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| Name | Class |
|---|---|
| IMS Health | OTHER |
The purpose of this study is to evaluate the effectiveness and safety of adalimumab as used in routine clinical practice in adult patients with moderate to severe chronic plaque psoriasis in Spain.
PROMISE is a 2 year post-authorization study of patients taking adalimumab for Psoriasis. Patients who volunteer to participate will be asked to provide information about their medical history and experiences with adalimumab. No study specific testing will be performed. Patients will be asked to provide data on their experiences with adalimumab approximately every 6 months, or as determined by the study doctor. No drug will be provided as a result of participation in the registry. All treatment decisions are independent of participation in the registry. A total of 547 subjects were enrolled: 532 in the ITT population were analyzed for efficacy (excluding 15 for lack of follow-up visits (n=8), non-fulfillment of the criteria of moderate to severe PS (n=6) and failure to initiate treatment at the baseline visit (n=1)); 542 were analyzed for safety (excluding 5 due to lack of evaluable safety data).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moderate-to-severe chronic plaque psoriasis | Participants with moderate-to-severe chronic plaque psoriasis treated with adalimumab in routine clinical practice |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) | PASI is a measurement of the severity of psoriasis. It is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A lower (and negative) value of change indicates an increase in the severity of the psoriasis, while a positive value indicates an improvement in the severity of the PS. Missing data were imputed using last observation carried forward (LOCF). | Baseline, month 1 and every 3 months the first year and every 6 months up to month 24 |
| Percentage of Participants Achieving a Reduction in PASI Score of at Least 50% (PASI 50) | PASI is a measurement of the severity of psoriasis. It is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI 50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score. Missing data were imputed using LOCF. | Baseline, month 1 and every 3 months the first year and every 6 months up to month 24 |
| Percentage of Participants Achieving a Reduction in PASI Score of at Least 75% (PASI 75) | PASI is a measurement of the severity of psoriasis. It is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI 75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score. Missing data were imputed using LOCF. | Baseline, month 1 and every 3 months the first year and every 6 months up to month 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Dermatology Life Quality Index (DLQI) | DLQI is a self-administered Health Related Quality of Life (HRQL) questionnaire specifically for patients with dermatological diseases, adapted and validated in the Spanish population. It consists of 10 items with a Likert response scale for 4 categories and uses a 7 day time reference. It generates a global score that ranges from 0 (better HRQL) to 30 (worse HRQL) points. Change in DLQI was calculated by deducting the final score from the baseline score. Missing data were imputed using LOCF. |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with moderate-to-severe chronic plaque psoriasis
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| Name | Affiliation | Role |
|---|---|---|
| Cristina Sancho Sanchez, PharmD | Abbvie Farmaceutica, S.L.U. Spain | Study Director |
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| Label | URL |
|---|---|
| Related Info | View source |
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A total of 547 subjects were enrolled: 532 in the ITT population were analyzed for efficacy (excluding 15 for lack of follow-up visits (n=8), non-fulfillment of the criteria of moderate to severe PS (n=6) and failure to initiate treatment at the baseline visit (n=1)); 542 were analyzed for safety (excluding 5 due to lack of evaluable safety data).
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| ID | Title | Description |
|---|---|---|
| FG000 | Moderate-to-severe Chronic Plaque Psoriasis | Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline analyses accounts for Intention to treat (ITT) population (all participants who received at least 1 dose of study drug and had at least 1 follow-up visit).
