Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003817-16 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a Phase 3, randomized, controlled, single-blind, multicenter, parallel-arm trial to assess the safety and efficacy of Pergoveris® (recombinant human follicle stimulating hormone [r-hFSH]/recombinant human luteinising hormone [r-hLH]) and GONAL-f® for multifollicular development as part of an assisted reproductive technology (ART) treatment cycle in poor ovarian responders, as aligned with the 2011 Consensus Meeting of the European Society of Human Reproduction and Embryology (ESHRE) criteria.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pergoveris® | Experimental |
| |
| GONAL-f® | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pergoveris® | Drug | Pergoveris (follitropin alfa and lutropin alfa) was administered subcutaneously once daily with a starting dose of 300 International Unit (IU) recombinant human follicular stimulating hormone (rhFSH)/ 150 IU recombinant human luteinizing hormone (rhLH) after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 millimeter (mm); 250 microgram (mcg) of r-hCG (Ovidrel) was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments while maintaining the 2:1 ratio of r hFSH to r-hLH in the Pergoveris group based on the subject's response per site standard clinical practice. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Oocytes Retrieved | Mean number of oocytes retrieved on the day of ovum pick up (OPU) was calculated. Oocyte retrieval was a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body. | At approximately 34 to 38 hours after r-hCG administration (Day 113) |
| Measure | Description | Time Frame |
|---|---|---|
| Ongoing Pregnancy Rate | Ongoing pregnancy rate was defined as the percentage of subjects with a ultrasound confirmation of at least one viable fetus (positive fetal heart beat). | 70 days after embryo transfer (Day 185) |
| Live Birth Rate |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Please contact the Merck KGaA Communication Center | Darmstadt | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28137754 | Result | Humaidan P, Chin W, Rogoff D, D'Hooghe T, Longobardi S, Hubbard J, Schertz J; ESPART Study Investigatorsdouble dagger. Efficacy and safety of follitropin alfa/lutropin alfa in ART: a randomized controlled trial in poor ovarian responders. Hum Reprod. 2017 Mar 1;32(3):544-555. doi: 10.1093/humrep/dew360. | |
| 26141305 | Derived |
Not provided
Not provided
Not provided
The study was conducted at 101 sites in 15 countries.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Pergoveris | Pergoveris (follitropin alfa and lutropin alfa) was administered subcutaneously once daily with a starting dose of 300 International Unit (IU) recombinant human follicular stimulating hormone (rhFSH)/ 150 IU recombinant human luteinizing hormone (rhLH) after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 millimeter (mm); 250 microgram (mcg) of recombinant human chorionic gonadotrophin (r-hCG) (Ovidrel) was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments while maintaining the 2:1 ratio of r hFSH to r-hLH in the Pergoveris group based on the subject's response per site standard clinical practice. |
| FG001 | GONAL-f | GONAL-f (r-hFSH) was self-administered subcutaneously once daily at a starting dose of 300 IU after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments based on the subject's response per site standard clinical practice. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All Randomized Subjects Set included all subjects who were randomized.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pergoveris | Pergoveris (follitropin alfa and lutropin alfa) was administered subcutaneously once daily with a starting dose of 300 IU rhFSH/150 IU rhLH after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments while maintaining the 2:1 ratio of r hFSH to r-hLH in the Pergoveris group based on the subject's response per site standard clinical practice. |
| 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 | Number of Oocytes Retrieved | Mean number of oocytes retrieved on the day of ovum pick up (OPU) was calculated. Oocyte retrieval was a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body. | Intent-to-treat (ITT) analysis set included all subjects randomized who received at least 1 dose of GONAL-f or Pergoveris. | Posted | Mean | Standard Deviation | oocytes | At approximately 34 to 38 hours after r-hCG administration (Day 113) |
|
Baseline up to 180 days after ongoing pregnancy (maximum up to 365 days)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pergoveris | Pergoveris (follitropin alfa and lutropin alfa) was administered subcutaneously once daily with a starting dose of 300 IU rhFSH/150 IU rhLH after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments while maintaining the 2:1 ratio of r hFSH to r-hLH in the Pergoveris group based on the subject's response per site standard clinical practice. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abortion missed | Pregnancy, puerperium and perinatal conditions | MedDRA (18.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia of pregnancy | Blood and lymphatic system disorders | MedDRA (18.0) | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Merck KGaA Communication Center | Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany | +49-6151-72-5200 | service@merckgroup.com |
Not provided
| ID | Term |
|---|---|
| D007246 | Infertility |
| D006379 | Helping Behavior |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012919 | Social Behavior |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| C551396 | pergoveris |
| C571801 | follitropin alfa |
| D006063 | Chorionic Gonadotropin |
| C412828 | Ovidrel |
| ID | Term |
|---|---|
| D006062 | Gonadotropins |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| GONAL-f® | Drug | GONAL-f (r-hFSH) was self-administered subcutaneously once daily at a starting dose of 300 IU after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments based on the subject's response per site standard clinical practice. |
|
|
| Recombinant human chorionic gonadotrophin (r-hCG) | Drug | On r-hCG day, 250 mcg of r-hCG was administered once subcutaneously |
|
|
Live birth rate was defined as the percentage of subjects with at least one live-born neonate.
