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| ID | Type | Description | Link |
|---|---|---|---|
| 2007_608 | Other Identifier | Merck | |
| V212-002 | Other Identifier | Merck |
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This study will evaluate the safety and immunogenicity of a heat-treated VZV vaccine in autologous or allogeneic hematopoietic cell transplant (HCT) recipients, human immunodeficiency virus (HIV)-infected participants with a baseline cluster of differentiation 4 (CD4) cell count ≤200 cells/mm^3, participants with solid tumor malignancy (STM; breast, colorectal, lung, or ovarian malignancies) receiving chemotherapy, and participants with hematologic malignancy (HM; leukemia or leukemia-like disease, lymphoma or lymphoma-like disease, or multiple myeloma). The primary hypothesis is that the heat-treated VZV vaccine will elicit significant VZV-specific immune responses measured by either glycoprotein-based enzyme-linked immunosorbent assay (gpELISA) or VZV gamma interferon enzyme-linked immunospot (IFN-ELISPOT) at 28 days post dose vaccination 4 in, HIV-infected participants, participants with STM, and participants with HM. The primary immunogenicity objective and endpoints were considered by the protocol as exploratory for the autologous and allogeneic HCT groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous HCT-V212 | Experimental | Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose. |
|
| Autologous HCT-Placebo | Placebo Comparator | Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose. |
|
| Allogeneic HCT-V212 | Experimental | Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose. |
|
| Allogeneic HCT-Placebo | Placebo Comparator | Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose. |
|
| STM-V212 | Experimental | Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V212 | Biological | 0.65 ml V212 in 4 dose regimen. Treatment period of 125 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Fold Rise (GMFR) in Varicella-Zoster (VZV) Antibody Responses Measured by Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) | Blood sample taken at predose (Day 1) and 28 days post vaccination 4 to determine the geometric mean titre (GMT) of VZV antibodies via gpELISA. The GMFR was calculated as GMT Post-dose/GMT Pre-vaccination | Baseline (Day 1 predose vaccination 1) and 28 days postdose 4 (~Day 118) |
| Geometric Mean Fold Rise (GMFR) in Varicella-Zoster (VZV) Antibody Responses Measured by by VZV Interferon-gamma (IFN-g) Enzyme-linked Immunospot (ELISPOT) Assay | Blood sample taken at predose (Day 1) and 28 days post vaccination 4 to determine the geometric mean titre (GMT) of VZV antibodies via ELISPOT. The GMFR was calculated as GMT Post-dose/GMT Pre-vaccination | Baseline (Day 1 predose vaccination 1) and 28 days postdose 4 (~Day 118) |
| Percentage of Participants Who Experience at Least 1 Serious Adverse Event (SAE) | An SAE was defined as an adverse event that resulted in death, was life threatening, resulted in persistent or significant disability or incapacity, resulted in or prolonged a hospitalization, is a congenital anomaly or birth defect, is a cancer, was an overdose, or was an important medical event based on appropriate medical judgment. The percentage of participants that experienced at least 1 SAE was summarized. | up to 28 days post vaccination 4 (up to ~Day 118) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With an Injection-site Adverse Event Prompted on the Vaccination Report Card (VRC) | An adverse event (AE) was defined as any untoward medical occurrence in a participant which did not necessarily have a causal relationship with study drug. An AE could therefore have been any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a preexisting condition that was temporally associated with the study drug or protocol-specified procedure was also an AE. The percentage of participants with an injection-site AE prompted on the VRC was summarized. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40396505 | Derived | Zorger AM, Hirsch C, Baumann M, Feldmann M, Brockelmann PJ, Mellinghoff S, Monsef I, Skoetz N, Kreuzberger N. Vaccines for preventing infections in adults with haematological malignancies. Cochrane Database Syst Rev. 2025 May 21;5(5):CD015530. doi: 10.1002/14651858.CD015530.pub2. | |
| 40237463 | Derived | Hirsch C, Zorger AM, Baumann M, Park YS, Brockelmann PJ, Mellinghoff S, Monsef I, Skoetz N, Kreuzberger N. Vaccines for preventing infections in adults with solid tumours. Cochrane Database Syst Rev. 2025 Apr 16;4(4):CD015551. doi: 10.1002/14651858.CD015551.pub2. |
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Autologous or allogeneic hematopoietic cell transplant (HCT) recipients, human immunodeficiency virus (HIV)-infected participants, participants with solid tumor malignancy (STM) and receiving chemotherapy, and participants with hematologic malignancy (HM) were enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Autologous HCT-V212 | Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose. |
| FG001 | Autologous HCT-Placebo | Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose. |
| FG002 | Allogeneic HCT-V212 | Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose. |
| FG003 | Allogeneic HCT-Placebo | Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose. |
| FG004 | STM-V212 | Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose. |
| FG005 | STM-Placebo | Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose. |
| FG006 | HM-V212 | Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose. |
| FG007 | HM-Placebo | Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose. |
| FG008 | HIV-V212 | Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose. |
| FG009 | HIV-Placebo | Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Autologous HCT-V212 | Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose. |
| BG001 | Autologous HCT-Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| 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 | Geometric Mean Fold Rise (GMFR) in Varicella-Zoster (VZV) Antibody Responses Measured by Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) | Blood sample taken at predose (Day 1) and 28 days post vaccination 4 to determine the geometric mean titre (GMT) of VZV antibodies via gpELISA. The GMFR was calculated as GMT Post-dose/GMT Pre-vaccination | All randomised participants in STM, HM and HIV arms who had received at least 1 dose of V212, had at least 1 valid immunogenicity evaluation for VZV antibody and had post-vaccination gpELISA data available for endpoint. As per the protocol, immunogenicity results for the autologous and allogeneic HCT groups were considered exploratory. | Posted | Geometric Mean | 90% Confidence Interval | Ratio | Baseline (Day 1 predose vaccination 1) and 28 days postdose 4 (~Day 118) |
