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This was a Phase IV randomized, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of subcutaneous efalizumab in adult patients (18 years of age and older) with chronic moderate to severe plaque psoriasis with involvement of the scalp who had no previous exposure to efalizumab. The study consisted of a screening period, a double-blind treatment period, an open-label treatment period, and an observation/follow-up period. The study enrolled 100 patients. 11 patients were excluded from all analyses because of data issues.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Efalizumab | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| efalizumab | Drug | All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24). |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients Who Achieved a ≥ 75% Decrease in Psoriasis Scalp Severity Index (PSSI) Score at 12 Weeks | Proportion of patients who achieved a ≥ 75% decrease in PSSI score at 12 weeks (Day 84) relative to baseline. The PSSI assessed: 1) extent of scalp psoriasis (i.e., percentage of area involved), which was scored from 1 to 6, where 1 = <10% and 6 = 90-100%); and 2) clinical signs (erythema, induration, and desquamation), which were scored from 0 to 4, where 0 = Absent and 4 = Severest possible). The sum of the separate scores for erythema, induration, and desquamation was multiplied by the score for the involved area. The PSSI score range was therefore 0-72. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients Who Achieved a ≥ 75% Decrease in PSSI Score at 24 Weeks | Proportion of patients who achieved a ≥ 75% decrease in PSSI score at 24 weeks (Day 168) relative to baseline. The PSSI assessed: 1) extent of scalp psoriasis (i.e., percentage of area involved), which was scored from 1 to 6, where 1 = <10% and 6 = 90-100%); and 2) clinical signs (erythema, induration, and desquamation), which were scored from 0 to 4, where 0 = Absent and 4 = Severest possible). The sum of the separate scores for erythema, induration, and desquamation was multiplied by the score for the involved area. The PSSI score range was therefore 0-72. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ivor Caro, M.D. | Genentech, Inc. | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | All patients received a conditioning dose of placebo equivalent subcutaneously (SC) on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24). |
| FG001 | Efalizumab | All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Double-Blind Treatment Period (Week 12) |
| |||||||||||||
| Open-Label Treatment Period (Week 24) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | All patients received a conditioning dose of placebo equivalent subcutaneously (SC) on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24). |
| BG001 |
| 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 | Proportion of Patients Who Achieved a ≥ 75% Decrease in Psoriasis Scalp Severity Index (PSSI) Score at 12 Weeks | Proportion of patients who achieved a ≥ 75% decrease in PSSI score at 12 weeks (Day 84) relative to baseline. The PSSI assessed: 1) extent of scalp psoriasis (i.e., percentage of area involved), which was scored from 1 to 6, where 1 = <10% and 6 = 90-100%); and 2) clinical signs (erythema, induration, and desquamation), which were scored from 0 to 4, where 0 = Absent and 4 = Severest possible). The sum of the separate scores for erythema, induration, and desquamation was multiplied by the score for the involved area. The PSSI score range was therefore 0-72. | Intent-to-treat (ITT) population. If PSSI at Day 84 was missing for a patient who discontinued before the final scheduled dose, the patient was considered a treatment failure (nonresponder) for analysis. If PSSI at Day 84 was missing for a patient who completed treatment, the last available PSSI from the treatment period was used for analysis. | Posted | Number | Proportion of patients | Week 12 |
|
Double-blind (12 weeks), open-label (24 weeks), and follow-up. Patients entered each period as follows: Double-blind: placebo n = 27; efalizumab n = 62 Open-label: placebo n = 22; efalizumab n = 55 Follow-up: placebo n = 18; efalizumab n = 48
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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 | Placebo: Double-Blind Period | All patients received a conditioning dose of placebo equivalent SC on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Splenomegaly | Blood and lymphatic system disorders | MedDRA (11.0) | Non-systematic Assessment |
