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| ID | Type | Description | Link |
|---|---|---|---|
| IND # 71,344 | Other Identifier | FDA |
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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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The purpose of this study is to determine whether taking a growth hormone (GH) drug called somatropin causes the intestine of a person with Crohn's Disease (CD) to heal faster when compared to a person with Crohn's Disease that does not receive growth hormone drug.
The optimal treatment goals in childhood CD include: 1) clinical remission in conjunction with mucosal healing and 2) restoration of normal growth and development. Current therapy in most cases includes induction of remission with corticosteroids followed by maintenance of remission with 6-mercaptopurine (6-MP) or mesalamine. With this approach, the goals of achieving mucosal healing with normalization of growth are not achieved in a significant number of children. GH therapy is now used in several chronic childhood diseases which are complicated by growth failure despite adequate GH secretion. These include chronic renal failure (CRF), juvenile rheumatoid arthritis (JRA), and Turner's syndrome. However, despite a comparable frequency and magnitude of permanent growth failure, the efficacy of GH therapy in this respect has not yet been determined in a controlled trial for CD. Moreover, whether GH therapy may also directly reduce disease activity and promote intestinal healing is not known. This represents a significant clinically unmet need in this patient population. Therefore, new therapeutic approaches are needed to both improve final adult height and enhance intestinal mucosal healing in children with CD.
The primary objective of this study is to determine the effect of growth hormone (GH) therapy upon colon mucosal healing in a 12 week randomized trial in children with Crohn's Disease (CD). Children with active CD will be randomized to GH + prednisone (GP) or prednisone alone (P) for a 12 week period. This study also involves a 52 week extension phase where all participants that meet eligibility will be given the opportunity to take or continue taking growth hormone for 52 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Growth Hormone plus cortecosteroid | Experimental | Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily) |
|
| Cortecosteroids alone | Active Comparator | Cortecosteroid therapy as prescribed by the referring gastroenterologist |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| growth hormone | Drug | Nutropin AQ 0.075mg/kg/day subcutaneously daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Crohn's Disease Histologic Index of Severity (CDHIS) | The CDHIS was developed and validated in order to determine the effect of therapies upon histologic disease activity in Crohn's Disease. It has been used to assess mucosal healing in response to infliximab and 6-MP/AZA.It contains eight items which reflect epithelial injury, mucosal inflammation, and the extent of involvement. Scores range from 0-16, with patients with moderate to severely active CD typically having scores of 6-12. It was computed by a GI pathologist. The higher the score indicates worsening of disease, the lowest score is 0 and highest possible is 16 | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Serum IGF-1 (Insulin-like Growth Factor 1)z Score | Elevated serum IGF-1 levels have been implicated in the development of colorectal cancer, both in the general population and in patients with an excess of growth hormone production. The serum IGF-1 levels were monitored to maintain them in the physiologic range during growth hormone therapy to reduce the risk of tumorigenesis. The levels are reported as a z score, a statistical way of standardizing data. The standard deviation is the unit of measurement of the z-score. Each z score corresponds to a point in a normal distribution, describing how much a point deviates from a mean. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lee Denson, M.D. | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
21 subjects enrolled, one withdrew consent prior to randomization.