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| ID | Title | Description |
|---|---|---|
| BG000 | Moderate-to-severe Chronic Plaque Psoriasis | Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice |
| 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 | Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) | PASI is a measurement of the severity of psoriasis. It is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A lower (and negative) value of change indicates an increase in the severity of the psoriasis, while a positive value indicates an improvement in the severity of the PS. Missing data were imputed using last observation carried forward (LOCF). | Efficacy analyses included all participants who received at least 1 dose of adalimumab and had at least one follow-up visit (ITT) with evaluable data. | Posted | Mean | Standard Deviation | units on a scale | Baseline, month 1 and every 3 months the first year and every 6 months up to month 24 |
|
Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
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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 | Moderate-to-severe Chronic Plaque Psoriasis | Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myelodisplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Information | AbbVie | 800-633-9110 |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Percentage of Participants Achieving a Reduction in PASI Score of at Least 90% (PASI 90) | PASI is a measurement of the severity of psoriasis. It is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI 90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score. Missing data were imputed using LOCF. | Baseline, month 1 and every 3 months the first year and every 6 months up to month 24 |
| Percentage of Participants Achieving a Reduction in PASI Score of 100% (PASI 100) | PASI is a measurement of the severity of psoriasis. It is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI 100 response is the percentage of participants who achieved a 100% reduction (improvement) from baseline in PASI score. Missing data were imputed using LOCF. | Baseline, month 1 and every 3 months the first year and every 6 months up to month 24 |
| Mean Change From Baseline in Body Surface Area (BSA) Affected | Body Surface Area (BSA) affected or the psoriasis area is determined by the direct calculation of the affected body surface area. This determination was used to evaluate the effectiveness of the treatment during each of the study visits. The change was calculated by deducting the final score from the baseline score. Increased scores correspond to reduction of severity and reduction of BSA. Missing data were imputed using LOCF. | Baseline, month 1 and every 3 months the first year and every 6 months up to month 24 |
| Percentage of Participants With Improvement From Baseline in Physician's Global Assessment (PGA) | The PGA was used to measure participants' disease status at the time of assessment. This tool is a horizontal visual analogue 6-point scale measuring the degree of overall psoriatic lesion severity, and scores range from 0 (clear) to 5 (very severe). The percentage of patients who showed an improvement from baseline in their PGA scores is presented. Missing data were imputed using LOCF. | Baseline, month 1 and every 3 months the first year and every 6 months up to month 24 |
| Baseline and every 6 months up to month 24 |
| Mean Change From Baseline in EuroQol Quality of Life Questionnaire (EQ-5D) Visual Analogue Scale (VAS) | The EQ-5D VAS records the participant's self-rated health on a scale from 0-100 where increased scores correspond to better HRQL. 0 is the 'worst imaginable health state' and 100 is the 'best imaginable health state'. Change in EQ-5D VAS score was calculated by deducting the final score from the baseline score. Increased scores correspond to better health state. Missing data were imputed using LOCF. | Baseline and every 6 months up to month 24 |
| Mean Change From Baseline in Percentage of Lost Productivity Assessed Using Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) | WPAI-SHP is a questionnaire used to evaluate lost productivity. The scores on the WPAI questionnaire are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Change in WPAI-SHP was calculated by deducting the final score from the baseline score. Increased (positive) scores correspond to a reduction in the percentage of lost work productivity. Missing data were imputed using LOCF. n=the number of participants with data at each time point. | Baseline and every 6 months up to month 24 |
| Number of Participants With Adverse Events of Special Interest (AESIs) | AESIs are adverse events of special interest, including infection, neoplasm, lupus-like, demyelinating disease, serious hepatic and/or haematological event. | From time of informed consent to the final visit after 2 years of observation |
| Number of Participants With Serious Adverse Events (SAEs) | SAEs are adverse event with any of the following severity criteria: Potentially fatal/endangers life, Hospitalisation or prolonging of hospitalisation, a medically important event that requires medical or surgical intervention to prevent a serious outcome, Disability or persistent incapacitation, death, congenital anomalies and/or miscarriage or abortion. See the Reported Adverse Events Section for more details. | From time of informed consent to the final visit after 2 years of observation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice |
|
|
| Primary | Percentage of Participants Achieving a Reduction in PASI Score of at Least 50% (PASI 50) | PASI is a measurement of the severity of psoriasis. It is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI 50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score. Missing data were imputed using LOCF. | Efficacy analyses included ITT population with evaluable data. | Posted | Number | percentage of participants | Baseline, month 1 and every 3 months the first year and every 6 months up to month 24 |
|
|
|
| Primary | Percentage of Participants Achieving a Reduction in PASI Score of at Least 75% (PASI 75) | PASI is a measurement of the severity of psoriasis. It is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI 75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score. Missing data were imputed using LOCF. | Efficacy analyses included ITT population with evaluable data. | Posted | Number | percentage of participants | Baseline, month 1 and every 3 months the first year and every 6 months up to month 24 |
|
|
|
| Secondary | Mean Change From Baseline in Dermatology Life Quality Index (DLQI) | DLQI is a self-administered Health Related Quality of Life (HRQL) questionnaire specifically for patients with dermatological diseases, adapted and validated in the Spanish population. It consists of 10 items with a Likert response scale for 4 categories and uses a 7 day time reference. It generates a global score that ranges from 0 (better HRQL) to 30 (worse HRQL) points. Change in DLQI was calculated by deducting the final score from the baseline score. Missing data were imputed using LOCF. | Efficacy analyses included ITT population with evaluable data. | Posted | Mean | Standard Deviation | units on a scale | Baseline and every 6 months up to month 24 |
|
|
|
