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| Name | Class |
|---|---|
| Celgene Corporation | INDUSTRY |
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During the course of HIV infection the number of CD4 cells decreases, resulting in a reduced immunological response and ultimately immune deficiency. Vacc-4x is a peptide-based HIV immunotherapy and the primary objective is to strengthen the immune system's response to HIV p24. By adding Lenalidomide, an immunomodulatory agent, as a supporting drug, it is anticipated that the effect of Vacc-4x might be enhanced.
Human immunodeficiency virus (HIV) infects the CD4 subset of T-cells that are critical for initiating immune responses to infection. The level of CD4 cells in the blood is a marker of a patient's immunological status. The number of CD4 cells decreases in the course of the HIV infection and results in a reduced immunological response and eventually immune deficiency.
Vacc-4x is one of the few peptide-based therapeutic vaccines tested, and consists of four, slightly modified HIV Gag p24 consensus peptides. Vacc-4x was first tested by intradermal injections using GM-CSF as adjuvant. A recent multinational placebo-controlled study found improvement of vaccine-specific T cell immunity and decrease in viral loads (presented at the AIDS vaccine 2011 conference, Bangkok).
Lenalidomide (CC-5013) is a substance in the class of immunomodulatory agents. The lenalidomide mechanism of action includes anti-neoplastic, pro-erythropoietic, and immunomodulatory properties. Lenalidomide inhibits proliferation of certain hematopoietic tumor cells, enhances T cell- and Natural Killer (NK) cell-mediated immunity and increases the number of NK T cells.
The anti-HIV p24 immune response resulting from Vacc-4x immunization could in combination with ART potentially improve immune reconstitution in patients who have not fully regained a healthy CD4 level (> 600 x106/L). Adding the immunomodulatory agent Lenalidomide (CC-5013) to Vacc-4x immunization could enhance the immune response to Vacc-4x and further strengthen immune reconstitution.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: lenalidomide dose escalation | Experimental | All patient receive intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide in a dose escalation (3+3) design. Dose level -1: 2.5 mg Lenalidomide (CC-5013) in the event Dose level 1 is non tolerated dose (NTD) Dose level 1(start): 5 mg Lenalidomide (CC-5013) Dose level 2: 10 mg Lenalidomide (CC-5013) Dose level 3: 25 mg Lenalidomide (CC-5013) |
|
| Part B: lenalidomide | Experimental | Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide (dose determined in Part A) two days prior to and at the day of immunization. |
|
| Part B: lenalidomide placebo | Placebo Comparator | Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide placebo two days prior to and at the day of immunization. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lenalidomide | Drug | In Part A a dose escalation design is used (2,5; 5; 10; 25 mg). Part B will use the dose confirmed by Part A |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A: To Establish Highest Tolerated Dose of Lenalidomide, Dose-Limiting Toxicity | Number of participants in each of the three groups that experienced any dose-limiting toxicity. | 31 days |
| Part A: To Establish Highest Tolerated Dose of Lenalidomide, CD4 Counts Over Time | 31 days | |
| Part B: Change in CD4 Count | Change in CD4 count from baseline to Week 26. | Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Part B: Change in CD8 Count | Change in CD8 count from baseline to week 26. | 26 weeks |
| Part B: Evaluate the Effect on HIV Viral Load | Results BLQ (<20 HIV copies/mL) have been replaced with BLQ/2 = 10 HIV copies/mL while 'not detected' results have been replaced with 0 HIV copies/mL. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kim Krogsgaard | Bionor Pharma ASA, Kronprinsesse Märthas Plass 1, P.O. Box 1477 Vika, NO-0116 Oslo, Norway | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Hamburg-Eppendorf | Hamburg | Free and Hanseatic City of Hamburg | 20246 | Germany | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12487807 | Background | Asjo B, Stavang H, Sorensen B, Baksaas I, Nyhus J, Langeland N. Phase I trial of a therapeutic HIV type 1 vaccine, Vacc-4x, in HIV type 1-infected individuals with or without antiretroviral therapy. AIDS Res Hum Retroviruses. 2002 Dec 10;18(18):1357-65. doi: 10.1089/088922202320935438. | |
| 15353973 | Background |
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Participants have not provided informed consent for their anonymized individual data to be made available beyond that described in the patient information sheet.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A: Lenalidomide 5 mg | Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 5 mg |
