10 completed. 10 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 4 | 10 | Completed 10 |
Follow Safety Issues: new trials by email Literature Review of Safety Issues trials Research Report on Safety Issues
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Effectiveness & Safety of Ovine Enoxaparin Sodium to Originator Enoxaparin in Non-ST-Segment Elevation ACS Patients Enoxaparin sodium injection - Safety Issues, Effect of Drug | Phase 4 | Completed | PT Bio Farma | 220 | 2023-06-01 | 2025-06-06 |
| Safety of Ibuprofen After Major Orthopaedic Surgeries Ibuprofen, Placebo - Pain, Acute, Hip Arthropathy | Phase 4 | Completed | Naestved Hospital | 2904 | 2023-04-17 | 2025-12-19 |
| Post Marketing Surveillance of Diphtheria Antitoxin (DAT) Diphtheria Antitoxin - Safety Issues | Phase 4 | Completed | PT Bio Farma | 68 | 2023-01-31 | 2023-11-18 |
| The Safety of Paxlovid in Hemodialysis Patients With Covid-19 Nirmatrelvir and ritonavir stage 1, Nirmatrelvir and ritonavir stage 2 - Safety Issues | Phase 4 | Completed | RenJi Hospital | 18 | 2022-05-06 | 2022-06-14 |
| COVID-19 CoronaVac in Patients With Autoimmune Rheumatic Diseases and HIV/AIDS CoronaVac - Rheumatic Disease, HIV Infections | Phase 4 | Completed | University of Sao Paulo General Hospital | 2196 | 2021-02-09 | 2024-03-26 |
| Safety of Gebauer's Pain Ease and Gebauer's Ethyl Chloride Gebauer's Pain Ease Top Aerosol Mist Spray, Gebauer's Ethyl Chloride - Spray, Pain | Phase 4 | Completed | Henry Ford Health System | 72 | 2021-01-26 | 2024-03-04 |
| Paracetamol Hypothermia Children Paracetamol - Safety Issues | Phase 4 | Completed | Saint George Hospital | 60 | 2019-07-01 | 2021-03-18 |
| Postoperative Safety Outcomes of Intraoperative Intracameral Preservative-Free Moxifloxacin Versus Levofloxacin Levofloxacin Ophthalmic, Moxifloxacin Ophthalmic - Cataract Senile, Endophthalmitis | Phase 4 | Completed | Peregrine Eye and Laser Institute | 114 | 2018-01-02 | 2020-05-27 |
| Reactogenicity and Protectivity Following Measles- Rubella (MR) Routine Immunization in Indonesian Infants and Children Measles-Rubella (MR) Vaccine - Safety Issues, Immunogenicity | Phase 4 | Completed | PT Bio Farma | 590 | 2017-11-16 | 2019-09-12 |
| Empagliflozin in Renal Transplant Recipients Empagliflozin, Placebo - Diabetes Mellitus, Renal Insufficiency | Phase 4 | Completed | Oslo University Hospital | 49 | 2016-11-07 | 2019-03-15 |
Acquired Immunodeficiency Syndrome (1) · Acute Pain (1) · Agnosia (1) · Arthritis, Rheumatoid (1) · COVID-19 (1) · Diabetes Mellitus (1) · Endophthalmitis (1) · HIV Infections (1) · Lupus Erythematosus, Systemic (1) · Pain (1) · Pain, Postoperative (1) · Postoperative Complications (1) · Renal Insufficiency (1) · Rheumatic Diseases (1)
Infections (2) · Neurologic Manifestations (2) · Pathological Conditions, Signs and Symptoms (2) · Signs and Symptoms (2) · Urogenital Diseases (2) · Arthritis (1) · Autoimmune Diseases (1) · Blood-Borne Infections (1) · Communicable Diseases (1) · Connective Tissue Diseases (1) · Coronaviridae Infections (1) · Coronavirus Infections (1) · Endocrine System Diseases (1) · Eye Diseases (1) · Eye Infections (1)
Acetaminophen (1) · Diphtheria Antitoxin (1) · Ethyl Chloride (1) · Ibuprofen (1) · Vaccines (1) · empagliflozin (1) · enoxaparin sodium (1) · nirmatrelvir (1) · pain ease refrigerant (1) · sinovac COVID-19 vaccine (1)
PT Bio Farma (3) · Henry Ford Health System (1) · Naestved Hospital (1) · Oslo University Hospital (1) · Peregrine Eye and Laser Institute (1) · RenJi Hospital (1) · Saint George Hospital (1) · University of Sao Paulo General Hospital (1)
Indonesia (3) · Brazil (1) · China (1) · Denmark (1) · Lebanon (1) · Norway (1) · Philippines (1) · United States (1)
Bambang Widyantoro, Ph.D (1) · Dominicus Husada, Dr (1) · Dominicus Husada, MD (1) · Harvey S Uy, MD (1) · Leyi Gu (1) · Ole Mathiesen, Professor (1)
PMID 30862658, PMID 32803882, PMID 34331051, PMID 34664616, PMID 34806342, PMID 34894235, PMID 34901885, PMID 34954325, PMID 35135832, PMID 35193873, PMID 35277389, PMID 35306594, PMID 35639644, PMID 35844042, PMID 36150668, PMID 36192386, PMID 36529052, PMID 36870351, PMID 37291679, PMID 42261247
2016 (1)