Health Condition 1: I10- Essential (primary) hypertension Health Condition 2: J09X- Influenza due to identified novelinfluenza A virus Health Condition 3: C509- Malignant neoplasm of breast of unspecified site Health Condition 4: C729- Malignant neoplasm of central nervous system, unspecified Health Condition 5: C399- Malignant neoplasm of lower respiratory tract, part unspecified Health Condition 6: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx Health Condition 7:
Conditions
Interventions
None listed
Sponsors
ACTREC Tata Memorial Centre
Eligibility
Inclusion criteria
Inclusion criteria: 1. Children and adults having an adverse event/s in the past 7 days 2. Having a valid prescription for an approved allopathic drug/s 3. Having adequate documentation of antecedent medical conditions including comorbidities 4. Having adequate documentation of other drugs, including complementary and alternative medicines (CAM), administered in the last one month.
Exclusion criteria
Exclusion criteria: 1. Patients receiving an investigational medicinal product. 2. Patients not willing to give a written informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Concordance, sensitivity, specificity, positive and negative predictive values of the SNG algorithm in Adverse event evaluation when compared with the physicianâ??s opinion on adverse event causality.Timepoint: On the day of enrolment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Sensitivity, specificity, positive and negative predictive values of the adverse event evaluation methods while using SNG, NS and WHO in monotherapy versus polytherapy.Timepoint: On the day of enrolment.;Sensitivity, specificity, positive and negative predictive values of the different causality assessment scales in the causality assessment of adverse events in patients with and without comorbidities when compared against the physicianâ??s opinion.Timepoint: On the day of enrolment.;Sensitivity, specificity, positive and negative predictive values of the SNG algorithm in adverse event evaluation when compared with the assessments by NS and WHO algorithms.Timepoint: On the day of enrolment. | — |
Countries
India
Contacts
Public ContactDr Manjunath Nookala Krishnamurthy
Advanced Centre for Treatment, Research and Education in Cancer, Tata Memorial Centre
Outcome results
None listed