| FG001 | Part A: Lenalidomide 10 mg | Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 10 mg |
| FG002 | Part A: Lenalidopmide 25 mg | Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 25 mg |
| FG003 | Part B: Lenalidomide | Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide (dose determined in Part A) two days prior to and at the day of immunization. Lenalidomide: In Part A a dose escalation design is used (2,5; 5; 10; 25 mg). Part B will use the dose confirmed by Part A Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water. rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant |
| FG004 | Part B: Lenalidomide Placebo | Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide placebo two days prior to and at the day of immunization. Lenalidomide placebo: Capsules are identical to the active Lenalidomide capsules used. Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water. rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Part A: Lenalidomide 5 mg | Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 5 mg |
| BG001 | Part A: Lenalidomide 10 mg | Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 10 mg |
| 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 | Part A: To Establish Highest Tolerated Dose of Lenalidomide, Dose-Limiting Toxicity | Number of participants in each of the three groups that experienced any dose-limiting toxicity. | ITT analysis set was used. | Posted | Count of Participants | Participants | 31 days |
|
Adverse events were collected from the time of signing informed consent and until last visit; 31 days in Part A and 26 weeks in Part B. In addition, a 5-year survival follow-up period during which telephone contact from site for all subjects who discontinue treatment at any time will be conducted every 4 months for the first two years and every 6 months thereafter for a minimum of 5 years post-inclusion for survival, cause(s) of death, disease progression and post-treatment therapy(ies).
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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 | Part A: Lenalidomide 5 mg | Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 5 mg |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abscess left upper arm | Infections and infestations | medDRA 15.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | medDRA 15.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maja Sommerfelt | Bionor Pharma ASA | +4723010960 | ms@bionorpharma.com |
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| ID | Term |
|---|---|
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000077269 | Lenalidomide |
| C494182 | Vacc-4x |
| C081222 | sargramostim |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
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|
| Lenalidomide placebo | Drug | Capsules are identical to the active Lenalidomide capsules used. |
|
|
| Vacc-4X | Drug | Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water. |
|
|
| rhuGM-CSF | Drug | Granulocyte macrophage colony stimulating factor as a local adjuvant |
|
|
| 26 weeks |
| Part B: Incidents of Delayed-type Hypersensitivity | Delayed-type hypersensitivity measured by induration and erythema. | 26 weeks |
| Part A and B: Safety and Tolerability | Part A: 31 days and Part B: 26 weeks |
| EIPMED - Gesellschaft fűr epidemiologische und klinische Forschung in der Medizin mbH Rubensstrasse 125 |
| Berlin |
| State of Berlin |
| 12157 |
| Germany |
| Charite Campus, Virchow-Klinikum Medizinische Klinik mit Schwerpunkt Infektiologie Station 59 (Suedring 11) Augustenburger Platz 1 | Berlin | State of Berlin | 13353 | Germany |
| Klinik I für Innere Medizin Klinikum Der Universität zu Köln | Cologne | 50937 | Germany |
| Kran AM, Sorensen B, Nyhus J, Sommerfelt MA, Baksaas I, Bruun JN, Kvale D. HLA- and dose-dependent immunogenicity of a peptide-based HIV-1 immunotherapy candidate (Vacc-4x). AIDS. 2004 Sep 24;18(14):1875-83. doi: 10.1097/00002030-200409240-00003. |
| 15802974 | Background | Kvale D, Kran AM, Sommerfelt MA, Nyhus J, Baksaas I, Bruun JN, Sorensen B. Divergent in vitro and in vivo correlates of HIV-specific T-cell responses during onset of HIV viraemia. AIDS. 2005 Mar 24;19(6):563-7. doi: 10.1097/01.aids.0000163932.76531.c6. |
| 15006729 | Background | Sommerfelt MA, Nyhus J, Sorensen B. Novel peptide-based HIV-1 immunotherapy. Expert Opin Biol Ther. 2004 Mar;4(3):349-61. doi: 10.1517/14712598.4.3.349. |
| BG002 | Part A: Lenalidopmide 25 mg | Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 25 mg |