Since the completion of this study, efalizumab has been voluntarily withdrawn from the U.S. market because of a safety issue.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Genentech, Inc. | 800-821-8590 |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C472181 | efalizumab |
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|
|
| placebo | Drug | All patients received a conditioning dose of placebo equivalent SC on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24). |
|
| Week 24 |
| Proportion of Patients Who Achieved a ≥ 50% Decrease in PSSI Score at 12 Weeks | Proportion of patients who achieved a ≥ 50% decrease in PSSI score at 12 weeks (Day 84) relative to baseline. The PSSI assessed: 1) extent of scalp psoriasis (i.e., percentage of area involved), which was scored from 1 to 6, where 1 = <10% and 6 = 90-100%); and 2) clinical signs (erythema, induration, and desquamation), which were scored from 0 to 4, where 0 = Absent and 4 = Severest possible). The sum of the separate scores for erythema, induration, and desquamation was multiplied by the score for the involved area. The PSSI score range was therefore 0-72. | Week 12 |
| Proportion of Patients Who Achieved a ≥ 50% Decrease in PSSI Score at 24 Weeks | Proportion of patients who achieved a ≥ 50% decrease in PSSI score at 24 weeks (Day 168) relative to baseline. The PSSI assessed: 1) extent of scalp psoriasis (i.e., percentage of area involved), which was scored from 1 to 6, where 1 = <10% and 6 = 90-100%); and 2) clinical signs (erythema, induration, and desquamation), which were scored from 0 to 4, where 0 = Absent and 4 = Severest possible). The sum of the separate scores for erythema, induration, and desquamation was multiplied by the score for the involved area. The PSSI score range was therefore 0-72. | Week 24 |
| Proportion of Patients Who Achieved a Whole Body (Including Scalp) Physician's Global Assessment (PGA) Rating of Clear (0), Almost Clear (1), or Mild (2) at 12 Weeks | Proportion of patients who achieved a whole body (including scalp) PGA rating of 0, 1, or 2 at 12 weeks (Day 84) Physician's Global Assessment (PGA) scale: 0: Clear. No signs of plaque psoriasis.
| Week 12 |
| Proportion of Patients Who Achieved a Whole Body (Including Scalp) PGA Rating of Clear (0), Almost Clear (1), or Mild (2) at 24 Weeks | Proportion of patients who achieved a whole body (including scalp) PGA rating of 0, 1, or 2 at 24 weeks (Day 168) For details on the PGA scale, refer to the Secondary Outcome Measure Description for 12 weeks. | Week 24 |
| Mean Change in Scalpdex Score at 12 Weeks | Mean change in Scalpdex score at 12 weeks (Day 84) relative to baseline. The Scalpdex point scoring scale ranges from 1=NEVER, 2='RARELY', 3='SOMETIMES', 4='OFTEN' and 5='ALL THE TIME'. | The two time points for Mean Change in Scalpdex Score at 12 Weeks are Day 0 and Day 84 |
| Mean Change in Scalpdex Score at 24 Weeks | Mean change in Scalpdex score at 24 weeks (Day 168) relative to baseline. The Scalpdex point scoring scale ranges from 1=NEVER, 2='RARELY', 3='SOMETIMES', 4='OFTEN' and 5='ALL THE TIME'. | Week 24 |
| Mean Change in a Visual Analog Scale (VAS) of Scalp Itch at 12 Weeks | Mean change in VAS of patient-reported scalp itch at 12 weeks (Day 84) relative to baseline. The Visual Analog Scale (VAS) of patient-reported scalp itch measured the severity of a patient's scalp itch on a scale of 0 to 10, where 0 was "no itching," 5 was "moderate itching," and 10 was "severe itching." | Week 12 |
| Mean Change in VAS of Patient-reported Scalp Itch at 24 Weeks | Mean change in VAS of patient-reported scalp itch at 24 weeks (Day 168) relative to baseline. The Visual Analog Scale (VAS) of patient-reported scalp itch measured the severity of a patient's scalp itch on a scale of 0 to 10, where 0 was "no itching," 5 was "moderate itching," and 10 was "severe itching." | Week 24 |
| Mean Change in Percentage of Whole Body (Including Scalp) Body Surface Area (BSA) Affected by Psoriasis at 12 Weeks | Mean change in percentage of whole body (including scalp) BSA affected by psoriasis at 12 weeks (Day 84) relative to baseline. BSA was assessed by percentage of sites affected per body segment (head, trunk, and limbs). Investigators were instructed to use the "rule of palm" to estimate lesional skin BSA (1% BSA = palm to first interphalangeal joint). | Week 12 |