| Secondary | Mean Change From Baseline in EuroQol Quality of Life Questionnaire (EQ-5D) Visual Analogue Scale (VAS) | The EQ-5D VAS records the participant's self-rated health on a scale from 0-100 where increased scores correspond to better HRQL. 0 is the 'worst imaginable health state' and 100 is the 'best imaginable health state'. Change in EQ-5D VAS score was calculated by deducting the final score from the baseline score. Increased scores correspond to better health state. Missing data were imputed using LOCF. | Analysis included ITT population with evaluable data. | Posted | Mean | Standard Deviation | units on a scale | Baseline and every 6 months up to month 24 |
|
|
|
| Secondary | Mean Change From Baseline in Percentage of Lost Productivity Assessed Using Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) | WPAI-SHP is a questionnaire used to evaluate lost productivity. The scores on the WPAI questionnaire are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Change in WPAI-SHP was calculated by deducting the final score from the baseline score. Increased (positive) scores correspond to a reduction in the percentage of lost work productivity. Missing data were imputed using LOCF. n=the number of participants with data at each time point. | Analysis included ITT population with evaluable data. | Posted | Mean | Standard Deviation | units on a scale (a derived score) | Baseline and every 6 months up to month 24 |
|
|
|
| Secondary | Number of Participants With Adverse Events of Special Interest (AESIs) | AESIs are adverse events of special interest, including infection, neoplasm, lupus-like, demyelinating disease, serious hepatic and/or haematological event. | Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data. | Posted | Number | participants | From time of informed consent to the final visit after 2 years of observation |
|
|
|
| Primary | Percentage of Participants Achieving a Reduction in PASI Score of at Least 90% (PASI 90) | PASI is a measurement of the severity of psoriasis. It is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI 90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score. Missing data were imputed using LOCF. | Efficacy analyses included ITT population with evaluable data. | Posted | Number | percentage of participants | Baseline, month 1 and every 3 months the first year and every 6 months up to month 24 |
|
|
|
| Primary | Percentage of Participants Achieving a Reduction in PASI Score of 100% (PASI 100) | PASI is a measurement of the severity of psoriasis. It is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI 100 response is the percentage of participants who achieved a 100% reduction (improvement) from baseline in PASI score. Missing data were imputed using LOCF. | Efficacy analyses included ITT population with evaluable data. | Posted | Number | percentage of participants | Baseline, month 1 and every 3 months the first year and every 6 months up to month 24 |
|
|
|
| Primary | Mean Change From Baseline in Body Surface Area (BSA) Affected | Body Surface Area (BSA) affected or the psoriasis area is determined by the direct calculation of the affected body surface area. This determination was used to evaluate the effectiveness of the treatment during each of the study visits. The change was calculated by deducting the final score from the baseline score. Increased scores correspond to reduction of severity and reduction of BSA. Missing data were imputed using LOCF. | Efficacy analyses included ITT population with evaluable data. | Posted | Mean | Standard Deviation | percentage of body surface area | Baseline, month 1 and every 3 months the first year and every 6 months up to month 24 |
|
|
|
| Primary | Percentage of Participants With Improvement From Baseline in Physician's Global Assessment (PGA) | The PGA was used to measure participants' disease status at the time of assessment. This tool is a horizontal visual analogue 6-point scale measuring the degree of overall psoriatic lesion severity, and scores range from 0 (clear) to 5 (very severe). The percentage of patients who showed an improvement from baseline in their PGA scores is presented. Missing data were imputed using LOCF. | Efficacy analyses included ITT population with evaluable data. | Posted | Number | percentage of participants | Baseline, month 1 and every 3 months the first year and every 6 months up to month 24 |
|
|
|
| Secondary | Number of Participants With Serious Adverse Events (SAEs) | SAEs are adverse event with any of the following severity criteria: Potentially fatal/endangers life, Hospitalisation or prolonging of hospitalisation, a medically important event that requires medical or surgical intervention to prevent a serious outcome, Disability or persistent incapacitation, death, congenital anomalies and/or miscarriage or abortion. See the Reported Adverse Events Section for more details. | Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data. | Posted | Number | participants | From time of informed consent to the final visit after 2 years of observation |
|
|
|
| 24 |
| 542 |
| 314 |
| 542 |
| Haemorrhage of the digestive tract | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Death | General disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Ferropenic anaemia | Blood and lymphatic system disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Lacunar stroke | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Generalized weakness | General disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Vertigo | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Tuberculous meningitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| acute pancreatitis | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| outbreak of psoriasis | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| subarachnoid haemorrhage after traumatic injury without mention of open intracraneal wound | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| ureterohydronephrosis | Renal and urinary disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| basocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
|
| squamous cell carcinoma of the lungs | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
|
| tonsil hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| scrotal abscess | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| clear cell carcinoma of the kidneys | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
|
| chest pain | General disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| arterial hypertension | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| myocardial infarction | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| class iii heart failure | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| neurosensory hypoacusia | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| unstable angina | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| psoriatic arthritis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| salmonellosis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| astrocytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
|
| invasive breast duct cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
|
| arthrodesis of the toe | Surgical and medical procedures | MedDRA 14.0 | Non-systematic Assessment |
|
| facial paralysis | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| alcoholic pancreatitis | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| cardiac ablation | Surgical and medical procedures | MedDRA 14.0 | Non-systematic Assessment |
|
| non-specific tachycardia | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| acute gastric ulcer with haemorrhage | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| angioedema | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| spondylarthropathy | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| psoriatic arthopathy | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| ovarian benign germ cell teratoma | Reproductive system and breast disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| suppurative hydradenitis | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| sebaceous cyst | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
