Adverse Reactions definition

Adverse Reactions means any adverse event associated with the use of a drug in humans, whether or not considered drug related, including the following: an adverse event occurring in the course of the use of a drug product in professional practice; an adverse event occurring from drug overdose, whether accidental or intentional; an adverse event occurring from drug abuse; an adverse event occurring from drug withdrawal; and any failure of pharmacological action.

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Adverse Reactions. The most commonly reported (≥25%) adverse reactions are: diarrhea, fatigue, nausea, decreased appetite, PPES, hypertension, vomiting, weight decreased, and constipation. Drug Interactions: ▇▇▇▇▇▇ ▇▇▇▇▇▇ inhibitors and inducers: Reduce the dosage of CABOMETYX if concomitant use with strong CYP3A4 inhibitors cannot be avoided. Increase the dosage of CABOMETYX if concomitant use with strong CYP3A4 inducers cannot be avoided.

Adverse Reactions means the suspected or alleged adverse reactions to the Product.

Examples of Adverse Reactions in a sentence

Pursuant to a sponsor’s safety reporting obligations under 21 CFR 312.32(c)(1), Pfizer will report to the Principal Investigator all Serious Unexpected Suspected Adverse Reactions (“SUSARs”).
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 most commonly reported adverse drug reactions (≥25%) are diarrhea, stomatitis, palmar-plantar erythrodysesthesia syndrome (PPES), decreased weight, decreased appetite, nausea, fatigue, oral pain, hair color changes, dysgeusia, hypertension, abdominal pain, and constipation.
Adverse Reactions: Following an intramuscular injection, it is common for patients to experience injection site pain and swelling.
Vzhľadom na povinnosť zadávateľa podávať správy o bezpečnosti v súlade so smernicou 21 CFR 312.32(c)(1) (Kodifikácia federálnych predpisov Spojených štátov amerických, ďalej “CFR”) spoločnosť Pfizer oznámi hlavnému skúšajúcemu všetky podozrenia na neočakávané závažné nežiaduce reakcie (Serious Unexpected Suspected Adverse Reactions, ďalej „SUSAR“).
V souladu s povinností zadavatele podávat hlášení o bezpečnosti podle 21 CFR 312.32(c)(1) bude společnost Pfizer hlásit hlavnímu zkoušejícímu všechna podezření na závažné neočekávané nežádoucí účinky (Serious Unexpected Suspected Adverse Reactions, „SUSAR“).
The Clinical Centre shall ensure that the Site Principal Investigator and his or her team comply with the requirements on the reporting of Serious Adverse Events and Serious Adverse Reactions described in the Protocol and as may be required under the Medicines for Human Use (Clinical Trials) Regulations 2004 and any subsequent amendments thereof.
Sponsor Ensure that all Suspected Unexpected Serious Adverse Reactions (SUSAR) are identified and fully reported to the regulatory authority and relevant ethics committee within the required timelines.
V souladu s povinností bezpečnostního hlášení zadavatele podle 21 CFR 312.32(c)(1), bude společnost Pfizer hlásit Hlavnímu zkoušejícímu všechna Podezření na závažné neočekávané nežádoucí účinky (Serious Unexpected Suspected Adverse Reactions, „SUSAR“).
Daiichi Sankyo hereby represents and warrants that as of the Effective Date, it is not aware of any Suspected, Unexpected, Serious Adverse Reactions (“SUSARs”) that have not been properly reported to all applicable Regulatory Authorities.

More Definitions of Adverse Reactions

Adverse Reactions. The most commonly reported (≥25%) adverse reactions are: diarrhea, fatigue, nausea, decreased appetite, PPES, Drug Interactions: Strong CYP3A4 inhibitors and inducers: Reduce the dosage of CABOMETYX if concomitant use with strong CYP3A4 inhibitors cannot be avoided. Increase the dosage of CABOMETYX if concomitant use with strong CYP3A4 inducers cannot be avoided. Lactation: Advise a lactating woman not to breastfeed during treatment with CABOMETYX and for 4 months after the final dose. Reproductive Potential: Contraception―Advise females of reproductive potential to use effective contraception during treatment with Hepatic Impairment: Reduce the CABOMETYX dose in patients with mild (Child-▇▇▇▇ score [C-P] A) or moderate (C-P B) hepatic impairment. CABOMETYX is not recommended for use in patients with severe hepatic impairment. About Exelixis Exelixis Forward-Looking Statements

Adverse Reactions means the definitions as set forth in EXHIBIT D.

Adverse Reactions include anaphylaxis and any other adverse reactions, whether foreseeable or not, including, but not limited to: i. Adverse reactions resulting from the administration of the vaccine, vaccine placebo, or other materials involved in the development of the vaccine or crude bulk, including challenge materials, ii. The failure of the vaccine to function as intended or to fail to confer immunity, iii. Side effects or performance of the vaccine in a manner not intended, and iv. Reactions that may be manifested long after exposure to the vaccine, vaccine placebo, or other materials associated with the development or manufacture of the vaccine or crude bulk (including challenge materials), which reactions are directly attributable to or result from the administration of such vaccine, vaccine placebo, or other materials.