|
Up to 28 days post vaccination 4 (~118 days)
Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Autologous HCT-V212 | Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D006562 | Herpes Zoster |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
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|
| STM-Placebo | Placebo Comparator | Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose. |
|
| HM-V212 | Experimental | Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose. |
|
| HM-Placebo | Placebo Comparator | Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose. |
|
| HIV-V212 | Experimental | Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose. |
|
| HIV-Placebo | Placebo Comparator | Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose. |
|
| Placebo | Biological | 0.65 ml V212 Pbo in 4 dose regimen. Treatment period of 125 days |
|
| Up to Day 5 post any vaccination |
| Percentage of Participants With a Systemic Adverse Event Prompted on the VRC | An adverse event (AE) was defined as any untoward medical occurrence in a participant which did not necessarily have a causal relationship with study drug. An AE could therefore have been any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a preexisting condition that was temporally associated with the study drug or protocol-specified procedure was also an AE. The percentage of participants with a VRC-prompted systemic (non-injection site) AE was summarized. | Up to 28 days post vaccination 4 (up to ~118 days) |
| Percentage of Participants With Elevated Oral Temperature (≥101.0°F (≥38.3ºC) Prompted on the VRC | Participants were instructed on the VRC to take and record their oral (or oral equivalent) temperature daily from the day of vaccination from the date of each vaccine dose through the day prior to the next dose, or for 28 days. Elevated temperature was defined as ≥101.0°F (≥38.3ºC). The percentage of participants that record an elevated temperature was summarized. | Up to 28 days post any vaccination (up to ~118 days) |
| 23908479 | Derived | Mullane KM, Winston DJ, Wertheim MS, Betts RF, Poretz DM, Camacho LH, Pergam SA, Mullane MR, Stek JE, Sterling TM, Zhao Y, Manoff SB, Annunziato PW. Safety and immunogenicity of heat-treated zoster vaccine (ZVHT) in immunocompromised adults. J Infect Dis. 2013 Nov 1;208(9):1375-85. doi: 10.1093/infdis/jit344. Epub 2013 Aug 1. |
| Lost to Follow-up |
|
| Physician Decision |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose. |
| BG002 | Allogeneic HCT-V212 | Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose. |
| BG003 | Allogeneic HCT-Placebo | Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose. |
| BG004 | STM-V212 | Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose. |
| BG005 | STM-Placebo | Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose. |
| BG006 | HM-V212 | Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose. |
| BG007 | HM-Placebo | Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose. |
| BG008 | HIV-V212 | Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose. |
| BG009 | HIV-Placebo | Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose. |
| BG010 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | HM-V212 | Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose. |
| OG002 | HIV-V212 | Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose. |
|
|
|
| Primary | Geometric Mean Fold Rise (GMFR) in Varicella-Zoster (VZV) Antibody Responses Measured by by VZV Interferon-gamma (IFN-g) Enzyme-linked Immunospot (ELISPOT) Assay | Blood sample taken at predose (Day 1) and 28 days post vaccination 4 to determine the geometric mean titre (GMT) of VZV antibodies via ELISPOT. The GMFR was calculated as GMT Post-dose/GMT Pre-vaccination | All randomised participants in STM, HM and HIV arms who had received at least 1 dose of V212, had at least 1 valid immunogenicity evaluation for VZV antibody and had post-vaccination IFN-g data available for endpoint. As per the protocol, immunogenicity results for the autologous and allogeneic HCT groups were considered exploratory. | Posted | Geometric Mean | 90% Confidence Interval | Ratio | Baseline (Day 1 predose vaccination 1) and 28 days postdose 4 (~Day 118) |
|
|
|
|
| Primary | Percentage of Participants Who Experience at Least 1 Serious Adverse Event (SAE) | An SAE was defined as an adverse event that resulted in death, was life threatening, resulted in persistent or significant disability or incapacity, resulted in or prolonged a hospitalization, is a congenital anomaly or birth defect, is a cancer, was an overdose, or was an important medical event based on appropriate medical judgment. The percentage of participants that experienced at least 1 SAE was summarized. | All enrolled participants that received at least 1 dose of V212 or placebo and had available follow-up data for endpoint. | Posted | Number | Percentage of Participants | up to 28 days post vaccination 4 (up to ~Day 118) |
|
|
|
|
| Secondary | Percentage of Participants With an Injection-site Adverse Event Prompted on the Vaccination Report Card (VRC) | An adverse event (AE) was defined as any untoward medical occurrence in a participant which did not necessarily have a causal relationship with study drug. An AE could therefore have been any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a preexisting condition that was temporally associated with the study drug or protocol-specified procedure was also an AE. The percentage of participants with an injection-site AE prompted on the VRC was summarized. | All enrolled participants that received at least 1 dose of V212 or placebo and had available follow-up data for endpoint. | Posted | Number | Percentage of Participants | Up to Day 5 post any vaccination |
|
|
|
|
| Secondary | Percentage of Participants With a Systemic Adverse Event Prompted on the VRC | An adverse event (AE) was defined as any untoward medical occurrence in a participant which did not necessarily have a causal relationship with study drug. An AE could therefore have been any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a preexisting condition that was temporally associated with the study drug or protocol-specified procedure was also an AE. The percentage of participants with a VRC-prompted systemic (non-injection site) AE was summarized. | All enrolled participants that received at least 1 dose of V212 or placebo and had available follow-up data for endpoint. | Posted | Number | Percentage of Participants | Up to 28 days post vaccination 4 (up to ~118 days) |
|
|
|
|