| Approximately 180 days following ongoing pregnancy determination (Day 365) |
| Embryo Implantation Rate | Embryo implantation rate was measured as the number of gestational sacs observed divided by the number of embryos transferred multiplied by 100. | 35-42 days post r-hCG administration (Day 154) |
| Clinical Pregnancy Rate | Clinical pregnancy rate defined as the percentage of subjects with a ultrasound confirmation of a gestational sac, with or without fetal heart activity. | 35-42 days post r-hCG administration (Day 154) |
| Biochemical Pregnancy Rate | Biochemical pregnancy rate was defined as the percentage of subjects with a positive beta-hCG result from the serum pregnancy test. | 15 to 20 days post r-hCG administration (Day 132) |
| Humaidan P, Schertz J, Fischer R. Efficacy and Safety of Pergoveris in Assisted Reproductive Technology--ESPART: rationale and design of a randomised controlled trial in poor ovarian responders undergoing IVF/ICSI treatment. BMJ Open. 2015 Jul 3;5(7):e008297. doi: 10.1136/bmjopen-2015-008297. |
| Protocol Violation |
|
| Spontaneous pregnancy |
|
| Lack of ovarian response to stimulation |
|
| No oocytes retrieved |
|
| No fertilization |
|
| Intention to freeze all embryos |
|
| All embryos discarded |
|
| Other |
|
| BG001 | GONAL-f | GONAL-f (r-hFSH) was self-administered subcutaneously once daily at a starting dose of 300 IU after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments based on the subject's response per site standard clinical practice. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | GONAL-f | GONAL-f (r-hFSH) was self-administered subcutaneously once daily at a starting dose of 300 IU after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments based on the subject's response per site standard clinical practice. |
|
|
|
| Secondary | Ongoing Pregnancy Rate | Ongoing pregnancy rate was defined as the percentage of subjects with a ultrasound confirmation of at least one viable fetus (positive fetal heart beat). | Modified intent-to-treat (MITT) analysis set included all randomized subjects who received at least 1 dose of GONAL-f or Pergoveris and did not have spontaneous pregnancy or death at approximately 34-38 hours after rhCG administration. | Posted | Number | percentage of subjects | 70 days after embryo transfer (Day 185) |
|
|
|
| Secondary | Live Birth Rate | Live birth rate was defined as the percentage of subjects with at least one live-born neonate. | MITT analysis set included all randomized subjects who received at least 1 dose of GONAL-f or Pergoveris and did not have spontaneous pregnancy or death at approximately 34-38 hours after rhCG administration. | Posted | Number | percentage of subjects | Approximately 180 days following ongoing pregnancy determination (Day 365) |
|
|
|
| Secondary | Embryo Implantation Rate | Embryo implantation rate was measured as the number of gestational sacs observed divided by the number of embryos transferred multiplied by 100. | MITT analysis set included all randomized subjects who received at least 1 dose of GONAL-f or Pergoveris and did not have spontaneous pregnancy or death at approximately 34-38 hours after rhCG administration. Here "Number of subjects analyzed" signifies those subjects who were evaluable for this outcome measure. | Posted | Number | percent sacs per embryo | 35-42 days post r-hCG administration (Day 154) |
|
|
|
| Secondary | Clinical Pregnancy Rate | Clinical pregnancy rate defined as the percentage of subjects with a ultrasound confirmation of a gestational sac, with or without fetal heart activity. | MITT analysis set included all randomized subjects who received at least 1 dose of GONAL-f or Pergoveris and did not have spontaneous pregnancy or death at approximately 34-38 hours after rhCG administration. | Posted | Number | percentage of subjects | 35-42 days post r-hCG administration (Day 154) |
|
|
|
| Secondary | Biochemical Pregnancy Rate | Biochemical pregnancy rate was defined as the percentage of subjects with a positive beta-hCG result from the serum pregnancy test. | MITT Analysis Set included all randomized subjects who received at least 1 dose of GONAL-f or Pergoveris and did not have spontaneous pregnancy or death at approximately 34-38 hours after rhCG administration. | Posted | Number | percentage of subjects | 15 to 20 days post r-hCG administration (Day 132) |
|
|
|
| 8 |
| 462 |
| 111 |
| 462 |
| EG001 | GONAL-f | GONAL-f (r-hFSH) was self-administered subcutaneously once daily at a starting dose of 300 IU after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments based on the subject's response per site standard clinical practice. | 17 | 477 | 151 | 477 |
| Abortion | Pregnancy, puerperium and perinatal conditions | MedDRA (18.0) | Non-systematic Assessment |
|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA (18.0) | Non-systematic Assessment |
|
| Premature labour | Pregnancy, puerperium and perinatal conditions | MedDRA (18.0) | Non-systematic Assessment |
|
| Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (18.0) | Non-systematic Assessment |
|
| Foetal death | Pregnancy, puerperium and perinatal conditions | MedDRA (18.0) | Non-systematic Assessment |
|
| Hyperemesis gravidarum | Pregnancy, puerperium and perinatal conditions | MedDRA (18.0) | Non-systematic Assessment |
|
| Imminent abortion | Pregnancy, puerperium and perinatal conditions | MedDRA (18.0) | Non-systematic Assessment |
|
| Premature baby | Pregnancy, puerperium and perinatal conditions | MedDRA (18.0) | Non-systematic Assessment |
|
| Premature delivery | Pregnancy, puerperium and perinatal conditions | MedDRA (18.0) | Non-systematic Assessment |
|
| Threatened labour | Pregnancy, puerperium and perinatal conditions | MedDRA (18.0) | Non-systematic Assessment |
|
