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| ID | Type | Description | Link |
|---|---|---|---|
| CTR20140698 | Other Identifier | www.ChinaDrugTrials.org.cn |
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The purpose is to compare the efficacy and safety of lanreotide autogel® 60mg, 90mg or 120mg with lanreotide 40mg PR in subjects with active acromegaly.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lanreotide Autogel® 60mg, 90mg and 120mg | Experimental | Lanreotide Autogel 90mg from day 1 to week 13, 1 injection every 4 weeks (4 in total), titrated to 60mg, 90mg, or 120mg at week 17, then from week 17 to week 29 each group receives 1 injection every 4 weeks (4 in total/group). |
|
| Lanreotide 40mg PR (Lanreotide Acetate for Injection ) | Active Comparator | Lanreotide PR 40mg from day 1 to week 15, 1 injection every 10 days, then at dose titration (week 16) injection frequency will either remain at 10 days or increase to 14 days or decrease to 7 days up until week 30 or 31. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lanreotide Autogel® | Drug | Lanreotide Autogel 60mg, 90mg, and 120mg, pre-filled syringe, deep subcutaneous injection (provided as a supersaturated solution of lanreotide acetate). |
| Measure | Description | Time Frame |
|---|---|---|
| Standardised Mean Change From Baseline in Age-adjusted IGF-1 Levels at the EOST/EW Visit | The standardised mean change from Baseline in age-adjusted log-transformed IGF-1 standard deviation score (SDS) at EOST/EW is presented for subjects treated with both lanreotide Autogel and lanreotide PR. Back-transformed results are presented in addition to the results without back-transformation. For each subject the IGF-1 SDS value was calculated based on the z-score derivation: IGF-1 SDS = (IGF-1 - mean)/ standard deviation (SD), with mean and SD derived from the upper limit of normal (ULN) and lower limit of normal (LLN) margins for each age category. ULN = Mean + 2 SD; LLN = Mean - 2 SD. The SDS indicates the number of standard deviations away from the mean. A SDS of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. A negative change in the SDS indicates a decrease in the mean age-adjusted IGF-1 values. | Baseline to EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Normal Age-adjusted IGF-1 Levels at the EOST/EW Visit | The percentage of subjects with normal age-adjusted IGF-1 levels at the EOST/EW Visit is presented for subjects treated with Lanreotide Autogel and Lanreotide PR. At baseline, all subjects had abnormal IGF-1 levels as per protocol entry criteria. | Baseline to EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group). |
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Inclusion Criteria:
Subject has active acromegaly defined as elevated GH and IGF-1 levels (measured at a central laboratory) as outlined below:
The subject has undergone surgical removal of an adenoma for acromegaly at least 3 months prior to Screening, or is likely to require pituitary surgery in the future but not before completing at least 32 weeks of study treatment plus an additional follow up of 8 weeks for subjects taking part in the pharmacokinetics (PK) extension, or for whom pituitary surgery is not an option (due to contraindications, refusal etc.) and is therefore never likely to undergo pituitary surgery.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | 100730 | China | |||
| West China Hospital, Sichuan University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32366244 | Derived | An Z, Lei T, Duan L, Hu P, Gou Z, Zhang L, Durand-Gasselin L, Wang N, Wang Y, Gu F; LANTERN study investigators. Efficacy and safety of lanreotide autogel compared with lanreotide 40 mg prolonged release in Chinese patients with active acromegaly: results from a phase 3, prospective, randomized, and open-label study (LANTERN). BMC Endocr Disord. 2020 May 4;20(1):57. doi: 10.1186/s12902-020-0524-7. |
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170 subjects were screened and 128 eligible subjects were stratified according to surgical history (previous pituitary surgery or no previous pituitary surgery) and randomised in a 1:1 ratio to receive lanreotide Autogel or lanreotide prolonged release (PR). All randomised subjects were treated.