| BG003 | Part B: Lenalidomide | Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide (dose determined in Part A) two days prior to and at the day of immunization. Lenalidomide: In Part A a dose escalation design is used (2,5; 5; 10; 25 mg). Part B will use the dose confirmed by Part A Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water. rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant |
| BG004 | Part B: Lenalidomide Placebo | Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide placebo two days prior to and at the day of immunization. Lenalidomide placebo: Capsules are identical to the active Lenalidomide capsules used. Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water. rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Gender | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| OG002 |
| Part A: Lenalidopmide 25 mg |
Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 25 mg |
|
|
| Primary | Part A: To Establish Highest Tolerated Dose of Lenalidomide, CD4 Counts Over Time | ITT analysis set was used. | Posted | Mean | Standard Deviation | 10^6 cells/mL | 31 days |
|
|
|
| Primary | Part B: Change in CD4 Count | Change in CD4 count from baseline to Week 26. | Analysis was performed for both the Intent To Treat (ITT) and Per Protocol (PP) analysis set. | Posted | Mean | Standard Deviation | 10^6 cells/L | Week 26 |
|
|
|
| Secondary | Part B: Change in CD8 Count | Change in CD8 count from baseline to week 26. | Not all patients had quantifiable blood samples/counts at all time points | Posted | Mean | Standard Deviation | 10^6 cells/L | 26 weeks |
|
|
|
| Secondary | Part B: Evaluate the Effect on HIV Viral Load | Results BLQ (<20 HIV copies/mL) have been replaced with BLQ/2 = 10 HIV copies/mL while 'not detected' results have been replaced with 0 HIV copies/mL. | ITT analysis set | Posted | Mean | Standard Deviation | Copies/mL | 26 weeks |
|
|
|
| Secondary | Part B: Incidents of Delayed-type Hypersensitivity | Delayed-type hypersensitivity measured by induration and erythema. | The IIT population was used for this outcome measure. Data for one patient was not reported at week 26. | Posted | Count of Participants | Participants | 26 weeks |
|
|
|
| Secondary | Part A and B: Safety and Tolerability | Posted | Number | participants | Part A: 31 days and Part B: 26 weeks |
|
|
|
| 0 |
| 3 |
| 3 |
| 3 |
| EG001 | Part A: Lenalidomide 10 mg | Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 10 mg | 0 | 3 | 2 | 3 |
| EG002 | Part A: Lenalidopmide 25 mg | Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 25 mg | 0 | 6 | 6 | 6 |
| EG003 | Part B: Lenalidomide | Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide (dose determined in Part A) two days prior to and at the day of immunization. Lenalidomide: In Part A a dose escalation design is used (2,5; 5; 10; 25 mg). Part B will use the dose confirmed by Part A Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water. rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant | 1 | 12 | 10 | 12 |
| EG004 | Part B: Lenalidomide Placebo | Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide placebo two days prior to and at the day of immunization. Lenalidomide placebo: Capsules are identical to the active Lenalidomide capsules used. Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water. rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant | 0 | 12 | 9 | 12 |
| Injection site erythema | General disorders | medDRA 15.0 | Systematic Assessment |
|
| Injection site pruritus | General disorders | medDRA 15.0 | Systematic Assessment |
|
| Injection site swelling | General disorders | medDRA 15.0 | Systematic Assessment |
|
| Injection site induration | General disorders | medDRA 15.0 | Systematic Assessment |
|
| Injection site pain | General disorders | medDRA 15.0 | Systematic Assessment |
|
| Injection site warmth | General disorders | medDRA 15.0 | Systematic Assessment |
|
| Application site pruritus | General disorders | medDRA 15.0 | Systematic Assessment |
|
| Application site erythema | General disorders | medDRA 15.0 | Systematic Assessment |
|
| Influenza like illness | General disorders | medDRA 15.0 | Systematic Assessment |
|
| Chest pain | General disorders | medDRA 15.0 | Systematic Assessment |
|
| Asthenia | General disorders | medDRA 15.0 | Systematic Assessment |
|
| Swelling | General disorders | medDRA 15.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | medDRA 15.0 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | medDRA 15.0 | Systematic Assessment |
|
| Abscess limb | Infections and infestations | medDRA 15.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | medDRA 15.0 | Systematic Assessment |
|
| Chlamydial infection | Infections and infestations | medDRA 15.0 | Systematic Assessment |
|
