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The objective of this Surveillance is to verify the following subject matters concerning Tofacitinib (Xeljanz) under general practice.
1) Occurrence of adverse reactions, factors that may potentially affect safety and efficacy 2） Long-term safety (particularly, malignant tumors and serious infections) and efficacy
Occurrences of malignant tumors and serious infections will be compared with a control group.
All the patients whom an investigator prescribes the Xeljanz or Standard of Care for rheumatoid arthritis should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tofacitinib (Xeljanz) | Tablets 5 mg BID |
| |
| Standard of Care | Standard of Care for Rheumatoid Arthritis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tofacitinib (Xeljanz) | Drug | 5 mg Tablet BID |
| |
| Etanercept, other Biologics, Disease-modifying antirheumatic drugs (DMARDs), etc |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Treatment-related Adverse Events or Serious Treatment-related Adverse Events in Participants Who Received XELJANZ | An adverse drug reaction (ADR) was any untoward medical occurrence attributed to XELJANZ in a participant who received XELJANZ. A serious adverse event/adverse drug reaction (SADR) was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to XELJANZ was assessed by the physician. | 36 months |
| Change in Disease Activity Based on Simplified Disease Activity Index (SDAI) | The SDAI is the numerical sum of five outcome parameters: tender joint count (TJC) and swollen joint count (SJC) based on a 28-joint assessment, patient global assessment (PtGA) and physician global assessment (PGA) assessed on 0-10 cm VAS, and C-reactive protein (CRP) (mg/dL). SDAI is defined as follows: ≤3.3, disease remission; >3.3 to ≤11, low disease activity, >11 to ≤26, moderate disease activity; and >26, high disease activity. SDAI was assessed at each evaluation time point and mean change from the start of XELJANZ was calculated with the 95% CI. | Baseline, 1, 6, 12, 24, 36 months |
| Change in Disease Activity Score Based on 28-joints Count (DAS28) | DAS28 is the numerical sum of 4 outcome parameters: tender joint count (TJC) and swollen joint count (SJC) based on a 28-joint assessment, PtGA assessed on 0-10 cm VAS, and the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]). DAS28 is defined as follows: <2.6, disease remission; ≥2.6 to <3.2, low disease activity, ≥3.2 to ≤5.1, moderate disease activity; and >5.1, high disease activity. DAS28 was assessed at each evaluation time point and mean change from the start of XELJANZ was calculated with the 95% CI. | Baseline, 1, 6, 12, 24, 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Serious Infection Events | Comparison of time to serious infection between XELJANZ group and control group. Hazard ratio (unadjusted): Baseline characteristics are unadjusted Hazard ratio (adjusted 1): Adjusted by propensity score estimated by logistic regression Hazard ratio (adjusted 2): Adjusted by propensity score estimated by random forest Hazard ratio (adjusted 3): Adjusted by propensity score estimated by logistic regression (with upper limit of weighting) Hazard ratio (adjusted 4): Adjusted by propensity score estimated by random forest (with upper limit of weighting) |
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Inclusion Criteria:
Exclusion Criteria:
Not Applicable
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Adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to over 8 mg Methotrexate for 3 months treatment.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tokyo | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37405710 | Derived | Kuwana M, Sugiyama N, Momohara S, Atsumi T, Takei S, Tamura N, Harigai M, Fujii T, Matsuno H, Takeuchi T, Yamamoto K, Takasaki Y, Tanigawa M, Endo Y, Hirose T, Morishima Y, Yoshii N, Mimori T, Takagi M. Six-month safety and effectiveness of tofacitinib in patients with rheumatoid arthritis in Japan: Interim analysis of post-marketing surveillance. Mod Rheumatol. 2024 Feb 26;34(2):272-286. doi: 10.1093/mr/road063. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Title | Description |
|---|---|---|
| FG000 | XELJANZ (Safety Analysis Set) | Participants who received XELJANZ Tablets 5 mg as indicated in the approved local product document were observed for a scheduled period of 36 months or 6 months. The dosage can be adjusted as per physician's discretion. Participants who did not meet the eligibility criteria and/or were not assessable for safety were excluded. |
| FG001 | Control (MTX Adherent Comparative Safety Analysis Set) | Participants with no experience of treatment with XELJANZ Tablets 5 mg, and received treatment other than XELJANZ Tablets 5 mg for rheumatoid arthritis (RA) were observed for a scheduled period of 36 months. The dosage can be adjusted as per physician's discretion. Participants who did not meet the eligibility criteria and/or were not assessable for safety were excluded. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Of the participants who were confirmed completed the study, those who met the eligibility criteria were included in the following analysis sets: XELJANZ safety analysis set, n=7021; Xeljanz MTX adherent safety analysis set, n=4574; Xeljanz MTX adherent comparative safety analysis set, n=3731; and Control MTX adherent comparative safety analysis set, n=2419.
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| ID | Title | Description |
|---|---|---|
| BG000 | XELJANZ (Safety Analysis Set) | Participants who received XELJANZ Tablets 5 mg as indicated in the approved local product document were observed for a scheduled period of 36 months or 6 months. The dosage can be adjusted as per physician's discretion. Participants who did not meet the eligibility criteria and/or were not assessable for safety were excluded. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | In the XELJANZ group, safety analysis set corresponds to overall. The MTX adherent safety analysis set is a group of participants who meet the eligibility criteria for MTX among the safety analysis set. The MTX adherent comparative safety analysis set is a group of participants in the safety analysis set who were observed for a scheduled period of 36 months and meet the eligibility criteria for MTX. In the Control group, the MTX adherent comparative safety analysis set corresponds to overall. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Treatment-related Adverse Events or Serious Treatment-related Adverse Events in Participants Who Received XELJANZ | An adverse drug reaction (ADR) was any untoward medical occurrence attributed to XELJANZ in a participant who received XELJANZ. A serious adverse event/adverse drug reaction (SADR) was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to XELJANZ was assessed by the physician. | The MTX adherent safety analysis set (n=4574) comprised of participants who received XELJANZ Tablets 5 mg at least once for the treatment of poorly controlled RA despite continuous use of MTX, excluding participants who did not meet the conditions to receive MTX, participated in a clinical trial, or transferred to another hospital. | Posted | Number | Percentage of Participants | 36 months |
|
36 months
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | XELJANZ (Safety Analysis Set) | Participants who received XELJANZ Tablets 5 mg as indicated in the approved local product document were observed for a scheduled period of 36 months or 6 months. The dosage can be adjusted as per physician's discretion. Participants who did not meet the eligibility criteria and/or were not assessable for safety were excluded. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 23.1 | Non-systematic Assessment |
According to the protocol, only three events, Serious Infection, Malignancy, and Death were collected in the control group for comparison with the Xeljanz group and other serious AEs or non-serious AEs were not to be collected although all AEs were collected in Xeljanz group. However several serious and non-serious AEs other than three events were incidentally reported by the investigators in the control group. Note that these AEs do not represent all AEs occurred in the control group.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 27, 2018 | Jun 15, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 6, 2021 | Jun 15, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C479163 | tofacitinib |
| D000068800 | Etanercept |
| D018501 | Antirheumatic Agents |
| ID | Term |
|---|---|
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
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| Drug |
Etanercept: 10 to 25 mg twice weekly, or 25 to 50 mg once weekly |
|
| 12 months |
| Occurrence of Malignancy | Comparison of time to malignancy between XELJANZ group and control group. The standard incidence ratio (SIR) was calculated using the general Japanese population as the reference population. Hazard ratio (unadjusted): Baseline characteristics are unadjusted Hazard ratio (adjusted 1): Adjusted by propensity score estimated by logistic regression Hazard ratio (adjusted 2): Adjusted by propensity score estimated by random forest Hazard ratio (adjusted 3): Adjusted by propensity score estimated by logistic regression (with upper limit of weighting) Hazard ratio (adjusted 4): Adjusted by propensity score estimated by random forest (with upper limit of weighting) | 36 months |
| Occurrence of Death | Comparison of time to death between XELJANZ group and control group. The standardized mortality ratio (SMR) was calculated using the general Japanese population as the reference population. Hazard ratio (unadjusted): Baseline characteristics are unadjusted | 36 months |
| BG001 |
| Control (MTX Adherent Comparative Safety Analysis Set) |
Participants with no experience of treatment with XELJANZ Tablets 5 mg, and received treatment other than XELJANZ Tablets 5 mg for RA were observed for a scheduled period of 36 months. The dosage can be adjusted as per physician's discretion. Participants who did not meet the eligibility criteria and/or were not assessable for safety were excluded. |
| BG002 | Total | Total of all reporting groups |
| Number |
| Participants |
|
| Sex: Female, Male | In the XELJANZ group, safety analysis set corresponds to overall. The MTX adherent safety analysis set is a group of participants who meet the eligibility criteria for MTX among the safety analysis set. The MTX adherent comparative safety analysis set is a group of participants in the safety analysis set who were observed for a scheduled period of 36 months and meet the eligibility criteria for MTX. In the Control group, the MTX adherent comparative safety analysis set corresponds to overall. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG000 |
| XELJANZ (MTX Adherent Safety Analysis Set) |
Participants who received XELJANZ Tablets 5 mg as indicated in the approved local product document were observed for a scheduled period of 36 months or 6 months. The dosage can be adjusted as per physician's discretion. The MTX adherent safety analysis set was defined as the participants within the safety analysis set who have been poorly controlled even though MTX was used continuously at a dose of more than 8 mg/week for 3 months or longer. |
|
|
| Secondary | Occurrence of Serious Infection Events | Comparison of time to serious infection between XELJANZ group and control group. Hazard ratio (unadjusted): Baseline characteristics are unadjusted Hazard ratio (adjusted 1): Adjusted by propensity score estimated by logistic regression Hazard ratio (adjusted 2): Adjusted by propensity score estimated by random forest Hazard ratio (adjusted 3): Adjusted by propensity score estimated by logistic regression (with upper limit of weighting) Hazard ratio (adjusted 4): Adjusted by propensity score estimated by random forest (with upper limit of weighting) | The MTX adherent comparative safety analysis set comprised of participants who satisfied the inclusion criteria and had received XELJANZ Tablets 5 mg or other treatment at least once for the treatment of poorly controlled RA despite continuous use of MTX. | Posted | Number | 95% Confidence Interval | Incidence rate; participants /100 PY | 12 months |
|
|
|
|