Adult subjects with active acromegaly, defined as elevated Insulin-like Growth Factor 1 (IGF-1) and Growth Hormone (GH) levels, were recruited into 10 study sites in China.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lanreotide Autogel | Subjects were randomised to receive lanreotide Autogel. Lanreotide Autogel was administered subcutaneously (s.c.) at a fixed dose of 90 milligrams (mg) every 4 weeks from Day 1, Week 1 to Week 17. At Week 17 the dose was continued at 90 mg or titrated to 60 mg or 120 mg, administered every 4 weeks according to the individual subject's response as determined by the mean value of the GH cycles and IGF-1 measured at the previous Week 13 Visit. The last dose of lanreotide Autogel was given at Week 29, followed by End of Study Treatment (EOST) / Early Withdrawal (EW) Visit at Week 33. |
| FG001 | Lanreotide PR | Subjects were randomised to receive lanreotide PR. Lanreotide PR was administered intramuscularly (i.m.) every 10 days from Day 1, Week 1 up to Week 16. At Week 16 the injection interval was maintained at 10 days or was adjusted to 7 or 14 days according to the individual subject's response as determined by the mean value of GH cycle and IGF-1 measured at the previous Week 13 Visit. The last dose of lanreotide PR was administered at Week 31. The EOST/EW Visit was at Week 32. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline characteristics are presented for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
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| ID | Title | Description |
|---|---|---|
| BG000 | Lanreotide Autogel | Subjects were randomised to receive lanreotide Autogel. Lanreotide Autogel was administered s.c. at a fixed dose of 90 mg every 4 weeks from Day 1, Week 1 to Week 17. At Week 17 the dose was continued at 90 mg or titrated to 60 mg or 120 mg every 4 weeks according to the individual subject's response as determined by the mean value of the GH cycles and IGF-1 measured at the previous Week 13 Visit. The last dose of lanreotide Autogel was given at Week 29, followed by EOST/EW Visit at Week 33. |
| 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 | Standardised Mean Change From Baseline in Age-adjusted IGF-1 Levels at the EOST/EW Visit | The standardised mean change from Baseline in age-adjusted log-transformed IGF-1 standard deviation score (SDS) at EOST/EW is presented for subjects treated with both lanreotide Autogel and lanreotide PR. Back-transformed results are presented in addition to the results without back-transformation. For each subject the IGF-1 SDS value was calculated based on the z-score derivation: IGF-1 SDS = (IGF-1 - mean)/ standard deviation (SD), with mean and SD derived from the upper limit of normal (ULN) and lower limit of normal (LLN) margins for each age category. ULN = Mean + 2 SD; LLN = Mean - 2 SD. The SDS indicates the number of standard deviations away from the mean. A SDS of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. A negative change in the SDS indicates a decrease in the mean age-adjusted IGF-1 values. | The Per Protocol population consisted of all subjects who were randomised and treated with at least one baseline and at least one postbaseline assessment of the primary efficacy parameter and for whom no major protocol deviations occurred with impact on efficacy assessment. | Posted | Least Squares Mean | Standard Error | SDS | Baseline to EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group). |
Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
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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 | Lanreotide Autogel | Subjects were randomised to receive lanreotide Autogel. Lanreotide Autogel was administered s.c. at a fixed dose of 90 mg every 4 weeks from Day 1, Week 1 to Week 17. At Week 17 the dose was continued at 90 mg or titrated to 60 mg or 120 mg every 4 weeks according to the individual subject's response as determined by the mean value of the GH cycles and IGF-1 measured at the previous Week 13 Visit. The last dose of lanreotide Autogel was given at Week 29, followed by EOST/EW Visit at Week 33. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pituitary tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director, Oncology | Ipsen | clinical.trials@ipsen.com |
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| ID | Term |