|
| complete auriculoventricular blockage | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| allergic bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| acute respiratory insufficiency | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| multiorganic failure | General disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| malignant neoplasms of the sigmoid colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
|
| adenocarcinoma of the breast | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
|
| state of confusion | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| tension headache | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| non-specific chest pain | General disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| deep vein thrombosis | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| hepatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
|
| adenocarcinoma of the colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
|
| radical prostatectomy | Surgical and medical procedures | MedDRA 14.0 | Non-systematic Assessment |
|
| abortion | Surgical and medical procedures | MedDRA 14.0 | Non-systematic Assessment |
|
| unwanted pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 14.0 | Non-systematic Assessment |
|
| community-acquired pneumonia | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| sarcoidosis | Immune system disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| tonsillectomy | Surgical and medical procedures | MedDRA 14.0 | Non-systematic Assessment |
|
| peritonsillar abscess | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| worsening of psoriasis | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| exacerbation of copd | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| septic arthritis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| lupus-like syndrome | Immune system disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| steroid-induced diabetes | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| pulmonary tuberculosis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| sepsis caused by methicillin-resistant staphylococcus aureus | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| autoimmune hepatitis | Immune system disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| infection by cytomegalovirus | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| miscarriage | Pregnancy, puerperium and perinatal conditions | MedDRA 14.0 | Non-systematic Assessment |
|
| ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 14.0 | Non-systematic Assessment |
|
| chrohn ileocolitis | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
|
| bronchial carcinoma, stage iv | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
|
| leukocytosis | Blood and lymphatic system disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| lymphocytosis | Blood and lymphatic system disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| hysterectomy | Surgical and medical procedures | MedDRA 14.0 | Non-systematic Assessment |
|
| anxiety | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| vertigo syndromes and non-specific labyrinth disorders | Ear and labyrinth disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| erysipela | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| chronic myelogenous leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
|
| carcinoma with unknown primary tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
|
| cervical lymphadenopathy | Blood and lymphatic system disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| bacterial pyelonephritis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| motorcycle accident | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
|
| comminuted fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
|
| dislocated hip | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
|
| femur fracture | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| torn anterior cruciate ligament | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
|
| bariatric surgery | Surgical and medical procedures | MedDRA 14.0 | Non-systematic Assessment |
|
| septic shock | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| acute myocardial infarction of the inferoposterior wall | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| pustular psoriasis | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| urothelial carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
|
| lung metastasis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
|
| bone metastasis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
|
| respiratory infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| infection by Escherichia coli | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| enterococcus bacteraemia | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| septicaemia by candida | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| normal nuclear magnetic resonance imaging | Investigations | MedDRA 14.0 | Non-systematic Assessment |
|
| oesophageal erosion | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Abdominal pain not otherwise specified | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Abnormal cholesterol in blood | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Abnormal gamma-glutamyl transferase | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Abnormal glucose | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Abnormal glutamate-pyruvate transaminase | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Abnormal uric acid in blood | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Abnormal erythrocytes | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Abnormal menstruation | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
|
| Abdominal abscess | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Abnormal triglycerides | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Abnormal triglycerides in blood | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Abscess on a limb | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Abscess on the back | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Achilles tendinitis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Acute bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Acute ear infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Acute gastroenteritis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Acute pharyngitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Acute sinusitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Acute tonsillitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Acute urticaria | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Allergic bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Allergic reaction | Immune system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Allergy to insect stings | Immune system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Alopecia areata | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Anal pain | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Angiomyolipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Ankle pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
|
| Anxiety attack | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
|
