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This post marketing observational study (PMOS) was conducted in Japan during the 2013-2014 and 2014-2015 Respiratory Syncytial Virus (RSV) seasons to assess the safety and effectiveness of palivizumab for the prevention of serious lower respiratory tract infection caused by RSV in participants 24 months of age and under, who have an immunocompromised medical condition (e.g., combined immunodeficiency disease, antibody deficiency, or other types of immunodeficiency; HIV infection; recovering from organ or bone marrow transplantation; on chemotherapy; on high-dose corticosteroid therapy; on immunosuppressants) or who have Down syndrome.
Palivizumab was prescribed according to the local label and independently of the decision to enroll participants in the study. Palivizumab was administered monthly throughout the Respiratory Syncytial Virus (RSV) infection seasons via intramuscular injection at a dose of 15 mg/kg of body weight. Survey forms were collected after the observation period. The number of adverse events and the frequency of hospitalizations due to RSV infections in surveyed participants were assessed to evaluate the safety and effectiveness of palivizumab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immunocompromised children | Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | An adverse event (AE) was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with their treatment. Adverse events were documented on the case report form (CRF). | From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks |
| Number of Participants With Serious Adverse Events | A serious adverse event was defined as any untoward medical occurrence in a participant that the investigator believed to be causally related to the study treatment and met at least one of the following criteria: death, life-threatening, hospitalization or prolongation of hospitalization, persistent or significant disability/incapacity, or important medical event requiring medical or surgical intervention to prevent serious outcome. Serious adverse events were documented on the case report form (CRF). | From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks |
| Number of Participants With Adverse Drug Reactions | An adverse event (AE) was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with their treatment. If a causal relationship with palivizumab was: "Related", "Causality cannot be ruled out", or "Not assessable" as determined by the investigator, it was classified as an adverse drug reaction (ADR). An AE was considered a serious adverse event (SAE) and a serious adverse drug reaction (SADR) if the severity of the AE or ADR was any one of the following, as determined by the investigator: "Death", "Life-threatening condition", "Hospitalization or prolonged hospitalization", "Persistent or significant disability", or "Other medically important condition". Information about AEs and ADRs was documented on the case report form (CRF). | From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Lower Respiratory Tract Infection (LRI) Score During the Study | The Lower Respiratory Tract Infection (LRI) Score ranged from 0 (well or baseline); 1 (Upper Respiratory tract Infection [URI]), mild); 2 (LRI); 3 (LRI, moderate); 4 (LRI, severe) to 5 (Respiratory Failure). Components of the score included respiratory rate per minute, oxygen saturation, and physical findings of LRI. LRI scores were documented on the case report form (CRF). |
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Inclusion Criteria:
Availability of a parent or legal guardian who was capable and willing to give written informed consent for his/her newborn, infant or young child to participate in the study
Participants receiving palivizumab for prevention of serious lower respiratory tract disease caused by RSV infection
Newborns, infants, or young children 24 months of age and under who have an immunocompromised medical condition:
Newborns, infants, or young children age of 24 months and under who have Down syndrome without a current hemodynamically significant Congenital Heart Disease. The participant must have had an experience with persistent respiratory symptoms or regular outpatient treatment due to respiratory tract infection prior to current RSV season.
Exclusion criteria:
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Single-arm, Multi-center, Prospective Cohort
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| Name | Affiliation | Role |
|---|---|---|
| Osamu Mikami, MD, PhD | AbbVie | Study Director |
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| Label | URL |
|---|---|
| Related Info | View source |
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Participants enrolled via consecutive enrollment method who had a completed CRF. Participants were excluded if there was enrollment at a non-contracting institution or beyond the contracted number; duplicate enrollment; no palivizumab administration; or if palivizumab administration began outside of the investigation period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Immunocompromised Children | Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants enrolled via consecutive enrollment method who had a completed CRF. Participants were excluded if there was enrollment at a non-contracting institution or beyond the contracted number; duplicate enrollment; no palivizumab administration; or if palivizumab administration began outside of the investigation period.