|---|---|
| D000172 | Acromegaly |
| ID | Term |
|---|---|
| D001849 | Bone Diseases, Endocrine |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006964 | Hyperpituitarism |
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| ID | Term |
|---|---|
| C060347 | lanreotide |
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| Lanreotide Acetate | Drug | Lanreotide PR 40mg white freeze-drying cake, 40mg/vial, deep subcutaneous injection (provided as a sterile injectable lyophilisate of lanreotide acetate). |
|
| Percentage of Subjects With GH ≤2.5 Micrograms Per Litre (mcg/L) at the EOST/EW Visit | The percentage of subjects with GH ≤2.5 mcg/L at the EOST/EW Visit is presented for subjects treated with lanreotide Autogel and lanreotide PR. At baseline, all subjects had GH levels >2.5 mcg/L as per protocol entry criteria. | Baseline to EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group). |
| The Percentage of Subjects With GH ≤1 mcg/L at the EOST/EW Visit | The percentage of subjects with GH ≤1 mcg/L at the EOST/EW Visit is presented for subjects treated with lanreotide Autogel and lanreotide PR. At baseline, all subjects had GH levels >2.5 mcg/L as per protocol entry criteria. | Baseline to EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group). |
| Percentage of Subjects With Normal Age-adjusted IGF-1 Levels and Who Have GH Levels >1 mcg/L and ≤2.5 mcg/L at the EOST/EW Visit | The percentage of subjects with normal age-adjusted IGF-1 levels and who have GH levels >1 mcg/L but ≤2.5 mcg/L at the EOST/EW Visit is presented for subjects treated with lanreotide Autogel and lanreotide PR. The calculation of percentages was based on the overall ITT population. At baseline, all subjects had abnormal IGF-1 levels and GH levels >2.5 mcg/L as per protocol entry criteria. | Baseline to EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group). |
| Mean Change From Baseline in GH Values at the EOST/EW Visit | The mean change from baseline in GH values at the EOST/EW Visit is presented for subjects treated with lanreotide Autogel and lanreotide PR. | Baseline to EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group). |
| Percentage of Subjects With at Least 20% Reduction in Tumour Volume at EOST/EW Visit Compared to Baseline | The percentage of subjects with at least a 20% reduction in the solid component of the tumour volume at the EOST/EW Visit compared to baseline is presented for the subgroup of subjects who had solid tumours at baseline. The tumour volume was measured by Magnetic Resonance Imaging (MRI) at Screening and at the EOST/EW Visit, and then assessed by two independent blinded readers. | Baseline to EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group). |
| Median Percentage Change From Baseline in Tumour Volume at the EOST/EW Visit | The median percentage change in the solid component of the tumour volume from baseline to the EOST/EW Visit is presented. The tumour volume was measured by MRI at Screening and at the EOST/EW Visit, and then assessed by two independent blinded readers. | Baseline to EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group). |
| Percentage of Subjects With at Least One Symptom of Acromegaly at Week 13 and at the EOST/EW Visit Compared to Baseline | The percentage of subjects with at least one symptom of acromegaly at Week 13 and at the EOST/EW Visit compared with baseline is presented for subjects treated with lanreotide Autogel and lanreotide PR. The symptoms of acromegaly monitored included: headache, excessive perspiration, fatigue, soft tissue swelling and arthralgia. | Baseline, Week 13 Visit and EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group). |
| Chengdu |
| 610041 |
| China |
| Fujian Provincial Hospital | Fuzhou | 350004 | China |
| The First Affiliated Hospital, Sun Yat-sen University | Guangzhou | 510080 | China |
| Affiliate Hospital of Guiyang Medical College | Guizhou | 550004 | China |
| Jiangsu Provincial People's Hospital | Nanjing | 210029 | China |
| Huashan Hospital Fudan University | Shanghai | 200040 | China |
| The Second Hospital of Hebei Medical University | Shijiazhuang | 050000 | China |
| Tianjin Medical University General Hospital | Tianjin | 300052 | China |
| Tongji Medical College Huazhong University of Science & Technology | Wuhan | 430030 | China |
| Adverse Event |
|
| Missed study visit |