| Mean Change in Percentage of Whole Body (Including Scalp) BSA Affected by Psoriasis at 24 Weeks | Mean change in percentage of whole body (including scalp) BSA affected by psoriasis at 24 weeks (Day 168) relative to baseline. BSA was assessed by percentage of sites affected per body segment (head, trunk, and limbs). Investigators were instructed to use the "rule of palm" to estimate lesional skin BSA (1% BSA = palm to first interphalangeal joint). | Week 24 |
| NOT COMPLETED |
|
| Efalizumab |
All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG000 |
| Placebo |
All patients received a conditioning dose of placebo equivalent subcutaneously (SC) on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24). |
| OG001 | Efalizumab | All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24). |
|
|
|
| Secondary | Proportion of Patients Who Achieved a ≥ 75% Decrease in PSSI Score at 24 Weeks | Proportion of patients who achieved a ≥ 75% decrease in PSSI score at 24 weeks (Day 168) relative to baseline. The PSSI assessed: 1) extent of scalp psoriasis (i.e., percentage of area involved), which was scored from 1 to 6, where 1 = <10% and 6 = 90-100%); and 2) clinical signs (erythema, induration, and desquamation), which were scored from 0 to 4, where 0 = Absent and 4 = Severest possible). The sum of the separate scores for erythema, induration, and desquamation was multiplied by the score for the involved area. The PSSI score range was therefore 0-72. | ITT population. If PSSI at Day 168 was missing for a patient who discontinued before the final scheduled open-label dose, the patient was considered a treatment failure (nonresponder) for analysis. If PSSI at Day 168 was missing for a patient who completed the Day 161 dose, the last available PSSI was used for analysis. | Posted | Number | 95% Confidence Interval | Proportion of patients | Week 24 |
|
|
|
| Secondary | Proportion of Patients Who Achieved a ≥ 50% Decrease in PSSI Score at 12 Weeks | Proportion of patients who achieved a ≥ 50% decrease in PSSI score at 12 weeks (Day 84) relative to baseline. The PSSI assessed: 1) extent of scalp psoriasis (i.e., percentage of area involved), which was scored from 1 to 6, where 1 = <10% and 6 = 90-100%); and 2) clinical signs (erythema, induration, and desquamation), which were scored from 0 to 4, where 0 = Absent and 4 = Severest possible). The sum of the separate scores for erythema, induration, and desquamation was multiplied by the score for the involved area. The PSSI score range was therefore 0-72. | ITT population. If PSSI at Day 84 was missing for a patient who discontinued before the final scheduled dose, the patient was considered a treatment failure (nonresponder) for analysis. If PSSI at Day 84 was missing for a patient who completed treatment, the last available PSSI from the treatment period was used for analysis. | Posted | Number | Proportion of patients | Week 12 |
|
|
|
|
| Secondary | Proportion of Patients Who Achieved a ≥ 50% Decrease in PSSI Score at 24 Weeks | Proportion of patients who achieved a ≥ 50% decrease in PSSI score at 24 weeks (Day 168) relative to baseline. The PSSI assessed: 1) extent of scalp psoriasis (i.e., percentage of area involved), which was scored from 1 to 6, where 1 = <10% and 6 = 90-100%); and 2) clinical signs (erythema, induration, and desquamation), which were scored from 0 to 4, where 0 = Absent and 4 = Severest possible). The sum of the separate scores for erythema, induration, and desquamation was multiplied by the score for the involved area. The PSSI score range was therefore 0-72. | ITT population. If PSSI at Day 168 was missing for a patient who discontinued before the final scheduled open-label dose, the patient was considered a treatment failure (nonresponder) for analysis. If PSSI at Day 168 was missing for a patient who completed the Day 161 dose, the last available PSSI was used for analysis. | Posted | Number | 95% Confidence Interval | Proportion of patients | Week 24 |
|
|
|
| Secondary | Proportion of Patients Who Achieved a Whole Body (Including Scalp) Physician's Global Assessment (PGA) Rating of Clear (0), Almost Clear (1), or Mild (2) at 12 Weeks | Proportion of patients who achieved a whole body (including scalp) PGA rating of 0, 1, or 2 at 12 weeks (Day 84) Physician's Global Assessment (PGA) scale: 0: Clear. No signs of plaque psoriasis.