| Folliculitis | Infections and infestations | medDRA 15.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | medDRA 15.0 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | medDRA 15.0 | Systematic Assessment |
|
| Tooth infection | Infections and infestations | medDRA 15.0 | Systematic Assessment |
|
| Sunisitis | Infections and infestations | medDRA 15.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | medDRA 15.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | medDRA 15.0 | Systematic Assessment |
|
| Pruritus generalized | Skin and subcutaneous tissue disorders | medDRA 15.0 | Systematic Assessment |
|
| Angioedema | Skin and subcutaneous tissue disorders | medDRA 15.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | medDRA 15.0 | Systematic Assessment |
|
| Actinic keratosis | Skin and subcutaneous tissue disorders | medDRA 15.0 | Systematic Assessment |
|
| Scab | Skin and subcutaneous tissue disorders | medDRA 15.0 | Systematic Assessment |
|
| Skin lesion | Skin and subcutaneous tissue disorders | medDRA 15.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | medDRA 15.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | medDRA 15.0 | Systematic Assessment |
|
| Abdominnal pain upper | Gastrointestinal disorders | medDRA 15.0 | Systematic Assessment |
|
| Abdominal tenderness | Gastrointestinal disorders | medDRA 15.0 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | medDRA 15.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | medDRA 15.0 | Systematic Assessment |
|
| Autonomic nervous system imbalance | Nervous system disorders | medDRA 15.0 | Systematic Assessment |
|
| Cerebral atrophy | Nervous system disorders | medDRA 15.0 | Systematic Assessment |
|
| Facial paresis | Nervous system disorders | medDRA 15.0 | Systematic Assessment |
|
| Grand mal convultion | Nervous system disorders | medDRA 15.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | medDRA 15.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | medDRA 15.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | medDRA 15.0 | Systematic Assessment |
|
| Groin pain | Musculoskeletal and connective tissue disorders | medDRA 15.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | medDRA 15.0 | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | medDRA 15.0 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | medDRA 15.0 | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | medDRA 15.0 | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | medDRA 15.0 | Systematic Assessment |
|
| Hypogonadism | Endocrine disorders | medDRA 15.0 | Systematic Assessment |
|
| Conjunctivitis allergic | Eye disorders | medDRA 15.0 | Systematic Assessment |
|
| Hypertransaminasaemia | Hepatobiliary disorders | medDRA 15.0 | Systematic Assessment |
|
| Injection related reaction | Injury, poisoning and procedural complications | medDRA 15.0 | Systematic Assessment |
|
| Aggression | Psychiatric disorders | medDRA 15.0 | Systematic Assessment |
|
| Listless | Psychiatric disorders | medDRA 15.0 | Systematic Assessment |
|
| Flushing | Vascular disorders | medDRA 15.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | medDRA 15.0 | Systematic Assessment |
|
The Sponsor (or designee) will prepare a final report on the study. The Investigator may not publish or present any information on this study without the express written approval of the Sponsor. Additionally, the Sponsor, may, for any reason, withhold approval for publication or presentation.
| D009930 |
| Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Week 4 |
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| Week 5 |
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| PP |
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| Week 1 |
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| Week 4 |
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| Week 12 |
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| Week 13 |
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| Week 1 |
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| Week 4 |
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| Week 12 |
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| Week 13 |
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| Week 21 |
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| Week 26 |
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| Week 1, Erythema |
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| Week 26, Induration |
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| Week 26, Erythema |
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| With TESAE |
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| With any AE resultiung in withdrawal |
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| Deaths |
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