|
| BG001 | Lanreotide PR | Subjects were randomised to receive lanreotide PR. Lanreotide PR was administered i.m. every 10 days from Day 1, Week 1 up to Week 16. At Week 16 the injection interval was maintained at 10 days or was adjusted to 7 or 14 days according to the individual subject's response as determined by the mean value of GH cycle and IGF-1 measured at the previous visit at Week 13. The last dose of lanreotide PR was administered at Week 31. The EOST/EW Visit was at Week 32. |
| BG002 | Total Title |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
|
|
| Secondary | Percentage of Subjects With Normal Age-adjusted IGF-1 Levels at the EOST/EW Visit | The percentage of subjects with normal age-adjusted IGF-1 levels at the EOST/EW Visit is presented for subjects treated with Lanreotide Autogel and Lanreotide PR. At baseline, all subjects had abnormal IGF-1 levels as per protocol entry criteria. | The Intention-To-Treat (ITT) population consisted of all randomised and treated subjects who had at least one baseline and at least one postbaseline assessment of the primary efficacy parameter. The ITT population was analysed using subjects as randomised. | Posted | Number | Percentage of Subjects | Baseline to EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group). |
|
|
|
|
| Secondary | Percentage of Subjects With GH ≤2.5 Micrograms Per Litre (mcg/L) at the EOST/EW Visit | The percentage of subjects with GH ≤2.5 mcg/L at the EOST/EW Visit is presented for subjects treated with lanreotide Autogel and lanreotide PR. At baseline, all subjects had GH levels >2.5 mcg/L as per protocol entry criteria. | The ITT population consisted of all randomised and treated subjects who had at least one baseline and at least one postbaseline assessment of the primary efficacy parameter. The ITT population was analysed using subjects as randomised. | Posted | Number | Percentage of Subjects | Baseline to EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group). |
|
|
|
|
| Secondary | The Percentage of Subjects With GH ≤1 mcg/L at the EOST/EW Visit | The percentage of subjects with GH ≤1 mcg/L at the EOST/EW Visit is presented for subjects treated with lanreotide Autogel and lanreotide PR. At baseline, all subjects had GH levels >2.5 mcg/L as per protocol entry criteria. | The ITT population consisted of all randomised and treated subjects who had at least one baseline and at least one postbaseline assessment of the primary efficacy parameter. The ITT population was analysed using subjects as randomised. | Posted | Number | Percentage of Subjects | Baseline to EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group). |
|
|
|
|
| Secondary | Percentage of Subjects With Normal Age-adjusted IGF-1 Levels and Who Have GH Levels >1 mcg/L and ≤2.5 mcg/L at the EOST/EW Visit | The percentage of subjects with normal age-adjusted IGF-1 levels and who have GH levels >1 mcg/L but ≤2.5 mcg/L at the EOST/EW Visit is presented for subjects treated with lanreotide Autogel and lanreotide PR. The calculation of percentages was based on the overall ITT population. At baseline, all subjects had abnormal IGF-1 levels and GH levels >2.5 mcg/L as per protocol entry criteria. | The ITT population consisted of all randomised and treated subjects who had at least one baseline and at least one postbaseline assessment of the primary efficacy parameter. The ITT population was analysed using subjects as randomised. | Posted | Number | Percentage of Subjects | Baseline to EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group). |
|
|
|
|
| Secondary | Mean Change From Baseline in GH Values at the EOST/EW Visit | The mean change from baseline in GH values at the EOST/EW Visit is presented for subjects treated with lanreotide Autogel and lanreotide PR. | The ITT population consisted of all randomised and treated subjects who had at least one baseline and at least one postbaseline assessment of the primary efficacy parameter. The ITT population was analysed using subjects as randomised. Subjects with data available at time of analysis are presented. | Posted | Mean | Standard Deviation | mcg/L | Baseline to EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group). |
|
|
|
|