| ITT population. If PGA rating at Day 84 was missing for a patient who discontinued before the final scheduled dose, the patient was considered a treatment failure (nonresponder) for analysis. If PGA rating at Day 84 was missing for a patient who completed treatment, the last available PGA rating from the treatment period was used for analysis. | Posted | Number | Proportion of patients | Week 12 |
|
|
|
|
| Secondary | Proportion of Patients Who Achieved a Whole Body (Including Scalp) PGA Rating of Clear (0), Almost Clear (1), or Mild (2) at 24 Weeks | Proportion of patients who achieved a whole body (including scalp) PGA rating of 0, 1, or 2 at 24 weeks (Day 168) For details on the PGA scale, refer to the Secondary Outcome Measure Description for 12 weeks. | ITT population. If PGA rating at Day 168 was missing for a patient who discontinued before the final scheduled open-label dose, the patient was considered a treatment failure (nonresponder) for analysis. If PGA rating at Day 168 was missing for a patient who completed the Day 161 dose, the last available PGA rating was used for analysis. | Posted | Number | 95% Confidence Interval | Proportion of patients | Week 24 |
|
|
|
| Secondary | Mean Change in Scalpdex Score at 12 Weeks | Mean change in Scalpdex score at 12 weeks (Day 84) relative to baseline. The Scalpdex point scoring scale ranges from 1=NEVER, 2='RARELY', 3='SOMETIMES', 4='OFTEN' and 5='ALL THE TIME'. | ITT population. If Scalpdex at Day 84 was missing for a patient who discontinued before the final scheduled dose, the patient was not included in the analysis. If Scalpdex at Day 84 was missing for a patient who completed treatment, the last available Scalpdex from the treatment period was used for analysis. | Posted | Mean | Standard Deviation | Points on Scalpdex | The two time points for Mean Change in Scalpdex Score at 12 Weeks are Day 0 and Day 84 |
|
|
|
|
| Secondary | Mean Change in Scalpdex Score at 24 Weeks | Mean change in Scalpdex score at 24 weeks (Day 168) relative to baseline. The Scalpdex point scoring scale ranges from 1=NEVER, 2='RARELY', 3='SOMETIMES', 4='OFTEN' and 5='ALL THE TIME'. | ITT population. If Scalpdex at Day 168 was missing for a patient who discontinued before the final scheduled dose, the patient was not included in the analysis. If Scalpdex at Day 168 was missing for a patient who completed the Day 161 dose, the last available Scalpdex was used for analysis. | Posted | Mean | Standard Deviation | Points on Scalpdex | Week 24 |
|
|
|
| Secondary | Mean Change in a Visual Analog Scale (VAS) of Scalp Itch at 12 Weeks | Mean change in VAS of patient-reported scalp itch at 12 weeks (Day 84) relative to baseline. The Visual Analog Scale (VAS) of patient-reported scalp itch measured the severity of a patient's scalp itch on a scale of 0 to 10, where 0 was "no itching," 5 was "moderate itching," and 10 was "severe itching." | ITT population. If VAS at Day 84 was missing for a patient who discontinued before the final scheduled dose, the patient was not included in the analysis. If VAS at Day 84 was missing for a patient who completed treatment, the last available VAS from the treatment period was used for analysis. | Posted | Mean | Standard Deviation | Points on VAS | Week 12 |
|
|
|
|
| Secondary | Mean Change in VAS of Patient-reported Scalp Itch at 24 Weeks | Mean change in VAS of patient-reported scalp itch at 24 weeks (Day 168) relative to baseline. The Visual Analog Scale (VAS) of patient-reported scalp itch measured the severity of a patient's scalp itch on a scale of 0 to 10, where 0 was "no itching," 5 was "moderate itching," and 10 was "severe itching." | ITT population. If VAS at Day 168 was missing for a patient who discontinued before the final scheduled dose, the patient was not included in the analysis. If VAS at Day 168 was missing for a patient who completed the Day 161 dose, the last available VAS was used for analysis. | Posted | Mean | Standard Deviation | Points on VAS | Week 24 |