| Secondary | Percentage of Participants With Elevated Oral Temperature (≥101.0°F (≥38.3ºC) Prompted on the VRC | Participants were instructed on the VRC to take and record their oral (or oral equivalent) temperature daily from the day of vaccination from the date of each vaccine dose through the day prior to the next dose, or for 28 days. Elevated temperature was defined as ≥101.0°F (≥38.3ºC). The percentage of participants that record an elevated temperature was summarized. | All enrolled participants that received at least 1 dose of V212 or placebo and had available follow-up data for endpoint. | Posted | Number | Percentage of Participants | Up to 28 days post any vaccination (up to ~118 days) |
|
|
|
|
| 1 |
| 40 |
| 13 |
| 40 |
| 40 |
| 40 |
| EG001 | Autologous HCT-Placebo | Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose. | 0 | 10 | 2 | 10 | 10 | 10 |
| EG002 | Allogeneic-V212 | Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose. | 11 | 40 | 32 | 40 | 40 | 40 |
| EG003 | Allogeneic-Placebo | Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose. | 2 | 10 | 7 | 10 | 9 | 10 |
| EG004 | STM-V212 | Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose. | 1 | 57 | 7 | 57 | 38 | 57 |
| EG005 | STM-Placebo | Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose. | 0 | 19 | 2 | 19 | 13 | 19 |
| EG006 | HM-V212 | Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose. | 4 | 61 | 12 | 61 | 51 | 61 |
| EG007 | HM-Placebo | Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose. | 0 | 19 | 1 | 19 | 10 | 19 |
| EG008 | HIV-V212 | Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose. | 1 | 60 | 8 | 60 | 33 | 60 |
| EG009 | HIV-Placebo | Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose. | 0 | 20 | 2 | 20 | 12 | 20 |
| Coagulopathy | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Haemolytic anaemia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Lymphatic obstruction | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Thrombotic thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Diabetes insipidus | Endocrine disorders | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Adverse drug reaction | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Multi-organ failure | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hepatitis | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Venoocclusive liver disease | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Acute graft versus host disease in intestine | Immune system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Acute graft versus host disease in liver | Immune system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Graft versus host disease | Immune system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Acinetobacter bacteraemia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Device related infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Escherichia bacteraemia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Escherichia sepsis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Hepatosplenic candidiasis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Klebsiella bacteraemia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Meningitis herpes | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Neutropenic sepsis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Peritonitis bacterial | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pneumonia fungal | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pneumonia legionella | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pneumonia primary atypical | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pneumonia respiratory syncytial viral | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pneumonia viral | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pseudomonal bacteraemia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pseudomonal sepsis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Systemic candida | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Wound infection pseudomonas | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Drug toxicity | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Epstein-Barr virus test positive | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Acute lymphocytic leukaemia recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Acute myeloid leukaemia recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Diffuse large B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Diffuse large B-cell lymphoma recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Epstein-Barr virus associated lymphoproliferative disorder | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Hodgkin's disease recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Lung adenocarcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Non-Hodgkin's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Recurrent cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| T-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Peripheral sensorimotor neuropathy | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Mental status changes | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cystitis haemorrhagic | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pulmonary alveolar haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Circulatory collapse | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Coagulopathy | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Lymph node pain | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Lymphatic obstruction | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Splenomegaly | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Thrombotic thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Atrioventricular block | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Atrioventricular block first degree | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cardiomegaly | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cardiomyopathy | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Intracardiac thrombus | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Mitral valve incompetence | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Tricuspid valve incompetence | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Ventricular extrasystoles | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Deafness neurosensory | Ear and labyrinth disorders | MedDRA 12.0 | Systematic Assessment |
|
| Ear congestion | Ear and labyrinth disorders | MedDRA 12.0 | Systematic Assessment |
|
| Ear haemorrhage | Ear and labyrinth disorders | MedDRA 12.0 | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA 12.0 | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA 12.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 12.0 | Systematic Assessment |
|
| Goitre | Endocrine disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 12.0 | Systematic Assessment |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Conjunctivochalasis | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Eye movement disorder | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Eye oedema | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Eyelid cyst | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Eyelid ptosis | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Keratopathy | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Ocular discomfort | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Ocular icterus | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Photophobia | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Vitreous floaters | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Anorectal discomfort | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Chapped lips | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Colonic polyp | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Gingival bleeding | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Glossodynia | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hiatus hernia | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Lip haemorrhage | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Lip pain | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Lip ulceration | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Localised intraabdominal fluid collection | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Neutropenic colitis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Odynophagia | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Oral disorder | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Oral mucosal erythema | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Peritonitis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Proctalgia | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Salivary hypersecretion | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Tongue discolouration | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Tongue ulceration | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Adverse drug reaction | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Axillary pain | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Catheter site discharge | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Catheter site erythema | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Catheter site haemorrhage | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Catheter site inflammation | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Catheter site pain | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cyst rupture | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Generalised oedema | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypothermia | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Injection site discolouration | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Injection site haematoma | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Injection site mass | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Injection site papule | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Injection site warmth | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Local swelling | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Medical device pain | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Mucosal haemorrhage | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Mucosal ulceration | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Suprapubic pain | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Swelling | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Temperature intolerance | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Tenderness | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Thrombosis in device | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Acute hepatic failure | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hepatic steatosis | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Acute graft versus host disease | Immune system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Acute graft versus host disease in intestine | Immune system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Acute graft versus host disease in skin | Immune system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Graft versus host disease | Immune system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Acute sinusitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Bronchitis bacterial | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Candidiasis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Catheter site infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Chronic sinusitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Clostridium difficile colitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Conjunctivitis infective | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Corona virus infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Cytomegalovirus colitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Cytomegalovirus infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Cytomegalovirus viraemia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Enterococcal bacteraemia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Enterocolitis infectious | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Escherichia bacteraemia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Escherichia urinary tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Eye infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Fungaemia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Fungal infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Fungal skin infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Furuncle | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Genital herpes | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Gingival infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Klebsiella bacteraemia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Lung infection pseudomonal | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Lyme disease | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Oesophageal candidiasis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Parainfluenzae virus infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pneumonia bacterial | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pneumonia fungal | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pneumonia haemophilus | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pneumonia staphylococcal | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pseudomonal bacteraemia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Rhinovirus infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Streptococcal bacteraemia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Subcutaneous abscess | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Tinea infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Urinary tract infection bacterial | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Urinary tract infection enterococcal | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Urinary tract infection pseudomonal | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Allergic transfusion reaction | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Anal injury | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Corneal abrasion | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Periorbital haematoma | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Postoperative wound complication | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Soft tissue injury | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Tongue injury | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Transfusion reaction | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Wound complication | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Bacterial test positive | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Blood magnesium increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Blood uric acid increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Cardiac murmur | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Clostridium test positive | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Crystal urine present | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Haematocrit decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Heart sounds abnormal | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Mean platelet volume decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Prostatic specific antigen increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Pulmonary function test decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Red blood cell count decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Sputum abnormal | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Troponin increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Urine output decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Viral test positive | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Vitamin D decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Fluid overload | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Iron deficiency | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Lactic acidosis | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Metabolic alkalosis | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Compartment syndrome | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Myopathy | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Neck mass | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Nodule on extremity | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Osteonecrosis of jaw | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Chronic myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Hepatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Penile wart | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Thyroid neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Balance disorder | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cognitive disorder | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dementia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Depressed level of consciousness | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dysarthria | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dysstasia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Encephalopathy | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Facial palsy | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hemiparesis | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Motor dysfunction | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Peripheral sensorimotor neuropathy | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Peroneal nerve palsy | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pneumocephalus | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Sinus headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Catatonia | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hallucination, visual | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Mental status changes | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Psychomotor retardation | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Restlessness | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Seasonal affective disorder | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Azotaemia | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Bladder pain | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cystitis haemorrhagic | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Nocturia | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Renal tubular necrosis | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Urethral pain | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Urinary hesitation | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Genital erythema | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
|
| Genital lesion | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
|
| Menorrhagia | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
|
| Penile exfoliation | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
|
| Penile pain | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
|
| Scrotal oedema | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
|
| Scrotal pain | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
|
| Uterine haemorrhage | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
|
| Vulvovaginal pain | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
|
| Vulvovaginal pruritus | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pharyngeal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pulmonary alveolar haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Rales | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Rhinalgia | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Sinus polyp | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Throat tightness | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Heat rash | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Periorbital oedema | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Rash follicular | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Rash vesicular | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Diastolic hypertension | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Peripheral embolism | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Thrombophlebitis superficial | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Vasodilatation | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Venous thrombosis | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication guidelines.
| D007239 | Infections |
Adjusted for prevaccination values |
| 0.004 |
Statistical criterion corresponds to the lower bound of the two-sided 90% confidence interval (CI) on the geometric mean fold rise (GMFR) in the vaccine recipients being >1.0 |
| Other |
| Single longitudinal regression model | Adjusted for prevaccination values | 0.026 | Statistical criterion corresponds to the lower bound of the two-sided 90% confidence interval (CI) on the geometric mean fold rise (GMFR) in the vaccine recipients being >1.0 | Other |
| Difference in Percentages |
| 10.0 |
| 2-Sided |
| 95 |
| -15.1 |
| 42.9 |
V212 minus placebo = Difference |
| Other |
| Difference in Percentages | 1.8 | 2-Sided | 95 | -20.4 | 15.7 | V212 minus placebo = Difference | Other |
| Difference in Percentages | 14.4 | 2-Sided | 95 | -6.5 | 27.6 | V212 minus placebo = Difference | Other |
| Difference in Percentages | 3.3 | 2-Sided | 95 | -18.1 | 17.0 | V212 minus placebo = Difference | Other |
| 0.302 |
| Difference in Percentages |
| 10.0 |
| 2-Sided |
| 95 |
| -18.8 |
| 23.2 |
V212 minus placebo = Difference |
| Other |
| Asymptotic method | 0.009 | Difference in Percentages | 31.6 | 2-Sided | 95 | 9.7 | 46.2 | V212 minus placebo = Difference | Other |
| Asymptotic method | 0.041 | Difference in Percentages | 22.6 | 2-Sided | 95 | 1.3 | 36.6 | V212 minus placebo = Difference | Other |
| Asymptotic method | 0.064 | Difference in Percentages | -11.7 | 2-Sided | 95 | -33.2 | 0.6 | V212 minus placebo = Difference | Other |
| 0.617 |
| Difference in Percentages |
| 2.5 |
| 2-Sided |
| 95 |
| -25.8 |
| 13.0 |
V212 minus placebo = Difference |
| Other |
| Asymptotic method | 0.411 | Difference in Percentages | 3.5 | 2-Sided | 95 | -13.7 | 12.0 | V212 minus placebo = Difference | Other |
| Asymptotic method | 0.328 | Difference in Percentages | 4.9 | 2-Sided | 95 | -12.3 | 13.6 | V212 minus placebo = Difference | Other |
| Asymptotic method | >0.999 | Difference in Percentages | 0.0 | 2-Sided | 95 | -19.2 | 10.0 | V212 minus placebo = Difference | Other |
| 0.696 |
| Difference in Percentages |
| 6.7 |
| 2-Sided |
| 95 |
| -22.5 |
| 39.4 |
V212 minus placebo = Difference |
| Other |
| Asymptotic method | 0.221 | Difference in Percentages | 7.5 | 2-Sided | 95 | -9.8 | 18.0 | V212 minus placebo = Difference | Other |
| Asymptotic method | 0.402 | Difference in Percentages | 6.8 | 2-Sided | 95 | -13.7 | 19.1 | V212 minus placebo = Difference | Other |
| Asymptotic method | 0.679 | Difference in Percentages | 3.8 | 2-Sided | 95 | -18.5 | 18.2 | V212 minus placebo = Difference | Other |