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| ID | Title | Description |
|---|---|---|
| BG000 | Immunocompromised Children | Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events | An adverse event (AE) was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with their treatment. Adverse events were documented on the case report form (CRF). | Participants enrolled via consecutive enrollment method who had a completed CRF. Participants were excluded if there was enrollment at a non-contracting institution or beyond the contracted number; duplicate enrollment; no palivizumab administration; or if palivizumab administration began outside of the investigation period. | Posted | Count of Participants | Participants | From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks |
|
All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
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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 | Immunocompromised Children | Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bacteraemia | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute sinusitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
The study population was a very specific, defined group, observed in the context of daily practice.The results of this study of the safety and effectiveness of palivizumab may not be applicable to the general population of healthy infants in Japan.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 |
| ID | Term |
|---|---|
| D018357 | Respiratory Syncytial Virus Infections |
| D007239 | Infections |
| D004314 | Down Syndrome |
| ID | Term |
|---|---|
| D018186 | Pneumovirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
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| From the first administration of palivizumab up to the last administration of palivizumab, up to 36 weeks |
| Number of Participants Hospitalized Due to Respiratory Syncytial Virus (RSV) Infection | Hospitalization due to RSV infection or the presence/absence of positive RSV antigen test results during hospitalization was documented on the case report form (CRF). | From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks |
| Mean Hospitalization Length Due to Respiratory Syncytial Virus (RSV) Infection | The date of hospitalization due to RSV infection and the date of hospital discharge were documented on the case report form (CRF). | From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks |
| Number of Hospitalized Participants Requiring Respiratory Support | The presence/absence of respiratory support, (oxygen therapy, mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure, and other mechanical respiratory support or Intensive Care Unit admission) the start and end dates of respiratory support, and the dates of hospitalization and discharge were documented on the case report form (CRF). | From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks |
| Mean Duration of Respiratory Support | The presence/absence of respiratory support (oxygen therapy, mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure, and other mechanical respiratory support or Intensive Care Unit admission) and the start and end dates of respiratory support were documented on the case report form (CRF). | From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks |
| Excluded from SAS: Ineligible for study |
|
| Did not meet inclusion criteria |
|
| Hospitalized for RSV at study start |
|
| months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Age at the start of treatment | Count of Participants | Participants |
|
| Body weight at the start of treatment | Count of Participants | Participants |
|
| Gestational age | Count of Participants | Participants |
|
| Body weight at birth | Count of Participants | Participants |
|
| Number of smokers in the household | Count of Participants | Participants |
|
| Familial predisposition to hypersensitivity | Count of Participants | Participants |
|
| Participant's predisposition to hypersensitivity | Count of Participants | Participants |
|
| Comorbidity | Count of Participants | Participants |
|
| Lower Respiratory Tract Infection score at the start of treatment | The Lower Respiratory Tract Infection (LRI) Score ranged from 0 (well or baseline); 1(Upper Respiratory tract Infection [URI]), mild; 2 (LRI); 3 (LRI, moderate); 4 (LRI, severe) to 5 (Respiratory Failure). Components of the score included respiratory rate per minute, oxygen saturation, and physical findings. LRI scores were documented on the case report form (CRF). | Count of Participants | Participants |
|
|
|
| Primary | Number of Participants With Serious Adverse Events | A serious adverse event was defined as any untoward medical occurrence in a participant that the investigator believed to be causally related to the study treatment and met at least one of the following criteria: death, life-threatening, hospitalization or prolongation of hospitalization, persistent or significant disability/incapacity, or important medical event requiring medical or surgical intervention to prevent serious outcome. Serious adverse events were documented on the case report form (CRF). | Participants enrolled via consecutive enrollment method who had a completed CRF. Participants were excluded if there was enrollment at a non-contracting institution or beyond the contracted number; duplicate enrollment; no palivizumab administration; or if palivizumab administration began outside of the investigation period. | Posted | Count of Participants | Participants | From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks |
|
|
|
| Primary | Number of Participants With Adverse Drug Reactions | An adverse event (AE) was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with their treatment. If a causal relationship with palivizumab was: "Related", "Causality cannot be ruled out", or "Not assessable" as determined by the investigator, it was classified as an adverse drug reaction (ADR). An AE was considered a serious adverse event (SAE) and a serious adverse drug reaction (SADR) if the severity of the AE or ADR was any one of the following, as determined by the investigator: "Death", "Life-threatening condition", "Hospitalization or prolonged hospitalization", "Persistent or significant disability", or "Other medically important condition". Information about AEs and ADRs was documented on the case report form (CRF). | Participants enrolled via consecutive enrollment method who had a completed CRF. Participants were excluded if there was enrollment at a non-contracting institution or beyond the contracted number; duplicate enrollment; no palivizumab administration; or if palivizumab administration began outside of the investigation period. | Posted | Count of Participants | Participants | From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks |
|
|
|
| Secondary | Change in Lower Respiratory Tract Infection (LRI) Score During the Study | The Lower Respiratory Tract Infection (LRI) Score ranged from 0 (well or baseline); 1 (Upper Respiratory tract Infection [URI]), mild); 2 (LRI); 3 (LRI, moderate); 4 (LRI, severe) to 5 (Respiratory Failure). Components of the score included respiratory rate per minute, oxygen saturation, and physical findings of LRI. LRI scores were documented on the case report form (CRF). | Participants with available data | Posted | Mean | Standard Deviation | units on a scale | From the first administration of palivizumab up to the last administration of palivizumab, up to 36 weeks |