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| Secondary | Mean Change in Percentage of Whole Body (Including Scalp) Body Surface Area (BSA) Affected by Psoriasis at 12 Weeks | Mean change in percentage of whole body (including scalp) BSA affected by psoriasis at 12 weeks (Day 84) relative to baseline. BSA was assessed by percentage of sites affected per body segment (head, trunk, and limbs). Investigators were instructed to use the "rule of palm" to estimate lesional skin BSA (1% BSA = palm to first interphalangeal joint). | ITT population. N's reflect patients who received at least one dose of study drug or placebo in the double-blind treatment period. | Posted | Mean | Standard Deviation | Pecentage of BSA | Week 12 |
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|
|
| Secondary | Mean Change in Percentage of Whole Body (Including Scalp) BSA Affected by Psoriasis at 24 Weeks | Mean change in percentage of whole body (including scalp) BSA affected by psoriasis at 24 weeks (Day 168) relative to baseline. BSA was assessed by percentage of sites affected per body segment (head, trunk, and limbs). Investigators were instructed to use the "rule of palm" to estimate lesional skin BSA (1% BSA = palm to first interphalangeal joint). | ITT population. N's reflect patients who received at least one dose of study drug in the open-label period. | Posted | Mean | Standard Deviation | Percentage of BSA | Week 24 |
|
|
|
| 1 |
| 27 |
| 11 |
| 27 |
| EG001 | Efalizumab: Double-Blind Period | All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24). | 1 | 62 | 32 | 55 |
| EG002 | Placebo: Open-Label Period | 0 | 22 | 11 | 22 |
| EG003 | Efalizumab: Open-Label Period | 1 | 55 | 22 | 55 |
| EG004 | Placebo: Follow-Up Period | 0 | 18 | 3 | 18 |
| EG005 | Efalizumab: Follow-Up Period | 2 | 48 | 15 | 48 |
| Abdominal pain | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Ear discomfort | Ear and labyrinth disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Feeling hot | General disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Injection site hematoma | General disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Cyst rupture | General disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Conjunctivitis bacterial | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
|
| Gastroenteritis bacterial | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
|
| Cat scratch disease | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
|
| Fungal infection | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
|
| Localised infection | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
|
| Bacteremia | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
|
| Impetigo | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
|
| Tinea infection | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
|
| Joint sprain | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
|
| Sunburn | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
|
| Back injury | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
|
| Full blood count abnormal | Investigations | MedDRA (11.0) | Non-systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA (11.0) | Non-systematic Assessment |
|
| Colonoscopy | Investigations | MedDRA (11.0) | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (11.0) | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA (11.0) | Non-systematic Assessment |
|
| Blood potassium decreased | Investigations | MedDRA (11.0) | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Hypercholesterolemia | Metabolism and nutrition disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Polyarthritis | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Psoriatic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Sinus headache | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Menorrhagia | Reproductive system and breast disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Diaphragmatic hernia | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Guttate psoriasis | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Rosacea | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Nephrolithiasis | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.