| Secondary | Percentage of Subjects With at Least 20% Reduction in Tumour Volume at EOST/EW Visit Compared to Baseline | The percentage of subjects with at least a 20% reduction in the solid component of the tumour volume at the EOST/EW Visit compared to baseline is presented for the subgroup of subjects who had solid tumours at baseline. The tumour volume was measured by Magnetic Resonance Imaging (MRI) at Screening and at the EOST/EW Visit, and then assessed by two independent blinded readers. | The ITT population consisted of all randomised and treated subjects who had at least one baseline and at least one postbaseline assessment of the primary efficacy parameter. The ITT population was analysed using subjects as randomised. Data is presented for the subgroup of subjects in the ITT population who had solid tumours at baseline. | Posted | Number | Percentage of Subjects | Baseline to EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group). |
|
|
|
|
| Secondary | Median Percentage Change From Baseline in Tumour Volume at the EOST/EW Visit | The median percentage change in the solid component of the tumour volume from baseline to the EOST/EW Visit is presented. The tumour volume was measured by MRI at Screening and at the EOST/EW Visit, and then assessed by two independent blinded readers. | The ITT population consisted of all randomised and treated subjects who had at least one baseline and at least one postbaseline assessment of the primary efficacy parameter. The ITT population was analysed using subjects as randomised. Data is presented for the subgroup of subjects in the ITT population who had solid tumours at baseline. | Posted | Median | Full Range | Percentage change in tumour volume | Baseline to EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group). |
|
|
|
| Secondary | Percentage of Subjects With at Least One Symptom of Acromegaly at Week 13 and at the EOST/EW Visit Compared to Baseline | The percentage of subjects with at least one symptom of acromegaly at Week 13 and at the EOST/EW Visit compared with baseline is presented for subjects treated with lanreotide Autogel and lanreotide PR. The symptoms of acromegaly monitored included: headache, excessive perspiration, fatigue, soft tissue swelling and arthralgia. | The ITT population consisted of all randomised and treated subjects who had at least one baseline and at least one postbaseline assessment of the primary efficacy parameter. The ITT population was analysed using subjects as randomised. | Posted | Number | Percentage of Subjects | Baseline, Week 13 Visit and EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group). |
|
|
|
| 0 |
| 64 |
| 1 |
| 64 |
| 59 |
| 64 |
| EG001 | Lanreotide PR | Subjects were randomised to receive lanreotide PR. Lanreotide PR was administered i.m. every 10 days from Day 1, Week 1 up to Week 16. At Week 16 the injection interval was maintained at 10 days or was adjusted to 7 or 14 days according to the individual subject's response as determined by the mean value of GH cycle and IGF-1 measured at the previous visit at Week 13. The last dose of lanreotide PR was administered at Week 31. The EOST/EW Visit was at Week 32. | 0 | 64 | 2 | 64 | 62 | 64 |
| Gastritis | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Gastrointestinal sounds abnormal | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Gastric dilatation | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Rectal tenesmus | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA (19.0) | Systematic Assessment |
|
| Gallbladder enlargement | Hepatobiliary disorders | MedDRA (19.0) | Systematic Assessment |
|
| Cholestasis | Hepatobiliary disorders | MedDRA (19.0) | Systematic Assessment |
|
| Hepatic cyst | Hepatobiliary disorders | MedDRA (19.0) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA (19.0) | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA (19.0) | Systematic Assessment |
|
| Protein urine present | Investigations | MedDRA (19.0) | Systematic Assessment |
|
| Blood parathyroid hormone increased | Investigations | MedDRA (19.0) | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
|
| Injection site induration | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Renal cyst | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
|
| Thyroid mass | Endocrine disorders | MedDRA (19.0) | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA (19.0) | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
|
Not provided
| D010900 |
| Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |