmed CR until PD (up to 161 months) |
|
|
|
| Primary | Duration of Response (DOR) in Confirmed Complete Responders | DOR is defined as the time from the first documented response to the first documented disease progression. CR is defined as the disappearance of all detectable clinical and radiographic evidence of disease and all disease-related symptoms. A confirmed response (CR and PR) requires that the response be confirmed by another response (same or better) at least 4 weeks apart. | ITT Population. Only those participants with a confirmed CR were included in this analysis of duration of response. Participants who did not have disease progression were censored in the analysis at the date of their last contact. | Posted | Median | 95% Confidence Interval | Months | From the time of the first documented CR until PD (up to 161 months) |
|
|
|
| Primary | Time to Progression or Death | Time to progression is defined as the time from the treatment start date to the first documented incidence of disease progression (PD) or death. PD is defined as greater than or equal to a 50% increase from nadir in the SPPD for all measurable disease. Lesion changes believed to represent measurement variation associated with radiographic technique should not be classified as PD. | ITT Population. Participants who did not have disease progression or death were censored in the analysis at the date of their last contact. | Posted | Median | 95% Confidence Interval | Months | From the treatment start date to the first documented incidence of disease progression (PD) or death (up to 161 months) |
|
|
|
| Secondary | Time to Treatment Failure | Time to treatment failure is defined as the time from the date of the dosimetric dose to the first occurrence of the following: treatment withdrawal, decision to seek additional therapy, study removal, disease progression, receipt of alternative therapy for lymphoma, or death study withdrawal for any reason. Participants withdrawn for reasons other than progression or death were censored at their date of withdrawal. | ITT Population. Participants who did not experience treatment failure were censored at the date of their last contact. | Posted | Median | 95% Confidence Interval | Months | From the dosimetric dose to the first occurrence of the following: treatment withdrawal, decision to seek additional therapy, study removal, disease progression, receipt of alternative therapy, or death (up to 161 months) |
|
|
|
| 204 |
| 765 |
| 650 |
| 765 |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Non-Hodgkin's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Central nervous system lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Colorectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Endometrial cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Hodgkin's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Infected neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Laryngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Metastases to breast | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Neuroendocrine carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Neuroendocrine carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Non-Hodgkin's lymphoma recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Rectal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Refractory cytopenia with unilineage dysplasi | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Richter's syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Salivary gland cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Skin cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Tongue neoplasm malignant stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Bone marrow failure | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Granulocytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Haemolytic anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Abdominal abscess | Infections and infestations | MedDRA | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Cellulitis orbital | Infections and infestations | MedDRA | Systematic Assessment |
|
| Clostridium difficile colitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Device related sepsis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Kidney infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Neutropenic sepsis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Peritoneal abscess | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pneumonia respiratory syncytial viral | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pseudomonal sepsis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Skin bacterial infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Staphylococcal sepsis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
|
| Chills | General disorders | MedDRA | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA | Systematic Assessment |
|
| Pain | General disorders | MedDRA | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA | Systematic Assessment |
|
| Generalised oedema | General disorders | MedDRA | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Hydropneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Laryngeal obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Obstructive airways disorder | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Stridor | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Abdominal wall mass | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Intestinal perforation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Odynophagia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Umbilical hernia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Cachexia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Lactic acidosis | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Atrioventricular block complete | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Left ventricular failure | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Spinal cord compression | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Depressed level of consciousness | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Paralysis | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA | Systematic Assessment |
|
| VIIth nerve paralysis | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Ureteric obstruction | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Mental disorder due to a general medical condition | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Mental status changes | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA | Systematic Assessment |
|
| Clostridium test positive | Investigations | MedDRA | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA | Systematic Assessment |
|
| Bile duct obstruction | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
| Hepatic lesion | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | MedDRA | Systematic Assessment |
|
| Serum sickness | Immune system disorders | MedDRA | Systematic Assessment |
|
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Ulna fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Acute febrile neutrophilic dermatosis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Platelets < 50000 cells/mm^3 | Investigations | MedDRA | Systematic Assessment |
|
| White blood cells < 2000 cells/mm^3 | Investigations | MedDRA | Systematic Assessment |
|
| Hemoglobin < 8.0 grams per deciliter | Investigations | MedDRA | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
|
| Chills | General disorders | MedDRA | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA | Systematic Assessment |
|
| Pain | General disorders | MedDRA | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA | Systematic Assessment |
|
| Malaise | General disorders | MedDRA | Systematic Assessment |
|
| Feeling hot | General disorders | MedDRA | Systematic Assessment |
|
| Axillary pain | General disorders | MedDRA | Systematic Assessment |
|
| Discomfort | General disorders | MedDRA | Systematic Assessment |
|
| Face oedema | General disorders | MedDRA | Systematic Assessment |
|
| Feeling cold | General disorders | MedDRA | Systematic Assessment |
|
| Local swelling | General disorders | MedDRA | Systematic Assessment |
|
| Oedema | General disorders | MedDRA | Systematic Assessment |
|
| Crepitations | General disorders | MedDRA | Systematic Assessment |
|
| Feeling abnormal | General disorders | MedDRA | Systematic Assessment |
|
| Infusion site pain | General disorders | MedDRA | Systematic Assessment |
|
| Infusion site pruritus | General disorders | MedDRA | Systematic Assessment |
|
| Injection site haematoma | General disorders | MedDRA | Systematic Assessment |
|
| Local reaction | General disorders | MedDRA | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA | Systematic Assessment |
|
| Sensation of foreign body | General disorders | MedDRA | Systematic Assessment |
|
| Spinal pain | General disorders | MedDRA | Systematic Assessment |
|
| Thirst | General disorders | MedDRA | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Gingival bleeding | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Epigastric discomfort | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Oedema mouth | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Abdominal tenderness | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Faces discoloured | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Gastrointestinal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Gingival pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Glossodynia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Hiatus hernia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Intra-abdominal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Lip dry | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Lip pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Lip swelling | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Oral disorder | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Oral pruritus | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Paraesthesia oral | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Regurgitation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Tongue disorder | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Granulocytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Lymph node pain | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Bone marrow failure | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Microcytic anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Priritus | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Skin efoliation | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Blood blister | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Exfoliative rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Leukocytoclastic vasculitis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Leukoplakia | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Livedo reticularis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Penile ulceration | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Umbilical erythema | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Sensation of heaviness | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Gouty arthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Mobility decreased | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pharyngeal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Throat tightness | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Allergic cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Apnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Nasal ulcer | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Orthopnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Painful respiration | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Rales | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Stridor | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Burning sensation | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Akathisia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Aphonia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Balance disorder | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Dysarthria | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Peripheral motor neuropathy | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Peroneal nerve palsy | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Restless legs syndrome | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Sensory loss | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Sinus headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA | Systematic Assessment |
|
| VIIth nerve paralysis | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Herpes virus infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA | Systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA | Systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Vaginal infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Abscess oral | Infections and infestations | MedDRA | Systematic Assessment |
|
| Bronchitis viral | Infections and infestations | MedDRA | Systematic Assessment |
|
| Candidiasis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Chronic sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Conjunctivitis infective | Infections and infestations | MedDRA | Systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Genital herpes | Infections and infestations | MedDRA | Systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA | Systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Paronychia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Parotitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Varicella | Infections and infestations | MedDRA | Systematic Assessment |
|
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA | Systematic Assessment |
|
| Blood pressure systolic decreased | Investigations | MedDRA | Systematic Assessment |
|
| Body temperature increased | Investigations | MedDRA | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA | Systematic Assessment |
|
| Blood thyroid stimulating hormone increased | Investigations | MedDRA | Systematic Assessment |
|
| Haematocrit decreased | Investigations | MedDRA | Systematic Assessment |
|
| Red blood cell count decreased | Investigations | MedDRA | Systematic Assessment |
|
| Band neutrophil count decreased | Investigations | MedDRA | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA | Systematic Assessment |
|
| Blood test abnormal | Investigations | MedDRA | Systematic Assessment |
|
| Electroencephalogram abnormal | Investigations | MedDRA | Systematic Assessment |
|
| Heart rate irregular | Investigations | MedDRA | Systematic Assessment |
|
| Prostatic specific antigen increased | Investigations | MedDRA | Systematic Assessment |
|
| Urine output decreased | Investigations | MedDRA | Systematic Assessment |
|
| Urine output increased | Investigations | MedDRA | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA | Systematic Assessment |
|
| Goitre | Endocrine disorders | MedDRA | Systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | MedDRA | Systematic Assessment |
|
| Thyroid disorder | Endocrine disorders | MedDRA | Systematic Assessment |
|
| Thyroid pain | Endocrine disorders | MedDRA | Systematic Assessment |
|
| Thyroiditis | Endocrine disorders | MedDRA | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hypophagia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Cachexia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Failure to thrive | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
|
| Pallor | Vascular disorders | MedDRA | Systematic Assessment |
|
| Peripheral coldness | Vascular disorders | MedDRA | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA | Systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Disorientation | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Panic attack | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA | Systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | MedDRA | Systematic Assessment |
|
| Photophobia | Eye disorders | MedDRA | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA | Systematic Assessment |
|
| Eye pruritus | Eye disorders | MedDRA | Systematic Assessment |
|
| Eye swelling | Eye disorders | MedDRA | Systematic Assessment |
|
| Eyelid oedema | Eye disorders | MedDRA | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA | Systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA | Systematic Assessment |
|
| Abnormal sensation in eye | Eye disorders | MedDRA | Systematic Assessment |
|
| Dark circles under eyes | Eye disorders | MedDRA | Systematic Assessment |
|
| Eye irritation | Eye disorders | MedDRA | Systematic Assessment |
|
| Eyelid ptosis | Eye disorders | MedDRA | Systematic Assessment |
|
| Vitreous floaters | Eye disorders | MedDRA | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Ligament injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Tracheal deviation | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Tumour flare | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Lymphoma transformation | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Follicle centre lymphoma, follicular grade I, II, III | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Intraductal proliferative breast lesion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Bladder discomfort | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Bladder spasm | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Micturition urgency | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Nocturia | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Ureteric obstruction | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Pelvic pain | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| Breast induration | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| Genital rash | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| Menorrhagia | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| Scrotal oedema | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| Testicular pain | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| Testicular swelling | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| Vaginal discharge | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| Vulvovaginal pruritus | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Palpitation | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Ventricular extrasystoles | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Arrthythmia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Left ventricular dysfunction | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Ear discomfort | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
|
| Ear congestion | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
|
| Hearing impaired | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
|
| Otorrhoea | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA | Systematic Assessment |
|
| Anaphylactoid reaction | Immune system disorders | MedDRA | Systematic Assessment |
|
| Hypogammaglobulinaemia | Immune system disorders | MedDRA | Systematic Assessment |
|
| Thyroid therapy | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |