Adverse Reactions Sample Clauses

Adverse Reactions. Nmap Technology is not designed to crash systems and should not pose any problems for standards-conformant network equipment. However, some systems, devices, and applications have occasionally been reported to react adversely to port scans, OS detection, service detection probes, and NSE scripts. This is an error in the network device in question, and not in Nmap Technology. Nmap Technology should not be used against mission-critical systems without careful monitoring.
Adverse Reactions. The Company and the Manufacturer shall observe the procedures and notification requirements with respect to Adverse Reactions described in Schedule 7.5 attached hereto.
Adverse Reactions. The adverse drug reaction profiles reported in clinical studies that compared RENFLEXISTM to the reference biologic drug were comparable. The description of adverse reactions in this section is based on clinical experience with the reference biologic drug. 9.1 Adverse Reaction Overview The most common adverse drug reactions reported from both clinical trials and post-marketing reports are infections, allergic reactions and infusion-related reactions. Less common adverse drug reactions from these sources which may be serious and clinically relevant include hepatobiliary events (see WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic), demyelinating disorders (see WARNINGS AND PRECAUTIONS, Neurological Events), and lymphoma (see WARNINGS AND PRECAUTIONS, Carcinogenesis and Mutagenesis). One of the most common reasons for discontinuation of treatment in clinical trials was infusion- related reactions (dyspnea, flushing, headache and rash) (see WARNINGS AND PRECAUTIONS, Hypersensitivity Reaction). Adverse events have been reported in a higher proportion of rheumatoid arthritis patients receiving the 10 mg/kg dose than the 3 mg/kg dose, however, no differences were observed in the frequency of adverse events between the 5 mg/kg dose and the 10 mg/kg dose in patients with Crohn’s disease or ulcerative colitis and between the 3 mg/kg and 5 mg/kg dose in patients with plaque psoriasis. 9.2 Clinical Trial Adverse Reactions Because clinical trials are conducted under very specific conditions, the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. Description of Data SourcesThe data described herein reflect the exposure infliximab for injection in 5561 patients in adequate and well-controlled studies. Infliximab for injection was studied in patients with rheumatoid arthritis (1304 patients exposed), juvenile rheumatoid arthritis (117 patients exposed), Crohn’s disease (1566 patients exposed, including 1427 adult and 139 pediatric patients), ulcerative colitis (544 patients exposed, including 484 adults and 60 children), plaque psoriasis (1373 patients exposed), psoriatic arthritis (293 patients exposed), ankylosing spondylitis (347 patients exposed) and other conditions (17 patients exposed), primarily in d...
Adverse Reactions. Sponsor agrees that HCRI is not responsible for the costs of diagnosis, care and treatment of any undesirable side effects, adverse reactions, illness or injury to a participant in the Trial which result from participation in the Trial, except to the extent such costs arise directly from HCRI’s gross negligence or reckless or intentional misconduct. This section is not intended to create any third-party contractual benefit for any participants or Clinical Sites in the Trial.
Adverse Reactions. Abrupt reversal of opioid effects in persons who are physically dependent on opioids may precipitate an acute opioid withdrawal syndrome. The acute opioid withdrawal syndrome may include: body aches, fever, sweating, runny nose, sneezing, piloerection, yawning, weakness, shivering or trembling, nervousness, restlessness or irritability, diarrhea, nausea or vomiting, abdominal cramps, increased blood pressure, tachycardia. A patient who develops a suspected adverse reaction to naloxone should call the pharmacy to report it. Pharmacists can recommend symptom management of the reaction, and/or patient referral. Development of life‐threatening symptoms should be immediately referred to the closest emergency room or urgent care clinic. Pharmacists should then report the adverse reaction to the FDA at MedWatch, found online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch‐online.htm or 1‐800‐FDA‐1088. Patients can also report suspected adverse drug reactions directly to the FDA at MedWatch.
Adverse Reactions. In CA209001 (n = 39), in which subjects received a single dose of Nivolumab (BMS- 936558) with possible retreatment at 3 months, the most frequent AEs were fatigue (56%), nausea (44%), proteinuria (38%), constipation (33%), back pain (33%), dry mouth (28%), vomiting (28%), rash (26%), and dyspnea (26%). There was no clear or consistent relationship between the incidence or severity of AEs and the Nivolumab (BMS-936558) dose level (0.3, 1, 3, or 10 mg/kg IV single dose, with possible retreatment at 3 months). Of 39 (100%) subjects who had at least one AE, 32 (82%) had Grade 3 or 4 AEs regardless of causality. Three treatment-related SAEs were reported: hypothyroidism (Grade 2), colitis (Grade 3), and anemia (Grade 2). Among 12 deaths, none were considered drug-related.In CA209003 (n = 296), as of the database lock date of 24-Feb-2012, BMS-936558- related AEs of any grade occurred in 70% of subjects. The most frequent drug-related AEs occurring in ≥5% of subjects included fatigue (24%), rash (12%), diarrhea (11%), pruritus (10%), nausea (8%), decreased appetite (8%), hemoglobin decreased (6%) and pyrexia (5%). The majority of events were low grade, with Grade 3/4 drug-related AEs observed in 14% of subjects. The most common Grade 3/4 drug-related AEs occurring in≥1% of subjects were fatigue (2%), pneumonitis (1%), hypoxia (1%), diarrhea (1%), colitis (1%), abdominal pain (1%), AST/ALT increased (1% each), blood alkaline phosphatase increased (1%), lipase increased (1%), pneumonia (1%), hypophosphatemia (1%), and lymphopenia (1%). Drug-related serious AEs (SAEs) occurred in 11% of subjects. Grade 3/4 drug-related SAEs occurring in ≥1% of subjects were: pneumonitis (1%), pneumonia (1%), lipase increased (1%), and diarrhea (1%). The spectrum, frequency, and severity of BMS-936558-related AEs were generally similar across dose levels and histological subtypes. Other drug-related AEs included vitiligo, hepatitis, hypophysitis, and thyroiditis. Hepatic or gastrointestinal events were managed with treatment interruption and administration of corticosteroids, and were generally completely reversible. Endocrine events were managed with replacement therapy. Several subjects in these categories successfully reinitiated treatment with BMS-936558. Drug-related pneumonitis occurred in 3% of subjects; Grade ≥3 pneumonitis developed in 3 subjects (1%). No clear relationship between the occurrence of pneumonitis and tumor type, dose level, or the number of doses received was...
Adverse Reactions. Each party shall be responsible for maintaining such records and making such reports as may be required in connection with any regulatory approval held by the party. Each party shall immediately inform the other of all adverse drug experience reports and other information relating to the safety or effectiveness of Product which come to its attention.
Adverse Reactions. Roche shall be responsible for reporting to the appropriate regulatory authorities all adverse events related to the use of Product worldwide, except that prior to the time Gilead transfers ownership of the IND to Roche as provided in Section 3.2(b), Gilead shall be responsible for the reporting of such adverse events in the U.S. Adverse events related to the use of Product worldwide shall be recorded in a single database, and the parties will coordinate their efforts to assure that all adverse events are reported properly.
Adverse Reactions. 6.1 Both Parties shall co-operate with one another and share information concerning the safety and efficacy of the Products and other information that may affect the use, sale and marketing of the Products.
Adverse Reactions. THERAPEUTICS shall be responsible for reporting to the appropriate regulatory authorities any and all adverse events related to the use of any Category I and Category II SDC Product(s), while INNOVATIVE shall bear said responsibility for all Category III SDC Product(s). Adverse events related to the use of any SDC Product(s) shall be recorded in a single database, maintained by THERAPEUTICS and the Parties will coordinate their efforts to assure that all adverse events are properly reported INNOVATIVE will report all adverse events to THERAPEUTICS within 5 days of notification regardless of the Category of the Product. In the event of termination or breach, or for any other reason THERAPEUTICS transfers its ownership of any Regulatory Filings for any SDC Product(s) to INNOVATIVE, INNOVATIVE shall assume and become responsible for the reporting of adverse events for any Category I and Category II SDC Product(s).