| Arm pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Arterial hypertension | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Articular inflammation | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Asthmatic bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Athlete's foot | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Average corpuscle volume | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Axillary abscess | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Balanitis | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
|
| Basocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Biliar colic | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Blepharitis | Eye disorders | MedDRA 14.0 | Systematic Assessment |
|
| Boil | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Bone fissure | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Bone oedema | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Bronchiolitis caused by respiratory syncytial virus | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cervical pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cervical lymphadenopathy | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cervicalgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Chest pain during exertion | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cholestasis | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Chronic hepatitis C | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Chronic nodular chondrodermatitis helicis | Ear and labyrinth disorders | MedDRA 14.0 | Systematic Assessment |
|
| Chronic renal insufficiency | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Circumcision | Surgical and medical procedures | MedDRA 14.0 | Systematic Assessment |
|
| Cold | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Common cold | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Common cold syndrome | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Compressive neuropathy | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Condylomata | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Condylomata acuminata | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA 14.0 | Systematic Assessment |
|
| Coronary artery calcification | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cutaneous erythema | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Decline | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
|
| Decompensated heart failure | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Decompensated diabetes | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Decreased platelets | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Deficit of vitamin B12 | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dental fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Dental implant | Surgical and medical procedures | MedDRA 14.0 | Systematic Assessment |
|
| Dental infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
|
| Determination of C1Q | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Diabetes mellitus Type-2 | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dishydrotic eczema | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dorsalgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Drowsiness | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Drug-induced liver disease | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dyspnea | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Earache | Ear and labyrinth disorders | MedDRA 14.0 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Eczema of the eyelids | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Elevated alpha-fetoprotein | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Elevated amylase | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Elevated average corpuscle volume | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Elevated creatinine | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Elevated ferritin in plasma | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Elevated glutamate oxaloacetate transaminase | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Elevated glutamate-pyruvate transaminase | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Elevated high-density lipoprotein | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Elevated lipase | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Elevated triglycerides | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Elevated gammaglobulin | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Elevated transaminases | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Elevation of creatine phosphokinase | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Elevation of gamma-glutamyl transferase | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Enthesitis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Eosinophilia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Epidermal cyst | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Epididimoorquitis | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
|
| Epigastralgia | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Epigastric pain | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Epileptic crisis | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
|
| Erectile impotence | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
|
| Erosive gastritis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Exacerbation of psoriasis | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Excessive tearing | Eye disorders | MedDRA 14.0 | Systematic Assessment |
|
| Exhaustion | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Extraction of wisdom tooth | Surgical and medical procedures | MedDRA 14.0 | Systematic Assessment |
|
| Eye discomfort | Eye disorders | MedDRA 14.0 | Systematic Assessment |
|
| Face cellulitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Facial paralysis | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Facial rash | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Falls | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Ferropenic anaemia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Fever | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Fibromyalgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Flu | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Foot cellulitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Foot pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Fractured metatarsal | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Functional dyspepsia | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Furunculosis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Gastritis caused by helicobacter pylori | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Gastroenteritis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| General discomfort | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Generalised rash | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Genital candidiasis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Genital wart | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Gingivitis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Glare | Eye disorders | MedDRA 14.0 | Systematic Assessment |
|
| Glaucoma | Eye disorders | MedDRA 14.0 | Systematic Assessment |
|
| Gonalgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Granulomatous lesion | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Haemangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Haemorrhagic erosive gastritis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Heel pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Heel spur | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hepatic steatosis | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Herniated disc | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| High cholesterol | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Hormonal imbalance | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Hydrocele | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hypercholesterolemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hypertension attack | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hyperuricemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 14.0 | Systematic Assessment |
|
| Increase in size of submaxillar gland | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Increased low-density lipoprotein | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Increased C-Reactive Protein | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Increased average corpuscular haemoglobin | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Increased bilirubin | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Increased creatine phosphokinase | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Increased gamma-glutamyl transferase | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Increased rheumatoid factor | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Increased serum glutamate-pyruvate transaminase | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Increased urea in blood | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Increased Hepatitis B viral load | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Increased vertical sleeve gastrectomy | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Ineffective drug | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Infected cyst | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Infected sebaceous cyst | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Infection by blastocystis hominis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Infection of upper airways not otherwise specified | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Inflammation of the middle ear | Ear and labyrinth disorders | MedDRA 14.0 | Systematic Assessment |
|
| Inguinal abscess | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Insomnia | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Instability | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Intestinal polyp | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Intoxication by immunosuppressants | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Irritable bowel | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Irritation of the palate | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Itching in the injection zone | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Joint pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Joint paint with involvement of the lower leg | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Knee pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Labial herpes | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Latent tuberculosis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Leg cellulitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Leg pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Leukoplakia of the oral mucosa (incl. tongue) | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Loss of dental piece | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Low folic acid | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Lower back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Low-grade fever | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Lumbar radiculopathy | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Lupus-like syndrome | Immune system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Macrocytosis | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Maculopapular rash | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Mandibular osteomyelitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Megaloblastic anaemia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Meniere's disease | Ear and labyrinth disorders | MedDRA 14.0 | Systematic Assessment |
|
| Metabolic syndrome | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Metrorrhagia | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
|
| Microcytic anaemia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Navicular fractures | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Negative tuberculosis test | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Non-specific chest pain | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Non-specific middle ear function | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Viral infection not otherwise specified | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Obstructive sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Odynophagia | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Oedema of the face | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Oedema of the feet | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Oedema of the leg | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Oedema of the limbs | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Oedema of the lower limbs | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Onphalitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Ophthalmological herpes simplex | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Oral infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Osteoarthrosis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Osteoarticular pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Osteochondrosis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Outbreak of psoriasis | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Outer ear infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Pain at the puncture location | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pain in hand | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pain in lower limbs | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pain in molars | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pain in the injection zone | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Painful knees | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Painful tongue | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Palmoplantar pustulosis | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Paradoxical reaction to a drug | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Paraesthesia in limbs | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Paronychia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Paroxistic tachycardia | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Penile candidiasis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Perianal abscess | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Pharyngitis not otherwise specified | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Pharyngoamygdalitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Photocoagulation | Surgical and medical procedures | MedDRA 14.0 | Systematic Assessment |
|
| Photophobia | Eye disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Polymenorrhea | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
|
| Polyuria | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Positive antinuclear antibodies | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Positive cutaneous tuberculosis test | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Positive lupus anticoagulant | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Positive tuberculosis test | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Posterior detachment of the vitreous humour | Eye disorders | MedDRA 14.0 | Systematic Assessment |
|
| Post-surgical pain | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pseudopterigion | Eye disorders | MedDRA 14.0 | Systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Psoriasis guttata | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Psoriasis of the scalp | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Psoriatic arthopathy | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Psoriatic arthritis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pulmonary consolidation | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Purulent secretion | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Raynaud's disease | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Reaction at injection site | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Rectorrhage | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Reduced sex drive | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
|
| Renal colic | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Renal lithotripsy | Surgical and medical procedures | MedDRA 14.0 | Systematic Assessment |
|
| Respiratory infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Rheumatic polymyalgia | Immune system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Rib fracture | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Root canal | Surgical and medical procedures | MedDRA 14.0 | Systematic Assessment |
|
| Sciatic | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Scrotal abscess | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Senile purpura | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Shoulder pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Sore left arm | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Sprained ankle | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Stasis dermatitis | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Stiffness in the morning | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Stiffness of limbs | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Stomach discomfort | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Streptococcus tonsillitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Sudden deafness | Ear and labyrinth disorders | MedDRA 14.0 | Systematic Assessment |
|
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Tarry stool | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Telogen alopecia | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Tendinitis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Terrien's marginal degeneration | Eye disorders | MedDRA 14.0 | Systematic Assessment |
|
| Throbbing headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Thyroid node | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Tingling sensation | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Tooth extraction | Surgical and medical procedures | MedDRA 14.0 | Systematic Assessment |
|
| Tooth sensitivity | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Traffic accident | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Transaminitis | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Trauma injuries of limbs | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Tubular colon adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Twisted and sprained feet | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Unspecified intestinal parasitosis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Urinary tract infection by Escherichia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Urination disorder | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Vaginal candidiasis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Verruca vulgaris | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 14.0 | Systematic Assessment |
|
| Viral gastroenteritis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Viral rash | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Viriasis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Vulvovaginal candidiasis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Warts (viral) | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Weight gain | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Weight loss | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Worsening of crohn's disease | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Worsening of the disease | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Worsening of depression | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
|
| Worsening of psoriasis | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Xerophthalmia | Eye disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hypersensitivity at injection site | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Traumatic injuries of the lumbosacral plexus | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Broken meniscus | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hypertensive nephropathy | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
|
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Measurements |
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| Month 9 |
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| Month 12 |
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| Month 18 |
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| Month 24 |
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| Title | Measurements |
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| Month 9 |
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| Month 12 |
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| Month 24 |
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| Title | Measurements |
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| Month 24 |
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| Title | Measurements |
|---|---|
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| Month 24 |
|
| Title | Measurements |
|---|---|
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| Month 24 (n=121) |
|
| Title | Measurements |
|---|---|
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| Congestive heart failure |
|
| Opportunistic infections |
|
| Lupus-like syndrome |
|
| Neoplasm |
|
| Title | Measurements |
|---|
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| Month 9 |
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| Month 12 |
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| Month 18 |
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| Month 24 |
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| Month 9 |
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| Month 12 |
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| Month 18 |
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| Month 24 |
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| Title | Measurements |
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| Month 9 |
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| Month 12 |
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| Month 18 |
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| Month 24 |
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| Title | Measurements |
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| Month 9 |
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| Month 12 |
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| Month 18 |
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| Month 24 |
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