| Ovarian cyst | Reproductive system and breast disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Ovarian cyst ruptured | Reproductive system and breast disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Ovarian haemorrhage | Reproductive system and breast disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Ovarian rupture | Reproductive system and breast disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Fallot's tetralogy | Congenital, familial and genetic disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Trisomy 21 | Congenital, familial and genetic disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Ventricular extrasystoles | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Lymph node pain | Blood and lymphatic system disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Ear swelling | Ear and labyrinth disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Photophobia | Eye disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Abdominal rigidity | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Abdominal tenderness | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Anal fissure | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Crying | General disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Hyperthermia | General disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Injection site haematoma | General disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Injection site pain | General disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Food allergy | Immune system disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Allergy to arthropod bite | Immune system disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Sinusitis bacterial | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Bacterial disease carrier | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Genital herpes | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Vaginal infection | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Vulvovaginal candidiasis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
|
| Animal bite | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
|
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
|
| Body temperature increased | Investigations | MedDRA (18.0) | Non-systematic Assessment |
|
| Weight increased | Investigations | MedDRA (18.0) | Non-systematic Assessment |
|
| Menstruation normal | Investigations | MedDRA (18.0) | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA (18.0) | Non-systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA (18.0) | Non-systematic Assessment |
|
| Blood urine present | Investigations | MedDRA (18.0) | Non-systematic Assessment |
|
| Nitrite urine present | Investigations | MedDRA (18.0) | Non-systematic Assessment |
|
| Urine ketone body | Investigations | MedDRA (18.0) | Non-systematic Assessment |
|
| Increased appetite | Metabolism and nutrition disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Fluid retention | Metabolism and nutrition disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Head discomfort | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Disturbance in attention | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Restless legs syndrome | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA (18.0) | Non-systematic Assessment |
|
| Abortion missed | Pregnancy, puerperium and perinatal conditions | MedDRA (18.0) | Non-systematic Assessment |
|
| Abortion | Pregnancy, puerperium and perinatal conditions | MedDRA (18.0) | Non-systematic Assessment |
|
| Foetal death | Pregnancy, puerperium and perinatal conditions | MedDRA (18.0) | Non-systematic Assessment |
|
| Placenta praevia | Pregnancy, puerperium and perinatal conditions | MedDRA (18.0) | Non-systematic Assessment |
|
| Vomiting in pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (18.0) | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Mood swings | Psychiatric disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Nervousness | Psychiatric disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Depressive symptom | Psychiatric disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Affective disorder | Psychiatric disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Depressed mood | Psychiatric disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Irritability | Psychiatric disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Libido increased | Psychiatric disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Tearfulness | Psychiatric disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Leukocyturia | Renal and urinary disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Cystitis noninfective | Renal and urinary disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Urethral pain | Renal and urinary disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Breast tenderness | Reproductive system and breast disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Adnexa uteri pain | Reproductive system and breast disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Dyspareunia | Reproductive system and breast disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Menstruation irregular | Reproductive system and breast disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Metrorrhagia | Reproductive system and breast disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Ovarian cyst | Reproductive system and breast disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Uterine polyp | Reproductive system and breast disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Vulvovaginal dryness | Reproductive system and breast disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Vulvovaginal pruritus | Reproductive system and breast disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Breast mass | Reproductive system and breast disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Nipple disorder | Reproductive system and breast disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Pelvic pain | Reproductive system and breast disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Premenstrual pain | Reproductive system and breast disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Vaginal inflammation | Reproductive system and breast disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Vulvovaginal burning sensation | Reproductive system and breast disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Vulvovaginal discomfort | Reproductive system and breast disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Papule | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Pityriasis rosea | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Skin burning sensation | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Solar dermatitis | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Abortion induced | Surgical and medical procedures | MedDRA (18.0) | Non-systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Circulatory collapse | Vascular disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Venous thrombosis | Vascular disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Breast pain | Reproductive system and breast disorders | MedDRA (18.0) | Non-systematic Assessment |
|
Not provided
Not provided
| D010926 | Placental Hormones |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011257 | Pregnancy Proteins |
| D011506 | Proteins |