|
|
|
| Secondary | Number of Participants Hospitalized Due to Respiratory Syncytial Virus (RSV) Infection | Hospitalization due to RSV infection or the presence/absence of positive RSV antigen test results during hospitalization was documented on the case report form (CRF). | Participants with available data | Posted | Count of Participants | Participants | From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks |
|
|
|
| Secondary | Mean Hospitalization Length Due to Respiratory Syncytial Virus (RSV) Infection | The date of hospitalization due to RSV infection and the date of hospital discharge were documented on the case report form (CRF). | Participants with available data | Posted | Mean | Standard Deviation | days | From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks |
|
|
|
| Secondary | Number of Hospitalized Participants Requiring Respiratory Support | The presence/absence of respiratory support, (oxygen therapy, mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure, and other mechanical respiratory support or Intensive Care Unit admission) the start and end dates of respiratory support, and the dates of hospitalization and discharge were documented on the case report form (CRF). | Participants with available data | Posted | Count of Participants | Participants | From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks |
|
|
|
| Secondary | Mean Duration of Respiratory Support | The presence/absence of respiratory support (oxygen therapy, mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure, and other mechanical respiratory support or Intensive Care Unit admission) and the start and end dates of respiratory support were documented on the case report form (CRF). | Participants with available data | Posted | Mean | Standard Deviation | days | From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks |
|
|
|
| 53 |
| 304 |
| 67 |
| 304 |
| Bronchitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Cytomegalovirus infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Epstein-Barr virus infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Peritonitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Bronchitis viral | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Pneumonia bacterial | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Device related infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Brain neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| Nephroblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Coagulopathy | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Haemolysis | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Histiocytosis haematophagic | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Bone marrow failure | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Chronic graft versus host disease | Immune system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Adrenal disorder | Endocrine disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hypophagia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| Febrile convulsion | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Neurological symptom | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Eyelid oedema | Eye disorders | MedDRA 18.1 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
|
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
|
| Anal atresia | Congenital, familial and genetic disorders | MedDRA 18.1 | Systematic Assessment |
|
| X-linked lymphoproliferative syndrome | Congenital, familial and genetic disorders | MedDRA 18.1 | Systematic Assessment |
|
| Omenn syndrome | Congenital, familial and genetic disorders | MedDRA 18.1 | Systematic Assessment |
|
| Condition aggravated | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| Norovirus test positive | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Croup infectious | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Cytomegalovirus infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Exanthema subitum | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Pseudomembranous colitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Viral pharyngitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Viral rash | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Catheter site infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Enteritis infectious | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Clostridial infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Enterocolitis viral | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Device related infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Viral rhinitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Enterocolitis bacterial | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Metapneumovirus infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Tinea manuum | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Gastroenteritis norovirus | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Histiocytosis haematophagic | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Graft versus host disease | Immune system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hypogammaglobulinaemia | Immune system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Engraftment syndrome | Immune system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Adrenal insufficiency | Endocrine disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| Lactose intolerance | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Uveitis | Eye disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Fibrinous bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Enterocolitis | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Penile ulceration | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Nephrotic syndrome | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| Blood culture positive | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| Antithrombin III decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| Aspergillus test positive | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| Frostbite | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| Vaccination complication | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| Postoperative ileus | Injury, poisoning and procedural complications | MedDRA 18.1 | 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.
| D014777 | Virus Diseases |
| D008607 | Intellectual Disability |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D025063 | Chromosome Disorders |
| D030342 | Genetic Diseases, Inborn |
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| 5 doses |
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| 6 doses |
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| 7 doses |
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| 8 doses |
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| 9 doses |
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