98 subjects were assessed for eligibility, 76 did not meet inclusion criteria, 21 refused to participate
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| ID | Title | Description |
|---|---|---|
| FG000 | Growth Hormone Plus Corticosteroid (CTX) | Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily) |
| FG001 | Corticosteroid (CTX) | Subjects took corticosteroid as prescribed by their physician |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline (0 Through 12 Weeks) |
| ||||||||||||||||
| Week 12 to Week 24 |
| ||||||||||||||||
| 52 Week Extension Phase |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Growth Hormone Plus Corticosteroid (CTX) | Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily) |
| BG001 | Corticosteroid (CTX) | Subjects took corticosteroid as prescribed by their physician |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Crohn's Disease Histologic Index of Severity (CDHIS) | The CDHIS was developed and validated in order to determine the effect of therapies upon histologic disease activity in Crohn's Disease. It has been used to assess mucosal healing in response to infliximab and 6-MP/AZA.It contains eight items which reflect epithelial injury, mucosal inflammation, and the extent of involvement. Scores range from 0-16, with patients with moderate to severely active CD typically having scores of 6-12. It was computed by a GI pathologist. The higher the score indicates worsening of disease, the lowest score is 0 and highest possible is 16 | Posted | Number | 95% Confidence Interval | scores on a scale | Baseline and 12 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Growth Hormone Plus Corticosteroid (CTX) | Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bruising at injection site | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic Rhinitis | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lee A. Denson | Cincinnati Children's Hospital Medical Center | 513-636-7575 | lee.denson@cchmc.org |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| C536215 | Pediatric Crohn's disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D013006 | Growth Hormone |
| D011241 | Prednisone |
| D019819 | Budesonide |
| ID | Term |
|---|---|
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| cortecosteroid | Drug | As prescribed by the referring gastroenterologist |
|
|
| Baseline, 12 weeks, 24 weeks |
| IMPACT III Score | Health-related quality of life (QOL)was assessed using the IMPACT 111 questionnnaire. It is a self-administered 35 item questionnaire which typically takes 10-15 minutes to complete. Scores range from 0-350, with higher scores reflecting better perceived quality of life. | Baseline, 12 weeks, 24 weeks |
| Pediatric Crohn's Disease Activity Index (PCDAI) | The PCDAI is a previously validated measure of clinical disease activity for children with CD. It contains three self-report items which reflect patient abdominal pain, diarrhea, and general well being; three laboratory values; height and weight velocity; and three physical examination parameters reflecting abdominal tenderness, perirectal disease, and extra-intestinal manifestations. Scores may range from 0-100. Remission is defined as 0-10, mild disease as 10-30, and moderate to severe disease as greater than 30. | Baseline, 12 and 24 weeks |
| Total Corticosteroid Use | The total corticosteroid use over 12 weeks between groups, using the unpaired t test. | 12 weeks |
| Crohn's Disease Endoscopic Index of Severity (CDEIS) | Measure of mucosal disease at baseline and week 12 obtained during colonoscopy. The CDEIS score generally ranges from 0-30. A higher score indicates more severe mucosal inflammation. | Baseline and 12 weeks |
| Height Velocity | Height velocity was computed every 12 weeks up to week 64 and then yearly during the Maintenance study. Since 40 to 80% of children with Crohn's disease have significant growth failure at diagnosis, height velocity is used to track for changes in height. It is calculated by measuring height at two points of time and then dividing the change by the amount of time. | Baseline, week 12, 24 and 48 |
| Fecal Calprotectin | Fecal calprotectin is a previously validated stool marker of intestinal inflammation in Crohn's Disease. | At 24 and 64 weeks |
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Corticosteroid (CTX) |
Subjects took corticosteroid as prescribed by their physician |
|
|
| Secondary | Serum IGF-1 (Insulin-like Growth Factor 1)z Score | Elevated serum IGF-1 levels have been implicated in the development of colorectal cancer, both in the general population and in patients with an excess of growth hormone production. The serum IGF-1 levels were monitored to maintain them in the physiologic range during growth hormone therapy to reduce the risk of tumorigenesis. The levels are reported as a z score, a statistical way of standardizing data. The standard deviation is the unit of measurement of the z-score. Each z score corresponds to a point in a normal distribution, describing how much a point deviates from a mean. | Posted | Mean | Standard Error | Z score | Baseline, 12 weeks, 24 weeks |
|
|
|
| Secondary | IMPACT III Score | Health-related quality of life (QOL)was assessed using the IMPACT 111 questionnnaire. It is a self-administered 35 item questionnaire which typically takes 10-15 minutes to complete. Scores range from 0-350, with higher scores reflecting better perceived quality of life. | Posted | Mean | 95% Confidence Interval | Scores on a scale | Baseline, 12 weeks, 24 weeks |
|
|
|
| Secondary | Pediatric Crohn's Disease Activity Index (PCDAI) | The PCDAI is a previously validated measure of clinical disease activity for children with CD. It contains three self-report items which reflect patient abdominal pain, diarrhea, and general well being; three laboratory values; height and weight velocity; and three physical examination parameters reflecting abdominal tenderness, perirectal disease, and extra-intestinal manifestations. Scores may range from 0-100. Remission is defined as 0-10, mild disease as 10-30, and moderate to severe disease as greater than 30. | Posted | Feb 2011 | Mean | 95% Confidence Interval | Scores on a scale | Baseline, 12 and 24 weeks |
|
|
|
|
| Secondary | Total Corticosteroid Use | The total corticosteroid use over 12 weeks between groups, using the unpaired t test. | Posted | Mean | Standard Error | mg | 12 weeks |
|
|
|
| Secondary | Crohn's Disease Endoscopic Index of Severity (CDEIS) | Measure of mucosal disease at baseline and week 12 obtained during colonoscopy. The CDEIS score generally ranges from 0-30. A higher score indicates more severe mucosal inflammation. | Posted | Mean | 95% Confidence Interval | Scores on a scale | Baseline and 12 weeks |
|
|
|
| Secondary | Height Velocity | Height velocity was computed every 12 weeks up to week 64 and then yearly during the Maintenance study. Since 40 to 80% of children with Crohn's disease have significant growth failure at diagnosis, height velocity is used to track for changes in height. It is calculated by measuring height at two points of time and then dividing the change by the amount of time. | Posted | Mean | Standard Error | cm/year | Baseline, week 12, 24 and 48 |
|
|
|
| Secondary | Fecal Calprotectin | Fecal calprotectin is a previously validated stool marker of intestinal inflammation in Crohn's Disease. | Posted | Mean | 95% Confidence Interval | micrograms per gram (microg/g) | At 24 and 64 weeks |
|
|
|
| 1 |
| 10 |
| 10 |
| 10 |
| EG001 | Corticosteroid (CTX) | Subjects took corticosteroid as recommended by their physician | 0 | 10 | 10 | 10 |
| EG002 | Extension Phase | Eligible subjects from both group A and group B continued on growth hormone in a 52 week extension phase | 2 | 17 | 17 | 17 |
| Abdominal Pain | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pancreatitis | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Lactose intolerant | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
|
| ANC elevated | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Basophils elevated | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Decreased hematocrit | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Eosinophils elevated | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Ferritin decrease | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hematocrit decreased | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hematocrit elevated | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hemoglobin decreased | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Iron level decreased | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Iron level elevated | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Leukocyte count decreased | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Lymphocyte count decreased | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Lymphocytes elevated | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Monocytes elevated | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| RBC decreased | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| RBC elevated | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| RDW elevated | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Sedimentation Rate Elevated | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Segs elevated | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Thrombocytosis | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fatigue | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Increased thirst | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Insomnia | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Weight loss | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Bruising at injection site | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Injection site reaction | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Insect bite | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Milia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Rash acneiform | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Rash desquamating | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Seborrhea | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Skin hypopigmentation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Skin striae | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Cushingoid | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Anal fissure | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Anorexia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dehydration | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Enteritis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fecal urgency | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| hemorrhoids | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hemorrhage nasal | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Lower gastrointestinal hemorrhage | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Colitis, infectious | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Gastric infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Oral thrush infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Skin Infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Vaginal Infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| ALT decreased | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| ALT increased | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| AST increased | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Alkaline phosphate decreased | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Anion gap high | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Anti-mitochondrial antibody | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| BUN | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| BUN decreased | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| BUN elevated | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Bilirubin increased | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Blood bicarbonate decreased | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Blood bicarbonate elevated | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Blood glucose decreased | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Blood glucose increased | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| CRP elevated | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Chloride elevated | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Creatnine decreased | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Creatinine elevated | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyperinsulinemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Serum albumin decreased | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Serum potassium decreased | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Serum potassium increased | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Serum sodium decreased | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Serum triglycerides increased | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Urine calcium decreased | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fracture | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Joint disorder | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Anxiety | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Concussion | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Eye irritation | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Depression | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Abdominal Pain | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Back pain | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Breast pain | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Chest pain | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Headache | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Joint Pain | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Myalgia | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain in extremity | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pharyngolaryngeal pain | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Rectal pain | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Shoulder | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Cough | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Sinus congestion | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dysuria | General disorders | CTCAE (3.0) | Systematic Assessment |
|
Not provided
Not provided
| D007410 | Intestinal Diseases |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| Week 24 |
|
| Week 24 |
|
| Week 24 |
|