| Secondary | Occurrence of Malignancy | Comparison of time to malignancy between XELJANZ group and control group. The standard incidence ratio (SIR) was calculated using the general Japanese population as the reference population. Hazard ratio (unadjusted): Baseline characteristics are unadjusted Hazard ratio (adjusted 1): Adjusted by propensity score estimated by logistic regression Hazard ratio (adjusted 2): Adjusted by propensity score estimated by random forest Hazard ratio (adjusted 3): Adjusted by propensity score estimated by logistic regression (with upper limit of weighting) Hazard ratio (adjusted 4): Adjusted by propensity score estimated by random forest (with upper limit of weighting) | The MTX adherent comparative safety analysis set comprised of participants who satisfied the inclusion criteria and had received XELJANZ Tablets 5 mg or other treatment at least once for the treatment of poorly controlled RA despite continuous use of MTX. | Posted | Number | 95% Confidence Interval | Incidence rate; participants /100 PY | 36 months |
|
|
|
|
| Secondary | Occurrence of Death | Comparison of time to death between XELJANZ group and control group. The standardized mortality ratio (SMR) was calculated using the general Japanese population as the reference population. Hazard ratio (unadjusted): Baseline characteristics are unadjusted | The MTX adherent comparative safety analysis set comprised of participants who satisfied the inclusion criteria and had received XELJANZ Tablets 5 mg or other treatment at least once for the treatment of poorly controlled RA despite continuous use of MTX. | Posted | Number | 95% Confidence Interval | Mortality rate; participants /100 PY | 36 months |
|
|
|
|
| Primary | Change in Disease Activity Based on Simplified Disease Activity Index (SDAI) | The SDAI is the numerical sum of five outcome parameters: tender joint count (TJC) and swollen joint count (SJC) based on a 28-joint assessment, patient global assessment (PtGA) and physician global assessment (PGA) assessed on 0-10 cm VAS, and C-reactive protein (CRP) (mg/dL). SDAI is defined as follows: ≤3.3, disease remission; >3.3 to ≤11, low disease activity, >11 to ≤26, moderate disease activity; and >26, high disease activity. SDAI was assessed at each evaluation time point and mean change from the start of XELJANZ was calculated with the 95% CI. | The MTX adherent efficacy analysis set (n=4455) comprised of participants who received XELJANZ Tablets 5 mg at least once for the treatment of poorly controlled RA despite continuous use of MTX, excluding participants who were confirmed ineligible or not assessable for effectiveness. Of the 4455 MTX adherent efficacy analysis set, the participants with available results at each evaluation point are described. | Posted | Mean | 95% Confidence Interval | Scores on a scale | Baseline, 1, 6, 12, 24, 36 months |
|
|
|
| Primary | Change in Disease Activity Score Based on 28-joints Count (DAS28) | DAS28 is the numerical sum of 4 outcome parameters: tender joint count (TJC) and swollen joint count (SJC) based on a 28-joint assessment, PtGA assessed on 0-10 cm VAS, and the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]). DAS28 is defined as follows: <2.6, disease remission; ≥2.6 to <3.2, low disease activity, ≥3.2 to ≤5.1, moderate disease activity; and >5.1, high disease activity. DAS28 was assessed at each evaluation time point and mean change from the start of XELJANZ was calculated with the 95% CI. | The MTX adherent efficacy analysis set (n=4455) comprised of participants who received XELJANZ Tablets 5 mg at least once for the treatment of poorly controlled RA despite continuous use of MTX, excluding participants who were confirmed ineligible or not assessable for effectiveness. Of the 4455 MTX adherent efficacy analysis set, the participants with available results at each evaluation point are described. | Posted | Mean | 95% Confidence Interval | Scores on a scale | Baseline, 1, 6, 12, 24, 36 months |
|
|
|
| 188 |
| 7,021 |
| 1,351 |
| 7,021 |
| 1,340 |
| 7,021 |
| EG001 | XELJANZ (MTX Adherent Comparative Safety Analysis Set) | Participants who received XELJANZ Tablets 5 mg as indicated in the approved local product document were observed for a scheduled period of 36 months. The dosage can be adjusted as per physician's discretion. The MTX adherent comparative safety analysis set was defined as the participants with RA who have been poorly controlled even though MTX was used continuously at a dose of more than 8 mg/week for 3 months or longer, excluding the participants with observation for 6 months or shorter. | 98 | 3,731 | 773 | 3,731 | 814 | 3,731 |
| EG002 | Control (MTX Adherent Comparative Safety Analysis Set) | Participants with no experience of treatment with XELJANZ Tablets 5 mg, and received treatment other than XELJANZ Tablets 5 mg for RA were observed for a scheduled period of 36 months. The dosage can be adjusted as per physician's discretion. Participants who did not meet the eligibility criteria and/or were not assessable for safety were excluded. | 16 | 2,419 | 112 | 2,419 | 28 | 2,419 |
| Anaemia folate deficiency | Blood and lymphatic system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Aplasia pure red cell | Blood and lymphatic system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Blood loss anaemia | Blood and lymphatic system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Myelosuppression | Blood and lymphatic system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Acute coronary syndrome | Cardiac disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Angina unstable | Cardiac disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Aortic valve stenosis | Cardiac disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Atrioventricular block complete | Cardiac disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Cardiac failure acute | Cardiac disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Cardiac failure chronic | Cardiac disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Cardiac valve disease | Cardiac disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Congestive cardiomyopathy | Cardiac disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Hydrocele | Congenital, familial and genetic disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Deafness | Ear and labyrinth disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Adrenal insufficiency | Endocrine disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Cataract | Eye disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Corneal degeneration | Eye disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Corneal perforation | Eye disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Eye haemorrhage | Eye disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Glaucoma | Eye disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Anorectal disorder | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Colitis ischaemic | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Diverticular perforation | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Diverticulum intestinal | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Diverticulum intestinal haemorrhagic | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Duodenal perforation | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Duodenitis | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Enterocolitis | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Enterocolitis haemorrhagic | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Faeces discoloured | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Gastric mucosal lesion | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Gastric perforation | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Gastrointestinal perforation | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Hiatus hernia | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Intestinal perforation | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Death | General disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Impaired healing | General disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Multiple organ dysfunction syndrome | General disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Perforation | General disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Bile duct stone | Hepatobiliary disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Amyloidosis | Immune system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Haemophagocytic lymphohistiocytosis | Immune system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Abscess jaw | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Abscess limb | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Adenoviral haemorrhagic cystitis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Arthritis bacterial | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Arthritis infective | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Aspergilloma | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Aspergillus infection | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Atypical mycobacterial infection | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Atypical pneumonia | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Bacterial infection | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Bacterial sepsis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Biliary tract infection | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Bone abscess | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Bone tuberculosis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Bronchiolitis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Bronchitis mycoplasmal | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Bursitis infective | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Cholangitis infective | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Chronic sinusitis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Cytomegalovirus chorioretinitis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Cytomegalovirus gastroenteritis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Cytomegalovirus infection | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Cytomegalovirus viraemia | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Disseminated varicella zoster virus infection | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Endocarditis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Enteritis infectious | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Epididymitis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Epiglottitis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Escherichia sepsis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Extradural abscess | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Focal peritonitis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Fungal infection | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Fungal sepsis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Hepatitis B | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Hepatitis B reactivation | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Hepatitis E | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Herpes dermatitis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Herpes ophthalmic | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Herpes virus infection | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Herpes zoster infection neurological | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Herpes zoster meningitis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Herpes zoster meningoencephalitis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Herpes zoster oticus | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Infectious pleural effusion | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Infective spondylitis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Intervertebral discitis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Joint abscess | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Large intestine infection | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Liver abscess | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Localised infection | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Lymph node tuberculosis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Mediastinal abscess | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Medical device site joint infection | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Meningitis aseptic | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Meningitis bacterial | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Muscle abscess | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Mycobacterium avium complex infection | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Mycobacterium kansasii infection | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Mycotic endophthalmitis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Necrotising fasciitis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Osteomyelitis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Otitis media acute | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Periodontitis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Peritonitis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Peritonsillitis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Pneumonia bacterial | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Pneumonia chlamydial | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Pneumonia cryptococcal | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Pneumonia cytomegaloviral | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Pneumonia herpes viral | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Pneumonia influenzal | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Pneumonia klebsiella | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Pneumonia legionella | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Pneumonia mycoplasmal | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Pneumonia pneumococcal | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Pneumonia pseudomonal | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Pneumonia viral | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Post procedural infection | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Pseudomembranous colitis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Pseudomonas infection | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Psoas abscess | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Pulmonary mycosis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Purulence | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Accident | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Adjacent segment degeneration | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Animal bite | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Atypical femur fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Comminuted fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Compression fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Dislocation of vertebra | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Forearm fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Foreign body in gastrointestinal tract | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Fractured sacrum | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Heat illness | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Ilium fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Muscle contusion | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Near drowning | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Open fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Patella fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 23.1 | Non-systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 23.1 | Non-systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA 23.1 | Non-systematic Assessment |
|
| Blood pressure decreased | Investigations | MedDRA 23.1 | Non-systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 23.1 | Non-systematic Assessment |
|
| CSF volume decreased | Investigations | MedDRA 23.1 | Non-systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 23.1 | Non-systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 23.1 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Hyperglycaemic hyperosmolar nonketotic syndrome | Metabolism and nutrition disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Ankle deformity | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Ankylosing spondylitis | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Atlantoaxial subluxation | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Cervical spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Chondrocalcinosis pyrophosphate | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Finger deformity | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Haemarthrosis | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Joint destruction | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Knee deformity | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Loose body in joint | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Osteonecrosis of jaw | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Acoustic neuroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Adenocarcinoma gastric | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Anal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Benign neoplasm of spinal cord | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Bile duct cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Bladder cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Bowen's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Breast cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Breast cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Castleman's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Cervix carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Cervix carcinoma stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Cholangiocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Chondromatosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Colon adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Colon cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Colon cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Diffuse large B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Epstein-Barr virus associated lymphoproliferative disorder | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| External ear neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Extranodal marginal zone B-cell lymphoma (MALT type) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Fibroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Gallbladder adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Gallbladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Gastric adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Gastric cancer stage I | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Hepatic cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Hodgkin's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Intraductal papillary mucinous neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Intraductal papillary-mucinous carcinoma of pancreas | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Laryngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Leser-Trelat sign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Lung carcinoma cell type unspecified stage I | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Lymphoproliferative disorder | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Metastases to lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Metastases to lymph nodes | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Altered state of consciousness | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Amyotrophic lateral sclerosis | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Brain stem haemorrhage | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Brain stem infarction | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Carotid artery aneurysm | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Cerebellar haemorrhage | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Cerebellar infarction | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Cerebral artery embolism | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Cubital tunnel syndrome | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Dementia | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Depressed level of consciousness | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Facial paralysis | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Frontotemporal dementia | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Hypoglycaemic encephalopathy | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Intracranial aneurysm | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Lacunar infarction | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Mononeuropathy multiplex | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Monoplegia | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Myelopathy | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Myoclonus | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Normal pressure hydrocephalus | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Phrenic nerve paralysis | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Abortion | Pregnancy, puerperium and perinatal conditions | MedDRA 23.1 | Non-systematic Assessment |
|
| Device connection issue | Product Issues | MedDRA 23.1 | Non-systematic Assessment |
|
| Device loosening | Product Issues | MedDRA 23.1 | Non-systematic Assessment |
|
| Completed suicide | Psychiatric disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Depressive symptom | Psychiatric disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Eating disorder | Psychiatric disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Schizophrenia | Psychiatric disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Bladder disorder | Renal and urinary disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Calculus urethral | Renal and urinary disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Calculus urinary | Renal and urinary disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Chronic kidney disease | Renal and urinary disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Diabetic nephropathy | Renal and urinary disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| End stage renal disease | Renal and urinary disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Glomerulonephritis membranous | Renal and urinary disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Henoch-Schonlein purpura nephritis | Renal and urinary disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| IgA nephropathy | Renal and urinary disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Adenomyosis | Reproductive system and breast disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Menorrhagia | Reproductive system and breast disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Pelvic haemorrhage | Reproductive system and breast disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Asphyxia | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Diffuse panbronchiolitis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Pneumomediastinum | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Pneumothorax spontaneous | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Pulmonary alveolar haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Dermatomyositis | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Haemorrhage subcutaneous | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Pemphigus | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Cataract operation | Surgical and medical procedures | MedDRA 23.1 | Non-systematic Assessment |
|
| Foot operation | Surgical and medical procedures | MedDRA 23.1 | Non-systematic Assessment |
|
| Gastrectomy | Surgical and medical procedures | MedDRA 23.1 | Non-systematic Assessment |
|
| Hip arthroplasty | Surgical and medical procedures | MedDRA 23.1 | Non-systematic Assessment |
|
| Hospitalisation | Surgical and medical procedures | MedDRA 23.1 | Non-systematic Assessment |
|
| Intra-thoracic aortic aneurysm repair | Surgical and medical procedures | MedDRA 23.1 | Non-systematic Assessment |
|
| Joint arthroplasty | Surgical and medical procedures | MedDRA 23.1 | Non-systematic Assessment |
|
| Knee arthroplasty | Surgical and medical procedures | MedDRA 23.1 | Non-systematic Assessment |
|
| Aortic aneurysm | Vascular disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Aortic aneurysm rupture | Vascular disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Aortic dissection | Vascular disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Artery dissection | Vascular disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Circulatory collapse | Vascular disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Embolism venous | Vascular disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Extremity necrosis | Vascular disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Peripheral artery occlusion | Vascular disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Peripheral embolism | Vascular disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Rheumatoid vasculitis | Vascular disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Shock haemorrhagic | Vascular disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Splenomegaly | Blood and lymphatic system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Myocardial rupture | Cardiac disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Pericarditis | Cardiac disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Adrenocorticotropic hormone deficiency | Endocrine disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Macular fibrosis | Eye disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Necrotising retinitis | Eye disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Deafness neurosensory | Ear and labyrinth disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Sudden hearing loss | Ear and labyrinth disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Diabetes insipidus | Endocrine disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Retinal detachment | Eye disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Scleritis | Eye disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Uveitis | Eye disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Large intestine perforation | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Large intestine polyp | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Mallory-Weiss syndrome | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Mechanical ileus | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Mesenteric panniculitis | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Oesophageal varices haemorrhage | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Pancreatic disorder | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Pancreatic mass | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Peptic ulcer | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Retroperitoneal fibrosis | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Small intestinal haemorrhage | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Small intestine ulcer | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Sudden death | General disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Hepatic steatosis | Hepatobiliary disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Hepatitis acute | Hepatobiliary disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Non-alcoholic steatohepatitis | Hepatobiliary disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Portal vein thrombosis | Hepatobiliary disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Immune reconstitution inflammatory syndrome | Immune system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Pyelonephritis acute | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Salpingitis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Sinusitis fungal | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Staphylococcal sepsis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Systemic mycosis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Tonsillitis bacterial | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Tuberculosis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Varicella | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Varicella zoster pneumonia | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Varicella zoster virus infection | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Periprosthetic fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Pneumoconiosis | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Silicosis | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Skin injury | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Spinal cord injury | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Spinal cord injury cervical | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Subcutaneous haematoma | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Suture rupture | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Traumatic intracranial haemorrhage | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Ulna fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Influenza virus test positive | Investigations | MedDRA 23.1 | Non-systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA 23.1 | Non-systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 23.1 | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 23.1 | Non-systematic Assessment |
|
| Protein urine present | Investigations | MedDRA 23.1 | Non-systematic Assessment |
|
| Urinary occult blood positive | Investigations | MedDRA 23.1 | Non-systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 23.1 | Non-systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Marasmus | Metabolism and nutrition disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Polychondritis | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Polymyalgia rheumatica | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Polymyositis | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Pseudarthrosis | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Rheumatoid nodule | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Wrist deformity | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Metastases to pelvis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Metastases to peritoneum | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Metastasis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Myeloproliferative neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Pancreatic carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Pharyngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Rectal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Renal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Salivary gland cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Sarcoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Seborrhoeic keratosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Small intestine carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Squamous cell carcinoma of lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Thyroid adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Tongue neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Tongue neoplasm malignant stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Uterine cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Post herpetic neuralgia | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Putamen haemorrhage | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Spinal cord compression | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Spinal subarachnoid haemorrhage | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Thalamus haemorrhage | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Thrombotic cerebral infarction | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Toxic encephalopathy | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Suicide attempt | Psychiatric disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Nephropathy | Renal and urinary disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Ureterolithiasis | Renal and urinary disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Prostatitis | Reproductive system and breast disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Uterine prolapse | Reproductive system and breast disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Pulmonary infarction | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Pulmonary sarcoidosis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Respiratory tract haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Rheumatoid lung | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Status asthmaticus | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Purpura | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Stasis dermatitis | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Ostectomy | Surgical and medical procedures | MedDRA 23.1 | Non-systematic Assessment |
|
| Oxygen therapy | Surgical and medical procedures | MedDRA 23.1 | Non-systematic Assessment |
|
| Rotator cuff repair | Surgical and medical procedures | MedDRA 23.1 | Non-systematic Assessment |
|
| Synovectomy | Surgical and medical procedures | MedDRA 23.1 | Non-systematic Assessment |
|
| Thrombophlebitis | Vascular disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Varicose vein | Vascular disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Vasculitis | Vascular disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Venous thrombosis limb | Vascular disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA 23.1 | Non-systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D007127 | Immunoglobulin Constant Regions |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| Male |
|
| Male |
|
| Hazard ratio (unadjusted) |
| 4.80 |
| 2-Sided |
| 95 |
| 3.31 |
| 6.96 |
| Other |
| Hazard ratio (adjusted 1) | 2.07 | 2-Sided | 95 | 0.95 | 4.51 | Other |
| Hazard ratio (adjusted 2) | 3.81 | 2-Sided | 95 | 2.24 | 6.47 | Other |
| Hazard ratio (adjusted 3) | 3.55 | 2-Sided | 95 | 2.08 | 6.09 | Other |
| Hazard ratio (adjusted 4) | 3.80 | 2-Sided | 95 | 2.31 | 6.25 | Other |
| Hazard ratio (unadjusted) |
| 1.55 |
| 2-Sided |
| 95 |
| 1.12 |
| 2.13 |
| Other |
| Hazard ratio (adjusted 1) | 1.86 | 2-Sided | 95 | 1.16 | 2.99 | Other |
| Hazard ratio (adjusted 2) | 1.61 | 2-Sided | 95 | 1.06 | 2.43 | Other |
| Hazard ratio (adjusted 3) | 1.53 | 2-Sided | 95 | 1.00 | 2.35 | Other |
| Hazard ratio (adjusted 4) | 1.51 | 2-Sided | 95 | 1.03 | 2.22 | Other |
| Hazard ratio (unadjusted) |
| 3.29 |
| 2-Sided |
| 95 |
| 1.93 |
| 5.61 |
| Other |